August 2010, Vol 3, No 5

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AUGUST 2010

www.TheOncologyNurse.com

VOL 3, NO 5

BREAST CANCER CANCER CENTER PROFILE

Albert Einstein Cancer Center Joins the NCCCP

By Dawn Lagrosa

Physicians, Patients React to FDA Committee Vote against Bevacizumab in Breast Cancer

By Caroline Helwick

B

evacizumab (Avastin, Genentech) has been a popular first-line treatment for metastatic breast cancer since 2008, when the US Food and Drug Administration (FDA) granted special, fast-track approval for use in combination with paclitaxel. The accelerated approval was based on positive early findings from the E2100 trial, which showed that the addition of bevacizumab added 5.5 months of progression-free survival (PFS) over paclitaxel alone. But two additional trials—AVADO and RIBBON 1—failed to confirm this magnitude of benefit, and

on July 21, 2010, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 1 to withdraw approval for the advanced breast cancer indication.

Should the FDA accept the panel’s recommendation on September 17, one oncologist who will mourn the loss of bevacizumab is Steven Vogl, MD, of Bronx, New York.

“I give the majority of my advanced breast cancer patients bevacizumab with a taxane, usually weekly paclitaxel, and my experience has tended to be more like that in E2100,” he said, referring to a Continued on page 38

Left to right: Tiffany Raroha, MSW; William J. Tester, MD, FACP; Lisa Jablon, MD, FACS; and Lawrence J. Solin, MD, FACR, FASTRO.

his past April, Albert Einstein Cancer Center was selected to join the National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP), which, in the words of William J. Tester, MD, FACP, medical director of Einstein’s Cancer Center, offers “an opportunity to bring more resources to our patients.”

NCCCP is designed to create new research opportunities across the cancer care continuum from screening and treatment to followup and survivorship care. NCCCP cancer centers are also tasked to reduce healthcare disparities and improve the quality of care at community hospitals.

T

Reducing disparities With its mission of delivering high-quality care, Albert Einstein Cancer Center (Einstein) has already been working to overcome those barriers that contribute to healthcare disparities. Located in north Philadelphia, Einstein serves a diverse population that includes large African-American, Hispanic, and Asian subpopulations. In this urban setting, Einstein delivers care to patients from multiple socioeconomContinued on page 16

NURSING PRACTICE

Averting the Perfect Storm: Creating a Healthy Work Environment

By Mary M. Gullatte, PhD, RN, APRN, BC, AOCN Emory University Hospital Midtown, Atlanta, Georgia

A

healthy work environment is one in which people are valued and priority is given to the multiple aspects of the workplace that affect employees’ ability to function well in order to accomplish the goals of the organization.1 Since its early days, nursing has been a profession of service in a high-stress, ever-changing healthcare environment, often without appropriate thanks, reward, recognition, or appreci-

ation. The psychological implication of these phenomena has garnered the interest of researchers over the past two decades. Concern about a high-stress work environment amidst a global nursing shortage leading to nurse burnout and increasing turnover in the workplace has seeded studies exploring psychological demands, social support, work complexity, inadequate staffing, workload imbalance, job strain, and Continued on page 8

Journal of Oncology

NAVIGATION & SURVIVORSHIP

™

The Official Journal of the Academy of Oncology Nurse Navigators ® AUGUST 2010

www.AONNonline.org

VOL 1, NO 3

GETTING STARTED

Launching the Navigation Program that is Best for You. Part 1: Defining your Program Leadership Council Lillie Shockney, RN, BS, MAS Johns Hopkins Breast Center Johns Hopkins University School of Medicine Baltimore, Maryland Sharon Gentry, RN, MSN, AOCN, CBCN Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, North Carolina Nicole Messier, RN Vermont Cancer Center Burlington, Vermont Pamela Matten, RN, BSN, OCN St. Joseph Hospital Orange, California Elaine Sein, RN, BSN, OCN, CBCN Fox Chase Cancer Center Partners Rockledge, Pennsylvania Tricia Strusowski MS, RN Helen F. Graham Cancer Center Christiana Care Health System Newark, Delaware Linda Fleisher, MPH, PhD(c) Fox Chase Cancer Center Cheltenham, Pennsylvania Susan M. Gardner, RN, CBEC, CBCN Valley Medical Center Renton, Washington Jay R. Swanson, RN, BSN, OCN Saint Elizabeth Cancer Institute Lincoln, Nebraska Carol Lewis, RN, BSN, OCN, CRNI Memorial Hermann The Woodlands, Texas

By Dawn Lagrosa CHICAGO—For those involved in Multiple strategies to successful navnavigation, or those who have looked igation programs were presented by a into starting navigation programs, one panel of nurses and administrators at the thing is evident: No two programs are third annual Oncology Update of the exactly the same. However, the advan- American College of Oncology tages of patient navigation can be had Administrators. by all—academic centers, “Navigation is even a buzzcommunity cancer cenword in our Capitol,” said ters, hospital-based cenBonnie Miller, RN, BSN, OCN, ters, multiple location who chaired the panel. Miller, groups. Despite the various who is administrative director of models of navigation, the the Women’s Cancer Center at goal remains the same, to Fox Chase, Philadelphia, noted help healthcare consumers that recent legislation has paved access and chart a course the road for navigation. through the healthcare The Patient Navigator, OutBonnie Miller, RN, system and overcome barreach, and Chronic Disease PreBSN, OCN riers to quality care. vention Act of 2005 identified,

from a legislative point of view, what navigators should do: • Anticipate, identify, and help patients overcome barriers within healthcare systems • Assist in coordination of healthcare services and referrals • Help and facilitate involvement of community organizations • Assist individuals at risk for either cancer or other chronic disease.

“Those of you who are navigators, if you look at your job descriptions, some of those things are a part of it,” said Miller. But each program is different, as is each navigator. “Before you implement a navigation program, remember Continued on page 2

CARE PLANS

Oncology Nurses Need More Training for Survivorship Planning

By Jill Stein SAN DIEGO—New survey results indicate that although most oncology nurses believe that survivorship planning for cancer patients is their responsibility, often they do not consider themselves sufficiently prepared to knowledgeably discuss survivorship issues with patients and their families.

The findings were reported at the

35th Annual Congress of the Oncology Nursing Society.

Joanne Lester, PhD, CRNP, ANPBC, AOCN, research scientist/nurse practitioner at James Cancer Hospital in Columbus, Ohio, presented the results of an online survey that assessed oncology nurses’ knowledge about survivorship care planning.

“Survivorship planning is a relatively new component of the overall management of cancer patients,” Lester, who is also clinical assistant professor at Ohio State University College of Nursing, pointed out.

In recent years, the Institute of Medicine has called on healthcare proContinued on page 3

AONN Staff Sean T. Walsh Executive Director sean@aonnonline.org

Journal of Oncology Navigation & Survivorship™

Y DA 0 R TO20 TE E $ GIS AV RE & S

First Annual Navigation and Survivorship Conference

September 17-19, 2010 • Baltimore, Maryland www.AONNonline. org ©2010 Green Hill Healthcare Communications, LLC

between pages 20 and 21

Inside

COMPLIMENTARY

CE CREDIT

ASCO: Supportive Care New Exercise Guidelines Issued for Cancer Patients Based on a presentation

by Kathryn Schmitz, PhD, MPH

Conference News ONS: Preventing Falls

Page 19

Page 22

Oncologic Emergencies Associated with Lung Cancer Page 12

©2010 Green Hill Healthcare Communications, LLC

Fostering a Dialogue to Improve Patient Care & Outcomes

Submit your cases online today at www.myelomacases.com

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When treating patients with HER2+ breast cancer

No one touches their HER2-positive status is associated with more aggressive disease and poorer outcomes than HER2-negative breast cancer. Women who received 1 year of Herceptin had a lower risk of HER2+ breast cancer returning.

We applaud you for playing such a critical role in helping patients with HER2+ breast cancer complete the full course of treatment with Herceptin.

Adjuvant indications Herceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer: s As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel s With docetaxel and carboplatin s As a single agent following multi-modality anthracyclinebased therapy *High-risk features for patients with ER/PR+ breast cancer include: tumor size >2 cm, age <35 years, and histologic and/or nuclear grade 2/3.

Metastatic indications Herceptin is indicated: s In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer s As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease Š2009 Genentech USA

Boxed WARNINGS and Additional Important Safety Information Herceptin administration can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure (CHF) and decreased left ventricular ejection fraction (LVEF). The incidence and severity of left ventricular cardiac dysfunction was highest in patients who received Herceptin concurrently with anthracyclinecontaining chemotherapy regimens. Discontinue Herceptin treatment in patients receiving adjuvant therapy and strongly consider discontinuation of Herceptin in patients with metastatic breast cancer who develop a clinically significant decrease in left ventricular function.

Patients should undergo monitoring for decreased left ventricular function before Herceptin treatment, and frequently during and after Herceptin treatment. More frequent monitoring should be employed if Herceptin is

So. San Francisco, CA

All rights reserved.

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lives like you

withheld in patients who develop significant left ventricular cardiac dysfunction. In one adjuvant clinical trial, cardiac ischemia or infarction occurred in the Herceptin-containing regimens.

Serious infusion reactions and pulmonary toxicity have occurred; fatal infusion reactions have been reported. In most cases, symptoms occurred during or within 24 hours of administration of Herceptin. Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Exacerbation of chemotherapy-induced neutropenia has also occurred. Herceptin can cause oligohydramnios and fetal harm

9568900

01/09

when administered to a pregnant woman.

The most common adverse reactions associated with Herceptin use were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.

Please see brief summary of full Prescribing Information, including Boxed WARNINGS and additional important safety information, on the following pages.

www.herceptin.com

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HERCEPTIN® (trastuzumab) Brief Summary For full Prescribing Information, see package insert.

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, and PULMONARY TOXICITY Cardiomyopathy Herceptin can result in sub-clinical and clinical cardiac failure manifesting as CHF and decreased LVEF. The incidence and severity of left ventricular cardiac dysfunction was highest in patients who received Herceptin concurrently with anthracycline-containing chemotherapy regimens.

Evaluate left ventricular function in all patients prior to and during treatment with Herceptin. Discontinue Herceptin treatment in patients receiving adjuvant therapy and strongly consider discontinuation of Herceptin treatment in patients with metastatic breast cancer for clinically significant decrease in left ventricular function. [see Warnings and Precautions and Dosage and Administration] Infusion Reactions; Pulmonary Toxicity Herceptin administration can result in serious infusion reactions and pulmonary toxicity. Fatal infusion reactions have been reported. In most cases, symptoms occurred during or within 24 hours of administration of Herceptin.

Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension.

Patients should be monitored until signs and symptoms completely resolve. Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. [see Warnings and Precautions] INDICATIONS AND USAGE Adjuvant Breast Cancer Herceptin is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies]) breast cancer • as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel • with docetaxel and carboplatin • as a single agent following multimodality anthracycline based therapy. Metastatic Breast Cancer Herceptin is indicated: • In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer • As a single agent for treatment of HER2overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.

CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Cardiomyopathy Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death [see Boxed Warning: Cardiomyopathy ]. Herceptin can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). There is a 4–6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving Herceptin as a single agent or in combination therapy compared with those not receiving Herceptin. The highest absolute incidence occurs when Herceptin is administered with an anthracycline. Withhold Herceptin for 16% absolute decrease in LVEF from pre-treatment values or an LVEF value below institutional limits of normal and 10% absolute decrease in LVEF from pretreatment values. [see Dosage and Administration] The safety of continuation or resumption of Herceptin in patients with Herceptin-induced left ventricular cardiac dysfunction has not been studied. Cardiac Monitoring Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended: • Baseline LVEF measurement immediately prior to initiation of Herceptin • LVEF measurements every 3 months during and upon completion of Herceptin • Repeat LVEF measurement at 4 week intervals if Herceptin is withheld for significant left ventricular cardiac dysfunction [see Dosage and Administration] • LVEF measurements every 6 months for at least 2 years following completion of Herceptin as a component of adjuvant therapy. In Study 1, 16% (136/844) of patients discontinued Herceptin due to clinical evidence of myocardial dysfunction or significant decline in LVEF. In Study 3, the number of patients who discontinued Herceptin due to cardiac toxicity was 2.6% (44/1678). In Study 4, a total of 2.9% (31/1056) patients in the TCH arm (1.5% during the chemotherapy phase and 1.4% during the monotherapy phase) and 5.7% (61/1068) patients in the AC-TH arm (1.5% during the chemotherapy phase and 4.2% during the monotherapy phase) discontinued Herceptin due to cardiac toxicity. Among 32 patients receiving adjuvant chemotherapy (Studies 1 and 2) who developed congestive heart failure, one patient died of cardiomyopathy and all other patients were receiving cardiac medication at last follow-up. Approximately half of the surviving patients had recovery to a normal LVEF (defined as 50%) on continuing medical management at the time of last follow-up. Incidence of congestive heart failure is presented in Table 1. The safety of continuation or resumption of Herceptin in patients with Herceptin-induced left ventricular cardiac dysfunction has not been studied.

Table 1 Incidence of Congestive Heart Failure in Adjuvant Breast Cancer Studies Study 1 & 2a 3 4 4 a

Regimen ACb Paclitaxel+ Herceptin Chemo Herceptin ACb Docetaxel+ Herceptin Docetaxel+Carbo+ Herceptin

Incidence of CHF Herceptin Control 2% (32/1677) 2% (30/1678)

0.4% (7/1600) 0.3% (5/1708)

2% (20/1068)

0.3% (3/1050)

0.4% (4/1056)

0.3% (3/1050)

Includes 1 patient with fatal cardiomyopathy. b Anthracycline (doxorubicin) and cyclophosphamide

Table 2 Incidence of Cardiac Dysfunctiona in Metastatic Breast Cancer Studies

Study 5 (AC)b 5 (paclitaxel)

Incidence NYHA I-IV NYHA III-IV Herceptin Control Herceptin Control

Event Cardiac 28% 7% 19% 3% Dysfunction Cardiac 11% 1% 4% 1% Dysfunction Cardiac 6 7% N/A 5% N/A Dysfunctionc a Congestive heart failure or significant asymptomatic decrease in LVEF. b Anthracycline (doxorubicin or epirubicin) and cyclophosphamide c Includes 1 patient with fatal cardiomyopathy.

Infusion Reactions Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia. [see Adverse Reactions]. In postmarketing reports, serious and fatal infusion reactions have been reported. Severe reactions which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension, were usually reported during or immediately following the initial infusion. However, the onset and clinical course were variable including progressive worsening, initial improvement followed by clinical deterioration, or delayed post-infusion events with rapid clinical deterioration.

For fatal events, death occurred within hours to days following a serious infusion reaction. Interrupt Herceptin infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered, which may include: epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen. Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. Permanent discontinuation should be strongly considered in all patients with severe infusion reactions.

There are no data regarding the most appropriate method of identification of patients who may safely be retreated with Herceptin after experiencing a severe infusion reaction. Prior to resumption of Herceptin infusion, the majority of patients who experienced a severe infusion reaction were pre-medicated with antihistamines and/or corticosteroids. While some patients tolerated Herceptin infusions, others had recurrent severe infusion reactions despite pre-medications. Exacerbation of Chemotherapy-Induced Neutropenia In randomized, controlled clinical trials in women with metastatic breast cancer, the perpatient incidences of NCI CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving Herceptin in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was not significantly increased. [see Adverse Reactions]. Pulmonary Toxicity Herceptin use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions [see Warnings and Precautions (5.2)].

Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity. HER2 Testing Detection of HER2 protein overexpression is necessary for selection of patients appropriate for Herceptin therapy because these are the only patients studied and for whom benefit has been shown. Assessment for HER2 overexpression and of HER2 gene amplification should be performed by laboratories with demonstrated proficiency in the specific technology being utilized. Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results. Several FDA-approved commercial assays are available to aid in the selection of patients for Herceptin therapy. These include HercepTestTM and Pathway® HER-2/neu (IHC assays) and PathVysion® and HER2 FISH pharmDxTM (FISH assays).

Users should refer to the package inserts of specific assay kits for information on the validation and performance of each assay.

Limitations in assay precision (particularly for the IHC method) and in the direct linkage between assay result and overexpression of the Herceptin target (for the FISH method) make it inadvisable to rely on a single method to rule out potential Herceptin benefit. A negative FISH result does not rule out HER2 overexpression and potential benefit from Herceptin.

Treatment outcomes for metastatic breast cancer (Study 5) as a function of IHC and FISH testing are provided in Table 9.

Treatment outcomes for adjuvant breast cancer (Studies 2 and 3) as a function of IHC and FISH testing are provided in Table 7.

HER2 Protein Overexpression Detection Methods HER2 protein overexpression can be established by measuring HER2 protein using an IHC method. HercepTest®, one test approved for this use, was assessed for concordance with the Clinical Trial Assay (CTA), using tumor specimens collected and stored independently from those obtained in Herceptin clinical studies in women with metastatic breast cancer. Data are provided in the package insert for HercepTest®. HER2 Gene Amplification Detection Method The presence of HER2 protein overexpression and gene amplification are highly correlated, therefore the use of FISH to detect gene amplification may be employed for selection of patients appropriate for Herceptin therapy.

PathVysion®, one test approved for this use, was evaluated in an exploratory, retrospective assessment of available CTA 2+ or 3+ tumor specimens collected as part of patient screening for clinical studies in metastatic breast cancer (Studies 5 and 6).

Data are provided in the package insert for PathVysion®.

Embryo-Fetal Toxicity (Pregnancy Category D) Herceptin can cause fetal harm when administered to a pregnant woman. Postmarketing case reports suggest that Herceptin use during pregnancy increases the risk of oligohydramnios during the second and third trimesters. If Herceptin is used during pregnancy or if a woman becomes pregnant while taking Herceptin, she should be apprised of the potential hazard to a

fetus. [see Use in Specific Populations]. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Cardiomyopathy [see Warnings and Precautions] • Infusion reactions [see Warnings and Precautions] • Exacerbation of chemotherapy-induced neutropenia [see Warnings and Precautions] • Pulmonary toxicity [see Warnings and Precautions] The most common adverse reactions in patients receiving Herceptin are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Adverse reactions requiring interruption or discontinuation of Herceptin treatment include CHF, significant decline in left ventricular cardiac function, severe infusion reactions, and pulmonary toxicity [see Dosage and Administration]. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adjuvant Breast Cancer Studies The data below reflect exposure to Herceptin across three randomized, open-label studies, Studies 1, 2, and 3, with (n= 3355) or without (n= 3308) trastuzumab in the adjuvant treatment of breast cancer. The data summarized in Table 3 below, from Study 3, reflect exposure to Herceptin in 1678 patients; the median treatment duration was 51 weeks and median number of infusions was 18. Among the 3386 patients enrolled in Study 3, the median age was 49 years (range: 21 to 80 years), 83% of patients were Caucasian, and 13% were Asian.

Table 3 Adverse Reactions for Study 3, All Gradesa: MedDRA (v. 7.1) 1 Year Herceptin Adverse Event Preferred Term (n= 1678) Cardiac Hypertension 64 (4%) Dizziness 60 (4%) Ejection Fraction Decreased 58 (3.5%) Palpitations 48 (3%) Cardiac Arrhythmiasb 40 (3%) Cardiac Failure Congestive 30 (2%) Cardiac Failure 9 (0.5%) Cardiac Disorder 5 (0.3%) Ventricular Dysfunction 4 (0.2%) Respiratory Thoracic Mediastinal Disorders Nasopharyngitis 135 (8%) Cough 81 (5%) Influenza 70 (4%) Dyspnea 57 (3%) URI 46 (3%) Rhinitis 36 (2%) Pharyngolaryngeal Pain 32 (2%) Sinusitis 26 (2%) Epistaxis 25 (2%) Pulmonary Hypertension 4 (0.2%) Interstitial Pneumonitis 4 (0.2%) Gastrointestinal Disorders Diarrhea 123 (7%) Nausea 108 (6%) Vomiting 58 (3.5%) Constipation 33 (2%) Dyspepsia 30 (2%) Upper Abdominal Pain 29 (2%) Musculoskeletal & Connective Tissue Disorders Arthralgia 137 (8%) Back Pain 91 (5%) Myalgia 63 (4%) Bone Pain 49 (3%) Muscle Spasm 46 (3%) Nervous System Disorders Headache 162 (10%) Paraesthesia 29 (2%) Skin & Subcutaneous Tissue Disorders Rash 70 (4%) Nail Disorders 43 (2%) Pruritis 40 (2%) General Disorders Pyrexia 100 (6%) Edema Peripheral 79 (5%) Chills 85 (5%) Aesthenia 75 (4.5%) Influenza-like Illness 40 (2%) Sudden Death 1 (.06%) Infections Nasopharyngitis 135 (8%) UTI 39 (3%) Immune System Disorders Hypersensitivity 10 (0.6%) Autoimmune Thyroiditis 4 (0.3%)

Observation (n= 1708) 35 (2%) 29 (2%) 11 (0.6%) 12 (0.7%) 17 (1%) 5 (0.3%) 4 (0.2%) 0 (0%) 0 (0%) 43 (3%) 34 (2%) 9 (0.5%) 26 (2%) 20 (1%) 6 (0.4%) 8 (0.5%) 5 (0.3%) 1 (0.06%) 0 (0%) 0 (0%) 16 (1%) 19 (1%) 10 (0.6%) 17 (1%) 9 (0.5%) 15 (1%) 98 (6%) 58 (3%) 17 (1%) 26 (2%) 3 (0.2%) 49 (3%) 11 (0.6%) 10 (.6%) 0 (0%) 10 (0.6%) 6 (0.4%) 37 (2%) 0 (0%) 30 (2%) 3 (0.2%) 0 (0%) 43 (3%) 13 (0.8%) 1 (0.06%) 0 (0%)

a The incidence of Grade 3/4 adverse reactions was <1% in both arms for each listed term. b Higher level grouping term.

The data from Studies 1 and 2 were obtained from 3206 patients enrolled, of which 1635 patients received Herceptin; the median treatment duration was 50 weeks. The median age was 49.0 years (range: 24-80); 84% of patients were White, and 7% were Black, 4% were Hispanic, and 4% were Asian. In Study 1, only Grade 3-5 adverse events, treatment-related Grade 2 events, and Grade 2-5 dyspnea were collected during and for up to 3 months following protocol-specified treatment. The following noncardiac adverse reactions of Grade 2-5 occurred at an incidence of at least 2% greater among patients randomized to Herceptin plus chemotherapy as compared to chemotherapy alone: arthralgia (31% vs. 28%), fatigue (28% vs. 22%), infection (22% vs. 14%), hot flashes (17% vs. 15%), anemia (13% vs. 7%), dyspnea (12% vs. 4%), rash/desquamation (11% vs. 7%), neutropenia (7% vs. 5%), headache (6% vs. 4%), and insomnia (3.7% vs. 1.5%). The majority of these events were Grade 2 in severity. In Study 2, data collection was limited to the following investigator-attributed treatment-related adverse reactions NCICTC Grade 4 and 5 hematologic toxicities, Grade 3–5 nonhematologic toxicities, selected Grade 2–5 toxicities associated with taxanes (myalgia, arthralgias, nail changes, motor neuropathy, sensory neuropathy) and Grade 1–5 cardiac toxicities occurring during chemotherapy and/or Herceptin treatment. The following non-cardiac adverse reactions of

Grade 2–5 occurred at an incidence of at least 2% greater among patients randomized to Herceptin plus chemotherapy as compared to chemotherapy alone: arthralgia (11% vs. 8.4%), myalgia (10% vs. 8%), nail changes (9% vs. 7%), and dyspnea (2.5% vs. 0.1%). The majority of these events were Grade 2 in severity. Safety data from Study 4 reflect exposure to Herceptin as part of an adjuvant treatment regimen from 2124 patients receiving at least one dose of study treatment [AC-TH: n = 1068; TCH: n = 1056]. The overall median treatment duration was 54 weeks in both the AC-TH and TCH arms. The median number of infusions was 26 in the AC-TH arm and 30 in the TCH arm, including weekly infusions during the chemotherapy phase and every three week dosing in the monotherapy period. Among these patients, the median age was 49 years (range 22 to 74 years). In Study 4, the toxicity profile was similar to that reported in Studies 1, 2, and 3 with the exception of a low incidence of CHF in the TCH arm. Metastatic Breast Cancer Studies The data below reflect exposure to Herceptin in one randomized, openlabel study, Study 5, of chemotherapy with (n=235) or without (n=234) trastuzumab in patients with metastatic breast cancer, and one single-arm study (Study 6; n=222) in patients with metastatic breast cancer. Data in Table 5 are based on Studies 5 and 6. Among the 464 patients treated in Study 5, the median age was 52 years (range: 25–77 years). Eighty-nine percent were White, 5% Black, 1% Asian and 5% other racial/ethnic groups.

All patients received 4 mg/kg initial dose of Herceptin followed by 2 mg/kg weekly. The percentages of patients who received Herceptin treatment for 6 months and 12 months were 58% and 9%, respectively. Among the 352 patients treated in single agent studies (213 patients from Study 6), the median age was 50 years (range 28–86 years), 100% had breast cancer, 86% were White, 3% were Black, 3% were Asian, and 8% in other racial/ ethnic groups. Most of the patients received 4 mg/kg initial dose of Herceptin followed by 2 mg/kg weekly. The percentages of patients who received Herceptin treatment for 6 months and 12 months were 31% and 16%, respectively.

Table 4 Per-Patient Incidence of Adverse Reactions Occurring in 5% of Patients in Uncontrolled Studies or at Increased Incidence in the Herceptin Arm (Studies 5 and 6) (Percent of Patients) Herceptin Single + Paclitaxel Herceptin ACb a Agent Paclitaxel Alone + ACb Alone n = 352 n = 91 n = 95 n = 143 n = 135 Body as a Whole Pain 47 61 62 57 42 Asthenia 42 62 57 54 55 Fever 36 49 23 56 34 Chills 32 41 4 35 11 Headache 26 36 28 44 31 Abdominal pain 22 34 22 23 18 Back pain 22 34 30 27 15 Infection 20 47 27 47 31 Flu syndrome 10 12 5 12 6 Accidental injury 6 13 3 9 4 Allergic reaction 3 8 2 4 2 Cardiovascular Tachycardia 5 12 4 10 5 Congestive 7 11 1 28 7 heart failure Digestive Nausea 33 51 9 76 77 Diarrhea 25 45 29 45 26 Vomiting 23 37 28 53 49 Nausea and 8 14 11 18 9 vomiting Anorexia 14 24 16 31 26 Heme & Lymphatic Anemia 4 14 9 36 26 Leukopenia 3 24 17 52 34 Metabolic Peripheral edema 10 22 20 20 17 Edema 8 10 8 11 5 Musculoskeletal Bone pain 7 24 18 7 7 Arthralgia 6 37 21 8 9 Nervous Insomnia 14 25 13 29 15 Dizziness 13 22 24 24 18 Paresthesia 9 48 39 17 11 Depression 6 12 13 20 12 Peripheral neuritis 2 23 16 2 2 Neuropathy 1 13 5 4 4 Respiratory Cough increased 26 41 22 43 29 Dyspnea 22 27 26 42 25 Rhinitis 14 22 5 22 16 Pharyngitis 12 22 14 30 18 Sinusitis 9 21 7 13 6 Skin Rash 18 38 18 27 17 Herpes simplex 2 12 3 7 9 Acne 2 11 3 3 <1 Urogenital Urinary tract 5 18 14 13 7 infection a Data for Herceptin single agent were from 4 studies, including 213 patients from Study 6. b Anthracycline (doxorubicin or epirubicin) and cyclophosphamide The following subsections provide additional detail regarding adverse reactions observed in clinical trials of adjuvant breast, metastatic breast cancer, or post-marketing experience.

Cardiomyopathy Serial measurement of cardiac function (LVEF) was obtained in clinical trials in the adjuvant treatment of breast cancer. In Study 3, the median duration of follow-up was 12.6 months (12.4 months in the observation arm; 12.6 months in the 1-year Herceptin arm); and in Studies 1 and 2, 23 months in

TON_August 2010_FINAL_TON 8/10/10 2:45 PM Page 3

the AC-T arm, 24 months in the AC-TH arm. In Studies 1 and 2, 6% of patients were not permitted to initiate Herceptin following completion of AC chemotherapy due to cardiac dysfunction (LVEF <50% or 15 point decline in LVEF from baseline to end of AC). Following initiation of Herceptin therapy, the incidence of new-onset dose-limiting myocardial dysfunction was higher among patients receiving Herceptin and paclitaxel as compared to those receiving paclitaxel alone in Studies 1 and 2, and in patients receiving Herceptin monotherapy compared to observation in Study 3 (see Table 5, Figures 1 and 2).

Table 5a Per-patient Incidence of New Onset Myocardial Dysfunction (by LVEF) Studies 1, 2, 3 and 4 LVEF <50% and Absolute Decrease from Baseline

Studies 1 & 2b AC TH (n=1606) AC T (n=1488) Study 3 Herceptin (n=1678) Observation (n=1708) Study 4c TCH (n=1056) AC TH (n=1068) AC T (n=1050)

LVEF ≥10% ≥16% <50% decrease decrease

Absolute LVEF Decrease <20% and ≥10% ≥20%

22.8% 18.3% (366) (294) 9.1% 5.4% (136) (81)

11.7% (188) 2.2% (33)

33.4% (536) 18.3% (272)

9.2% (148) 2.4% (36)

8.6% (144) 2.7% (46)

7.0% (118) 2.0% (35)

3.8% (64) 1.2% (20)

22.4% (376) 11.9% (204)

3.5% (59) 1.2% (21)

8.5% (90) 17% (182) 9.5% (100)

5.9% (62) 13.3% (142) 6.6% (69)

3.3% (35) 9.8% (105) 3.3% (35)

34.5% (364) 44.3% (473) 34% (357)

6.3% (67) 13.2% (141) 5.5% (58)

a For Studies 1, 2 and 3, events are counted from the beginning of Herceptin treatment. For Study 4, events are counted from the date of randomization. b Studies 1 and 2 regimens: doxorubicin and cyclophosphamide followed by paclitaxel (AC T) or paclitaxel plus Herceptin (AC TH) c Study 4 regimens: doxorubicin and cyclophosphamide followed by docetaxel (AC T) or docetaxel plus Herceptin (AC TH); docetaxel and carboplatin plus Herceptin (TCH)

Figure 1 Studies 1 and 2: Cumulative Incidence of Time to First LVEF Decline of 10 Percentage Points from Baseline and to Below 50% with Death as a Competing Risk Event

Time 0 is initiation of paclitaxel or Herceptin + paclitaxel therapy.

Figure 2 Study 3: Cumulative Incidence of Time to First LVEF Decline of 10 Percentage Points from Baseline and to Below 50% with Death as a Competing Risk Event

Time 0 is the date of randomization.

Figure 3 Study 4: Cumulative Incidence of Time to First LVEF Decline of 10 Percentage Points from Baseline and to Below 50% with Death as a Competing Risk Event

Time 0 is the date of randomization.

The incidence of treatment emergent congestive heart failure among patients in the metastatic breast cancer trials was classified for severity using the New York Heart Association classification system (I–IV, where IV is the most severe level of cardiac failure) (see Table 2). In the metastatic breast cancer trials the probability of cardiac dysfunction was highest in patients who received Herceptin concurrently with anthracyclines. Infusion Reactions During the first infusion with Herceptin, the symptoms most commonly reported were chills and fever, occurring in approximately 40% of patients in clinical trials. Symptoms were treated with acetaminophen, diphenhydramine, and meperidine (with or without reduction in the rate of Herceptin infusion); permanent discontinuation of Herceptin for infusional toxicity was required in <1% of patients. Other signs and/or symptoms may include nausea, vomiting, pain (in some cases at tumor sites), rigors, headache, dizziness, dyspnea, hypotension, elevated blood pressure, rash, and asthenia.

Infusional toxicity occurred in 21% and 35% of patients, and was severe in 1.4% and 9% of patients, on second or

www.theOncologyNurse.com

subsequent Herceptin infusions administered as monotherapy or in combination with chemotherapy, respectively. In the post-marketing setting, severe infusion reactions, including hypersensitivity, anaphylaxis, and angioedema have been reported. Anemia In randomized controlled clinical trials, the overall incidence of anemia (30% vs. 21% [Study 5]), of selected NCI-CTC Grade 2–5 anemia (12.5% vs. 6.6% [Study 1]), and of anemia requiring transfusions (0.1% vs. 0 patients [Study 2]) were increased in patients receiving Herceptin and chemotherapy compared with those receiving chemotherapy alone.

Following the administration of Herceptin as a single agent (Study 6), the incidence of NCI-CTC Grade 3 anemia was < 1%. Neutropenia In randomized controlled clinical trials in the adjuvant setting, the incidence of selected NCI-CTC Grade 4–5 neutropenia (2% vs. 0.7% [Study 2]) and of selected Grade 2–5 neutropenia (7.1% vs. 4.5 % [Study 1]) were increased in patients receiving Herceptin and chemotherapy compared with those receiving chemotherapy alone. In a randomized, controlled trial in patients with metastatic breast cancer, the incidences of NCI-CTC Grade 3/4 neutropenia (32% vs. 22%) and of febrile neutropenia (23% vs. 17%) were also increased in patients randomized to Herceptin in combination with myelosuppressive chemotherapy as compared to chemotherapy alone. Infection The overall incidences of infection (46% vs. 30% [Study 5]), of selected NCI-CTC Grade 2–5 infection/febrile neutropenia (22% vs. 14% [Study 1]) and of selected Grade 3–5 infection/febrile neutropenia (3.3% vs. 1.4%) [Study 2]), were higher in patients receiving Herceptin and chemotherapy compared with those receiving chemotherapy alone. The most common site of infections in the adjuvant setting involved the upper respiratory tract, skin, and urinary tract. In study 4, the overall incidence of infection was higher with the addition of Herceptin to AC-T but not to TCH [44% (AC-TH), 37% (TCH), 38% (AC-T)]. The incidences of NCI-CTC grade 3-4 infection were similar [25% (AC-TH), 21% (TCH), 23% (AC-T)] across the three arms. In a randomized, controlled trial in treatment of metastatic breast cancer, the reported incidence of febrile neutropenia was higher (23% vs. 17%) in patients receiving Herceptin in combination with myelosuppressive chemotherapy as compared to chemotherapy alone. Pulmonary Toxicity Adjuvant Breast Cancer Among women receiving adjuvant therapy for breast cancer, the incidence of selected NCICTC Grade 2–5 pulmonary toxicity (14% vs. 5% [Study 1]) and of selected NCI-CTC Grade 3–5 pulmonary toxicity and spontaneous reported Grade 2 dyspnea (3.4 % vs. 1% [Study 2]) was higher in patients receiving Herceptin and chemotherapy compared with chemotherapy alone. The most common pulmonary toxicity was dyspnea (NCI-CTC Grade 2–5: 12% vs. 4% [Study 1]; NCI-CTC Grade 2–5: 2.5% vs. 0.1% [Study 2]). Pneumonitis/pulmonary infiltrates occurred in 0.7% of patients receiving Herceptin compared with 0.3% of those receiving chemotherapy alone. Fatal respiratory failure occurred in 3 patients receiving Herceptin, one as a component of multi-organ system failure, as compared to 1 patient receiving chemotherapy alone. In Study 3, there were 4 cases of interstitial pneumonitis in Herceptin-treated patients compared to none in the control arm. Metastatic Breast Cancer Among women receiving Herceptin for treatment of metastatic breast cancer, the incidence of pulmonary toxicity was also increased. Pulmonary adverse events have been reported in the post-marketing experience as part of the symptom complex of infusion reactions. Pulmonary events include bronchospasm, hypoxia, dyspnea, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, and acute respiratory distress syndrome. For a detailed description, see Warnings and Precautions. Thrombosis/Embolism In 4 randomized, controlled clinical trials, the incidence of thrombotic adverse events was higher in patients receiving Herceptin and chemotherapy compared to chemotherapy alone in three studies (3.0% vs. 1.3% [Study 1], 2.5% and 3.7% vs.

2.2% [Study 4] and 2.1% vs. 0% [Study 5]). Diarrhea Among women receiving adjuvant therapy for breast cancer, the incidence of NCI-CTC Grade 2–5 diarrhea (6.2% vs. 4.8% [Study 1]) and of NCI-CTC Grade 3–5 diarrhea (1.6% vs. 0% [Study 2]), and of grade 1-4 diarrhea (7% vs. 1% [Study 3]) were higher in patients receiving Herceptin as compared to controls. In Study 4, the incidence of Grade 3–4 diarrhea was higher [5.7% AC-TH, 5.5% TCH vs. 3.0% AC-T] and of Grade 1–4 was higher [51% AC-TH, 63% TCH vs. 43% AC-T] among women receiving Herceptin. Of patients receiving Herceptin as a single agent for the treatment of metastatic breast cancer, 25% experienced diarrhea.

An increased incidence of diarrhea was observed in patients receiving Herceptin in combination with chemotherapy for treatment of metastatic breast cancer.

Glomerulopathy In the postmarketing setting, rare cases of nephrotic syndrome with pathologic evidence of glomerulopathy have been reported. The time to onset ranged from 4 months to approximately 18 months from initiation of Herceptin therapy. Pathologic findings included membranous glomerulonephritis, focal glomerulosclerosis, and fibrillary glomerulonephritis.

Complications included volume overload and congestive heart failure. Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. Among 903 women with metastatic breast cancer, human anti-human antibody (HAHA) to Herceptin was detected in one patient using an enzyme-linked immunosorbent assay (ELISA). This patient did not experience an allergic reaction. Samples for assessment of HAHA were not collected in studies of adjuvant breast cancer. The incidence of antibody formation is highly dependent on the sensitivity and the specificity of the assay.

Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample

collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Herceptin with the incidence of antibodies to other products may be misleading. USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Category D [see Warnings and Precautions] Herceptin can cause fetal harm when administered to a pregnant woman. Postmarketing case reports suggest that Herceptin use during pregnancy increases the risk for oligohydramnios during the second and third trimester. If Herceptin is used during pregnancy or if a woman becomes pregnant while taking Herceptin, she should be apprised of the potential hazard to a fetus. In the postmarketing setting, oligohydramnios was reported in women who received Herceptin during pregnancy, either alone or in combination with chemotherapy. In half of these women, amniotic fluid index increased after Herceptin was stopped. In one case, Herceptin was resumed after the amniotic fluid index improved, and oligohydramnios recurred. Women using Herceptin during pregnancy should be monitored for oligohydramnios. If oligohydramnios occurs, fetal testing should be done that is appropriate for gestational age and consistent with community standards of care. Additional intravenous (IV) hydration has been helpful when oligohydramnios has occurred following administration of other chemotherapy agents, however the effects of additional IV hydration with Herceptin treatment are not known. Reproduction studies in cynomolgus monkeys at doses up to 25 times the recommended weekly human dose of 2 mg/kg trastuzumab have revealed no evidence of harm to the fetus. However, HER2 protein expression is high in many embryonic tissues including cardiac and neural tissues; in mutant mice lacking HER2, embryos died in early gestation. Placental transfer of trastuzumab during the early (Days 20-50 of gestation) and late (Days 120-150 of gestation) fetal development period was observed in monkeys. [See Nonclinical Toxicology] Because animal reproduction studies are not always predictive of human response, Herceptin should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Registry Pregnant women with breast cancer who are using Herceptin are encouraged to enroll in MotHER- the Herceptin Pregnancy Registry: phone 1-800-690-6720. Nursing Mothers It is not known whether Herceptin is excreted in human milk, but human IgG is excreted in human milk. Published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Trastuzumab was present in the breast milk of lactating cynomolgus monkeys given 12.5 times the recommended weekly human dose of 2 mg/kg of Herceptin. Infant monkeys with detectable serum levels of trastuzumab did not have any adverse effects on growth or development from birth to 3 months of age; however, trastuzumab levels in animal breast milk may not accurately reflect human breast milk levels.

Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from Herceptin, a decision should be made whether to discontinue nursing, or discontinue drug, taking into account the elimination half-life of trastuzumab and the importance of the drug to the mother. Pediatric Use The safety and effectiveness of Herceptin in pediatric patients has not been established. Geriatric Use Herceptin has been administered to 386 patients who were 65 years of age or over (253 in the adjuvant treatment and 133 in metastatic breast cancer treatment settings). The risk of cardiac dysfunction was increased in geriatric patients as compared to younger patients in both those receiving treatment for metastatic disease in Studies 5 and 6, or adjuvant therapy in Studies 1 and 2. Limitations in data collection and differences in study design of the 4 studies of Herceptin in adjuvant treatment of breast cancer preclude a determination of whether the toxicity profile of Herceptin in older patients is different from younger patients. The reported clinical experience is not adequate to determine whether the efficacy improvements (ORR, TTP, OS, DFS) of Herceptin treatment in older patients is different from that observed in patients <65 years of age for metastatic disease and adjuvant treatment.

OVERDOSAGE There is no experience with overdosage in human clinical trials. Single doses higher than 8 mg/kg have not been tested. PATIENT COUNSELING INFORMATION • Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Boxed Warning: Cardiomyopathy]. • Advise women with reproductive potential to use effective contraceptive methods during treatment and for a minimum of six months following Herceptin [see Pregnancy]. • Encourage pregnant women who are using Herceptin to enroll in MotHER- the Herceptin Pregnancy Registry [see Pregnancy].

HERCEPTIN® [trastuzumab] Manufactured by: 4839803 Genentech, Inc. Initial US Approval: Sept. 1998 1 DNA Way Revision Date: March 2009 South San Francisco, CA LK0726 7172911 94080-4990 7172713 ©2009 Genentech, Inc.

Letter to the Editor

I

n an upcoming issue, I would like to see a rebuttal to Dr. Gottlieb’s viewpoint on the health reform law [The Oncology Nurse June 2010]. His very biased opinion, coming from the radically right American Enterprise Institute, should not go unanswered.

I believe he gives your publication a bad name because he sounds like he is all for physicians and insurance companies to grow wealthy on the backs of the ill and suffering in America.

He complains about having to purchase IT systems that have been shown to be safer for patients. The IOM has let us know our shame over a decade with no change in the rate of mortality and morbidity due to system errors.

Dr. Gottlieb has the typical conservative viewpoint—do nothing to save lives if it will cost the wealthy some money.

I know the American Nurses Association has backed health reform. This is a nurse’s journal. Where is their opinion?

Alice Peterson, RN, MPH, CHES, CMSRNN Lakeland, Florida (The opinions I have expressed are my own and are not intended to represent those of my employer.)

Letters The Oncology Nurse welcomes readers’ comments on all issues relevant to oncology practice. Please send your comments to editorial@greenhillhc.com.

News Notes Thirdhand Smoke Identified as Health Hazard Residual nicotine from tobacco smoke sorbed to indoor surfaces was found to react with ambient nitrous acid to form carcinogenic tobacco-specific nitrosamines (TSNAs).

This recently identified chemical reaction poses an unappreciated health hazard. This tobacco residue, termed “thirdhand smoke,” can enter the human body through dermal exposure, dust inhalation, and ingestion.

Performing both laboratory and field testing, researchers developed a process to measure the presence of TSNAs on common indoor surfaces, including hair, skin, and cotton and in homes and on furniture. In laboratory testing using cellulose as a model indoor material, they found >10-fold increase of surface-bound TSNAs when sorbed secondhand smoke was exposed to 60 ppbv ambient nitrous acid for 3 hours. The significant problem is the difficulty in removing thirdhand smoke from soft indoor surfaces, such as carpet and upholstery, as the cleaner must be acidic (Sleiman M, et al. Proc Natl Acad Sci U S A. 2010;107:6576-6581). ●

August 2010 I VOL 3, NO 5

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Editorial Board EDITOR-IN-CHIEF

Sharon S. Gentry,

Kena C. Miller,

Rita Wickham,

Beth Faiman,

RN, MSN, AOCN

RN, MSN, FNP

OCN, PhD, RN

RN, MSN, APRN, BC, AOCN

Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC

Roswell Park Cancer Institute Buffalo, NY

Rush University College of Nursing Rush-PresbyterianSt. Luke’s Medical Center Chicago, IL

Cassandra J. Hammond, RN,

Patricia Molinelli,

Karla Wilson, RN,

Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Elizabeth Bilotti, RN, MSN, APRN, BC, OCN

MS, RN, APN-C, AOCNS

MSN, FNP-C, CPON

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Avid Education Partners, LLC Sharpsburg, MD

Somerset Medical Center Somerville, NJ

City of Hope National Medical Center Duarte, CA

Catherine S. Bishop, DNP, NP,

Shannon Hazen,

Dolores “Jeff” Nordquist, RN, MS,

Pharmacy John F. Aforismo,

AOCNP

Novant Health, Presbyterian Cancer Center Chapel Hill, NC

CS, FNP

Hematology-Oncology Associates of Fredericksburg Fredericksburg, VA

BSc Pharm, RPh, FASCP

Deena Damsky Dell, RN, MSN,

Patricia Irouer Hughes, RN, MSN,

Melinda Oberleitner, RN,

Nutrition Karen Connelly,

DNS, APRN, CNS

RD, CSO

MSN, CRNP

RN, BSN, OCN

Mayo Clinic Rochester, MN

AOCN, BC

BSN, OCN

Fox Chase Cancer Center Philadelphia, PA

Piedmount Healthcare Rex, GA

Wendy DiSalvo,

Taline Khoukaz,

Gary Shelton,

DNP, APRN, AOCN

NP, MSN, ACNP-C

Genentech New London, NH

University of Southern California Norris Cancer Center & Hospital Los Angeles, CA

MSN, ARNP, AOCN

Denice Economou, RN,

Sandra E. Kurtin,

Lori Stover, RN,

RN, MS, AOCN, ANP-C

BSN

MN, AOCN City of Hope National Medical Center Duarte, CA

Arizona Cancer Center Tucson, AZ

Constance Engelking, RN,

Elizabeth Lima,

MS, OCN

Cleveland Clinic Taussig Cancer Institute Cleveland, OH

The CHE Consulting Group, Inc. Mt. Kisco, NY

PA-C

College of Nursing and Allied Health Professions University of Louisiana Lafayette, LA

R. J. Health Systems International, LLC Wethersfield, CT

Somerset Medical Center Somerville, NJ

Patient Advocate Peg Ford Coronado, CA

NYU Cancer Institute New York, NY

Social Work Carolyn Messner,

Western Pennsylvania Cancer Institute Pittsburgh, PA

DSW, MSW, LCSW-R, BCD

Pamela Hallquist Viale, RN, MS,

Managed Care and Pharmaceutical Management Burt Zweigenhaft,

CS, ANP, AOCN Saratoga, CA

CancerCare New York, NY

BS BioPharma Partners LLC New York, NY

Isabell Castellano, RN Amy Ford, RN,

Ann McNeill,

Connie Visovsky,

BSN, OCN

MSN, RN, NP-C, OCN

RN, PhD, APRN

Innovex Dallas, TX

The Cancer Center at Hackensack University Medical Center Hackensack, NJ

University of Nebraska College of Nursing Omaha, NE

Bristol-Myers Squibb Children’s Hospital Robert Wood Johnson University Hospital New Brunswick, NJ

Lyssa Friedman, RN, MPA, OCN Veracyte, Inc South San Francisco, CA

Jeanne Westphal, RN Meeker County Memorial Hospital Litchfield, MN

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August 2010 I VOL 3, NO 5

www.theOncologyNurse.com

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SARCOMA: THE ONLY THING PROGRESSING IS THE DISEASE T HE 5 - Y EAR SURV IVA L RATE IS 17 % F O R PATIEN TS WITH ME TASTATIC SOF T TI SSU E SA RC O MA , YET SIG NIF ICAN T THE RA PEU TIC ADVANCEM ENTS ARE L A GGIN G.1

NEW TREATMENTS ARE URGENTLY NEEDED.

Reference: 1. National Cancer Institute. Surveillance Epidemiology and End Results. seer.cancer.gov/statfacts/html/soft.html. Accessed March 19, 2010.

Copyright © 2010 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. 21003100(5)-ARI

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FROM THE EDITOR

R

esults of a meta-analysis of calcium supplement use by healthy adults just published in BMJ show an increased risk of myocardial infarction in those who took calcium supplements without vitamin D. This may come as a surprise to those of us who take calcium supplements ourselves and recommend them to our patients. However, Beth Faiman, RN, the analysis included only studies of MSN, APRN, calcium supplements, not dietary BC, AOCN calcium intake and the cardiovascuEditor-in-Chief lar risks may only apply to use of calcium supplements.

Even though this study is not about cancer patients, it does have important implications for oncology nurses and patients. It reinforces the need for nurses to keep up with the latest findings not only on cancer and its treatments but about health-related issues in general so that

PUBLISHING STAFF Publisher Philip Pawelko phil@greenhillhc.com Editorial Director Karen Rosenberg karen@greenhillhc.com Associate Editor Dawn Lagrosa dawn@greenhillhc.com Director, Client Services John W. Hennessy john@greenhillhc.com Production Manager Stephanie Laudien Business Manager Blanche Marchitto blanche@greenhillhc.com Executive Administrator Andrea Boylston Circulation Department circulation@greenhillhc.com Editorial Contact: Telephone: 732-992-1891 Fax: 732-656-7938

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Copyright ©2010 by Green Hill Healthcare Communications, LLC. All rights reserved. The Oncology Nurse®-APN/PA logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher.

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Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the Editorial Board nor the Publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician.

Please convey any errors to the Editorial Director.

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AugusT 2010 I VOL 3, NO 5

we can answer patients’ questions. No need at this point to caution people against mother’s milk, but we do have to give them good evidence-based advice if they are concerned about what they have heard.

To help readers stay informed on the enormous amount of cancer-related information released daily, we are adding daily news updates and other new features to The Oncology Nurse website (www.theoncologynurse. com). We hope you will visit the website and share your thoughts on the issues of the day.

Another recent enhancement to our journal is the addition of “APN/PA” to our logo to reflect our commitment to providing content of interest to all healthcare professionals involved in cancer care. To help us achieve that goal, we are pleased to announce the addition of several new editorial board members with different areas of expertise—Dr Catherine S. Bishop, an advanced practice nurse, Shannon Hazen, an oncology nurse educator, Elizabeth Lima, a physician assistant, and Peg Ford, a patient advocate. ●

CONTENTS FEATURE ARTICLES 12 Continuing Education Oncologic emergencies associated with lung cancer

19 ASCO: Supportive Care New exercise guidelines issued for cancer patients Risk factors for chemotherapy toxicity in elderly identified

20 ASCO: Prostate Cancer Cabazitaxel improves overall survival in patients with hormone-refractory prostate cancer

20 ASCO: Hematologic Cancers In CML, longer follow-up confirms superiority of nilotinib over imatinib

21 ASCO: Skin Cancer

AugusT 2010 • VOL 3, NO 5 3D-EBRT for prostate cancer may increase risk of hip fracture

32 Psychosocial Issues A team approach to psychosocial care The teenager with cancer: struggling to be heard and understood

DEPARTMENTS 3 Letter to the Editor 3 News Notes 28 Oncology Drug Codes 37 Books and Media 40 International News 40 Nursing Life 41 Meetings

New monoclonal antibody treatment offers hope for treatment of metastatic melanoma

22 Conference News: ONS

Journal of Oncology

A multidisciplinary program prevents falls in cancer patients

NAVIGATION & SURVIVORSHIP

Oncology nurses can improve the safety of chemotherapy disposal

Between pages 20 and 21

Local ONS chapters use creative strategies to recruit, retain members, strengthen community ties

Launching the navigation program that is best for you. Part 1: defining your program

Diverse educational programs keep oncology nurses up to date

™

The Official Journal of the Academy of Oncology Nurse Navigators ®

FEATURE ARTICLES Journal of Oncology

Page 1

NAVIGATION & SURVIVORSHIP

™

The Official Journal of the Academy of Oncology Nurse Navigators ® AUGUST 2010

Novel agents improve survival in refractory metastatic breast cancer

Launching the Navigation Program that is Best for You. Part 1: Defining your Program Leadership Council Lillie Shockney, RN, BS, MAS Johns Hopkins Breast Center Johns Hopkins University School of Medicine Baltimore, Maryland Sharon Gentry, RN, MSN, AOCN, CBCN Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, North Carolina Nicole Messier, RN Vermont Cancer Center Burlington, Vermont

30 Nursing Careers

Elaine Sein, RN, BSN, OCN, CBCN Fox Chase Cancer Center Partners Rockledge, Pennsylvania

Oncology nurses need more training for survivorship planning Page 1

Tricia Strusowski MS, RN Helen F. Graham Cancer Center Christiana Care Health System Newark, Delaware Linda Fleisher, MPH, PhD(c) Fox Chase Cancer Center Cheltenham, Pennsylvania Susan M. Gardner, RN, CBEC, CBCN Valley Medical Center Renton, Washington Jay R. Swanson, RN, BSN, OCN Saint Elizabeth Cancer Institute Lincoln, Nebraska Carol Lewis, RN, BSN, OCN, CRNI Memorial Hermann The Woodlands, Texas

By Dawn Lagrosa CHICAGO—For those involved in Multiple strategies to successful navnavigation, or those who have looked igation programs were presented by a into starting navigation programs, one panel of nurses and administrators at the thing is evident: No two programs are third annual Oncology Update of the exactly the same. However, the advan- American College of Oncology tages of patient navigation can be had Administrators. by all—academic centers, “Navigation is even a buzzcommunity cancer cenword in our Capitol,” said ters, hospital-based cenBonnie Miller, RN, BSN, OCN, ters, multiple location who chaired the panel. Miller, groups. Despite the various who is administrative director of models of navigation, the the Women’s Cancer Center at goal remains the same, to Fox Chase, Philadelphia, noted help healthcare consumers that recent legislation has paved access and chart a course the road for navigation. through the healthcare The Patient Navigator, Outsystem and overcome bar- Bonnie Miller, RN, reach, and Chronic Disease PreBSN, OCN riers to quality care. vention Act of 2005 identified,

New evidence shows that large-scale prostate cancer screening saves lives

from a legislative point of view, what navigators should do: • Anticipate, identify, and help patients overcome barriers within healthcare systems • Assist in coordination of healthcare services and referrals • Help and facilitate involvement of community organizations • Assist individuals at risk for either cancer or other chronic disease.

“Those of you who are navigators, if you look at your job descriptions, some of those things are a part of it,” said Miller. But each program is different, as is each navigator. “Before you implement a navigation program, remember Continued on page 2

CARE PLANS

Oncology Nurses Need More Training for Survivorship Planning

By Jill Stein SAN DIEGO—New survey results indicate that although most oncology nurses believe that survivorship planning for cancer patients is their responsibility, often they do not consider themselves sufficiently prepared to knowledgeably discuss survivorship issues with patients and their families.

The findings were reported at the

35th Annual Congress of the Oncology Nursing Society.

Joanne Lester, PhD, CRNP, ANPBC, AOCN, research scientist/nurse practitioner at James Cancer Hospital in Columbus, Ohio, presented the results of an online survey that assessed oncology nurses’ knowledge about survivorship care planning.

“Survivorship planning is a relatively new component of the overall management of cancer patients,” Lester, who is also clinical assistant professor at Ohio State University College of Nursing, pointed out.

In recent years, the Institute of Medicine has called on healthcare proContinued on page 3

AONN Staff Sean T. Walsh Executive Director sean@aonnonline.org

AY OD 0 R T 20 TE E $ GIS AV RE & S

First Annual Navigation and Survivorship Conference

September 17-19, 2010 • Baltimore, Maryland www.AONNonline. org

Rita Wickham wins ONS publishing award

31 Prostate Cancer

VOL 1, NO 3

GETTING STARTED

Pamela Matten, RN, BSN, OCN St. Joseph Hospital Orange, California

27 ASCO: Breast Cancer

www.AONNonline.org

©2010 Green Hill Healthcare Communications, LLC

Risk-based screening detects toxicities in childhood cancer survivors, even 30 years later Page 4

www.TheOncologyNurse.com

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www.BioOncology.com

Exploring uncharted territories — bringing advances in oncology to light

At Genentech BioOncology, we’re transforming the way cancer is treated by gaining a broad understanding of cancer biology and following a comprehensive approach to drug discovery.

A robust pipeline — We currently have 22 new molecules in clinical development across a range of pathways, from angiogenesis to apoptosis.

Innovative molecules — Our new molecular entities target the fundamental mechanisms of cancer growth and include antibody-drug conjugates, a HER2 dimerization inhibitor, a potent and specific B-Raf inhibitor, a Hedgehog pathway inhibitor, and antibodies targeting cancer cell-surface antigens.

Extensive clinical trial program — We and our partners are currently enrolling patients in over 750 ongoing trials for both postapproval and pipeline products in dozens of tumor types.

Our goal is to fundamentally change the way that cancer is treated — not just with incremental advances, but with new standards of care.

© 2010 Genentech USA, Inc. All rights reserved. 10201500 Printed in USA.

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Nursing Practice Averting the Perfect Storm... Continued from cover Photo courtesy R. Gullatte, Sr

decision latitude among In the past decade, the nurses.2-7 phrase “healthy work environNurse burnout is a consement” has gained prominence quence of an unrelenting to describe a workplace with stressful work environment, minimal psychological distress, which leads to job dissatisand embraces, among other faction and subsequent elements, staff empowerment turnover.4 When nurses do and shared decision-making. not feel empowered, work The Association of CriticalMary M. Gullatte, under strained staffing conCare Nurses (ACCN)’s Healthy ditions, and lack manage- PhD, RN, APRN, Work Environment Initiative is BC, AOCN ment and organizational a multiyear effort to engage prosupport, the workplace can become fessional nurses and healthcare organizaweakened, resulting in patient-safety tions to recognize the importance of colrisks.8 Improved workplace health and laborative teamwork and meaningful safety increases productivity and recognition to improve the working envipatient safety.9 ronment for nurses.10

Both The Joint Commission and the Institute of Medicine have identified elements of a healthy work environment for nurses and are advising healthcare organizations to be aware of the impact of unhealthy work environments on in creased healthcare costs, increased job dissatisfaction, nurse turnover, and patient safety concerns.11,12 A report by Isgur documented a turnover rate of 27.1% among new graduate nurses within their first year of employment,13 and the cost of registered nurse turnover continues to rise. A survey by the Maryland Hospital Association revealed that, in 2000, the estimated cost to fill a vacant nurse position was between

$30,000 and $50,000.14 Total turnover cost can be staggering, not just in the cost to find a nurse replacement, but also in staff morale and retention. Given the current economic climate, unhealthy work environments will be even more costly to the bottom-line finances of healthcare organizations.

Oncology nurses face life-and-death scenarios daily in the care of their patients. High-stress levels are inherent in the specialty. Patient care also encompasses the care of families who are involved and concerned about their loved ones. Today’s healthcare climate of shrinking resources of both personnel and supplies, coupled with a strained work-

Table 1. Professional Organizations’ Perspectives on Essentials of a Healthy Work Environment

8

American Association of Critical-Care Nurses • Skilled communication • True collaboration • Effective decision-making • Appropriate staffing • Meaningful recognition • Authentic leadership

American Organization of Nurse Executives • Collaborative practice culture • Communication-rich culture • Culture of accountability • Presence of adequate numbers of qualified nurses • Presence of expert, competent, credible, visible leadership • Shared decision-making at all levels • Encouragement of professional practice and continued growth/development • Recognition of the value of nursing’s contribution • Recognition by nurses for their meaningful contribution to practice

Florida Center for Nursing • Collaborative teamwork • Autonomy and accountability • Control of practice • Staffing • Leadership • Professional development • Competitive wages • Nurse recognition • Adequate support

National Health Care for the Homeless Council • Values-based environment and management practices • Clarity and unity of purpose • Open communication and dialog • Collegiality and sharing within a team • Recognizing employees’ contributions • Supporting reasonable risk-taking and decision latitude • Encouraging employees to have a balanced life

Institute of Medicine • Nursing boards that focus on safety • Leadership and evidence-based management structures and processes • Effective nursing leadership • Adequate staffing • Organizational support for ongoing learning and decision support • Mechanisms that promote interdisciplinary collaboration • Work design that promotes safety • Organizational culture that continuously strengthens patient safety

The Joint Commission • Create a culture of retention for nursing staff • Adopt fair and competitive compensation and benefit packages for nursing staff • Minimize the paperwork and administrative burden • Adopt zero-tolerance policies for abusive behavior by physicians and other healthcare practitioners • Measure, analyze, and improve staffing effectiveness • Provide management training and resources for nurse executives • Delegate authority to nurse executives and other nurse managers who, in turn, staff nurses for patient care and resource deployment decisions • Limit the use of mandatory overtime to emergency situations • Set staffing levels based on competency and skill mix applicable to patient mix and acuity • Adopt information, ergonomic, and other technologies designed to improve workflow and reduce risks of error and injury

August 2010 I VOL 3, NO 5

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Nursing Practice force with more demand than supply of nurses and other healthcare providers, is a formula for the perfect storm of an unhealthy work environment.

Nurses are all too familiar with the nursing workforce trends of the past decade, including supply and demand, aging of nurses, compensation, and higher acuity of patients. Even with the lack of supply of nurses to meet current demands, especially in specialties like oncology, several elements are within the control of nurse leaders to support and inspire a healthy work environment.

Based on the forces of magnetism identified by the ANCC, nurse managers should focus on three primary priority forces: organizational structure, management style, and interdisciplinary relationships.

Elements of an unhealthy work environment Today’s healthcare environment is fraught with challenges such as unfilled staffing vacancies, staff dissatisfaction, hostile/volatile work environment, recruitment, and retention as well as issues surrounding patient safety resulting from inadequate staffing, stress, and caregiver fatigue. Work environments that lack trust, collaboration, and teamwork are at risk. Organizations that fail to recognize unhealthy work environments will have a revolving door of nursing staff as a result of staff distress, dissatisfaction, and burnout.

Aspects of an unhealthy work environment start with relationships between employees. Inherent in any relationship are attributes of trust, integrity, open and honest communication, transparency, and intention. A lack of any one of these attributes can derail the workplace and lead to an atmosphere that unintentionally fosters workplace aggression, violence, and discord. A healthy work environment is integral to averting the perfect storm. The organization’s reputation as a good or bad place to work will affect its recruitment efforts.

Transforming the workplace environment The first step in creating a healthy work environment is to recognize and understand the signs of an unhealthy work environment. Often underreported, some forms of workplace violence do not involve physical violence. In a survey by Hader, types of workplace violence included intimidation, angry outbursts, hypersensitivity to criticism, and harassment.15 The players involved, includ-

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ing healthcare staff, nurses, physicians, patients, and visitors, were categorized as either victims or perpetrators. Intimidating, aggressive, and disruptive behavior in the workplace can undermine a culture of safety. Nurses should take an introspective look at their behaviors and identify where they may be the victim or perpetrator in any given situation.

Transforming the work environment will require transforming the organization’s culture, which will require commitments from every level of organizational leadership. Nursing leadership can implement key strategies to create positive workplace initiatives, including improving staffing levels and initiating programs centered on employee health and wellbeing, dignity, and respect. These pro-

grams will need to address psychosocial health, shared decision-making, and empowerment.16-18 The organization must adopt a zero-tolerance policy of unhealthy behaviors by employees, physicians, patients, and visitors. In addition, the organization must adopt a fair and just culture that supports a no-blame and punitive-free reporting system. Some Continued on page 10

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Nursing Practice Averting the Perfect Storm... Continued from page 9 organizations have instituted anonymous tip lines for employees to report behavioral infractions related to unhealthy work behavior. According to the ACCN, fostering a healthy work environment requires a fundamental commitment to three basic assertions: (1) a link to patient safety, (2) a formal program, and (3) a program driven by leadership.19 Professional organizations’ healthy work initiatives Table 1 outlines the elements of workplace health necessary for staff satisfaction, improved communication, collaboration, shared decisionmaking, retention, and patient safety, as identified by nursing organizations and governmental agencies. Organizations that have achieved Magnet designation are more likely to exhibit the elements of a healthy work environment. Several common themes are threaded throughout the different organizational descriptions of healthy work environment elements. The “14 forces of magnetism” identified in the American Nurses Credentialing Center (ANCC) Magnet model fall into five key areas that represent the fundamental components of a healthy work environment, including transformational leadership; structural

empowerment; exemplary professional practice; new knowledge, innovations, and improvement; and empirical quality outcomes (Table 2).

Optimal clinical practice environment According to a study by Beal and colleagues, the key characteristics of an optimal practice environment include: (1) valuing scholarly practice, (2) seamless support for nurses at every level of the organization, (3) support for professional development needs of clinical nurses, and (4) nurses’ respect for and appreciation of their value and worth.20 Based on the forces of magnetism identified by the ANCC, nurse managers should focus on three primary priority forces: organizational structure, management style, and interdisciplinary relationships.21 First, the organizational infrastructure must embrace transforming the culture to value the worth and contributions of nurses as professionals. This promotes transparency and shared decision-making, while fostering empowerment of voice and action. Second, the style of management must embrace shared decision-making in aspects of organizational governance that impact nursing practice to facilitate positive patient outcomes.

Table 2. Crosswalk of new ANCC Magnet Model and Forces of Magnetism Model components

Forces of magnetism

Transformational leadership

Force 1: Quality of nursing leadership Force 3: Management style

Structural empowerment

Force 2: Organizational structure Force 4: Personnel policies and programs Force 10: Community and the healthcare organization Force 12: Image of nursing Force 14: Professional development

Exemplary professional practice

Force 5: Professional models of care Force 6: Quality of care: ethics, patient Force 7: Quality improvement Force 8: Consultation and resources Force 9: Autonomy Force 11: Nurses as teachers Force 13: Interdisciplinary relationships

New knowledge, innovations, and improvements

Force 6: Quality of care: research and evidence based practice Force 7: Quality improvement

Empirical quality outcomes

Force 6: Quality of care

ANCC indicates American Nurses Credentialing Center.

Reprinted with permission from: American Nurses Credentialing Center. A new model of ANCC’s magnet recognition program. http://www.nursecredentialing.org/Documents/Magnet/NewModelBrochure.aspx

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August 2010 I VOL 3, NO 5

Creating a healthy work environment is not something that can be accomplished by one person. It requires the committed efforts of nursing leadership and staff, organizational support, and physician engagement, but it is created one person at a time.

Third, the organization must create the ideal environment by promoting interdepartmental and interdisciplinary teamwork among all healthcare providers to achieve desired patient outcomes. An environment in which individual and professional value and worth, as well as respect for what each discipline brings to the whole, is also part of what makes for the optimal clinical practice workplace.

Creating a healthy work environment Inherent in creating a healthy work environment is establishing and nurturing trust, one of the most powerful forms of motivation and inspiration in the workplace.22 Organizations without positive employee and leadership relationships and trust are at risk for dysfunctional, toxic, and punishing systems and unhappy employees. Organizations with healthy trust relationships have complete open, transparent, and effortless communication between employees and leadership, resulting in a team of professionals working together with true joy, characterized by caring and love.22 Opportunities exist for managers to avoid the storm of an unhealthy work environment and transform a culture that embodies shared decision-making, trust, and positive communication.

Creating a healthy work environment is not something that can be accomplished by one person. It requires the committed efforts of nursing leadership and staff, organizational support, and physician engagement, but it is created one person at a time. Within the zone of empowerment, ask yourself and your staff what you can do to empower your voice and connect in the workplace. Begin by understanding the administrative structure related to policy development, budget structure (operations, capital, and salary), and how staffing decisions are made for both professional and unlicensed assistive personnel. Form a shared decision-making model to engage front-line staff in all aspects of decisions that inform professional practice. Create a professional nursing environment that fosters open transparent communication, autonomy, accountability, respect, dignity, and professional development. Develop strategies to offer meaningful recognition of nursing staff for top-level performance.

There will be a significant return on investment to the organization with cost savings, increase in staff satisfaction, high

retention rates, patient satisfaction and safety, and improved overall quality of patient care and a reputation of being an employer of choice. ● References 1. Kraybill K; The National Health Care for the Homeless Council. Creating and maintaining a healthy work environment. Presented at the 2005 Primary Health Care All Grantee Meeting; June 24, 2005; Washington, DC. 2. Karasek R, Theorell T. Healthy Work: Stress, Productivity and the Reconstruction of Working Life.

New York, NY: Basic Books; 1992.

3. Johnson JV, Hall EM, Theorell T. Combined effects of job strain and social isolation on cardiovascular disease morbidity and mortality in a random sample of the Swedish male working population. Scand J Work Environ Health.

1989;15:271-279.

4. Spence Laschinger H, Leiter M. The impact of nursing work environments on patient safety outcomes. J Nurs Adm. 2006;36:259-267.

5. Aiken L, Clarke S, Sloan D; International Hospital Outcomes Research Consortium. Hospital staffing, organization, and quality of care: cross-national findings. Int J Qual Health Care. 2002;14:5-13.

6. Bowles C, Candela L. First job experience of recent RN graduates: improving the work environment.

J Nurs Admin. 2005;35:130-137.

7. Lavoie-Tremblay M, Wright D, Desforges N, et al.

Creating a healthy workplace for new-generation nurses. J Nurs Scholarsh. 2008;40:290-297.

8. Lin L, Liang BA. Addressing the nursing work environment to promote patient safety. Nurs Forum. 2007;42:20-30.

9. Thomason DL, Lagowski LR. Sustaining a healthy work force in the 21st century—a model for collaborating through reciprocation. AAOHN J. 2008;56:503-513.

10. American Association of Critical-Care Nurses.

AACN’s Healthy Work Environment Initiative backgrounder. 2005. www.aacn.org/WD/Practice/ Docs/HWEBackgrounder.pdf. Accessed February 7, 2009.

11. Armstrong K, Laschinger H, Wong C. Workplace empowerment and magnet hospital characteristics as predictors of patient safety. J Nurs Care Qual.

2009;24:55-62.

12. Page A, ed. Keeping Patients Safe: Transforming the Work Environment of Nurses. Washington, DC: National Academy of Sciences Press; 2004.

13. Isgur B. What works: healing the healthcare staffing shortage. Presented at the National Conference of Nursing Workforce Leaders; June 11, 2008; Denver, CO. 14. Crowley C. Severe nursing shortage. Maryland Hospital Association News. August 29, 2000.

15. Hader R. Workplace violence survey 2008.

Unsettling findings: employees’, safety isn’t the norm in our healthcare settings. Nurs Manage.

2008;39:13-19.

16. Tomey AM. Nursing leadership and management affects work environments. J Nurs Manag.

2009;17:15-25.

17. Porter-O’Grady T, Malloch K. Managing for Success in Healthcare. St. Louis, MO: Mosby; 2006.

18. Lawless J, Moss C. Exploring the value of dignity in the work-life of nurses. Contemp Nurs. 2007;24: 225-236.

19. American Association of Critical-Care Nurses.

Standards for establishing and sustaining healthy work environment, executive summary. 2005. www.aacn.org/WD/HWE/Docs/ExecSum.pdf.

February 10, 2009.

20. Beal J, Riley J, Lancaster D. Essential elements of an optimal clinical practice environment. J Nurs Adm. 2008;38:488-493.

21. Wolf GA, Greenhouse PK. A road map for creating a Magnet work environment. J Nurs Adm. 2006;36:458-462.

22. Covey SM, Merrill R. The Speed of Trust: The One Thing That Changes Everything. New York, NY: Free Press; 2006.

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CONTINUING EDUCATION PROGRAM CNE001 • RELEASE DATE: AUGUST 15, 2010 • EXPIRATION DATE: AUGUST 15, 2011 ESTIMATED TIME TO COMPLETE: 1.0 HOUR

Oncologic Emergencies Associated with Lung Cancer

By Kelly Leggett, MSN, BSN, RN1; and Constance G. Visovsky, PhD, RN, ACNP2 Oncology Nurse, Iowa Methodist Medical Center, Des Moines, Iowa; 2Associate Professor, University of Nebraska Medical Center College of Nursing, Omaha

1

STATEMENT OF NEED

Oncology nurses are the frontline members of the healthcare team for the assessment and management of complications associated with lung cancer and its treatment. Oncology nurses caring for patients with lung cancer need to be familiar with paraneoplastic syndromes and common oncologic emergencies that can present in these patients. Paraneoplastic manifestations, though rare, are seen in approximately 10% to 20% of patients with lung cancer, and represent a feature of advanced disease.

Oncologic emergencies result from metabolic, hematologic, and structural changes caused by the cancer or the side effects of its treatment.

This review provides updated information regarding pathophysiology, signs and symptoms, diagnosis, and treatment of paraneoplastic syndromes–based oncologic emergencies associated with lung cancer.

TARGET AUDIENCE

Advanced practice nurses, registered nurses, and other interested healthcare professionals, especially those caring for cancer patients LEARNING OBJECTIVES

After completing this activity, the reader should be able to: • Identify the major paraneoplastic syndromes and oncologic emergencies associated with lung cancer and its treatment • Recognize the signs and symptoms of paraneoplastic syndromes associated with lung cancer and its treatment • Develop management strategies for the major paraneoplastic syndromes and oncologic emergencies associated with lung cancer and its treatment.

L

ung cancer represents the leading cause of cancer death, with 157,300 deaths in the United States expected in 2010.1 More people die from lung cancer than any other type of cancer, with men and women equally affected. Deaths from lung cancer exceeded those from breast, prostate, and colon cancer combined in 2006, the most recent year for which statistics are currently available.2 Although recent advances and multimodal therapies have increased overall survival rates, lung cancer poses additional challenges when it is accompanied by paraneoplastic syndromes and oncologic emergencies that can compromise patient quality of life, morbidity, and mortality. Paraneoplastic mani-

12

August 2010 I VOL 3, NO 5

festations, although rare, are seen in approximately 10% to 20% of patients with lung cancer and represent a feature of advanced disease.3 Oncologic emergencies result from metabolic, hematologic, and structural changes caused by the cancer or from the side effects of its treatment. This review provides updated information regarding the pathophysiology, signs and symptoms, diagnosis, and treatment of paraneoplastic syndromes and oncologic emergencies associated with lung cancer.

of malignancy, ectopic adrenocorticotropic hormone (ACTH) syndrome (Cushing syndrome), and the syndrome of inappropriate antidiuretic hormone hypersecretion (SIADH).4 Humoral hypercalcemia of malignancy.

Hypercalcemia is most commonly seen in lung cancer patients with squamous cell histology, and is typically associated with advanced disease states.4,5 Humoral hypercalcemia of malignancy is often mediated by the production of parathy-

Paraneoplastic syndromes Paraneoplastic syndromes occur in 10% to 20% of patients diagnosed with lung cancer, and are not directly related to the primary lung tumor or progressive metastatic disease. They are instead the result of more remote clinical effects of cancer. Hormones, growth factors, cytokines, and antibodies secreted by the primary tumor have been implicated in the development of paraneoplastic syndromes and can affect the endocrine, neurologic, hematologic, and musculoskeletal systems.3

Lung cancer poses additional challenges when it is accompanied by paraneoplastic syndromes and oncologic emergencies.

Endocrine paraneoplastic syndromes Endocrine paraneoplastic syndromes, the most commonly seen and best understood of the paraneoplastic syndromes, are thought to be caused by hormones, steroids, and cytokines. The endocrine paraneoplastic syndromes most commonly seen in patients with lung cancer are humoral hypercalcemia CONTINUING NURSING EDUCATION ACCREDITATION AND CONTACT HOURS STATEMENT

Science Care is approved by the California Board of Registered Nursing, Provider number 15559, for 1.0 Contact hour.

METHOD OF PARTICIPATION

1. Read the article in its entirety 2. Go to www.TheOncologyNurse.com 3. Select "Continuing Education" 4. Click on this article's title from the list shown 5. Select "Click here to complete the posttest and obtain a CE certificate online" 6. Complete and submit the CE posttest and CE Activity Evaluation 7. Print your Certificate of Credit This activity is provided free of charge to participants.

roid hormone–related protein (PTHrP), a protein member of the parathyroid hormone family. PTHrP is related to the normal parathyroid hormone in function; however, PTHrP peptides have a much broader spectrum of effects.

Normal parathyroid hormone and some of the PTHrP peptides bind to the same receptor, but PTHrP peptides also bind to several other receptors. When a tumor secretes PTHrP, however, hypercalcemia is induced by stimulation of the resorption of calcium from bone and suppression of calcium loss in urine.

Hypercalcemia can also be induced through osteolysis associated with

malignancy and by cytokine secretion (tumor necrosis factor, interleukin-1, interleukin-6) that induces macrophages to differentiate into osteoclasts, leading to bone destruction.6 Hypercalcemia is diagnosed by measuring serum ionized calcium. If only the serum calcium is measured, the corrected calcium can be found by using a formula that accounts for the albumin level: total calcium = 0.8(4.0 – albumin). A complete metabolic panel should be checked, particularly as a low serum chloride level is also associated with hypercalcemia of malignancy.

Signs and symptoms of hypercalcemia of malignancy can include mental status changes (confusion, lethargy), nausea, vomiting, anorexia, polyuria, polydipsia, constipation, and fatigue. The presence and severity of these symptoms depend on the extent of calcium increase and are often correlated with the degree and rate of onset of hypercalcemia.7 As calcium levels increase, dehydration occurs as a result of fluid loss and impaired fluid intake. The resulting extracellular fluid impairs the kidneys’ inability to resorb sodium, which can further exacerbate dehydration.

Treatment must be instituted immediately to avoid morbidity. Treatment consists of immediate rehydration to reduce hypovolemia and the use of bisphosphonates. Vigorous hydration with intravenous (IV) normal saline is given to restore intravascular volume and urine output. After the patient is euvolemic, loop diuretics may be used to

FACULTY DISCLOSURES

DISCLAIMER

As a provider accredited by the California Board of Registered Nursing, Science Care must ensure balance, independence, objectivity, and scientific rigor in all its activities. All course directors, faculty, planners, and any other individual in a position to control the content of this educational activity are required to disclose to the audience any relevant financial relationships with any commercial interest. Science Care must determine if the faculty’s relationships may influence the educational content with regard to exposition or conclusion and resolve any conflicts of interest prior to the commencement of the educational activity.

Disclosures are as follows: • Dawn Lagrosa has nothing to disclose.

• Kelly Leggett, MSN, BSN, RN, has nothing to disclose • Karen Rosenberg has nothing to disclose.

• Constance G. Visovsky, PhD, RN, ACNP, has nothing to disclose.

The opinions and recommendations expressed by faculty, authors, and other experts whose input is included in this program are their own and do not necessarily represent the viewpoint of Science Care or Green Hill Healthcare Communications, LLC.

The staff of Science Care have nothing to disclose.

COPYRIGHT STATEMENT

Copyright © 2010 Science Care. All rights reserved.

EDITORIAL BOARD

Kelly Leggett, MSN, BSN, RN Iowa Methodist Medical Center 1212 Pleasant Street Des Moines, IA 50315 Constance G. Visovsky, PhD, RN, ACNP Associate Professor University of Nebraska Medical Center College of Nursing 985330 Nebraska Medical Center Omaha, NE 68198-5330

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www.TheOncologyNurse.com increase calcium excretion. Bisphosphonates act by blocking osteoclatic bone resorption. Pamidronate and zoledronic acid are most often used for the treatment of hypercalcemia of malignancy.5 Calcitonin, given subcutaneously or by intramuscular injection, can lower calcium levels, but to a more modest degree compared with bisphosphonates.4,5 Monitoring the patientâ&#x20AC;&#x2122;s renal function and electrolytes during rehydration is important to foresee any long-term complications. Control of the underlying cancer is important to maintain control of the hypercalcemia.4 Possible complications related to untreated hypercalcemia include renal failure, cardiac arrest, and coma.6 Ectopic adrenocorticotropic hormone syndrome. Ectopic ACTH (Cushing) syndrome is mostly seen in patients with small-cell lung cancer (SCLC). Cushing syndrome presents when the cancer has produced too much ACTH, which in turn stimulates the adrenal glands to produce excessive corticosteroids.

Although not well understood, the mechanism for ectopic ACTH production appears to be the irregular transcription and overexpression of inactive precursor peptides of ACTH. Signs and symptoms of Cushing syndrome include proximal muscle weakness, hypokalemia, metabolic alkalosis, glucose intolerance, and hypertension.4,6 Treatment of Cushing syndrome in cludes management of the primary tumor and pharmacologic therapy.

Ketoconazole is the most commonly used pharmacologic agent, because it has a rapid onset of action and inhibits corti-

hypoosmolality, and urine hyperosmolality.9 As a result, the serum sodium level decreases and weight gain without edema occurs.10 Patients who present with mild hyponatremia may be asymptomatic or have general symptoms of tiredness, headache, weakness, muscle cramps, or decreased appetite. Patients with moderate hyponatremia may present with confusion, nausea, vomiting, oliguria, increased thirst, lethargy and, less commonly, loss of deep-tendon reflexes. Severe symptoms of SIADH develop when serum sodium levels are between 100 mEq/L and 115 mEq/L and include seizure activity and coma.9,11 Treatment of the underlying cancer, correction of electrolyte abnormalities, and fluid restriction of 500 to 1000 mL/day are the mainstays of treatment.

Infusion of 3% hypertonic saline may help to increase serum sodium levels.

Recurrent SIADH may be the first sign of cancer progression.11 Individuals with moderate hyponatremia will require IV fluids, diuretics, and electrolyte replacement.11 Specific guidelines direct the amount of sodium replacement needed to prevent neurologic problems; rapidly correcting the sodium level can lead to osmotic demyelination syndrome, characterized by severe progressive extremity weakness and other neurologic symptoms.9,11 Demeclocycline, a tetracycline antibiotic, may be used if the preceding measures have failed to produce results. As a side effect, demeclocycline induces nephrogenic diabetes insipidus, resulting in dehydration caused by the inability to concentrate urine.10

An oncologic emergency is defined as a clinical condition that results from a structural or metabolic change caused by cancer or its treatment requiring immediate medical attention to prevent loss of life or permanent disability. costeroid production.4 Ketoconazole and chemotherapy can be used in conjunction to treat patients with SCLC. Ketoconazole can cause adrenal suppression, so the patientâ&#x20AC;&#x2122;s liver enzymes as well as adrenal gland function must be monitored throughout the course of treatment.4,8 Syndrome of inappropriate antidiuretic hormone hypersecretion. In the paraneoplastic SIADH, the tumor secretes a protein similar to antidiuretic hormone (ADH). This abnormal production of ADH is unresponsive to the normal feedback mechanism, resulting in water intoxication. SCLC is responsible for up to 75% of cases of SIADH.9 Individuals with SIADH resulting from malignancy present with excess fluid buildup, leading to dilutional hyponatremia, serum

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Hematologic paraneoplastic syndromes Trousseau syndrome. Trousseau syndrome is the earliest paraneoplastic syndrome described, and demonstrates the association between thrombosis and malignancy. This syndrome is a hypercoagulable state with migratory thrombophlebitis and develops primarily in patients with mucin-producing tumors, such as adenocarcinomas of the lung. Trousseau syndrome occurs in 40% to 50% of patients with solid tumors. It is believed that mucin-producing carcinomas and tissue factor are responsible for the release of highly glycosylated secretory products of epithelial cells into the bloodstream, initiating thromboembolic events.12 Trousseau syndrome is associated with the occur-

Table. Oncologic Emergencies Associated with Lung Cancer Urgency/emergency Superior vena cava syndrome

6-7

Cardiac effusion and cardiac tamponade

5-10

Pleural effusion

Spinal cord compression

Selected signs and symptoms

Incidence, %

Dyspnea; head fullness; chest pain; facial, neck, and arm swelling; stridor; positive distension of superficial veins of chest, neck, upper arms Dyspnea, cough, anxiety, jugular vein distension, tachycardia, pulsus paradoxis, substernal chest pain Dyspnea, dry cough, pleuritic chest pain, dullness on chest percussion, tracheal deviation

15-20

Thoracic: 10 Lumbosacral: 20 Cervical: 10

Back pain followed by weakness and sensory deficits.

Paraesthesias and a decrease or loss of temperature and vibratory sensation may also be experienced

Source: Reference 4.

rence of deep vein thrombosis (DVT) and pulmonary emboli.4 Signs and symptoms of DVT include pain and swelling of the affected extremity. Early on, mild pain may occur at the affected area without swelling, and patients may remain asymptomatic.

Those with superficial thrombophlebitis may have only erythema at the site.

Patients with shortness of breath and chest pain need to be assessed for pulmonary emboli. They may present with anginal chest pain, and, as the syndrome progresses, this may change to pleuritic chest pain with dyspnea.13 Treatment typically includes anticoagulation using IV continuous infusion unfractionated heparin.4 Low-molecular-weight heparins have been approved by the US Food and Drug Administration for outpatient management of DVT and inpatient management of pulmonary embolus. Low-molecular-weight heparins are dosed based on the weight of the patient; these drugs have been found to have good bioavailability, a long half-life, and predictable anticoagulant activity.14 In addition, laboratory monitoring is not necessary.14 Oncologic emergencies An oncologic emergency is defined as a clinical condition that results from a structural or metabolic change caused by cancer or its treatment requiring immediate medical attention to prevent loss of life or permanent disability10,15 (Table).

Superior vena cava syndrome. Superior vena cava syndrome (SVCS), caused by a gradual obstruction of the superior

vena cava, can be caused by tumor, thrombosis, radiation, fibrosis, or infection.4 The superior vena cava drains into the right atrium of the heart, and can become compressed by a lung tumor as it grows. The superior vena cava lies close to intrathoracic lymph nodes, and lung cancer that spreads to these lymph nodes causes them to enlarge. Enlarged lymph nodes compress the vein, which slows the blood flow, and may ultimately result in complete blockage. Sixty percent to 95% of cases of SVCS arise from bronchogenic carcinoma.16 The onset of SVCS is usually slow, but can occur rapidly in the face of a rapidly growing tumor or thrombosis.5 Because of the slow progression of SVCS, collateral circulation has time to develop.

Dyspnea is the most common presenting symptom with SVCS, occurring in more than 60% of patients.4 Distension of the neck and chest wall veins, facial edema and redness, and edema of the upper extremities are the most common presenting signs.5 Other symptoms include cough, dysphasia, and chest pain. The severity of symptoms is a reflection of the rapidity of the obstruction, the degree of the obstruction, and whether collateral circulation has been able to develop.17 Diagnosis of SVCS can include chest film, computed tomography (CT), venogram, magnetic resonance imaging (MRI), and a venous ultrasound. The goals for treatment of SVCS are symptom relief and therapy for the primary Continued on page 14

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CONTINUING EDUCATION Continued from page 13

Oncologic Emergencies Associated with Lung Cancer cancer. The preferred treatments for SVCS resulting from lung cancer include chemotherapy and/or radiation.4 For patients unable to tolerate the more aggressive forms of treatment, steroids and diuretics may be used.

Stenting of the superior vena cava is effective in relieving associated symptoms when chemotherapy and/or radiation therapy has failed, or if SVCS occurs after conventional therapy.18 Stenting of the superior vena cava is successful in 68% to 100% of patients, with a recurrence rate of 4% to 45%.19 Malignant pericardial effusion and car-

ponade, echocardiographically guided pericardiocentesis is a safe and effective procedure. A percutaneous pericardial drain can be left in place to drain the remaining fluid. Surgical management with a pericardial window procedure is performed for recurrent or loculated effusions.24 There is controversy concerning agents for pericardial sclerosis.

Thiotepa, a chemotherapeutic drug classified as an alkylating agent, has been used for pericardial sclerosis.

Thiotepa, 15 mg in 50 mL of normal saline, can be instilled into the drained pericardial space. The use of talc as a

Recognition and prompt treatment of cardiac tamponade will help to prevent severe hemodynamic alterations and death.

diac tamponade. Pericardial effusions are an abnormal increase of fluid in the pericardial sac resulting from metastases, cancer, or cancer-related therapy, which can lead to cardiac tamponade.5 Pericardial effusions are generally seen in locally advanced lung tumors.

Patients who present with pericardial effusion from malignancy have a poor prognosis and usually die within 1 year.20 The incidence of pericardial effusions is high in patients with lung cancer, approximately 40% to 80%.21,22 Cardiac tamponade can result from a rapid progression of pericardial fluid that compresses the chambers of the heart.23 If fluid accumulates in the pericardium at a rapid rate, it can cause the patient to decompensate and become critically ill. However, patients with small pericardial effusions are usually asymptomatic. Symptoms of pericardial effusion include dyspnea, cough, chest pain, dysphasia, hiccups, and hoarseness. Objective findings include tachycardia, distant heart sounds, jugular venous distension, bilateral lower and upper extremity edema, and pulsus paradoxus.5 Diagnosis of cardiac tamponade is made by two-dimensional echocardiogram. Right atrial compression and diastolic collapse of the right ventricle are common findings. Other diagnostic tests include chest film and electrocardiogram. Patients who present with asymptomatic malignant pericardial effusions may not require treatment other than close observation. For those presenting with life-threatening tam-

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August 2010 I VOL 3, NO 5

sclerosing agent is associated with pain, fever, and pericardial constriction.25 For patients presenting with cardiac tamponade, the initial goal is rapid removal of the accumulating fluid. Recognition and prompt treatment of cardiac tamponade will help to prevent severe hemodynamic alterations and death. The best preventive measure for cardiac tamponade or pericardial effusion is effective control of the underlying tumor.

Spinal cord compression. Lung cancer is the leading cause of spinal cord compression (SCC). SCC results from tumor invasion of the vertebrae and subsequent collapse, or from invasion of the spinal canal by the tumor that places pressure on the cord. Seventy percent of SCC occurs in the thoracic region, 20% in the lumbosacral region, and 10% in the cervical region.10 The most common presenting sign of SCC is back pain, followed by weakness and sensory deficits.26 Band-like pain and constriction are reported from patients with SCC of the thoracic region. In SCC, the back pain experienced travels along the dermatome innervated by the affected nerve root. SCC should be suspected with new-onset back pain that worsens with lying down, movement, or coughing.27 Paraesthesias and a decrease or loss of temperature and vibratory sensation may also be experienced. Without treatment, SCC can progress to include such symptoms as ataxia, hypotonicity, lower extremity weakness, bowel/bladder incontinence, or paraplegia.27 Diagnostic radiographic tests of SCC include radiographs of the spine, bone

scan, CT, or MRI. MRI with contrast is considered the best diagnostic test for epidural SCC. Rapid diagnosis and management of SCC is imperative to preserve function. High-dose corticosteroid therapy is used to decrease cord edema and inflammation. Dexamethasone 10 mg IV should be administered, followed by 4 mg four times daily.28 External beam radiation therapy to the spine, which targets two vertebrae above and below the compression, is given to shrink the tumor and decrease accompanying pressure on the cord. Surgical decompression is reserved for radio-resistant tumors and for spinal instability and significant pain.

The diagnosis of SCC is a very poor prognostic indicator, with a life expectancy of 3 months or less.10 Nursing considerations Oncology nurses are the frontline members of the healthcare team for the assessment and management of complications associated with lung cancer and its treatment. Those caring for patients with lung cancer need to be familiar with paraneoplastic syndromes and common oncologic emergencies that can present in these patients. Continued education regarding the presenting symptoms and updated treatment options remain important for oncology nurses. Oncology nurses need to be prepared to promptly assess and initiate appropriate interventions for paraneoplastic syndromes and oncologic emergencies for patients with lung cancer. Patient and family education regarding symptoms associated with paraneoplastic syndromes and oncologic emergencies should be an integral part of the care of patients with lung cancer. ● References 1. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2010. CA Cancer J Clin. July 7, 2010. Epub ahead of print.

2. Centers for Disease Control and Prevention.

Lung cancer statistics. www.cdc.gov/cancer/lung/ statistics. Accessed July 8, 2010.

3. Busick NP, Fretz PC, Galvin JR, Peterson MW. Neoplastic and paraneoplastic syndromes. In: Lung Tumors: A Multidisciplinary Database [multimedia textbook]. 2003. www.vh.org/adult/ provider/radiology/Lungtumors/Paraneoplastic pro cesses/text/paraneoplasticprocesses.html.

Accessed February 22, 2009.

4. Tyson L. Oncologic urgencies and emergencies.

In: Houlihan N, ed. Site-specific Cancer Series: Lung Cancer. Pittsburgh, PA: Oncology Nursing Society Publishing Division; 2004:45-55.

5. Halfdanarson T, Hogan W, Moynihan T. Oncologic emergencies: diagnosis and treatment.

Mayo Clinic Proceedings. 2006;81:835-848.

6. Spiro SG, Gould MK, Colice GL; for the American College of Chest Physicians. Initial evaluation of the patient with lung cancer: symptoms, signs, laboratory tests and paraneoplastic syndromes ACCP evidence-based clinical prac-

tice guidelines (2nd ed). Chest. 2007;132(3 suppl):149S-160S. 7. Bushinsky DA, Monk RD. Electrolyte quintet: calcium. Lancet. 1998;352:306-311.

8. Lin CS, Yao NS, Cheng MF, Lin SH. Ectopic ACTH syndrome associated with large cell neuroendocrine carcinoma of the lung. Am J Med Sci. 2007;334:487-489.

9. Keenan AM. Syndrome of inappropriate secretion of antidiuretic hormone in malignancy.

Semin Oncol Nurs. 1999;15:160-167.

10. Tan SJ. Recognition and treatment of oncologic emergencies. J Infus Nurs. 2002;25:182-188.

11. Ezzone SA. Syndrome of inappropriate antiduretic hormone. In: Camp-Sorrell D, Hawkins RA, eds. Clinical Manual for the Oncology Advanced Practice Nurse. Pittsburgh, PA: Oncology Nursing Society Publishing Division; 2000:571-575.

12. Varki A. Trousseau’s syndrome: multiple definitions and multiple mechanisms. Blood. 2007;110: 1723-1729.

13. Feied C. Pulmonary embolism. In: Rosen P, Barkin R, eds. Emergency Medicine Concepts and Clinical Practice. St. Louis, MO: Mosby; 1998: 1770-1805.

14. Koopman MW, Prandoni P, Piovella F, et al.

Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low-molecular-weight heparin administered at home. The Tasman Study Group. N Engl J Med. 1996; 334:682-687.

15. Stinson D. Oncologic emergencies. Radiation Therapist. 2004;13:107-119.

16. Stewart IE. Superior vena cava syndrome: an oncologic complication. Semin Oncol Nurs.

1996;112:312-317.

17. Mack KC. Superior vena cava syndrome. In: Gates RA, Fink RM, eds. Oncology Nursing Secrets. Philadelphia, PA: Hanley & Belfus; 1997:356-362.

18. Lanciego C, Chacon JL, Julian A, et al. Stenting as first option for endovascular treatment of malignant superior vena cava syndrome. AJR: Am J Roentgenol. 2001;177:585-593.

19. Aurora R, Milite F, Vander Els NJ. Respiratory emergencies. Semin Oncol. 2000;27:256-269.

20. Garcia-Riego A, Cuiñias C, Villanova JJ. Malignant pericardial effusion. Acta Cytol.

2001;45:561-566.

21. Kaplow R. Cardiac tamponade. In: Yarbro CH, Frogge MH, Goodman M, Groenwald SL, eds.

Cancer Nursing: Principles and Practice. 5th ed.

Sudbury, MA: Jones and Bartlett; 2000:857-868.

22. Shelton BK. Pericarditis/pericardial effusion/cardiac tamponade. In: Camp-Sorrell D, Hawkins RA, eds. Clinical Manual for the Oncology Advanced Practice Nurse. Pittsburgh, PA: Oncology Nursing Society Publishing Division; 2000:207-316.

23. Spodick DH. Acute cardiac tamponade. N Engl J Med. 2003;349:684-690.

24. Georghiou GP, Stamler A, Sharoni E, et al. Video assisted thoracoscopic pericardial window for diagnosis and management of pericardial effusions. Ann Thorac Surg. 2005;80:607-610.

25. Keefe DL. Cardiovascular emergencies in the cancer patient. Semin Oncol. 2000;27:244-255.

26. Kwock Y, DeYoung C, Garafalo M, et al.

Radiation oncology emergencies. Hematol Oncol Clin North Am. 2006;20:505-522.

27. Keho C. Getting to know oncologic emergencies.

Nursing Made Incredibly Easy. 2007;5:49-56.

28. Vecht CJ, Haaxma-Reiche H, van Putten WL, et al. Initial bolus of conventional versus high-dose dexamethasone in metastatic spinal cord compression. Neurology. 1989;39:1255-1257.

www.theOncologyNurse.com

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Request a Complimentary CE Program in Your Area:

Case Studies in the Proactive Management of Indolent and Mantle Cell Lymphomas Continuing Education Series for Nurses and Pharmacists To request a free CE presentation in your area, please visit us at www.avid-ed.com/when.html.

Alternatively, you can e-mail us at lymphoma@avid-ed.com. The request must come from a medical institution (office, clinic, hospital, organization), or a nurse or pharmacist, and a contact must be designated. This individual will serve as the primary contact for all communications.

TARGET AUDIENCE This activity is designed for oncology nurses and pharmacists interested in learning more about indolent and

mantle cell lymphomas and the results of the latest research that promise to improve clinical outcomes.

STATEMENT OF NEED The American Cancer Society (ACS) estimates that in 2009 there will be 65,900 new cases of non-Hodgkin’s lymphoma (NHL) and 19,500 deaths due to NHL, making NHL one of the leading causes of cancer and cancerrelated deaths in the United States. NHL has been classified into two types, indolent and aggressive. Two types are difficult to treat: indolent and mantle cell. Indolent lymphoma makes up 70% of NHL and generally presents with slowly progressive disease and painless peripheral lymphadenopathy. Characterized by a relatively slow rate of growth, indolent lymphomas have a low potential for cure with currently available treatments.

The majority of indolent lymphoma patients are diagnosed with advanced-stage disease, and the median survival is approximately 8 to 10 years. Mantle cell lymphoma (MCL) is an aggressive B-cell lymphoma that comprises 6% of NHLs. Patients with MCL typically present in an advanced stage with widespread lymphadenopathy, involvement of the bone marrow, and a predilection for gastrointestinal infiltration. Although the majority of MCL patients are able to achieve response, relapse almost always occurs. Currently, MCL has no standard therapy at diagnosis or relapse, and no curative options exist. The aggressive clinical course of MCL has resulted in a median overall survival of 3 to 4

years with fewer than 15% of patients alive at 5 years.

Treatments of indolent lymphoma and MCL are areas of ongoing research, and promising results with combination therapy and novel agents were recently presented at the 2009 American Society of Hematology (ASH) meeting in New Orleans. Due to the high incidence rate of indolent lymphomas, community practice oncology nurses and pharmacists need to understand patient management issues associated with the “watch-and-wait” treatment strategy for asymptomatic patients as well as available treatment options for symptomatic disease.

Community practice oncology healthcare professionals (HCPs) may not be familiar with MCL due to the relatively few cases diagnosed per year. However, the aggressive nature of MCL makes appropriate management more intense and treatment more difficult than that of indolent lymphomas. Clinical trials in indolent lymphoma and MCL are generally conducted in academic institutions, and it becomes challenging for oncology nurses and pharmacists not directly involved in the trials to keep abreast of the latest data. Through discussion of case studies in these lymphomas, from diagnosis through recurrence, oncology HCPs will have a better understanding of newer treatments and research, as well as their potential impact on managing lymphoma patients.

LEARNING OBJECTIVES At the end of each program participants will be able to: • Describe the typical clinical presentation of indolent and mantle cell lymphomas • Discuss the pharmacology of treatment regimens This activity is jointly sponsored by Medical Learning Institute, Inc. and Avid Education Partners, LLC.

ACCREDITATION Medical Learning Institute, Inc. (MLI) is an approved provider of continuing nursing education by the California Board of Registered Nursing, Provider Number 15106, for 1.0 contact hour.

Supported by an educational grant from Millennium Pharmaceuticals, Inc. and Cephalon Oncology.

• Identify the side effects seen with therapies • Enact interventions for symptom management of frequently occurring side effects of bio-/chemotherapy

MLI is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This CE activity provides 1.0 contact hour. The universal program number for this activity is 0468-9999-09-044-L01-P.

Faculty Disclosure: It is the policy of MLI and Avid Education Partners, LLC (AEP) to ensure balance, independence, objectivity, and scientific rigor in all its educational activities. All faculty will disclose the existence of any financial interest and/or relationship(s) they might have with the manufacturer(s) of any commercial product(s) to be discussed during their presentation(s). Presenters will inform participants of any offlabel discussions. The associates of MLI and AEP have no financial relationships to disclose.

TON_August 2010_FINAL_TON 8/10/10 2:46 PM Page 16

Cancer Center Profile Albert Einstein Cancer Center Joins the NCCCP Continued from cover

Dr William Tester, a medical oncologist, and Tiffany Raroha, an oncology social worker, counsel a patient.

ic groups, some of whom are uninsured or underinsured.

But the staff believes they can do better. For example, radiation oncology “has advanced radiation treatment equipment for patient care,” Lawrence J. Solin, MD, FACR, FASTRO, chair, Department of Radiation Oncology told The Oncology Nurse. “It is extremely important to make sure that our patients not only have access to treatment, but that we provide them with the support services to complete their prescribed therapy.” To help patients do

well as being able to do continuous follow-up of their psychosocial needs,” said Raroha. Einstein also plans to add patient navigators to help patients get through the system more easily.

Enhancing quality For more than 20 years, Einstein has employed site-specific multidisciplinary cancer programs. For most disease sites, physicians and support staff meet and discuss all new cases as well as cases where a problem has arisen or a patient has a recurrence. These groups include

“For those patients that are starting chemotherapy for the first time, we have developed what we call a patient teaching appointment. The patient comes in and has one-on-one time with a social worker, a treatment nurse, and a dietician.”

—Tiffany Raroha, MSW

that, Einstein plans to expand its nutrition, dietary, and social services for patients undergoing radiation oncology.

These expansions will go well beyond radiation oncology. “For those patients that are starting chemotherapy for the first time, we have developed what we call a patient teaching appointment. The patient comes in and has one-on-one time with a social worker, a treatment nurse, and a dietician,” said Tiffany Raroha, MSW, one of two oncology social workers at Einstein. The center’s plan is to reach every patient starting a new cancer treatment, expanding social services not only to radiation oncology patients but also to surgical oncology patients. “We plan to be more proactive with doing psychosocial assessments up front with newly diagnosed patients as

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August 2010 I VOL 3, NO 5

more than just the medical, surgical, and radiation oncologists. In addition to these oncologists, for example, the lung cancer program has regular attendance by its thoracic surgeon, its pulmonologist, a research nurse, social services, and a pathologist, according to Tester. In the breast health program, 15 to 20 people meet every Wednesday, including representatives from breast surgery, medical oncology, radiation oncology, radiology, pathology, plastic surgery, genetics, and rehabilitation. “This is a great way to involve all the experts, so when a patient returns for her 1-week checkup after completing her surgery, and I tell her that she needs to see the medical oncologist, that physician has already fully reviewed her case. I can tell the patient what the medical oncologist

plans on giving her and which trials will be available to her,” said Lisa Jablon, MD, FACS, a breast surgeon who is director of the Breast Health Program.

At present, Einstein has multidisciplinary programs in breast cancer, lung cancer, gastrointestinal cancer, and hematologic malignancies, and hopes to develop an active urologic program with the NCCCP funding.

To integrate care further, Tester has one initiative he has been thinking about and is excited about the possibility of implementing now that Einstein is an NCCCP cancer center. “What we could do with NCCCP support is bring the patient into the multidisciplinary conferences. We have always discussed cases, reviewed pathology, radiologic imaging, and clinical trials that would be appropriate, but we have never actually brought the patient into the discussion room. Multidisciplinary care is an initiative that is important to the NCCCP, and we are planning and want to make that work. At the very least, we want to have a multidisciplinary clinic that meets after the tumor board meeting where the patient could actually meet three or four of the clinicians involved in his or her care. The presence of the patient will show him or her that our approach is truly multidisciplinary, and that his or her personal issues and input are considered in making final treatment decisions.”

In addition, Einstein plans to incorporate more survivorship services. “Our plan is to offer survivorship strategies to all patients at the time of diagnosis and continue that through and beyond treatment,” said Tester. The NCCCP grant allows Einstein to hire a coordinator to run survivorship services.

Jablon provided an illustration of how this would work in breast health: “We do have an active cancer program and social workers. Plus, different organizations like the American Cancer Society offer a lot of programs that are integrated with our local hospital, such as Reach to Recovery and Look Good…Feel Better. We would like to make survivorship even more of a focus for our patients after they have passed through their primary treatment. For example, I just got back from a conference where they talked a lot about how we don’t integrate improvements in exercise or weight control into our cancer population. Even though we tell our patients that they need to lose weight, we offer no specific, active programs for them to go out and do that. One of my thoughts is to go out into the community and organize walking groups of cancer survivors and people interested in cancer prevention to integrate exercise into the community practice.”

Clinical trials and biospecimen research Einstein has been active in clinical trials since it was originally funded by the NCI in 1972. “We have always had a strong commitment to offering patients state-of-the-art clinical trials, and I think that is exemplified by the array of clinical trials we offer through the Eastern Cooperative Oncology Group (ECOG), the Radiation Therapy Oncology Group (RTOG), and the National Surgical Adjuvant Breast and Bowel Project (NSABP),” Solin said. “One of the things we would like to do is enhance access to clinical trials for our population through the NCCCP grant.”

Biospecimen collection, however, will be something new. “We have done a lot of clinical work at Einstein but not as much in the basic science arena,” said Tester in an interview with The Oncology Nurse. “But with the NCCCP to support our collection of biospecimens, we are going to be creating our own tissue bank, and we are going to be able to be involved in more translational research activities.” For example, Einstein currently works in collaboration with Thomas Jefferson University, which has a strong basic science program and translational research. Tester believes that Einstein’s involvement in those types of research “could increase as we put aside tumor specimens and ship them for special molecular studies, and then tie that into clinical trials where we are going to evaluate the effect of certain new targeted therapies on patients according to which molecules are expressed by their tumors. With the assistance of Corrado Minimo, MD, and our pathology department, we plan to develop a strong biomarker program this summer.”

To the future “Cancer affects not just the patient but the entire family as a unit. So our hope is to expand our program to meet the needs of not just the patient but the family unit. We are hoping we can provide a bereavement program for families of those unfortunate patients who lose the battle to cancer and, possibly, some programs that will meet the needs of children whose parents have cancer,” Raroha told The Oncology Nurse. ●

Did You Know?

In 2005, only 0.08% of US women aged 40 to 79 years without a personal history of breast cancer took tamoxifen for prevention of breast cancer, according to National Health Interview Survey data.

www.theOncologyNurse.com

TON_August 2010_FINAL_TON 8/10/10 2:46 PM Page 17

YOU INFUSE ANTHRACYCLINES, BUT ARE YOU PREPARED FOR AN EXTRAVASATION? TWO PRICE OPTIONS AVAILABLE

Totect® Kit (dexrazoxane) for injection is for intravenous infusion only. Totect is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.

First and only FDA approved treatment for anthracycline extravasation.

Supplied as a convenient and accessible complete three day treatment kit for single patient use, which should be proactively stocked on-site and infused as soon as possible and within 6 hours of an anthracycline extravasation.

Demonstrates 98% overall efficacy based on two biopsy-confirmed clinical trials1,2 in reducing or avoiding surgical intervention (i.e., surgical debridement, plastic surgery and their related costs), thereby reducing postponement of a patient’s chemotherapy treatments and the avoidance of long-term consequences.

Cited in nursing guidelines.3,4 Extravasation management is now a chemotherapy administration safety standard.5

For more information, call 866-478-8274 or visit our website at www.totect.com To order Totect®, contact one of our authorized distributors.

ASD Healthcare Cardinal Specialty McKesson/OTN Oncology Supply US Oncology (800) 746-6273 (866) 677-4844 (800) 482-6700 (800) 633-7555 (888) 987-6679 1

Mouridsen HT et al. Treatment of anthracycline extravasation with savene (dexrazoxane).

Results from two prospective clinical multicentre studies. Ann Oncol 2007; 18:546-550.

2 Totect® package insert.

3 Polovich M, White JM, Olsen, M (eds.). Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (ed 3). Pittsburgh, PA, Oncology Nursing Society, 2009.

4 Alexander M, Corrigan A, Gorski L, Hankins J, Perucca R. (eds). Infusion Nurses Society Infusion Nursing an Evidence-Based Approach (ed 3). Boston, MA, Infusion Nurses Society, 2009.

5 Jacobsen J., et al. American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards. Oncology Nursing Forum, 2009; 36:651-658. © 2010 Topotarget USA. All rights reserved. TOT0112/7-10 Totect and its logo mark are registered trademarks of Topotarget A/S 10:55:02 AM

TON_August 2010_FINAL_TON 8/10/10 2:47 PM Page 18

Totect® – Brief prescribing information Please refer to the package insert for full prescribing information. Each Totect carton contains 10 vials of Totect® (dexrazoxane for injection) 500 mg and 10 vials of 50 mL diluent. Indication: Treatment of extravasation resulting from IV anthracycline chemotherapy. Dosage and administration: Totect is a cytotoxic drug. Vial contents must be mixed and diluted before use. Totect should not be mixed or administered with any other drug during the infusion. Administration of Totect should begin as soon as possible and within 6 hours following the anthracycline extravasation. Totect should be given as an intravenous (IV) infusion once daily for 3 consecutive days. The dose of Totect is based on the patient’s body surface area: day one, 1000 mg/m2; day two, 1000 mg/m2; day three, 500 mg/m2. For patients with a body surface area of > 2 m2, a dose of 2000 mg should be given on days 1 and 2, and a dose of 1000 mg should be given on day 3. Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the first day. The Totect dose should be reduced 50% for patients with creatinine clearance values of <40 mL/minute. Cooling procedures such as ice packs should be removed from the affected area at least 15 minutes prior to Totect administration. Totect (dexrazoxane for injection) must be reconstituted with diluent supplied in the carton. The patient’s Totect dose is diluted in 0.9% 1000 mL NaCl prior to administration. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.3-5 Direct contact of Totect® with the skin or mucous membranes prior to and following reconstitution should be avoided. If contact occurs, wash immediately and thoroughly with water. Contraindications: None.

Warnings and Precautions: Myelosuppression: treatment with Totect is associated with leukopenia, neutropenia, and thrombocytopenia. Hematological monitoring should be performed. Use in Pregnancy: Pregnancy Category D. Totect can cause fetal harm when administered to a pregnant woman. There is no adequate information about the use of Totect in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Adverse reactions: The most common adverse reactions (≥ 16%) are nausea, pyrexia, injection site pain and vomiting.

www.totect.com

Rx only

Totect® is a registered trademark of Topotarget A/S US Patent No. 6,727,253B2 NDC 38423-110-01

TOT0112/7-10 © 2010 Topotarget USA

Drug Interactions: No drug interactions have been identified. Based on anecdotal reports concurrent use of topical dimethyl sulfoxide (DMSO) at the site of tissue injury may reduce the benefit of Totect. Additionally, nonclinical studies using a mouse model that simulates extravasation of anthracyclines has shown that concomitant treatment with topical DMSO decreases the efficacy of systemic dexrazoxane. Use in Specific Populations: Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of drug to the mother. Renal Impairment: Reduce the Totect dose by 50% In patients with creatinine clearance values <40 mL/min. Pediatric Use: The safety and effectiveness of Totect in pediatric patients have not been established.

Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Overdosage: There are no data on overdosage. There is no known antidote for dexrazoxane.

Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of dexrazoxane has not been investigated. Nevertheless, a study by the National Cancer Institute has reported that long term dosing with razoxane (the racemic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malignancies in rats and possibly in mice. Dexrazoxane was not mutagenic to bacteria in vitro (Ames assay), but caused significant chromosomal aberrations in mammalian cells in vitro. It also increased the formation of micronucleated polychromatic erythrocytes in mice. Thus, dexrazoxane is mutagenic and clastogenic. The possible adverse effects of Totect on the fertility of humans and experimental animals, male or female, have not been adequately studied. Testicular atrophy was seen with dexrazoxane administration at doses as low as 30 mg/kg weekly for 6 weeks in rats (about 1/5 the human dose on a mg/m2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs (about half the human dose on a mg/m2 basis).

Manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Hameln Pharmaceuticals GmbH 31789 Hameln Germany

Manufactured for: Topotarget A/S Fruebjergvej 3 DK-2100 Copenhagen Denmark

TON_August 2010_FINAL_TON 8/10/10 2:47 PM Page 19

ASCO Highlights The following articles are based on presentations at the 46th annual meeting of the American Society of Clinical Oncology held June 4-8, 2010, in Chicago.

SUPPORTIVE CARE

New Exercise Guidelines Issued for Cancer Patients

By John Schieszer

CHICAGO—Cancer patients and survivors should strive to get 150 minutes per week of moderate-intensity aerobic exercise, according to new national guidelines. That is the same recommendation for the general public.

Although the evidence indicates that most types of physical activity, from swimming to yoga to strength training, are beneficial for cancer patients, the guidelines say clinicians should tailor exercise recommendations to individual patients.

The new national guidelines (Exercise Testing and Prescription for Cancer Survivors: Guidelines from the American College of Sports Medicine) call for taking into account the patient’s general fitness level, specific diagnosis, and factors about his or her disease that might influence safety.

Change in body mass, both weight gain and weight loss related to disease symptoms and treatment side effects, is a persistent area of concern for patients with cancer. Patients with hormonebased tumors, such as breast and prostate cancers, tend to gain weight during treatment and frequently have difficulty losing it. Other patients, especially those with gastrointestinal tumors, experience weight loss caused by loss of appetite and changes in their ability to swallow and properly digest food. Both groups can benefit from exercise, according to the new guidelines.

Several published studies have shown

that exercise for weight control and reduction in body mass may actually reduce the risk of recurrence for breast cancer patients, and, ultimately, reduce breast cancer mortality. For patients with cancer-related weight loss, physical activity can help to maintain lean body mass, which can contribute to increased strength and well-being. Overall, the guidelines suggest avoiding inactivity as a means of boosting quality of life, strength, and fitness.

Kathryn Schmitz, PhD, MPH, an associate professor of epidemiology and biostatistics at the University of Pennsylvania School of Medicine, Philadelphia, presented the guidelines.

She said one of the aims of the new guidelines is to make cancer exercise rehabilitation programs as common as those offered to people who have had a myocardial infarction or undergone cardiac surgery. Schmitz led a 13-member American College of Sports Medicine expert panel that developed the new recommendations after reviewing and evaluating literature on the safety and efficacy of exercise training during and after cancer therapy.

“We have to get doctors past the ideas that exercise is harmful to their cancer patients. There is still a prevailing attitude out there that patients shouldn’t push themselves during treatment. But our message ‘avoid inactivity’ is essential,” said Schmitz. “We now have a compelling body of high-quality evi-

dence that exercise during and ther study. Age, for instance, after treatment is safe and benis a critical variable. Schmitz eficial for these patients, even noted that more research is those undergoing complex needed to determine the procedures such as stem cell effects of physical activity in transplants. If physicians want cancer patients more than to avoid doing harm, they 65 years of age and to develneed to incorporate these op interventions that may guidelines into their clinical help these patients continue Kathryn Schmitz, practice in a systematic way.” to live and function indePhD, MPH Schmitz and her colleagues pendently. The panel urges analyzed published studies relatfitness professionals to ened to five adult cancer types (breast, both hance their capacity to serve the unique during and after treatment; prostate; needs of cancer survivors. hematologic, with and without stem cell “Oncology nurses are the ones who transplant; colon; and gynecologic), and started the field of exercise and cancer. reviewed the evidence for multiple They were the ones back in the 1970s health outcomes. The panel found that and early 1980s who were trying to although there are specific risks associat- push patients to exercise to see if it was ed with cancer treatments that need to be safe,” said Schmitz in an interview with considered when patients exercise, there The Oncology Nurse. “The pioneers for is consistent evidence that exercise train- this work were nurses at Ohio State ing can lead to improvements in aerobic University.” fitness, muscular strength, quality of life, She said oncology nurses are the and fatigue in breast, prostate, and hema- most important players in getting the tologic cancer patients and survivors. message out to patients that exercise “Individuals who undergo a treat- during and after treatment can help ment for cancer often lose about 10 with fatigue, weight problems, and years worth of function. They feel slow- well-being. “The big word for the er, and it is a physiologic effect, and oncology nurse is that they are the exercise training can reverse that. ones who are going to be able to There are also effects on quality of life,” deliver this message. We don’t believe Schmitz said. that physicians are going to be the The panel found that the data for ones to deliver this message. We think colon and gynecologic cancers were oncology nurses are the way that insufficient to draw firm conclusions, information is going to get dissemiand identified several areas requiring fur- nated,” Schmitz said. ●

Risk Factors for Chemotherapy Toxicity in Elderly Identified

By Wayne Kuznar

CHICAGO—A risk stratification schema can be used to identify older patients who are at risk of grade 3 to 5 toxicity from chemotherapy. The schema includes risk factors based on cancer type, patient age, upfront dose of chemotherapy, the chemotherapeutic regimen used, and history of falling, among others, said Arti Hurria, MD. “We wanted to develop a predictive model for tolerance to therapy in older adults with cancer,” she said.

To this end, 500 cancer patients 65 years or older from seven institutions completed a prechemotherapy assessment that captured sociodemographic characteristics, tumor characteristics, treatment characteristics, laboratory values, and geriatric assessment parameters. Chemotherapy toxicity was sub-

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sequently graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.

Two physicians graded toxicity to adjudicate whether or not the toxicity was due to the chemotherapy. Patients were followed until the end of the chemotherapy regimen.

The geriatric assessment included functional status (including Karnofsky Performance Rating Scale), comorbidity, cognition, psychological status, social functioning, social support, and nutrition (body mass index and the percentage of body weight lost in the past 6 months).

The most common tumor type was lung, in 144 patients, followed by gastrointestinal (137), gynecologic (86), breast (56), urologic (50), and other (27). Sixty percent of the patients had

stage IV disease, 70% received polychemotherapy, and 18% received white blood cell growth factor with cycle 1 of treatment.

Almost half (43%) required assistance with instrumental activities of daily living (IADLs), 18% had fallen within the past 6 months, 44% had more than two comorbidities, and 38% had weight loss of at least 5% in past 6 months.

“Fifty three percent had grade 3 to 5 toxicity that was adjudicated as being secondary to chemotherapy,” said Hurria, the vast majority being grade 3 toxicity. Grade 3 to 5 hematologic and nonhematologic toxicity occurred in 26% and 43%, respectively.

The most common grade 3 to 5 hematologic toxicities were low absolute neutrophil count (11%), low

white blood cell count (10%), and low hemoglobin levels (10%); the most common nonhematologic toxicities were fatigue (16%), infection (9%), and dehydration (9%).

On the first model developed (through multivariate analysis), predictors of chemotherapy toxicity were age 73 years or older, gastrointestinal or genitourinary cancers, standard-dose chemotherapy given upfront, receipt of polychemotherapy, falls within the past 6 months, assistance required in IADLs, and decreased social activity.

Individuals with zero to two risk factors had a 34% chance of toxicity, those with three to four risk factors had a 54% chance of toxicity, and those with five to seven risk factors had an 85% risk of Continued on page 38

AugusT 2010 I VOL 3, NO 5

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ASCO Highlights PROSTATE CANCER

Cabazitaxel Improves Overall Survival in Patients with Hormone-refractory Prostate Cancer

By Wayne Kuznar

CHICAGO—Cabazitaxel is the first treatment to show a survival benefit in patients with metastatic castration-resistant prostate cancer (mCRPC), according to data from a phase 3 trial.

On June 17, cabazitaxel became the first drug approved by the US Food and Drug Administration (FDA) for the treatment of hormone-refractory prostate cancer. Results from the phase 3 trial delivered at ASCO were included in the FDA review.

“The standard of care for treating mCRPC is docetaxel, which improves both overall survival and quality of life.

At progression following docetaxel, however, there is currently no standard of care for treating these patients, although there are a number of investigational drugs being studied, and treatment in this setting is largely for palliation,” said Johann Sebastian De Bono, MD, PhD, who presented the final and updated results of the multinational trial.

Cabazitaxel is a tubulin-binding drug developed specifically to overcome the emergence of resistance to established taxanes, including docetaxel.

For this multinational trial, conducted in 146 centers in 26 countries, 755 patients with mCRPC were randomized

On June 17, cabazitaxel became the first drug approved by the US Food and Drug Administration for the treatment of hormone-refractory prostate cancer. to receive either prednisone (10 mg/day) in combination with either mitoxantrone (12 mg/m2) or cabazitaxel (25 mg/m2) administered three times weekly. Patients enrolled had received prior hormone

therapy, chemotherapy, and radiotherapy, but had progressive disease during or after treatment with docetaxel (cumulative dose ≥225 mg/m2).

Upon primary intent-to-treat analysis, overall survival in the cabazitaxel combination arm was significantly higher compared with that in the mitoxantrone arm (15.1 months vs 12.7 months, respectively; P <.0001). Recently updated results of overall survival showed that the combination of cabazitaxel and prednisone significantly reduced the risk of death by 28% (P <.0001).

Pain-free survival, response rates, and time to progression also significantly favored the cabazitaxel arm.

“The safety profile of this drug was manageable, but proactive management of side effects associated with this drug, particularly febrile neutropenia and diarrhea, has to be carefully considered when treating a patient with this drug,” said De Bono, senior lecturer at Royal Marsden

See also page 31.

Hospital, London.

The most frequent grade 3/4 hematologic adverse events in the cabazitaxel arm were neutropenia (81.7%), leukopenia (69.2%), anemia (10.5%), and febrile neutropenia (7.5%). Discontinuation of treatment due to adverse events occurred in 18.3% of patients in the cabazitaxel arm, and 8.4% of those in the mitoxantrone arm.

Deaths due to adverse events were 4.9% in the cabazitaxel arm (predominantly caused by neutropenia and its complications) versus 1.9% in the mitoxantrone arm.

“Cabazitaxel demonstrates a statistically and clinically significant improvement in overall survival—evident across all subgroups—compared with mitoxantrone in this study population.

Cabazitaxel also improved secondary end points of progression-free survival, response rate, and time to progression,” he concluded. ●

HEMATOLOGIC CANCERS

In Chronic Myeloid Leukemia, Longer Follow-up Confirms Superiority of Nilotinib Over Imatinib

By Walter Alexander

CHICAGO—Among patients with chronic myeloid leukemia (CML) in the Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients (ENESTnd) study, major molecular response (MMR) rates with nilotinib remain superior to those with imatinib after follow-up extended to a median of 18.5 months. The finding suggests that nilotinib should be “a new standard of care” in this population, according to lead investigator Richard Larson, MD, director of the leukemia program at the University of Chicago Medical Center in Chicago, Illinois. He noted that although nilotinib is the most selective inhibitor of BCR-ABL, imatinib is the current standard of care for CML. ENESTnd included 846 patients, all diagnosed with Philadelphia chromosome–positive (Ph+ CML) in chronic phase within the previous 6 months.

They were randomized to receive nilotinib 300 mg twice daily (n = 282), nilotinib 400 mg twice daily (n = 281), or imatinib 400 mg once daily (n = 283), with planned 5-year follow-up and a primary end point of MMR response (MMR, ≤ 0.1% BCR-ABLIS) at 12 months and 24 months.

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August 2010 I VOL 3, NO 5

In prior reporting of 12-month follow-up, MMRs were achieved by 44% of patients taking nilotinib 300 mg twice daily, 43% of patients taking nilotinib 400 mg twice daily, and 22% of patients taking imatinib 400 mg once daily (P <.0001 for both nilotinib groups vs imatinib). After median follow-up of 18.5 months in 525 patients, MMRs were achieved by 69% of those taking nilotinib 300 mg twice daily (n = 178), 63% of those taking nilotinib 400 mg twice daily (n = 175), and 36% of those taking imatinib 400 mg once daily (n = 172).

Among 145 patients with follow-up out to 24 months, MMR rates were 86% for nilotinib 300 mg twice daily (n = 49), 88% for nilotinib 400 mg twice daily (n = 48), and 48% for imatinib 400 mg once daily (n = 48).

Similar percentages of patients remain on treatment in all groups (80% nilotinib 300 mg twice daily; 81% nilotinib 400 mg twice daily; 75% imatinib 400 mg once daily).

Although dose escalation was not permitted in the nilotinib arms, imatinib dose escalation to 800 mg/day for suboptimal response or treatment failure

was allowed and occurred in 24%.

Progression to accelerated phase or blast crisis was reported in <1% of nilotinib patients (0.7% nilotinib 300 mg twice daily; 0.4% nilotinib 400 mg twice daily) and in 4.2% of imatinib 400-mg once-daily patients (P =

“Longer follow-up supports nilotinib as a new standard of care in patients with newly diagnosed CML.” —Richard Larson, MD

.006/.003 for nilotinib 300/400 mg twice daily versus imatinib 400-mg once-daily).

Edema was more common among patients receiving imatinib. Grade 3 to 4 adverse events were rare (<1%) across all treatments. No clinically relevant prolongations of QT interval or left ventricular ejection fraction were reported.

CML-related deaths were significantly (P = .03) less common for nilotinib 400 mg twice daily compared with imatinib (1 vs 8; 2 with nilotinib 300 mg twice daily, P = .28).

Larson concluded, “With longer follow-up, rates of MMR and CCyR [complete cytogenetic response] remain superior for nilotinib versus imatinib.

Molecular responses are continuing to deepen over time.” He added, “Longer follow-up supports nilotinib as a new standard of care in patients with newly diagnosed CML.” In response to a question about the implications of the dose findings, Larson commented, “The data from this trial show that while the efficacy of the 300- mg twice-daily dose is equivalent to that of the 400-mg, the side effect profile favors the lower dose—so that is probably the dose that will go forward.”

The US Food and Drug Administration granted nilotinib priority review status for newly diagnosed CML in February 2010, and, based on the ENESTnd results, approved the drug for adults with newly diagnosed Ph+ CML in chronic phase in June 2010. ●

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Journal of Oncology

NAVIGATION & SURVIVORSHIP

™

The Official Journal of the Academy of Oncology Nurse Navigators ® AUGUST 2010

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VOL 1, NO 3

GETTING STARTED

Launching the Navigation Program that Is Best for You. Part 1: Defining Your Program Leadership Council

By Dawn Lagrosa

Lillie Shockney, RN, BS, MAS Johns Hopkins Breast Center Johns Hopkins University School of Medicine Baltimore, Maryland

CHICAGO—For those involved in successful navigation programs were navigation, or those who have looked presented by a panel of nurses and into starting navigation programs, one administrators at the third annual thing is evident: No two programs are Oncology Update of the American exactly the same. However, the advan- College of Oncology Administrators. tages of patient navigation can be had “Navigation is even a buzzword in our by all—academic centers, community Capitol,” said Bonnie Miller, RN, BSN, cancer centers, hospitalOCN, who chaired the panel. based centers, multiple Miller, who is administrative location groups. Despite director of the Women’s Cancer the various models of navCenter at Fox Chase, Philaigation, the goal remains delphia, noted that recent legisthe same, to help healthlation has paved the road for care consumers access and navigation. chart a course through the The Patient Navigator, Outhealthcare system and reach, and Chronic Disease Preovercome barriers to qualvention Act of 2005 identified, Bonnie Miller, RN, ity care. from a legislative point of view, BSN, OCN Multiple strategies to what navigators should do:

Sharon Gentry, RN, MSN, AOCN, CBCN Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, North Carolina Nicole Messier, RN Vermont Cancer Center Burlington, Vermont Pamela Matten, RN, BSN, OCN St. Joseph Hospital Orange, California Elaine Sein, RN, BSN, OCN, CBCN Fox Chase Cancer Center Partners Rockledge, Pennsylvania Tricia Strusowski, MS, RN Helen F. Graham Cancer Center Christiana Care Health System Newark, Delaware Linda Fleisher, MPH, PhD(c) Fox Chase Cancer Center Cheltenham, Pennsylvania Susan M. Gardner, RN, CBEC, CBCN Valley Medical Center Renton, Washington Jay R. Swanson, RN, BSN, OCN Saint Elizabeth Cancer Institute Lincoln, Nebraska Carol Lewis, RN, BSN, OCN, CRNI Memorial Hermann The Woodlands, Texas

• Anticipate, identify, and help patients overcome barriers within healthcare systems • Assist in coordination of healthcare services and referrals • Help and facilitate involvement of community organizations • Assist individuals at risk for either cancer or other chronic disease.

“Those of you who are navigators, if you look at your job descriptions, some of those things are a part of it,” said Miller. But each program is different, as is each navigator. “Before you implement a navigation program, remember that one size does not fit all. You have to review your current system and look at your gaps in care,” Miller explained.

Continued on page 2

CARE PLANS

Oncology Nurses Need More Training for Survivorship Planning

By Jill Stein

SAN DIEGO—New survey results indicate that although most oncology nurses believe that survivorship planning for cancer patients is their responsibility, often they do not consider themselves sufficiently prepared to knowledgeably discuss survivorship issues with patients and their families.

The findings were reported at the

35th Annual Congress of the Oncology Nursing Society.

Joanne Lester, PhD, CRNP, ANPBC, AOCN, research scientist/nurse practitioner at James Cancer Hospital in Columbus, Ohio, presented the results of an online survey that assessed oncology nurses’ knowledge about survivorship care planning.

“Survivorship planning is a relatively new component of the overall management of cancer patients,” Lester, who is also clinical assistant professor at Ohio State University College of Nursing, pointed out.

In recent years, the Institute of Medicine has called on healthcare proContinued on page 3

AONN Staff Sean T. Walsh Executive Director sean@aonnonline.org

AY D TO 00 R E $2 T E S GI SAV E R & September

First Annual Navigation and Survivorship Conference 17-19, 2010 • Baltimore, Maryland www.AONNonline. org ©2010 Green Hill Healthcare Communications, LLC

TON_August 2010_FINAL_TON 8/10/10 2:47 PM Page B2

Launching the Navigation Program that Is Best for You... Continued from cover “When we launched our breast cancer navigation program at Fox Chase, we did a gap analysis regarding the entire breast service line and we found a great opportunity in the intake systems. We had wonderful schedulers, but they were finding that the patients were asking so many clinical questions, that support was need up front. That way the scheduler could work on scheduling an appointment and getting the demographic and the financial data. We connect the nurse navigator on the phone to the patients that day.

It was an immediate gap, and an immediate opportunity.”

Existing staff should be consulted.

Any good program will need buy-in from the physicians and participation from other clinical staff. You need to “identify the fact that the navigator will not take their job, or the nurse educator job, or the scheduler job. The navigator is a layer laid on top of the existing program to connect the dots with patients through the continuum,” Miller noted.

One way to promote success and avoid pitfalls, she suggested, is to define the navigator’s role clearly, realizing that it will evolve over time.

tional travel time and lost time from work,” DeAntonio noted. In addition, in rural eastern North Carolina, there are barriers such as delays in care, fragmentation of care, distrust of the healthcare system, fear or refusal of care, lack of insurance and transportation, and cultural beliefs.

The program began with just one navigator. An experienced RN case manager was chosen specifically because she “was well-versed in identifying the medical, psychosocial, and emotional needs of her patients as an RN case manager,” according to DeAntonio.

Navigation usually begins at the point of the suspicious finding, because “this is when our patients need the most information and guided support on what to do, especially someone who has never been sick or has never been active in the healthcare system.”

The goals of the program were set and the role of the navigator defined.

DeAntonio encouraged “anyone who wants to develop a navigation program, to develop criteria from the start of the program to make sure the nurse is focusing on her role and the other members of the healthcare team are focusing on theirs. This keeps from muddying the waters, especially if the volumes increase.”

Goals of navigation include improved illness status, improved coordination of services for patients, increased patient adaptation to her illness, and timelier delivery of services. The navigator’s duties include: • Educate patients and their families • Participate in community education health fairs, screenings, and other prevention and early detection programs • Participate in educational events and tumor conferences • Create liaison between healthcare team members and patient • Link patients with appropriate resources and services throughout the community • Address survivorship issues, contributing to the survivorship care plan.

Pitt County Memorial Hospital Greenville, North Carolina Pitt County Memorial Hospital (PCMH), the largest of six hospitals in the University Health Systems of Eastern Carolina, is a teaching hospital accredited by the American College of Surgeons Commission on Cancer.

PCMH has 861 licensed beds, and in addition to cancer, provides heart, women’s, children’s, trauma, neuroscience, and bariatric services. It serves a 29-county referral area and, with some of its tertiary services, that area increases to 55 counties. PCMH is also affiliated with the Brody School of Medicine, East Carolina University.

In October 2007, PCMH “recognized the need to address patients’ needs across the continuum, from diagnosis to survivorship,” explained Phyllis DeAntonio, RN, MSN, FAAMA, the cancer services administrator who presented the model used at her center. The navigation program was pilot-tested to serve gynecology and Patient- and family-centered care The nurse navigator at breast cancer patients, who PCMH educates not only were among the groups idenpatients but also their famitified as having many issues lies. Education topics include with continuity of care and their diagnosis and treatment, care coordination. as well as how to avoid secThe registered nurse (RN) ondary cancers. For family navigator’s duties were develmembers, she stresses prevenoped to meet the needs of the tion and early detection and population. “Our service area coordinates specific services a is quite extensive, and patients may travel 2 to 3 Phyllis DeAntonio, family may need. For examhours to our facility. If a RN, MSN, FAAMA ple, a breast cancer patient may fear that her family patient is seeing two to three specialists, it is more convenient to see members are at risk. The navigator can them on the same day, to eliminate addi- bring in a genetic counselor while they

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August 2010 I VOL 1, NO 3

are at the clinic.

The navigator considers the immediate needs as well as the future needs of the patient. “If a patient is on her service, the navigator follows that patient from inpatient to outpatient to home and back. She may even follow the patient to hospice or homecare,” DeAntonio said.

The navigator also links patients with appropriate resources and services throughout the community, such as support groups. She promotes healthy lifestyles with patients who have cancer and also with their families. She helps patients adapt to their illness and follow the treatment plan by utilizing their coping mechanisms to help them move forward and survive their cancers, according to DeAntonio.

For patients who need support because of their socioeconomic situation (eg, illiteracy, uninsured, underinsured), the navigator works to remove those barriers. “She looks at their financial resources; she looks at educational materials for them from the National Cancer Institute or the American Cancer Society; she addresses their survivorship issues.”

hospitals, CKHS diagnoses a little more than 2000 cancer cases per year.

After an initial setback, CKHS restarted its program by establishing goals and defining what would be considered success. To start, “we looked at outreach,” explained Marie DeStefano, RN, MSN, FAAMA, administrative director of oncology, who presented the CKHS model for navigation services. “We wanted to look at early screening and diagnosis, and we focused on the barriers—financial, internal systems, and communication.” Physicians were involved in the design of the program from the beginning, which she emphasizes is important for any such program. The first positions were the breast care patient navigators.

Breast navigators CKHS currently has three breast navigators. Criteria were developed as to when they would become involved with patients. CKHS captures data on patients during mammography screening. The navigator intervenes when a patient’s BI-RADS score is 4 or 5, even before she knows if the patient has a The “right” navigator malignancy. There is one breast navigaA nurse navigator is a role requiring tor at each of the main hospitals and a a high level of interpersonal skills, third who works exclusively with empathy, and coordination ability. uninsured and underinsured women.

“You need to find someone who knows This nurse is an expert at getting about the disease/disease process, is patients medical assistance, developing compassionate, and most important— extensive knowledge of the support is a good listener,” DeAntonio services and financial services available. advised.

The job duties are the same Because the navigator for the two navigators of position requires the nurse insured patients: patient eduto serve as a liaison between cation and navigating patients the physicians and the through the health system. patients and the rest of the However, each has her own healthcare team, hiring method of helping patients someone who can handle traverse the system. “At one of these relationships is very the campuses, the nurse naviimportant, she said. The Marie DeStefano, gator is contacted if there is a nurse she hired was an expe- RN, MSN, FAAMA patient with an abnormal rienced RN case manager finding or who is BI-RAD 4 or with 12 years of oncology experience. 5. She comes down and walks the “Sometimes she can anticipate what the patient right up to the breast surgeon’s physician is going to say about a patient’s office. If the breast surgeon is not availplan of care, before she even makes the able but the nurse practitioner is, the call. She knows the physicians very well. nurse practitioner sees the patient the She knows how they treat their same day. Together they are able to get patients,” DeAntonio said. The naviga- the patient scheduled with the surgeon, tor also needs the fortitude to advocate and then to get a biopsy,” DeStefano for the patients and do whatever is in the explained. “The navigator at the other patients’ best interest. site goes with everyone to get a biopsy and then communicates with them Crozer-Keystone Health System once the pathology findings are final. In Delaware County, Pennsylvania addition, both navigators go to the hosCrozer-Keystone Health System pital to see their patients when they are (CKHS) is a five-hospital health system hospitalized. in a very competitive market located The navigators are also responsible near several major medical centers in for community outreach activities. For the Philadelphia area. The largest hos- example, they work with local soccer pital, Crozer-Chester Medical Center, leagues to raise awareness of breast canhas 371 beds, a cancer center, trauma cer and encourage women to schedule unit, and burn center. Across the five mammograms. www.AONNonline.org

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Lung and colon navigators This year, CKHS hired two lung and colon navigators, both of whom work with both lung and colon patients. A navigator meets with all lung cancer patients who are scheduled for a computed tomography–guided biopsy. The pathology department faxes all the positive results to the nurse navigator, in conjunction with the patients’ primary care physicians, so that she can reach out to them for education, scheduling, and support.

For patients undergoing testing for colon cancer, the navigator goes to the endoscopy suite, and, if there are any suspicious findings, introduces herself and helps schedule appointments with the medical oncologist or the surgeon as appropriate.

A “good fit” “When we started to look at navigation, we started to think who did we want, what did we expect from them, when should services begin, when should services end, and what’s the goal of the position,” DeStefano said. At CKHS, the search for the right navigator faced the unique challenge of meeting the potential navigator’s need to do what she believes is best for her patient and also meeting the administration’s need to keep patients from leaving the system for better-known local hospitals. DeStefano discusses with candidates that the program’s goal is to make sure the patient gets the best quality care in a prompt timeframe, and if a patient wants to go to another center for a second opinion, she will help them. She is careful to note, however, that at CKHS “we believe that we deliver quality cancer care that compares or surpasses other local community hospitals, so our goal is to decrease outmigration of patients, assuring patients quality care in a prompt timeframe.”

Community Cancer Center Normal, Illinois The Community Cancer Center in Normal, Illinois, is located in a community of about 120,000 people. It is a joint venture of the two healthcare systems in its community, Advocate BroMenn Medical Center and OSF Health Care Systems represented by OSF St. Joseph Medical Center in BloomingtonNormal. The Community Cancer Center houses outpatient cancer services and offers a full complement of supportive services. Medical oncology is represented by two independent groups that lease space at the center. Radiation oncology is staffed by employed physicians.

Surgery is not offered at the center.

The Community Cancer Center opened 11 years ago to meet the cancer needs of its community. According to Barb Nathan, executive director, who presented her center’s model, “Our aim as a community cancer center has never been to just affect patient care inside of our building.

And that’s the challenge when you are talking about a community setting, because all the rest of cancer care— the surgical intervention, the issues of early detection—happen outside of our building. Our goal is to facilitate the continuum, and that’s what brought us to patient navigation.”

In 2005, the Community Cancer Center began its initiative to improve breast services. Using a national dashboard, the center found that it should be doing a better job. The next step was to identify physician champions in all of the specialties, who then worked with the center’s administration to create a flowchart of the typical patient’s process through the local healthcare system. The group also determined any challenges that had to be overcome as they went forward. This initiative led to the Comprehensive Breast Service at the Community Cancer Center, with navigation included.

“That’s the challenge when you are talking about a community setting, because all the rest of cancer care— the surgical intervention, the issues of early detection—happen outside of our building. Our goal is to facilitate the continuum.” —Barb Nathan

This program was designed to provide patients multidisciplinary treatment planning, which required the development of a breast tumor board.

It was decided that the breast services navigator must be an RN who could do a variety of different things as required in a small center.

The navigator’s job responsibilities were defined as follows: • Facilitate the treatment decided on by the breast tumor board • Provide comprehensive education and support to patients • Provide community education • Develop and run survivor and support services • See about a third of all breast cancer patients each year • Educate professionals in the community, specifically teach nursing students about breast disease.

Community-centered care Most of the navigator’s referrals come at the point of diagnosis, not at the time of a suspicion of disease. Referrals come from surgeons, radiation oncologists, and medical oncologists, and patients can self-refer to the navigator. “One of the beauties of the Community Cancer Center is we treat everyone. Patients don’t have to be seeing a doctor at our place to get the services of the navigator, the social worker, or the dietician.”

The navigator also runs the survivor and support services. She works with a

program called reNEW™, which is a 4-week nutrition, exercise, and wellness program for breast cancer survivors. The program is followed by an ongoing support initiative, allowing participants to get together every 4 weeks in a support group to monitor their plans for their nutrition, exercise, and wellness. In addition, she developed a lymphedema class and coordinates the Reach to Recovery and the Look Good…Feel Better program.

Community education and outreach also fall to the navigator. With the center’s master’s prepared nurse, the navigator provides community education and a program for breast selfexaminations. In addition, she participates in the multicultural leadership program in the community.

“One Size Does Not Fit All” As these three models illustrate, there are many ways to set up a navigation program. In each, the core goal of helping patients traverse their journey through cancer care remains the same. It is hoped that these models will help all nurses reduce the disparities in and increase access to cancer care as well as improve the timeliness of care, no matter where your system is in the road to formal navigation programs. ●

Part 2 of this series will discuss tracking and reporting outcome measures of these navigation programs.

Oncology Nurses Need More Training... Continued from cover fessionals who are involved with cancer survivors to develop a comprehensive and methodical follow-up plan for patients upon completion of their cancer treatment. “Oncology nurses must embrace the challenge,” she said.

Lester and her colleagues examined knowledge about survivor care planning in nurses working in a National Cancer Institute–designated comprehensive cancer center.

The survey aimed to identify gaps in knowledge that is considered “indispensable” for the implementation of cancer survivorship care planning.

Overall, 90% of respondents said they believed that cancer survivorship planning was a nursing responsibility.

However, many nurses believe they www.AONNonline.org

are ill-equipped to discuss important survivorship issues. “For example,

families,” Lester observed.

In addition, the percent of nurses who

“Oncology nurses are able to provide important knowledge on some components of survivorship; however, their level of knowledge in some areas is suboptimal.”

—Joanne Lester, PhD, CRNP, ANP-BC, AOCN

fewer than 40% said that they had the knowledge to address such issues as osteoporosis screening, prevention, and treatment with patients and their

said they are knowledgeable enough to discuss employment issues was only 29%, 20% for genetic risks, 18% for insurance issues, and 13% for postcancer fertility.

In contrast, 83% said they are knowledgeable about discussing skin protection, and 82%, 79%, and 78%, said they are knowledge about discussing diet, exercise, and fatigue, respectively.

“Our findings thus show that oncology nurses are able to provide important knowledge on some components of survivorship; however, their level of knowledge in some areas is suboptimal,” Lester observed.

“The take-home message for oncology nurses is to try to understand the basic concepts of cancer survivorship care planning and start with at least one segment of the plan,” she said.

“Several forms are available online that are easy to complete.” ● August 2010 I VOL 1, NO 3

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LONG-TERM FOLLOW-UP

Risk-based Screening Detects Toxicities in Childhood Cancer Survivors, Even 30 Years Later

By Wayne Kuznar

CHICAGO—Even as many as 30 years after childhood cancer, risk-based screening may detect previously undiagnosed cancer-related toxicity in a substantial number of survivors.

This discovery comes from an evaluation of the St. Jude Lifetime (SJLIFE) study, which was presented at the 2010 annual meeting of the American Society of Clinical Oncology.

“Research has established that adverse cancer-related late effects may result in premature onset of common diseases associated with aging,” said Melissa M. Hudson, MD, lead investigator, pediatric hematologist/oncologist, the St. Jude Children’s Research

Hospital, Memphis. “Risk-based screening identifies individuals who may be candidates for interventions designed to slow or prevent progression of subclinical disease.”

Seven-hundred thirty-two patients taking part in SJLIFE underwent risk-based assessments appropriate for cancer diagnosis and treatment as recommended by the Children’s Oncology Group Long-term Followup Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers. To be included in the study, patients had to be at least 10 years from diagnosis.

Risk-based assessments were derived

from several factors abstracted from patient records, including chemotherapy cumulative doses, radiation fields and doses, and survival procedures.

Ninety percent of the cohort was white, non-Hispanic. Their median age at diagnosis was 7.0 years, and at evaluation it was 36.3 years. The median time from their cancer diagnosis was 27.5 years. Primary diagnoses included acute lymphoblastic leukemia, lymphoma, and solid tumor.

For survivors at risk for adverse pulmonary outcomes (ie, patients treated with lung radiotherapy, and/or bleo mycin and/or nitrosoureas), the yield from screening was 33% for pul-

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The Official Journal of the Academy of Oncology Nurse Navigators ®

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3. Waters R, Pettypiece S. Drug sales in the US grow at slower pace as generic use surges. Bloomberg news, March 12, 2008. www. bloomberg.com/apps/news?pid=newsarchive&sid=aLfUw7_sYMRY. Accessed March 13, 2008.

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monary fibrosis and 33% for pulmonary dysfunction.

For survivors at risk of cardiac toxicities (ie, those treated with anthracycline and/or heart radiotherapy), the yield from screening was 29% for a heart valve disorder, 12% for a conduction disorder, and 11% for cardiomyopathy.

For those determined to be at risk for neurologic or neurosensory outcomes (ie, childhood treatment with cisplatin/carboplatin and/or vincristine/vinblastine, and/or radiotherapy of a neurosensory organ), screening detected hearing loss in 30%, neuropathy in 24%, and cataracts in 9%.

Screening revealed a 9% yield for hypogonadism in women treated with alkylating agents in childhood.

Screening men who had radiotherapy to the hypothalamic-pituitary-gonadal axis administered during childhood led to a discovery of abnormal semen analysis in 60% and hypogonadism in 10%.

Twenty-three percent of survivors had dyslipidemia after exposure to cisplatin or carboplatin during childhood, 29% of those treated with methotrexate or corticosteroids had bone mineral density deficit, and 1% to 3% had chronic hepatitis (B or C) with a history of transfusion.

Among survivors at risk for adverse adrenal outcomes (radiotherapy to the hypothalamic-pituitary axis), 39% had a suggestion of adrenocorticotropic hormone deficiency (based on low morning cortisol levels) and 3% were hypothyroid. Five percent treated with thyroid radiotherapy had thyroid nodules discovered on screening.

Among those at risk for renal toxicity, 3% were found to have proteinuria, 2% hematuria, <1% renal insufficiency, and <1% tubular disorder.

In those at risk for subsequent cancers (exposure to alkylating agents, epipodophyllotoxins, and/or any radiotherapy), there were 17 new primary cancers (9 breast cancers in women who had breast radiation).

Eleven percent of survivors at risk for cardiomyopathy had an ejection fraction <55% on echocardiography screening “and the prevalence of the late effect was 15%,” said Hudson.

The yield from screening for heart valve disorder was 29%, and the prevalence of heart valve disorders (late effect) in this cohort was 35%. Among those at risk for breast cancer after radiation, the yield of screening was 9%, and the prevalence of breast cancer in those at risk was 16%. ●

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ASCO Highlights SKIN CANCER

By Wayne Kuznar

CHICAGO—A human monoclonal antibody that blocks a receptor that downregulates T-cell responses improves long-term survival in patients with previously treated advanced melanoma, according to the results of a phase 3 trial.

“This is the first time we have shown a survival benefit in metastatic melanoma,” said Steven O’Day, MD, lead investigator of the study, and chief of research and director of the melanoma program at The Angeles Clinic and Research Institute in Los Angeles.

“What is equally impressive is the near doubling in the 1-year and 2-year landmark overall survival analyses.”

The study was a head-to-head comparison of treatments in 676 patients with previously treated, unresectable stage III or IV melanoma. There were three treatment arms: monotherapy with ipilimumab (n = 137), gp100 peptide vaccine alone (n = 136), and the combination of these two agents (n = 403).

Ipilimumab is a fully human monoclonal antibody that blocks the CTLA4 receptor (CTLA-4 is an antigen found on T cells that downregulates the T-cell response) and potentiates Tcell activation. gp100 is a vaccine that produces T-cell–specific immune responses, and served as the active control arm for this study.

“By blocking CTLA-4, ipilimumab keeps the T-cell potentiated and hopefully leads to antitumor immunity,” O’Day explained.

Patients in both ipilimumab arms achieved improvements in overall survival. In the gp100 vaccine plus placebo group, median overall survival was 6.4 months, which is comparable with results with placebo in previous studies. In each of the two arms receiving ipilimumab, median overall survival was 10.0 months.

One-year survival was 44% in patients who received combination treatment with ipilimumab plus vaccine, and 46% in those treated with ipilimumab alone, compared with 25% in the gp100 vaccine group. Two-year survival was 22% and 24%, respectively, compared with 14% in patients in the vaccine group.

Better disease control was also seen in both groups treated with ipilimumab. After 6 months, melanoma progression was halted in approximately 30% of patients, compared with only 11% of those who received the gp100 vaccine alone.

Serious adverse events were more common in both ipilimumab arms, at 17.4% and 22.9%, respectively, compared with

www.TheOncologyNurse.com

11.4% in the gp100 plus placebo arm.

Of significance are the side effects with ipilimumab related to the immune system. These occurred in two thirds of the ipilimumab arm patients and in only one third of the gp100 vaccine group. In ipilimumab-treated patients, T cells began attacking normal tissue at sites, the most

common being dermatologic, gastrointestinal, endocrine, and hepatic tissue.

“Ipilimumab represents a new class of T4 potentiators, and an important advance for the field of immunooncology,” O’Day said. “Further development of ipilimumab is ongoing. We are very interested in looking at alternative combina-

© ASCO/Phil McCarten 2010

New Monoclonal Antibody Treatment Offers Hope for Treatment of Metastatic Melanoma

Steven O’Day, MD

tions with this drug, as well as in refining its dosage and schedule.” ●

Presents the Third Annual Curriculum for

CONSIDERATIONS IN MULTIPLE MYELOMA A Newsletter Series for Cancer Care Professionals Center of Excellence Media, along with Editor-in-Chief Sagar Lonial, MD, of Emory University, are pleased to offer your multidisciplinary cancer team this series of newsletters focusing on the challenges of treating patients with multiple myeloma.

SAGAR LONIAL, MD Associate Professor of Hematology and Oncology Emory University School of Medicine

★ Earn Continuing Education Credits ★ 8-part newsletter series

CASE STUDY DISCUSSIONS: • Front-line Therapy

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• Bone Health

Each newsletter will feature: • Contributions from thought-leading physicians, nurses, and pharmacists

• Continuing Education credits available to physicians, nurses, and pharmacists

PARTICIPATE TODAY at www.COEXM.com For complete learning objectives and accreditation information, please refer to each activity.

Target Audience These activities were developed for physicians, nurses, and pharmacists.

These activities are jointly sponsored by

These activities are supported by an educational grant from Millennium Pharmaceuticals, Inc.

AugusT 2010 I VOL 3, NO 5

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Conference News ONS

The following articles are based on presentations at the 35th Annual Congress of the Oncology Nursing Society held in San Diego, California, May 13-16, 2010.

A Multidisciplinary Program Prevents Falls in Cancer Inpatients

By Jill Stein

SAN DIEGO—A program that calls for direct communication between interdisciplinary caregivers may help decrease falls in a hematology/oncology inpatient unit, according to data reported by Boston researchers.

Deborah O’Connor, RN, MS, CNML, at the Brigham and Women’s Hospital in Boston, and her colleagues presented the results of a falls prevention program that was “piloted” in a hematopoietic stem cell transplant (HSCT) unit at a tertiary academic teaching hospital.

The intervention involved collaboration between nurses, physician/physician assistants (PAs), and pharmacists. “While fall prevention is frequently considered the responsibility of nursing staff, all members of the healthcare team have a role in maintaining patient safety,” said O’Connor, who is nursing director of hematology/oncology.

minimized. The team may also consult with the psychiatry and physical therapy departments to address fall risk factors

associated with acute impairments in cognition and mobility.

The pharmacist typically conducts an

independent review of medications prescribed to patients who have been identified as high risk by the team and then

With the intervention, nurses assess fall risk in high-risk patients at least once during both the day and night shifts using the Morse Fall Scale.

Nurses assess fall risk in high-risk patients at least once during both the day and night shifts using the Morse Fall Scale. Nurses note on the patient’s chart if the patient’s score exceeds 45, which indicates a high risk of a fall. The score is later communicated to the nurse in charge of that patient on the next shift.

Each day-shift nurse caring for a highrisk HSCT patient initiates a discussion of safety measures during the morning rounds with other members of the HSCT team.

Sara Close, PA-C, who works with O’Connor, explained that the physician and PA aim to ensure that safety measures reviewed by the nursing staff are reinforced to the patient and his or her family during team rounds each morning when the physician and PA examine the patient and develop a plan for the day.

The PA communicates the Morse Falls Score to the team during the presentation of vital signs and clinical events overnight, and the score is used to guide the conversation about patient safety with the patient and family.

The team also consults with the pharmacist to make sure that high-risk medications are avoided or their risks are

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August 2010 I VOL 3, NO 5

Neulasta® (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Neulasta® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information Do not administer Neulasta® to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Splenic rupture, including fatal cases, can occur following the administration of Neulasta®. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta®.

Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta®. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta® for ARDS. Discontinue Neulasta® in patients with ARDS. Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta®. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta® in patients with serious allergic reactions.

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Conference News makes recommendations to the team about changes in drug regimens that might be needed to curb the risk of falls.

Important safety measures include: • High-risk fall signs • Comfort rounds • Identification of fall risk on the problem list • Bed alarms • Keeping the patient close to the nursing station

• Removing clutter; keeping assistive devices close to the patient • Keeping patient call bell within patient reach.

Overall, nine patients in the unit where the program was implemented were identified as being at high risk of a fall. At the time of the ONS meeting 6 months after the start of the program, no patient had sustained a fall.

O’Connor pointed out that although

the sample size in the study was small, her group hopes that “our intraprofessional communication model” will be adopted by other teams on the current unit and extended to other inpatient oncology units.

“We believe that direct communication between interdisciplinary caregivers influences the patient’s understanding and compliance with the established care plan to prevent in-

juries from falls,” she said. “In addition, integrating a discussion of fall risk and a plan for high-risk patients during medical rounds with various disciplines may be beneficial because it introduces the potential for a wider range of perspectives and interventions. Daily discussion of patient safety goals by team members holds promise for a simple but effective model to decrease negative outcomes for our patients.” ●

Help reduce the risk of infection in patients receiving moderate-risk* chemotherapy regimens

Act before febrile neutropenia strikes Potential consequences of febrile neutropenia may be serious and can impact patient care First- and every-cycle Neulasta® achieved: ■ 94% reduction in febrile neutropenia (17% placebo vs 1% Neulasta®; P < 0.001).1,2 ■ 93% reduction in febrile neutropenia–related hospitalization (14% placebo vs 1% Neulasta®; P < 0.001).1,2 ■ 80% reduction in febrile neutropenia–related IV anti-infective use (10% placebo vs 2% Neulasta®; P < 0.001).1,2

Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta®. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.

The granulocyte colony-stimulating factor (G-CSF) receptor, through which pegfilgrastim and filgrastim act, has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded.

Bone pain and pain in extremity occurred at a higher incidence in Neulasta®-treated patients as compared with placebotreated patients.

Please see brief summary of Neulasta® Prescribing Information on the adjacent page. *Regimens associated with ≥ 17% risk of febrile neutropenia.

References: 1. Vogel C, et al. J Clin Oncol. 2005;23:1178-1184. 2. Neulasta® (pegfilgrastim) Prescribing Information. Thousand Oaks, Calif: Amgen. © 2010 Amgen. All rights reserved.

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Conference News

Oncology Nurses Can Improve the Safety of Chemotherapy Disposal

By Jill Stein

SAN DIEGO—Oncology nurses can implement simple measures to ensure the safe disposal of cytotoxic therapies,

according to Baltimore researchers.

The measures are aimed at reducing the hazards posed by chemotherapy dis-

posal to neighboring communities and the environment.

According to standard policy at most

References: 1. Vogel C, et al. J Clin Oncol. 2005;23:1178-1184. 2. Neulasta® (pegfilgrastim) Prescribing Information. Thousand Oaks, Calif: Amgen.

BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

CONTRAINDICATIONS Neulasta is contraindicated in patients with known hypersensitivity to E coli-derived proteins‚ pegfilgrastim‚ Filgrastim, or any other component of the product.

WARNINGS General The safety and efficacy of Neulasta for peripheral blood progenitor cell (PBPC) mobilization has not been evaluated in adequate and well-controlled studies.

Neulasta should not be used for PBPC mobilization.

Splenic Rupture SPLENIC RUPTURE, INCLUDING FATAL CASES, HAS BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA AND ITS PARENT COMPOUND, FILGRASTIM. PATIENTS RECEIVING NEULASTA WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. Acute Respiratory Distress Syndrome (ARDS) Acute respiratory distress syndrome (ARDS) has been reported in patients receiving Neulasta, and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs. Patients receiving Neulasta who develop fever, lung infiltrates, or respiratory distress should be evaluated for the possibility of ARDS. In the event that ARDS occurs, Neulasta should be discontinued and/or withheld until resolution of ARDS and patients should receive appropriate medical management for this condition.

Allergic Reactions Allergic reactions to Neulasta, including anaphylaxis, skin rash, urticaria, and erythema/flushing have been reported in postmarketing experience. The majority of reported events occurred upon initial exposure. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Neulasta should be permanently discontinued in patients with serious allergic reactions.

Sickle Cell Disorders Severe sickle cell crises have been associated with the use of Neulasta in patients with sickle cell disorders. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. Only physicians qualified by specialized training or experience in the treatment of patients with sickle cell disorders should prescribe Neulasta for such patients, and only after careful consideration of the potential risks and benefits.

PRECAUTIONS General Use With Chemotherapy and/or Radiation Therapy Neulasta should not be administered in the period between 14 days before and 24 hours after administration of cytotoxic chemotherapy (see DOSAGE AND ADMINISTRATION) because of the potential for an increase in sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy.

The use of Neulasta has not been studied in patients receiving chemotherapy associated with delayed myelosuppression (eg, nitrosoureas, mitomycin C).

The administration of Neulasta concomitantly with 5-fluorouracil or other antimetabolites has not been evaluated in patients. Administration of pegfilgrastim at 0, 1, and 3 days before 5-fluorouracil resulted in increased mortality in mice; administration of pegfilgrastim 24 hours after 5-fluorouracil did not adversely affect survival.

The use of Neulasta has not been studied in patients receiving radiation therapy.

Potential Effect on Malignant Cells Pegfilgrastim is a growth factor that primarily stimulates neutrophils and neutrophil precursors; however, the G-CSF receptor through which pegfilgrastim and Filgrastim act has been found on tumor cell lines, including some myeloid, T-lymphoid, lung, head and neck, and bladder tumor cell lines. The possibility that pegfilgrastim can act as a growth factor for any tumor type cannot be excluded. Use of Neulasta in myeloid malignancies and myelodysplasia (MDS) has not been studied. In a randomized study comparing the effects of the parent compound of Neulasta, Filgrastim, to placebo in patients undergoing remission induction and consolidation chemotherapy for acute myeloid leukemia, important differences in remission rate between the two arms were excluded. Disease-free survival and overall survival were comparable; however, the study was not designed to detect important differences in these endpoints.* Information for Patients Patients should be informed of the possible side effects of Neulasta and be instructed to report them to the prescribing physician. Patients should be informed of the signs and symptoms of allergic drug reactions and be advised of appropriate actions. Patients should be counseled on the importance of compliance with their Neulasta treatment, including regular monitoring of blood counts.

If it is determined that a patient or caregiver can safely and effectively administer Neulasta (pegfilgrastim) at home, appropriate instruction on the proper use of Neulasta (pegfilgrastim) should be provided for patients and their caregivers, including careful review of the “Information for Patients and Caregivers” insert.

Patients and caregivers should be cautioned against the reuse of needles, syringes, or drug product, and be thoroughly instructed in their proper disposal.

A puncture-resistant container for the disposal of used syringes and needles should be available.

Laboratory Monitoring To assess a patient’s hematologic status and ability to tolerate myelosuppressive chemotherapy, a complete blood count and platelet count should be obtained before chemotherapy is administered. Regular monitoring of hematocrit value and platelet count is recommended.

Drug Interaction No formal drug interaction studies between Neulasta and other drugs have been performed. Drugs such as lithium may potentiate the release of neutrophils;

patients receiving lithium and Neulasta should have more frequent monitoring of neutrophil counts.

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone-imaging results.

Carcinogenesis, Mutagenesis, and Impairment of Fertility No mutagenesis studies were conducted with pegfilgrastim. The carcinogenic potential of pegfilgrastim has not been evaluated in long-term animal studies.

In a toxicity study of 6 months duration in rats given once weekly subcutaneous injections of up to 1000 mcg/kg of pegfilgrastim (approximately 23-fold higher than the recommended human dose), no precancerous or cancerous lesions were noted.

When administered once weekly via subcutaneous injections to male and female rats at doses up to 1000 mcg/kg prior to, and during mating, reproductive performance, fertility, and sperm assessment parameters were not affected.

Pregnancy Category C Pegfilgrastim has been shown to have adverse effects in pregnant rabbits when administered subcutaneously every other day during gestation at doses as low as 50 mcg/kg/dose (approximately 4-fold higher than the recommended human dose). Decreased maternal food consumption, accompanied by a decreased maternal body weight gain and decreased fetal body weights were observed at 50 to 1000 mcg/kg/dose. Pegfilgrastim doses of 200 and 250 mcg/kg/dose resulted in an increased incidence of abortions. Increased post-implantation loss due to early resorptions was observed at doses of 200 to 1000 mcg/kg/dose, and decreased numbers of live rabbit fetuses were observed at pegfilgrastim doses of 200 to 1000 mcg/kg/dose, given every other day.

Subcutaneous injections of pegfilgrastim of up to 1000 mcg/kg/dose every other day during the period of organogenesis in rats were not associated with an embryotoxic or fetotoxic outcome. However, an increased incidence (compared to historical controls) of wavy ribs was observed in rat fetuses at 1000 mcg/kg/dose every other day. Very low levels (< 0.5%) of pegfilgrastim crossed the placenta when administered subcutaneously to pregnant rats every other day during gestation.

Once weekly subcutaneous injections of pegfilgrastim to female rats from day 6 of gestation through day 18 of lactation at doses up to 1000 mcg/kg/dose did not result in any adverse maternal effects. There were no deleterious effects on the growth and development of the offspring and no adverse effects were found upon assessment of fertility indices.

There are no adequate and well-controlled studies in pregnant women. Neulasta should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Nursing Mothers It is not known whether pegfilgrastim is excreted in human milk. Because many drugs are excreted in human milk‚ caution should be exercised when Neulasta is administered to a nursing woman.

Pediatric Use The safety and pharmacokinetics of Neulasta were studied in 37 pediatric patients with sarcoma. The mean (± Standard Deviation) systemic exposure (AUC0-inf) of Neulasta after subcutaneous administration at 100 mcg/kg was 22.0 (±13.1) mcg·hr/mL in the 6–11 years age group (n = 10), 29.3 (±23.2) mcg·hr/mL in the 12–21 years age group (n = 13) and 47.9 (±22.5) mcg·hr/mL in the youngest age group (0–5 years, n = 11).

The terminal elimination half-lives of the corresponding age groups were 20.2 (±11.3) hours, 21.2 (±16.0) hours and 30.1 (±38.2) hours, respectively. The most common adverse reaction was bone pain.

The 6 mg fixed dose single-use syringe formulation should not be used in infants, children, and smaller adolescents weighing less than 45 kg.

Geriatric Use Of the 932 patients with cancer who received Neulasta in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients.

ADVERSE REACTIONS (See WARNINGS, Splenic Rupture, Acute Respiratory Distress Syndrome (ARDS), Allergic Reactions, and Sickle Cell Disorders.)

Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Neulasta cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to Neulasta use and for approximating rates.

The data described below reflect exposure to Neulasta in 932 patients.

Neulasta was studied in placebo- and active-controlled trials (n = 467, and n = 465, respectively). The population encompassed an age range of 21 to 88 years. Ninety-two percent of patients were female. The ethnicity of the patients was as follows: 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian.

Patients with solid tumors (breast [n = 823], lung and thoracic tumors [n = 53]) or lymphoma (n = 56) received Neulasta after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles.

In the placebo-controlled trial, bone pain occurred at a higher incidence in Neulasta-treated patients as compared to placebo-treated patients. The incidence of other commonly reported adverse events were similar in the Neulasta- and placebo-treated patients, and were consistent with the underlying cancer diagnosis and its treatment with chemotherapy. The data in Table 1 reflect those adverse events occurring in at least 10% of patients treated with Neulasta in the placebo-controlled study.

Table 1. Adverse Events Occurring in ≥ 10%a of Patients in the Placebo-Controlled Study Event Alopecia Bone Painb Diarrhea Pyrexia (not including febrile neutropenia) Myalgia Headache Arthralgia Vomiting Asthenia Peripheral Edema Constipation

Neulasta (n = 467) 48% 31% 29%

Placebo (n = 461) 47% 26% 28%

23%

22%

21% 16% 16% 13% 13% 12% 10%

18% 14% 13% 11% 11% 10% 6%

a

Events occurring in ≥ 10% of Neulasta-treated patients and at a higher incidence as compared to placebo-treated patients Bone pain is limited to the specified adverse event term “bone pain”

b

In the active controlled studies, common adverse events occurred at similar rates and severities in both treatment arms (Neulasta, n = 465; Filgrastim, n = 331).

These adverse experiences occurred at rates between 72% and 15% and included: nausea, fatigue, alopecia, diarrhea, vomiting, constipation, fever, anorexia, skeletal pain, headache, taste perversion, dyspepsia, myalgia, insomnia, abdominal pain, arthralgia, generalized weakness, peripheral edema, dizziness, granulocytopenia, stomatitis, mucositis, and neutropenic fever.

Bone Pain The analysis of bone pain described below is based on a composite analysis using multiple, related, adverse event terms.

In the placebo-controlled study, the incidence of bone pain was 57% in Neulasta-treated patients compared to 50% in placebo-treated patients.

Bone pain was generally reported to be of mild-to-moderate severity.

Among patients experiencing bone pain, approximately 37% of Neulasta-and 31% of placebo-treated patients utilized non-narcotic analgesics and 10% of Neulasta- and 9% of placebo-treated patients utilized narcotic analgesics.

In the active-controlled studies, the use of non-narcotic and narcotic analgesics in association with bone pain was similar between Neulasta-and Filgrastimtreated patients. No patient withdrew from study due to bone pain.

Laboratory Abnormalities In clinical studies, leukocytosis (WBC counts > 100 x 109/L) was observed in less than 1% of 932 patients with nonmyeloid malignancies receiving Neulasta. Leukocytosis was not associated with any adverse effects.

Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment. None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors, including sample handling, concomitant medications, and underlying disease. Therefore, comparison of the incidence of antibodies to Neulasta with the incidence of antibodies to other products may be misleading.

Cytopenias resulting from a neutralizing antibody response to exogenous growth factors have been reported on rare occasions in patients treated with other recombinant growth factors. There is a theoretical possibility that an antibody directed against pegfilgrastim may cross-react with endogenous G-CSF, resulting in immune-mediated neutropenia. This has not been observed in clinical studies of Neulasta.

Postmarketing Experience The following adverse reactions have been identified during postapproval of Neulasta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• splenic rupture (see WARNINGS: Splenic Rupture) • acute respiratory distress syndrome (ARDS) (see WARNINGS: Acute Respiratory Distress Syndrome) • allergic reactions (including anaphylaxis, skin rash, urticaria, erythema/flushing) (see WARNINGS: Allergic Reactions) • sickle cell crisis (see WARNINGS: Sickle Cell Disorders) • injection site pain • Sweet’s syndrome (acute febrile dermatosis) OVERDOSAGE The maximum amount of Neulasta that can be safely administered in single or multiple doses has not been determined. Single subcutaneous doses of 300 mcg/kg have been administered to 8 healthy volunteers and 3 patients with non-small cell lung cancer without serious adverse effects. These patients experienced a mean maximum ANC of 55 x 109/L, with a corresponding mean maximum WBC of 67 x 109/L. The absolute maximum ANC observed was 96 x 109/L with a corresponding absolute maximum WBC observed of 120 x 109/L. The duration of leukocytosis ranged from 6 to 13 days. Leukapheresis should be considered in the management of symptomatic individuals.

DOSAGE AND ADMINISTRATION The recommended dosage of Neulasta is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. Neulasta should not be administered in the period between 14 days before and 24 hours after administration of cytotoxic chemotherapy (see PRECAUTIONS).

The 6 mg fixed-dose formulation should not be used in infants, children, and smaller adolescents weighing less than 45 kg.

No dosing adjustment is necessary for renal dysfunction.

Neulasta should be visually inspected for discoloration and particulate matter before administration. Neulasta should not be administered if discoloration or particulates are observed.

Rx Only This product, its production, and/or its use may be covered by one or more US Patents, including US Patent Nos. 5,824,784; 4,810,643; 4,999,291; 5,582,823; 5,580,755, as well as other patents or patents pending.

REFERENCE *Heil G, Hoelzer D, Sanz MA, et al. A randomized, double-blind, placebocontrolled, phase III study of Filgrastim in remission induction and consolidation therapy for adults with de novo Acute Myeloid Leukemia.

Blood. 1997;90:4710-4718. v.10 Issue Date: 11/2008

Manufactured by: Amgen Manufacturing, Limited, a subsidiary of Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 © 2002–2009 Amgen Inc. All rights reserved.

MC45288

Amanda Choflet, BSN, RN, OCN

cancer centers, chemotherapy waste is collected in designated yellow plastic containers, which are disposed of as regulated medical waste and incinerated, Amanda Choflet, BSN, RN, OCN, nurse manager of the Blood and Marrow Transplant Unit at the University of Maryland Medical Center, pointed out.

Choflet and her colleagues found, however, that there was no scientific basis to support the practice. What’s more, yellow plastic containers, popularly referred to as “yellow buckets,” may be harmful to individuals and the environment when manufactured and disposed of.

The group recommends that the use of yellow plastic containers be discontinued. Red biohazard containers (the same ones used for sharps disposal) should be used instead for the disposal of trace chemotherapy. Bulk chemotherapy, greater than 3% of the original dose, should be handled as hazardous waste and disposed of in black containers.

“These practice changes mean that all biohazard waste can be streamlined into one container,” Choflet observed.

Preliminary results using the new strategy have been encouraging. “We can now save the roughly $40,700 that our institution spent each year on the purchase of yellow chemotherapy buckets plus the estimated $2600 on the disposal of yellow buckets including their contents,” she said. In addition, about 10,000 lb of plastic are now diverted from the incinerator each year, she added.

Choflet explained that concern about the environmental damage caused by purchasing and waste disposal practices at her cancer center and elsewhere prompted her group to examine the “greening” of chemotherapy.

The energy used to manufacture polypropylene yellow chemotherapy containers, which constitute the majority of yellow chemotherapy containers, along with the combustion of used containers cause emission of greenhouse gases and other toxic by-products, she said.

Also, patients who live near medical waste incinerators have higher rates of cancer, heart disease, diabetes, and learning disabilities. “Preventing unContinued on page 25

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August 2010 I VOL 3, NO 5

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Conference News

Local ONS Chapters Use Creative Strategies to Recruit, Retain Members, Strengthen Community Ties

By Karen Rosenberg

SAN DIEGO—Creative strategies used by local chapters of the Oncology Nursing Society (ONS) to recruit and retain members and reach out to their local communities were described in poster presentations at the 2010 Congress. Using these strategies, the chapters not only increased membership but also strengthened ties with their communities.

San Diego ONS chapter meets goal of 210 by 2010 With the prospect of hosting the 35th ONS Congress in 2010, the San Diego, California, 2008 chapter president set a goal of having 210 members by 2010.

Thanks to the efforts of the chapter members, membership increased by more than 50% from 134 members in 2008 to 205 in December 2009. By April 2010, the chapter reached its goal and then some. Membership was at 219.

Chapter committees were formed, drawing up detailed plans with a 2-year timeline. The members used innovative interventions to recruit and retain members. Methods for recruitment included: • Creating a network of nurse liaisons to verbally communicate to nurses in their practice about chapter events, distribute applications, and answer questions

Oncology Nurses Can Improve...

Continued from page 24

necessary waste from reaching the incineration facilities protects these vulnerable communities,” she said.

Choflet’s group reviewed a comprehensive body of literature on chemotherapy waste disposal methods and found a complete lack of evidence to justify the use of yellow plastic containers for chemotherapy and the incineration of such containers.

“That’s why we decided to remove the yellow buckets,” she said.

Finally, she noted that additional opportunities for change include the use of smaller flush bags with chemotherapy, the implementation of measures to ensure that recycling containers are available in patient care areas, and the implementation of a paper recycling program aimed at protecting patient privacy. ●

www.TheOncologyNurse.com

• Developing a PowerPoint presentation and presenting it to nurses in practices that lacked membership • Reaching out to student nurses by offering free dinner meetings, guidance, and mentorship • Holding contests for membership recruitment efforts and meeting attendance • Using an e-mail campaign to national ONS members who were not local chapter members.

Efforts to retain members included: • Offering eight $400 educational scholarships per year • Offering a discount for 2-year membership • Holding meetings in all areas of the county • Offering continuing education units at dinner meetings.

This dramatic increase has proved beneficial on many levels. Chapter efforts continue, with the chapter now developing a strong community presence.

According to Ellie Flores, past president of the San Diego ONS chapter, “We feel that our nursing colleagues and employers throughout the county truly value the nurse who belongs to the Oncology Nursing Society. We also hope that by sharing these interven-

tions with other chapters we have established an effective model for chapter growth and development.”

Richmond chapter rekindles the flame The Richmond, Virginia, chapter of ONS also made efforts to revitalize their membership and get back to their original goals and mission. As described by Jennifer Graff, RN, OCN, CHPN, of Thomas Johns Cancer Hospital, the chapter set specific goals, including: • Establishing a scholarship program to send someone to ONS Congress • Fundraising for community events • Holding organized business meetings • Improving members’ accountability • Increasing chapter participation • Creating a local chapter website • Involving chapter members in national ONS interests.

With direction provided by the ONS Leadership Development Institute and the ONS Mentorship Weekend, the chapter took steps to achieve these goals, including recruiting volunteers to establish the chapter website and chair a scholarship committee. Through the efforts of the scholarship committee, the chapter was able to send a represen-

tative to Congress and community outreach programs are planned.

Ann Arbor chapter reaches out to community Jeanne McDonagh, MSN, RN, OCN, and Tsu-Yin Wu, PhD, RN, of Eastern Michigan School of Nursing, Ypsilanti, reported on a project carried out by the Ann Arbor, Michigan, chapter of ONS. Chapter members collaborated with a local school of nursing, local school districts, and other organizations to design, implement, and evaluate a colorectal cancer (CRC) screening and awareness project in an underserved community.

The project team trained community health nursing students as program facilitators to deliver interventions in middle school and high school classrooms. A total of 1800 students received the interventions and wrote letters to their significant others and family members about the importance of CRC screening. The project increased participants’ awareness of CRC and their intention to be screened. The success of this project, the investigators said, shows that “oncology chapters and individuals can develop this type of intervention to make a significant impact in their communities.” ●

Diverse Educational Programs Keep Oncology Nurses Up to Date

By Jill Stein

SAN DIEGO—Oncology nurses who work in an adult community–based practice can remain abreast of new information provided that a range of options for continuing education (CE) is available, according to a new study.

“The provision of multiple CE opportunities is important in a busy practice environment where most nurses are certified by OCN/AOCN and need continuing education credits to maintain certification,” Sandra Purl, RN, MS, AOCN, oncology nurse clinical specialist at Oncology Specialists, S.C. in Park Ridge, Illinois, observed.

“What’s more, the availability of programs in a variety of formats that provide information on a variety of clinical topics with instruction by a variety

of healthcare professionals has meant that most of our nurses have been able to retain their ONS certification.”

It is essential for oncology nurses to establish and maintain a strong knowledge base in order to provide optimal care for their patients, who often have complex management issues.

It is essential for oncology nurses to establish and maintain a strong knowledge base in order to provide

optimal care for their patients, who often have complex management issues, she said.

Purl outlined a list of some of the programs available to oncology nurses in her practice: • Interdisciplinary meetings known as “Stump the Chump,” where difficult cases that have been referred to oncologists in the practice are discussed. The oncemonthly hour-long meeting is routinely attended by physicians and staff from the pharmacy, nursing, and billing departments, and in recent years, members of the palliative care and ethics services. Among the topics to Continued on page 38

AugusT 2010 I VOL 3, NO 5

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ASCO Highlights BREAST CANCER

Novel Agents Improve Survival in Refractory Metastatic Breast Cancer CHICAGO—Several new agents elicited excitement for the treatment of women with advanced breast cancer, including a novel cytotoxic agent that is the first to improve survival as monotherapy in this challenging patient population.

In an international study, patients with metastatic breast cancer refractory to numerous treatments lived 2.5 months longer when treated with eribulin mesylate, a synthetic analog of the novel halichondrin B family, versus single agents alone.

Principal investigator Christopher Twelves, MD, of the University of Leeds in the United Kingdom, said, “The improvement is statistically significant and clinically meaningful for these women with a poor prognosis.”

The Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice versus Eribulin (EMBRACE) was a global, randomized, open-label phase 3 trial involving 762 metastatic breast cancer patients who had received a median of four prior chemotherapy regimens. Most were estrogen receptor–positive and human epidermal growth factor receptor type 2 (HER2)negative, and about half had two or more metastatic sites.

Patients were randomized 2:1 to eribulin given intravenously twice a month every 3 weeks or to a treatment of physician’s choice (TPC), which could be any single agent—cytotoxic, endocrine, or biologic—approved for the treatment of cancer.

“We allowed physician’s choice because there is no single established standard and we felt it was inappropriate to restrict the options. This was a real-life comparison,” Twelves noted.

Overall survival improved by 2.5 months Median overall survival (OS), the primary end point, improved from 10.65 months with standard singleagent therapy to 13.12 months with eribulin, representing a 19% reduction in mortality risk (P = .04). One-year survival was 53.9% with eribulin and 43.7% in the TPC arm.

“The benefits were achieved with a manageable toxicity,” Twelves an nounced. Serious adverse events (AEs) were observed in 25% of each arm, and AEs leading to treatment interruption, dose delays, and interruptions and discontinuations were similar.

“EMBRACE is the first phase 3 singleagent study in heavily pretreated

www.TheOncologyNurse.com

metastatic breast cancer to meet its primary end point of prolonged overall survival, so these are striking findings,” Twelves concluded. “The 2.5-month improvement in median survival represented a 23% benefit. We see these findings as potentially establishing eribulin as a new option.”

Eric P. Winer, MD, head of medical oncology at Dana-Farber Cancer Center, Boston, commented at a press briefing that a 2.5-month improvement is “a difference that is sufficient to make one look seriously at this agent.”

T-DM1 effective after trastuzumab A small phase 1 trial found that trastuzumab conjugated to DM-1 (TDM1), with or without the monoclonal antibody pertuzumab, was efficacious in women with advanced HER2positive breast cancers who were previously treated with trastuzumab. T-DM1 is a HER2-targeted antibody drug conjugate composed of the cytotoxic agent DM1 (an antimicrotubule agent) conjugated to the monoclonal antibody

© ASCO/Todd Buchanan 2010

By Caroline Helwick

“The 2.5-month improvement in median survival represented a 23% benefit. We see these findings as potentially establishing eribulin as a new option.” —Christopher Twelves, MD

trastuzumab. Pertuzumab is a monoclonal antibody that binds to a different HER2 receptor than T-DM1.

The theory is that the use of these agents in combination will offer complementary modes of action that will more fully cover the HER receptors and thus be more effective in treating HER2-overexpressing tumors.

The study has so far enrolled 44 patients with advanced or metastatic HER2-positive breast cancers, all of whom had previously received tras tuzumab. Outcomes were reported for 28 of the participants, 10 of whom

had partial responses, for a 36% response rate, when treated with TDM1 and pertuzumab, according to Kathy Miller, MD, of Indiana University, Indianapolis.

Edith Perez, MD, the Serene M. and Frances C. Durling Professor of Medicine at the Mayo Clinic, Jacksonville, commented, “The use of two targeted agents in these advanced breast cancer patients is a reasonable approach to therapy.” ● For more ASCO coverage, go to www.theoncologynurse.com/asco.

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This curriculum is supported by Cooperative Agreement U27 DD00326 from the Centers for Disease Control and Prevention.

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

Medications Used for the Treatment of Colorectal Cancer Colon cancer forms in the tissues of the colon (the longest part of the large intestine). Most colon cancers are adenocarcinomas (cancers that begin in cells that make and release mucus and other fluids). Rectal cancer forms in the tissues of the rectum (the last several inches of the large intestine closest to the anus). The following sections will assist healthcare professionals and payers by providing appropriate coding, billing, and reimbursement information associated with the management of colorectal cancer.

The following sections include: • Associated ICD-9-CM codes used for the classification of colorectal cancer • Drugs that have been FDA-approved in the treatment of colorectal cancer • Drugs that are Compendia listed for off-label use for colorectal cancer based on clinical studies that suggest beneficial use in some cases. Please note: if a check mark appears in the FDA column it will NOT appear in the compendia off-label use column • Corresponding HCPCS/CPT® codes and code descriptions • Current Code Price (AWP-based pricing) • Most recent ASP plus 6% (Medicare allowable), if applicable • Possible CPT® Administration Codes for each medication

28

generic (Brand) name

HCPCS code: code description

bacillus Calmette-Guerin (Tice BCG, TheraCys) bevacizumab (Avastin) capecitabine (Xeloda) capecitabine (Xeloda) carmustine (BiCNU) cetuximab (Erbitux) cisplatin (Platinol AQ) cisplatin (Platinol AQ)

J9031: bCG (intravesical), per installation J9035: injection, bevacizumab, 10 mg J8520: capecitabine, oral, 150 mg J8521: capecitabine, oral, 500 mg J9050: injection, carmustine, 100 mg J9055: injection, cetuximab, 10 mg J9060: cisplatin, powder or solution, per 10 mg J9062: cisplatin, 50 mg

August 2010 I VOL 3, NO 5

Associated ICD-9-CM Codes Used for Colorectal Cancer 153 Malignant neoplasm of colon Excludes: benign carcinoid tumor of colon (209.50-209.56) malignant carcinoid tumor of colon (209.10-209.16) 153.0 Hepatic flexure 153.1 Transverse colon 153.2 Descending colon Left colon 153.3 Sigmoid colon Sigmoid (flexure) Excludes: rectosigmoid function (154.0) 153.4 Cecum Ileocecal valve 153.5 Appendix 153.6 Ascending colon Right colon 153.7 Splenic flexure 153.8 Other specified sites of large intestine Malignant neoplasm of contiguous or overlapping sites of colon whose point of origin cannot be determined Excludes: ileocecal valve (153.4) rectosigmoid junction (154.0) 153.9 Colon, unspecified Large intestine, not otherwise specified 154 Malignant neoplasm of rectum, rectosigmoid junction, and anus Excludes: benign carcinoid tumor of rectum (209.57) malignant carcinoid tumor of rectum (209.17) 154.0 Rectosigmoid junction Colon with rectum Rectosigmoid (colon) 154.1 Rectum Rectal ampulla 154.8 Other Anorectum Cloacogenic zone Malignant neoplasm of contiguous or overlapping sites of rectum, rectosigmoid junction, and anus whose point of origin cannot be determined

FDAapproved for colorectal cancer

Compendia listed off-label use for colorectal cancera

✓

Current code price (AWP-based pricing), effective 7/1/10

Medicare allowable (ASP + 6%), effective 7/1/10-9/30/10

CPT® administration codes

$169.10

$110.31

96413, 96415

✓

$66.99

$58.45

96413, 96415

✓

$8.52

$6.86

96413, 96415

✓

$28.41

$22.48

96413, 96415

$205.69

$176.15

96413, 96415

$57.60

$49.73

96413, 96415

✓

$4.33

$1.89

96409, 96413, 96415

✓

$21.66

$9.45

96409, 96413, 96415

✓ ✓

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

generic (Brand) name

HCPCS code: code description

doxorubicin (Adriamycin) floxuridine (FUDR) fluorouracil (Adrucil) irinotecan (Camptosar) leucovorin calcium (Wellcovorin)

J9000: injection, doxorubicin hydrochloride, 10 mg J9200: injection, floxuridine, 500 mg J9190: injection fluorouracil, 500 mg J9206: injection, irinotecan, 20 mg J0640: injection, leucovorin calcium, per 50 mg J0641: injection, levoleucovorin calcium, 0.5 mg

levoleucovorin calcium (Fusilev) lomustine (CeeNu) lomustine (CeeNu) methotrexate sodium methotrexate sodium mitomycin (Mutamycin) mitomycin (Mutamycin) mitomycin (Mutamycin) mitoxantrone (Novantrone) oxaliplatin (Eloxatin) panitumumab (Vectibix) pemetrexed (Alimta) teniposide (Vumon) topotecan (Hycamtin) topotecan (Hycamtin) vinCRIStine (Vincasar) vinCRIStine (Vincasar) vinCRIStine (Vincasar)

FDAapproved for colorectal cancer

Compendia listed off-label use for colorectal cancera

Current code price (AWP-based pricing), effective 7/1/10

Medicare allowable (ASP + 6%), effective 7/1/10-9/30/10

CPT® administration codes

✓

$13.20

$2.94

✓

$121.06

$43.10

✓

$3.37

$1.48

96409

✓

$31.48

$6.79

96413, 96415

✓

$3.60

$0.95

96372, 96374, 96409

✓

$1.54

$0.65

96365, 96366

J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0178: lomustine, oral, 10 mg

✓

✓

NDC level pricing $10.59

J9250: methotrexate sodium, 5 mg J9260: methotrexate sodium, 50 mg J9280: mitomycin, 5 mg

✓

$0.29

NDC level pricing S0178: not payable by Medicare $0.19

✓

$2.86

$1.92

✓

$67.20

$20.19

96372, 96374, 96401, 96409, 96450 96372, 96374, 96401, 96409, 96450 96409

J9290: mitomycin, 20 mg

✓

$218.40

$80.74

96409

J9291: mitomycin, 40 mg

✓

$300.00

$161.48

96409

J9293: injection, mitoxantrone hydrochloride, per 5 mg J9263: injection, oxaliplatin, 0.5 mg J9303: injection, panitumumab, 10 mg J9305: injection, pemetrexed, 10 mg Q2017: injection, teniposide, 50 mg J8705: topotecan, oral, 0.25 mg J9350: injection topotecan, 4 mg J9370: vincristine sulfate, 1 mg J9375: vincristine sulfate, 2 mg J9380: vincristine sulfate, 5 mg

✓

$106.50

$40.88

96409, 96413

✓

$8.25

$4.46

96413, 96415

✓

$101.85

$87.24

96413, 96415

✓

$60.67

$51.69

96409

✓

$376.55

$324.27

✓

$89.73

$74.59

✓

$1,306.10

$1,058.74

96413

✓

$7.22

$4.53

96409

✓

$14.44

$9.06

96409

✓

$36.10

$22.65

96409

96409 96422, 96423, 96425

N/A

N/A

96413, 96415 N/A

Continued on page 30

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems Continued from page 29

Compendia references available upon request.

When billing a non-classified medication using a CMS 1500 claim form you must include both the HCPCS code (ie, J8999 for CeeNu) in Column 24D and the drug name, strength, and National Drug Code (NDC) in Box 19 in order to ensure appropriate reimbursement. a

b

References HCPCS Level II Expert 2010 • Current Procedural Terminology (CPT®) 2010 • ICD-9-CM for Professionals Volumes 1 & 2 2010 • The Drug Reimbursement Coding and Pricing Guide by RJ Health Systems International, LLC, Volume 7, Number 3, 3rd Quarter 2010 • FDA-approved indication (from product’s prescribing information) • National Cancer Institute® • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Wethersfield, Connecticut • CMS (Centers for Medicare & Medicaid Services)—Medicare Allowable 3rd Quarter 2010 (effective dates 7/1/109/30/10).

Prices listed herein are effective as of July 1, 2010.

ASP indicates average sales price; AWP, average wholesale price; CMS, Centers for Medicare & Medicaid Services; CPT®, Current Procedural Terminology; FDA, US Food and Drug Administration; HCPCS, Healthcare Common Procedure Coding System; NDC, National Drug Code.

This information was supplied by:

PO BOX 290616, Wethersfield, CT 06109 T: (860) 563-1223 • F: (860) 563-1650 www.RJHealthSystems.com

NURSING CAREERS

Rita Wickham Wins ONS Publishing Award

By Karen Rosenberg

cles, book chapters, and monographs, primarily on supportive care and palliative care topics, and is a member of The Oncology Nurse editorial board as well as ONS and other nursing and oncology organizations.

R

ita Wickham, PhD, RN, AOCN, of Rapid River, Michigan, received the Rose Mary CarrollJohnson Distinguished Award for Consistent Contribution to Nursing Literature at the 35th Annual Congress of the Oncology Nursing Society (ONS).

The award recognizes the impact the recipient has made on the oncology nursing profession using the written word to share research findings, describe content basic to the care of patients with cancer, and support the professional development of colleagues. Dr Wickham received her bachelor and master of science in nursing degrees from Northern Illinois University and her doctorate from the University of Illinois. An associate professor at Rush University College of Nursing in Chicago, she has written arti-

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August 2010 I VOL 3, NO 5

How did you first get involved in research and publishing?

When I started to work in medical oncology at Rush in 1982, I worked with a group of oncology clinical nurse specialists. Almost everybody who worked there had a master’s degree, which was very unusual at that time, and these nurses had the title Practitioner Teacher. It was a great model that emulated the medical model at Rush and assumed that professionals with advanced degrees would not only be clinicians but also educators as well.

My colleague Michelle Goodman, who is widely published, was my mentor and coach along with my other nurse colleagues. These colleagues invited me to write with them and gave me constructive feedback to improve my writing, which is what I would recommend to new writers. It’s very hard to start writing by oneself.

What did you write about?

I wrote about clinical things I encountered in my practice, mainly on symptom management and quality-of-life issues. The first major paper I wrote that was published in Oncology Nursing Forum in 1982 was on chemotherapyinduced nausea and vomiting—a prob-

“When I write an article or chapter, I try to take complex concepts and distill and translate them down to essential nursing components.” lem I was not sure would be of interest to oncology nurses.

Now that I don’t have a clinical position, I have more time to write, which is a luxury for many nurses. I focus first on learning the normal underlying physiology and the pathogenesis and components of a problem I am writing about. This has always been the way I approached nursing; if I understood normal anatomy and physiology, I could better understand a patient’s medical and collaborative problem and formulate nursing management. When I write an article or chapter, I try to take complex concepts and distill and translate them down to essential nursing components.

What advice would you give to aspiring writers?

I have taken a couple of writing courses, and I would recommend that to others interested in writing. They can be invaluable in terms of helping you understand that you shouldn’t use 1000 words if 100 words will do, that simple words are generally more effective than more complex words, such as “use” instead of “utilize,” and to distill and write content so that it makes sense to clinicians.

I sometimes tell people that I write what I call “the idiot’s version,” and I don’t mean that in a derogatory sense at all. What I mean is that I try to make it clear enough so that all readers can go away with greater understanding. I try to do the same thing when I do lectures and oral presentations. If there’s a layperson in the audience and they tell me they understood what I said, I feel good about that because that is the point—to make the message clear so it gets across.

When a nurse or a couple of nurses who work in the same institution, particularly if they’ve worked there for a long time, are writing an article, it’s very useful to get the perspective of somebody who works in a different clinical area or a different institution. This broadens your perspective on the topic.

Also, I always encourage someone who has given a good presentation to consider writing it up. The hardest thing is to get started. I tell people when you write, just write something. It doesn’t matter if it’s grammatically correct, just write. You can come back to it later on and revise it. I’m happy to serve as coach for anyone who has an idea and wants some help getting started in writing about it. ●

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Prostate Cancer

New Evidence Shows that Large-scale Prostate Cancer Screening Saves Lives See also page 20.

By Jill Stein

SAN FRANCISCO—Two new studies presented at the 2010 annual meeting of the American Urological Association (AUA) suggest that large-scale prostate cancer screenings can indeed save lives.

Researchers in Innsbruck, Austria, evaluated data from the state of Tyrol within Austria, where an early detection and treatment program has been in place for more than 20 years. They found that these programs have been associated with a reduction in mortality in areas where effective treatment is available to all men.

The Tyrol Project was started in 1988, offering free prostate-specific antigen (PSA) testing to men aged 45 to 75years beginning in 1993. Approximately 120,000 men were screened. In men with organ-confined lesions, prostatectomy was recommended (2153 radical prostatectomies were performed); 86.3% of patients with T1 or T2 disease were treated with low-morbidity radical prostatectomy; 8.7% received brachytherapy; and 8.7% received radiotherapy. After 1 year, 95.1% of men were continent, and potency was preserved in 78.9% of men younger than 65 years of age.

The researchers found that since 1996, there was a significant reduction in mortality from prostate cancer in Tyrol. In the years 2003-2008, prostate cancer mortality rates decreased by 48% (2003), 55% (2004), 52% (2005), 49% (2006), 41% (2007), and 64% (2008). In other states within Austria, there were also

declines in prostate cancer mortality, but the percentages in those areas were only approximately 30%. The investigators concluded that when screening and treatment are available and free, prostate cancer mortality is decreased by population-wide screening efforts.

NNS and NNT to save one life with PSA screening One way of decreasing prostate cancer deaths is through screening with PSA serum testing. However, the tradeoff between reducing prostate cancer deaths through screening and possible overdiagnosis and overtreatment is the subject of continuing intense debate.

In 2009, prospective, randomized clinical trials of prostate cancer screening reported disparate results, with the Prostate, Lung, Colorectal, Ovarian Cancer (PLCO) trial finding no mortality benefit and the European Ran domized Study of Screening for Prostate Cancer (ERSPC) showing a 20% mortality benefit (30% in men actually screened). The ERSPC researchers estimated, however, that at a median follow-up of 9 years, 1410 men would need to be screened (number needed to screen [NNS]) and 48 treated (number needed to treat [NNT]) to avoid one prostate cancer death. The most frequently quoted and troubling statistic to clinicians and patients alike is the estimate that 48 men need to be treated to prevent one prostate cancer

death, which is very high compared with an NNT of 10 for breast cancer screening.

Alternative explanations for a high NNT could be that screening overdetects a large proportion of indolent cancers or that the limited follow-up of the ERSPC population overestimated the

When screening and treatment are available and free, prostate cancer mortality is decreased by population-wide screening efforts. true NNS and NNT. Using extrapolated data from the ERSPC, a multicenter team of researchers set out to discover the true NNS for prostate cancer and the true NNT to save one life as well as to assess the effect of follow-up times on these calculations.

Based on published ERSPC data, researchers from Chicago and Baltimore estimated the cumulative hazard ratios and NNS/NNT out to 12 years of follow-up. At year 10, the model yielded an NNS of 837 and NNT of 29, similar to the ERSPC report. However, by year 12, the NNS decreased to 503 and the NNT was 18. Noting that the NNS and NNT to save one life are directly affected

by the length of follow-up, the researchers concluded that more than 10 years of follow-up may be necessary to truly show the value of populationbased prostate cancer screening. A prominent feature of prostate cancer screening is that the benefits take a long time to achieve and the true magnitude of overdiagnosis and overtreatment remain largely unquantified.

“The Tyrol study shows the benefits of freely available PSA testing and the importance of effective treatment once cancer is found,” said AUA spokesman Christopher Amling, MD, a professor of urology at Oregon Health & Science University, Port land. “Although the ERSPC screening study showed a significant mortality reduction with PSA screening, it also showed that with early follow-up, a relatively large number of men need to be screened and treated to prevent one prostate cancer death. By extrapolation of data from the ERSPC trial, the researchers from Chicago and Baltimore were able to demonstrate that with longer follow-up, the NNS and NNT are significantly lower, suggesting that the value of PSA-based screening may be greater than this study suggests.”

Amling said the AUA believes that early detection of and risk assessment for prostate cancer should be offered to asymptomatic men 40 years of age or older who have a life expectancy of at least 10 years. ●

3D-EBRT for Prostate Cancer May Increase Risk of Hip Fracture SAN FRANCISCO—Prostate cancer patients undergoing three-dimensional external beam radiation therapy (3DEBRT) for prostate cancer may be at an increased risk of hip fracture and could benefit from additional measures to improve bone health following treatment, according to a study by Minneapolis researchers. They presented new data at the 2010 annual meeting of the American Urological Association (AUA) suggesting that prostate cancer patients treated with 3D-EBRT may be at significantly more risk of fracture than previously recognized.

EBRT has been shown to increase hip fracture risk in women but little is

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known regarding how significantly EBRT impacts a man’s risk. Until now, studies have not looked at whether

Undergoing 3D-EBRT increased a man’s risk of hip fracture by 58%, without increasing the risk of wrist fracture.

EBRT’s impact on a man’s risk for fracture extends beyond the radiation field.

Shaheen Alanee, MD, a medical

resident in urologic surgery at the University of Minnesota, Minneapolis, and colleagues identified 166,162 prostate cancer patients, aged 66 years and older, in the Surveillance, Epidemiology, and End Results database. The investigators compared hip fracture risk (inside the radiation field) with wrist fracture risk (outside the radiation field) in men who had undergone 3D-EBRT and those who had not. After controlling for those who were undergoing androgen suppression therapy (AST), which weakens bones, as well as other risk factors, including osteoporosis, race, and age, the researchers determined that

undergoing 3D-EBRT increased a man’s risk of hip fracture by 58%, without increasing the risk of wrist fracture.

Patients being treated with AST had an increased risk of both types of break.

“Maintaining bone health is an important part of treating prostate cancer patients, particularly those on AST,” said urologist Jeff Holzbeierlein, MD, who is an AUA spokesman.

“These data suggest that we might consider taking similar measures with our patients who are receiving threedimensional external beam radiation therapy.” ● —JS

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Psychosocial Issues

A Team Approach to Psychosocial Care

By Susan S. Hendrick, PhD Horn Professor of Psychology, Texas Tech University, Lubbock Everardo Cobos, MD Professor and Associate Dean for Oncology Programs; Division Chief, Oncology/Hematology, Texas Tech University, School of Medicine, Lubbock Vasia Craddick, RNC, BSN Director of Clinical Operations, Southwest Cancer Treatment and Research Center, Lubbock, Texas

Case Report Karen is a 35-year-old married mother of two (Anna, age 11 and Kevin, age 9), who is a high school history teacher. She visited her primary care physician after she found a lump in her breast.

Subsequent testing confirmed there was a small mass.

She was diagnosed with stage II, non–estrogendependent cancer in her left breast. Treatment

involved lumpectomy, radiation, and chemotherapy—as well as patient education, navigation through the healthcare system, and individual, couple, and family counseling. The individual counseling focused on anxiety, depression, and the pressure to think positive. The couple counseling focused on patient and caregiver stresses, caregiver burden, and communica-

Left to right, front row: Kristin Goodheart, Abby Diehl, Erin Logue, Andrew Friedman; back row: Susan Hendrick, Ryan Graham, Matt Ashton, R.B. Watts, Cynthia Willmon.

The ripple effect This case example presents state-ofthe-art treatment for cancer, and it can take place in virtually every cancer center and oncology practice in the community. Cancer affects many if not most families, whether because of cancer in a family member, a friend, a friend’s parent, or a coworker. Cancer’s ripple effect is apparent to all who work in oncology.

The traditional medical focus has been on the patient’s disease, sometimes on the patient and the disease, and in recent years also on those closest to the patient who are most hit by the ripple effect.

Many eminent organizations have taken note of this ripple effect and its psychosocial cost for the patient and close others. The Institute of Medicine addressed psychosocial issues in its volume Cancer Care for the Whole Patient: Meeting Psychosocial Needs,1 and other publications such as those from the American Cancer Society address cancer’s emotional toll. This article describes a practical, counseling team approach to psychosocial care that works effectively within the larger multidisci-

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plinary team approach common in many of today’s cancer treatment settings.

The cancer center The Southwest Cancer Treatment and Research Center (SCTRC) is a regional cancer center affiliated with Texas Tech University School of Medicine and administered jointly by Texas Tech University Health Sciences Center and University Medical Center (UMC), a teaching hospital that is also the county hospital. SCTRC had more than 24,000 patient visits in 2009. It is accredited by the American College of

tion between the spouses. Family counseling focused on offering age-appropriate information about both breast cancer and their mother’s condition for the children, describing the family as a team, and providing a picture of the family’s new normal. Karen is now in remission, yet the cancer center counselors continue to check in with her at every visit.

Surgeons Commission on Cancer and is a member of the Southwest Oncology Group, the Children’s Oncology Group, and the Cancer Trials Support Unit. SCTRC is involved in numerous clinical trials. It also administers an inpatient bone marrow transplant (BMT) unit and serves a large catchment area in west Texas and eastern New Mexico.

Although it began in 1991 and opened a greatly expanded and updated facility in 2004, the SCTRC did not offer a consistent program of psychosocial services until summer 2004, when it began a novel partnering with Texas Tech University’s Department of Psychology. Aided initially by a federal grant, a practicum site for clinical and counseling psychology doctoral students was set up at SCTRC. Beginning with one student and currently sustaining eight students, SCTRC has nurtured its counseling team even as it has added other psychosocial providers, such as its patient navigator who is funded, in part, by the American Cancer Society.

What the team does The current team of 10 includes three students with positions funded by UMC for 10 hr/week, and seven students working either 0.5 day/week (a half practicum) or two 0.5 day/week (a full practicum). SCTRC is typically staffed for all of the working week (MondayFriday), except Friday afternoons. An additional team member, the supervisor

Cancer patients and their families have a need to be understood on their very difficult journey and to be appreciated for their struggle. The physician has time pressures, fears not doing enough or doing too much, and has a wish to really connect with each patient and family. Yet no one person can meet all the needs of the patient and his or her family, making the team approach essential. The counselors are observers, translators, and sometimes almost serve as a physician’s sixth sense. The counselors are a natural part of the treatment team. I don’t know how we used to get along without them.

—Everardo Cobos, MD, Chief Medical Oncologist

who is a Texas Tech University psychology professor, works 0.5 day/week as the counselor at the dedicated clinic for lung cancer patients. This clinic is also staffed by a medical oncologist, pulmonologist, lung surgeon, and nurse practitioner. Students typically self-select into a particular site within SCTRC, though the team members carry pagers and attempt to provide coverage wherever it is needed. Some counselors work alongside physicians and extenders in the outpatient clinics, whereas others prefer the infusion area or the BMT unit, where they can spend more time talking with patients and family members. All counselors try to help staff the radiation area. A patient, such as the one in the case example, might encounter several counselors in the course of his or her treatment, for example, touching base briefly in the clinic, talking at greater length (and depth) in the infusion suite, and sometimes seeing a counselor in the radiation area.

Continuity of care is always an issue.

Weekly group supervision of the team and extensive note taking and exchange allow the team to function much like a relay team rather than as a series of unconnected individuals. The team has seen many members come and go during the 6 years of its existence (nearly 30 counselors, including current ones). The unifying themes across students and years have been (1) commitment to patient service, (2) particular interest in working with ill people in an outpatient medical setting, and (3) unfailing team cohesiveness. No one has been recruited to the team; virtually every counselor has sought out the team.

Much of the therapeutic work is supportive counseling and assessment of anxiety and depression in patients and, just as commonly, in their spouse/partner. During a recent afternoon, one counselor celebrated with a patient who was diagnosed with a benign breast

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Psychosocial Issues

Nurses receive both medical and interpersonal skills training. I have come to view most patients who have a cancer diagnosis as remarkable. They endure difficult treatment and sometimes worry more about others, like spouses, than they do about themselves. Sometimes a spouse is more stressed about the patient’s condition; sometimes a spouse is less accepting of the reality of how the patient is doing. I believe that nurses do a good job medically and interpersonally in spite of limited time and resources, but patients and their families are often in deep emotional distress. The counselors help patients and families directly.

In addition, partnering with the counselors helps me help each patient more effectively. We really are a team.

ly obtain supervision from the academic unit whose students it trains.

The process of arranging such a partnership is not difficult. It simply requires due diligence, excellent communication, mutual respect, and the shared

goal of providing training opportunities for psychosocial professionals and improving psychosocial cancer care for patients and their families and caregivers. The goals are worthwhile and achievable. ●

References 1. Institute of Medicine Committee on Psychosocial Services to Cancer Patients/Families in a Community Setting; Adler NE, Page AEK, eds. Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs. Washington, DC: The National Academies Press; 2008.

2. Hendrick SS, Cobos E. A practical model for psychosocial care. J Oncol Pract. 2010;6:34-36.

Before the research is published…

Before the guideline is issued…

—Vassia Craddick, RNC, BSN Nurse Director of Clinical Services

lump instead of breast cancer, helped an adult woman come to terms with her father’s cancer diagnosis, emphasized the value of hospice services for an older widow recently referred to hospice, established rapport with a new patient and her husband by commenting on how the husband’s nonverbal behaviors answered the physician’s question even before the patient answered them (a humorous bonding moment for counselor and couple), and stood next to a favorite longtime patient when he was told that his cancer had recurred. Many counselors have referred to their work at SCTRC as a “gift,” and counselor satisfaction with their SCTRC experience is high.

How to develop a team Our model of a counseling team is novel, practical, and could serve as a prototype for other cancer centers and community oncology practices.2 Oncology practices could partner with a local college or university, most of which would have undergraduate/graduate programs in psychology or social work. Students in such programs are commonly required to participate in practica or externships in a community agency or other setting.

A cancer center is a perfect setting, given the right preparation for both students and practicum site. Often a practicum site will provide supervision for the practicum students. If that is not available, by providing really good training for students, a site would like-

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Before the drug is approved…

You read it first in

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www.AONNonline.org JOIN TODAY $39.95 First Year Membership Member Benefits Include: â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘ â&#x20AC;˘

Best Practices Continuing Education Networking Community Resources Publications

BLOGS

Experts from various disciplines will be featured in blog segments over the course of the year, allowing members to interact with their colleagues on multiple subject areas.

RESOURCES

Informational/educational resources to help you and your patients navigate their cancer treatment and improve their quality of life.

PUBLICATIONS

Members receive subscriptions to the Journal of Oncology Navigation & Survivorship, The Oncology Nurse, and the bimonthly Journal of Multidisciplinary Cancer Care (a more than $150 value).

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NAVIGATING PATIENTS ACROSS THE CONTINUUM OF CANCER CARETM

First Annual Navigation and Survivorship Conference September 17-19, 2010 - Baltimore, Maryland Conference Overview The first national meeting dedicated to advancing navigation and survivorship in cancer care. Guided by the expertise of leaders in these fields, attendees will receive a thorough understanding of the evolution of navigation and survivorship, and will be able to implement, improve, and sustain their programs and improve patient care.

Who Should Attend Specifically designed for clinical and non-clinical professionals involved or interested in patient navigation and survivorship. This conference is intended to enhance the skills and knowledge of: • Oncology Nurse Navigators • Administrators • Oncology Social Workers • Patient Navigators • Case Managers • Oncology Nurses & • Practice Managers Nurse Practitioners

Accreditation The Institute for Johns Hopkins Nursing is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

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Conference Location Baltimore Marriott Waterfront Hotel 700 Aliceanna Street, Baltimore, MD 21202 Phone: 410.385.3000 Website: www.baltimoremarriottwaterfront.com

Credit Designation Statement This 11.9 contact hour Educational Activity is provided by The Institute for Johns Hopkins Nursing.

Co-Provided by The Institute for Johns Hopkins Nursing

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Psychosocial Issues

The Teenager with Cancer: Struggling to Be Heard and Understood

By Caroline Helwick

BERLIN—The field of oncology has come a long way in improving communication between healthcare providers and their patients with cancer—that is, unless the patient happens to be an adolescent. From diagnosis through treatment, profound deficits still remain in the care of this age group, according to several presentations at the Joint Congress of the European Cancer Organisation and European Society for Medical Oncology.

A study by British researchers may be the first to ask young patients about their experiences from the onset of symptoms to diagnosis. The researchers conducted narrative interviews with 24 patients aged 16 to 24 years, 2 to 4 months after they were diagnosed with solid tumors.

The medical notes for each participant were also examined.

Although individual experiences varied, several common themes emerged.

Key findings included a pattern of not being heard and frequent delays in diagnosis, stemming from the belief that “young people don’t get cancer,” said Susie Pearce, health service researcher at the University College Hospital, London. She presented the study at the meeting.

Although cancer is rare in young people, it is the most frequent cause of death in persons aged 15 to 24. The long-term

outcome for some malignancies is relatively poor, compared with that of children and adults, and delay in diagnosis is thought to be a factor, she said.

“While symptoms in some young people were promptly recognized by primary care physicians and the person was referred to specialists quickly, other patients recounted tales of protracted periods of suffering, with rationalization of their own symptoms or numerous disappointing visits to doctors before the cancer was diagnosed,” she said.

From symptom onset to diagnosis: often years In the study, the time period between symptom onset and diagnosis ranged from 8 weeks to 11 years. The subjects’ symptoms were often attributed to menstrual problems, irritable bowel syndrome, excess body weight or fluid, and lack of exercise.

“One consistent thread through these stories is young people’s perception that they were not being listened to and that cancer was being ruled out on age alone,” Pearce said.

In one case, a 22-year-old woman with metastatic colon cancer recounted a frustrating battle to be taken seriously after 9 years of suspicious symptoms, such as food aversion, abdominal pain, frequent diarrhea, and rectal bleeding,

from the age of 14. She had previously received two separate diagnoses of familial adenomatous polyposis, which carries a high risk of colon cancer. The young woman died soon after her participation in this study.

The survey found that the reaction of parents was important in determining how long the adolescents were willing to endure symptoms and how hard they pushed for answers to their concerns.

The threshold usually came when normal physical, social, and emotional functioning became impossible.

“The stories are, sadly, far from unique,” Pearce added. “Doctors should be making urgent referrals when children or young people come to see them several times with the same problem, and persistent parental anxiety should be sufficient reason for referral.”

like for a young person to be diagnosed with cancer and how they cope with normative developmental processes,” she advised.

Caring for the adolescent with cancer “It is fundamental to the care of young people with cancer to maintain open lines of communication and to treat them as equals in an environment of mutual trust and honesty. We need to seek out and listen to what young people tell us about their experience of cancer care,” said Faith Gibson, PhD (Nursing), clinical professor of children’s and young people’s cancer care, University College London Institute of Child Health, and Great Ormond Street Hospital for Children, London.

With communication lines open, next comes the patients’ involvement in complex discussions and decisionmaking. This means involving them as active agents in the partnership of care, and helping them understand the implications of what is happening to them and the consequences of the decisions they make. They need to be able to take control and to know their options. And they need individualized information, because, certainly for this age group, “one size does not fit all,” she said.

A cancer is a tremendous challenge to a young person, she explained, because he or she is in a pivotal stage of development. Young people are in the process of forming a clear identity, accepting a new body image, gaining freedom from parents, developing a personal values system, achieving social and financial independence, developing relationships with both sexes, developing cognitive skills and abstract thinking, and taking responsibility for their behavior.

“We need to understand what it is

Special needs of young patients This can lead to special needs that are not observed as much for patients of other ages, she said, illustrating them through case studies and narratives. Some of their special needs are shown in the Table.

“What does this mean for how we deliver cancer care?” she asked. It means that staff should understand the adolescent culture, design an appropriate environment for them, listen to their concerns, treat them with respect, understand their family and social structure, and enable them to have close contact, not only with family but with friends, who are particularly important at this age.

“It also depends on our understanding the supportive behaviors that promote coping strategies,” she added, which include “hoping for the best, having the right attitude, knowing what to expect, making sense of a bad situation, taking one day at a time, taking time for yourself, and staying connected.”

Cancer care for young people is still a work in progress, she acknowledged, with many “unknowns.” Researchers such as Gibson are striving to better understand: • What information would help young people make a treatment choice • The most effective and preferred way to receive information • How well services already involve young people in decision-making • The best way to deliver complex information over time • What information would help young people continue to engage with services and follow-up. ●

Table. What Is Important to Young People with Cancer • Appropriate environment (not part of the children’s ward) • Privacy • Consideration of their viewpoints • Information about what is happening • Being heard, feeling understood • Being left alone when feeling unwell • Being treated as a mature person • Support from others, including peers

©iStockphoto.com/Nicole S. Young

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Books and Media

Site-Specific Cancer Series: Skin Cancer Paula Muehlbauer and Christine McGowan, eds.

Pittsburgh, PA: Oncology Nursing Society; 2009 120 pages. Softcover. $35.00 (ONS members); $49.00 (ONS nonmembers)

S

kin Cancer, edited by Paula Muehlbauer and Christine McGowan, is the first publication in the Oncology Nursing Societyâ&#x20AC;&#x2122;s SiteSpecific Cancer Series. This book is a good primary resource for basic information on skin cancers. Skin Cancer is not a comprehensive textbook on skin cancer, but rather, is a compendium of information on common and less common types of skin cancer that may be encountered in the clinical setting. The 14 contributing authors, who include oncology and dermatology nurse practitioners, research nurses, and educators, provide a strong clinical focus for the content. In that regard, the book is a valuable resource for advanced practice nurses, nurse practitioners, and other clinicians who may not routinely work with patients with skin cancer.

The preface lays a foundation for the seriousness of skin cancer in the United States, the book itself, and the role of the nurse in regard to skin cancer. The four chapters cover anatomy and physiology of the skin, nonmelanoma skin cancer (basal, squamous, and Merkel cell cancers; Kaposiâ&#x20AC;&#x2122;s sarcoma), melanoma, and T-cell lymphoma. A strength of this book is its conciseness of information; however, some important content is deficient or missing. For example, the chapter on anatomy and physiology primarily describes skin structure, rather than physiology, but sufficiently lays the groundwork for discussion of skin cancers. The chapter on nonmelanoma skin cancer could be strengthened by including a schema and short discussion of ultraviolet radiation carcinogenesis pathways. The chapter on melanoma underdiscusses the role of genetics (eg, the BRAF gene) in melanoma etiology and does not address the controversy regarding ultraviolet radiation as a potential cause. All chapters could have included relative risk ranges associated with each risk factor to add to the clinical utility of this information.

The disease-focused chapters define the cancer and contain information on etiology, epidemiology, risk factors, types and subtypes, staging, treatment, a summary, and references. However, chapter formats lack parallel consistency, meaning that certain topics such as prevention, patient management and evaluation, patient education, psychosocial issues, and survivor issues are covered in some chapters but not in others. This inconsistency makes it more difficult to quickly access specific information, even when viewing the table of contents. Also

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of concern is that many of the references in all chapters are outdated and are secondary, rather than primary, references.

Skin Cancer contains 68 images of the skin and skin cancers. For the most part, these images enhance and complement the text. The color of many of the images is not â&#x20AC;&#x153;true,â&#x20AC;? which is problematic when

color is a hallmark feature of every type of skin cancer. This is a book that should have an accompanying CD-ROM to allow easier access to clearer images (and content) in the clinical setting.

Despite some shortcomings, Skin Cancer is a welcome addition to the existing and often pricey texts on this topic. â&#x2014;?

Lois J. Loescher, PhD, RN Associate Professor The University of Arizona College of Nursing Director of Behavioral Research, Skin Cancer Institute at the Arizona Cancer Center loescher@nursing.arizona.edu

CONTINUING EDUCATION CREDITS

Current activities at www.COEXM.com include:

AugusT 2010 I VOL 3, NO 5

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Breast Cancer Physicians, Patients React to FDA... Continued from cover high likelihood of response and durable remissions.

Vogl said without third-party coverage for the drug, essentially all his patients will have to do without it.

“The cost is unconscionable,” he maintained. “Today, two of my patients spent hours while getting chemotherapy discussing how they might get Avastin if the FDA changes the label.

They are very worried.”

One of these women is Lori Baur of Sleepy Hollow, New York. Vogl prescribed bevacizumab in March 2009 after a second primary (triple-negative) breast cancer spread to the liver, lungs, and brain. The drug has produced substantial tumor shrinkage. “The tumors in my brain are no longer visible. From research I’ve done, it seems that Avastin can penetrate the brain, while other agents I have taken cannot,” she said in an interview with The Oncology Nurse. She believes bevacizumab may be particularly helpful in triple-negative tumors, judging from her own response and that of other triple-negative patients she has heard from. “Maybe coverage could be determined on a case-by-case basis,” Baur suggested.

“I’m just 41 years old and I have an aggressive cancer that I am afraid will rebound if I go off Avastin. I want to be around a while longer, and this is frightening,” she said. “I don’t think the FDA should take this drug away from patients who are responding to it. In my case, at the pace it’s helping, Avastin has been almost a miracle drug.”

Elizabeth Thompson, senior vice president of medical and scientific affairs for Susan G. Komen for the Cure, has a similar point of view. “We are reviewing the recommendation of the advisory panel before deciding whether we will take a position before the FDA,” she said. “But we do hope that those women who are currently being treated with Avastin for breast cancer will continue to have access to it and that third-party payers continue to fund the use of this drug for women who are being treated with it.”

Some see it differently Unfortunately, robust responders such as Baur may be the exception, according to the ODAC, which emphasized the lack of a survival benefit and undue toxicity in making its recommendation. Not all patients are disagreeing with the panel.

“I’m really not seeing that this has a benefit for patients,” Natalie Compagni Portis, the patient representative on the committee, said during the meeting in Gaithersburg, Maryland. “Hope is very important, but to offer hope that isn’t substantiated I don’t think is responsible.”

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Patients want beneficial options only Musa Mayer, of New York, a breast cancer survivor, patient advocate, and creator of AdvancedBC.org, has been following more than 1000 women living with metastatic breast cancer through her blog, BCMets.org, and has found reaction to the ODAC recommendation to be mixed. “It depends on the patient’s personal experience with the drug—its activity and toxicity, and of course, there’s the issue of cost,” she said. Due to the lack of a survival benefit, many women have not been persuaded that bevacizumab is a good option for them, she said, especially considering the potential for serious toxicity.

These responses show “that patients do not necessarily argue for more options, but for more beneficial options—drugs that are better than what we have now or at least provide a unique benefit,” she claimed. Although prolongation of PFS is important, she agreed with the ODAC that it is only meaningful when it is lengthy and does not impair quality of life, and this is not the case for many patients. “Avastin is not a benign drug, so it better provide real benefit, and there is no good evidence of that.”

She acknowledged that some patients do have robust and durable responses to treatment with bevacizumab, but these patients need to be identified prior to treatment. Patient advocates have been “pressing hard,” she said, on Genentech to mine the data for clues, which may lie in the presence of particular mutations of the vascular endothelial growth factor, some scientists believe. “We are

hoping that Genentech will take this as an incentive to start looking more urgently at who responds. It may turn out to be a good drug for a subset but we don’t know that, and it should not be on the market until we do,” she said.

The hope is that a search for relevant markers and diagnostics will become part of drug development. Streamlined testing and targeted treatment is not only the ideal, but has become the only approach that makes sense, according to Mayer, who is calling for drugs to “no longer be introduced in a mass way, but in a more selective way.”

Views are changing Oncologists can expect patients to respond as individuals, and patient advocacy groups to hold various points of view on the committee recommendations, reminded Eric P. Winer, MD, Director of the Breast Oncology Center at Dana-Farber Cancer Institute, Boston.

“The advocacy community is broad and heterogeneous. Some feel strongly that only drugs that lead to substantial improvement in survival need to be approved but others accept more modest benefits. You can’t generalize.”

But he acknowledged that thinking has been shifting toward a more conservative stance on new agents. “I think we are in a slightly different time when it comes to patients’ perceptions of cancer treatments,” he told The Oncology Nurse. “My sense for several years has been that patients are less interested in drugs that offer very marginal improvements, whether for themselves or for women in general. There was a time

SUPPORTIVE CARE

Risk Factors for Chemotherapy Toxicity...

Continued from page 19

toxicity, said Hurria, director of the Cancer and Aging Research Program at City of Hope in Duarte, California.

The first model was then refined through an internal validation process, calibration of the data, and further analysis of individual items in the geriatric assessment measure (to increase ease of administration and scoring), and yielded the following risk factors for grade 3 to 5 toxicity: • Age 73 years or older • Gastrointestinal or genitourinary cancers • Standard-dose chemotherapy • Receipt of polychemotherapy • Low hemoglogin levels (<11 g/dL male; <10 g/dL female) • Low creatinine clearance (Jelliffeideal weight <34) • Falls in the past 6 months • Hearing impairment (fair or worse) • Limited in walking one block • Assistance required in medication intake • Decreased social activity. ●

when patients would say, ‘I want to do absolutely everything I can, even if the benefit is tiny.’ Now, patients have a better understanding of what it all means, and they are evaluating their choices in a different way.” ●

CONFERENCE NEWS

Diverse Educational Programs...

Continued from page 25

date: caring for adults with Down’s syndrome and caring for patients with comorbidities who are not candidates for standard treatments.

• Weekly hour-long nurse meetings where operational and clinical issues are discussed. Details of the meeting are recorded and distributed to staff members who are unable to attend.

• Pharmaceutical company lectures, usually a breakfast or dinner program, provide updates on how to use a new drug or existing drug with new indications. Typically, an expert will discuss the pharmacokinetics, administration, and symptom management of the drug, and there is always an opportunity for attendees to ask questions. Ideally, a lecture is held before the drug being discussed has been introduced in the oncology practice.

• Presentations are given by fourthyear medical students rotating through outpatient oncology. The subject matter, which is selected jointly by the medical student and an oncologist and clinical nurse specialist in the practice, usually involves oncology or hematology but also includes general medical and psychosocial issues. Presentations are limited to 30 minutes. Topics have included depression in cancer patients, Bell’s palsy, thyroid disorders, and hot flashes.

• A journal club offers a forum for nursing and other nonphysician staff to meet and discuss a journal article that focuses on clinical or nonclinical topics that are relevant to clinical practice. A staff nurse from the practice and a clinical nurse specialist select an arti-

cle for discussion, and a copy of the article is distributed to each nurse in the practice along with a flyer specifying the date, time, and location of the meeting plus the name of the facilitator. Meetings are scheduled in the morning before patients arrive. Topics to date have included healthcare literacy, navigating a package insert, and nursing professionalism. ● Sandra Purl died shortly after the ONS meeting where she presented her research.

Her friend and colleague Danielle M. Gale, ND, MSN, of Oswego Illinois said, “Sandy was a role model to many oncology nurses.... Sandy’s passion was to improve the care of oncology patients through her work and volunteer activities in the Chicago chapter of the Oncology Nursing Society.”

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The Essential Role of Immunotherapy in Follicular Lymphoma Management LOG ON TODAY TO PARTICIPATE www.coexm.com/ace03.asp Release Date: March 19, 2010 Expiration Date: March 18, 2011

TARGET AUDIENCE This activity is intended for hematologists, oncologists and other healthcare professionals who are involved with the care of patients with follicular lymphoma.

STATEMENT OF NEED Non-Hodgkin's lymphoma (NHL), the most common hematologic malignancy, represents a large proportion of the case load for the typical oncology practitioner. That load is likely to grow, since NHL is increasing in prevalence. The introduction of rituximab, the monoclonal antibody against CD20, changed the treatment landscape of lymphoma and it has been advanced further by immunotherapies that combine CD20-directed targeting with radiotherapy. The recent rapid advances in therapeutics and impressive research across this broad, heterogeneous group of malignancies represent an educational challenge for the clinician trying to stay current and provide the most appropriate, up-to-date therapy tailored for the individual patient. Immunotherapy plays a key role at all stages of the disease in reaching the goal of the highest quality response.

EDUCATIONAL OBJECTIVES On completion of this activity, participants should be able to: • Define the goals of therapy for follicular lymphoma (FL) • Describe strategies for patient selection for immunotherapy (including radioimmunotherapy [RIT]), in both the up-front and relapsed/refractory setting • Define different immunotherapy approaches in terms of efficacy, safety, and tolerability • Propose strategies to overcome adverse events and access issues that create barriers to the provision of optimal immunotherapy in FL

FACULTY Stephanie A. Gregory, MD Professor of Medicine Director, Section of Hematology Rush University Medical Center Chicago, Illinois

David Maloney, MD, PhD Associate Professor of Medicine Division of Oncology University of Washington Member Fred Hutchinson Cancer Research Center Seattle, Washington

With commentary by: Peter S. Conti, MD, PhD Professor Nuclear Medicine Keck School of Medicine University of Southern California Los Angeles, California

This activity is supported by an educational grant from Spectrum Pharmaceuticals.

This activity has been approved for 1.0 AMA PRA Category 1 Credits™.

For further information and to participate, please go to: www.coexm.com/ace03.asp

In collaboration with

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International News

Reports from the 25th Anniversary EAU Annual Congress and the 15th Congress of the EHA

By Jill Stein

Once-yearly Histrelin Implant Provides Sustained Improvement in Prostate Cancer Patients BARCELONA—Investigators have documented the long-term efficacy and tolerability of a once-yearly histrelin subdermal implant in men with advanced prostate cancer.

Histrelin acetate, a synthetic luteinizing hormone-releasing hormone (LHRH) agonist, is available as an implant and is inserted subcutaneously under local anesthesia during an officebased procedure. After 12 months, the implant is removed, and another implant may then be inserted, if indicated.

Neal D. Shore, MD, FACS, with Carolina Urologic Research Center/ Atlantic Urology Clinics in Myrtle Beach, South Carolina, reported the

findings of an extension trial that included 138 patients assigned to the histrelin arm in the original 52-week, phase 3 registration study. All men enrolled in the extension trial had achieved the primary end point of testosterone suppression at 4 weeks in the phase 3 trial.

The histrelin subdermal implants, which were replaced every 12 months, maintained the testosterone suppression initially documented at 1 year for a full 4 years without evidence of surge in serum testosterone. The most common side effects were mild-to-moderate hot flashes.

Because histrelin only needs to be replaced every 12 months, the implant may be preferable to other LHRH agonists, which are usually given by injection and need to be repeated at 1-, 3-, 4-, or 6-month intervals, he said.

NURSING LIFE

Balsamic Beet Vinaigrette

S

ummer is a great time to take advantage of the local produce that is in season. This is the time to be creative and make each meal more nutritious, from breakfast to a late-night snack. Add extra raw vegetables and berries to salads, dress up chicken and fish with peaches, berries, or plums, use them as accompaniments for dips, and try using them as a base for salad dressings. The following recipe uses nutrient-packed beets as a base for this simple, yet delicious, salad dressing. This dressing is best over a rich green salad with arugula or mixed baby greens. It also goes well over a simple salad of tomatoes and cucumbers.

Ingredients 4 beets (roasted, peeled, cooled, and sliced) ½ cup balsamic vinegar ½ cup olive oil

Directions • Place beets and balsamic vinegar in a blender and puree.

• Slowly whisk in the olive oil.

• Toss with your favorite salad.

24 servings (serving size: 2 tablespoons)

Nutritional Information 45 calories, 4.5 g fat, 0.5 g saturated fat, 0 mg cholesterol, 10 mg sodium, 1 g carbohydrate, 0 g dietary fiber, 1 g sugar, 0 g protein.

Recipe courtesy of Peter Pascale, CCC Executive Chef, Somerville, New Jersey. ©iStockphoto.com/Joe Biafore

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August 2010 I VOL 3, NO 5

Shore presented the data at the 25th Anniversary European Association of Urology (EAU) Annual Congress.

for early integration into treatment regimens in patients with newly diagnosed MM,” Morgan said.

Zoledronic Acid Boosts Survival in Multiple Myeloma Patients

Deferasirox Treatment Provides Ongoing Benefit in Beta-thalassemia and Myocardial Siderosis

BARCELONA—Zoledronic acid improves survival in newly diagnosed multiple myeloma (MM) patients compared with clodronate, investigators announced at the 15th Congress of the European Hematology Association (EHA).

Their study also found that zoledronic acid was associated with a larger decrease in skeletal-related events (SREs).

Zoledronic acid’s survival advantage was independent of the SRE reduction.

The results are from the phase 3 Medical Research Council Myeloma IX study, which was conducted by a UK group.

Principal investigator Gareth J. Morgan, MD, with the Institute of Cancer Research in London, said that the findings bolster earlier preclinical studies suggesting anticancer activity for zoledronic acid.

In the study, newly diagnosed MM patients were randomized to intravenous zoledronic acid (4 mg, dose-adjusted based on renal function) every 3 to 4 weeks plus first-line chemotherapy or to daily oral clodronate (1600 mg) plus first-line chemotherapy.

Bone disease is common in MM patients, and bisphosphonates are widely used to prevent or treat bone disease in this population, Morgan pointed out.

About 70% of patients in each treatment group had bone disease.

Patients continued treatment with their assigned bisphosphonate at least until disease progression.

A total of 1960 patients were evaluable, with a median follow-up of 3.7 years.

Zoledronic acid plus first-line chemo therapy significantly improved overall survival by 16%, with a 5.5-month difference in the median overall survival.

The percent of patients who experienced an SRE was decreased by 24% in patients receiving zoledronic acid versus clodronate. SKEs included bone fractures, radiation to bone, surgery to bone, and spinal cord compression.

Zoledronic acid’s survival benefit was maintained after controlling for the potential effect of SREs on survival. Both bisphosphonates were generally well tolerated.

“Our findings provide evidence that zoledronic acid should be considered

BARCELONA—Continued therapy with deferasirox over 2 years is effective in removing cardiac iron in betathalassemia patients with cardiac siderosis and is also well tolerated, according to data released at the 15th Congress of the European Hematology Association (EHA).

Dudley J. Pennell, MD, FRCP, FACC, with the Royal Brompton Hospital in London, United Kingdom, presented results in 82 heavily transfused beta-thalassemia patients with myocardial siderosis who had completed a 1-year trial of deferasirox and then continued treatment for an additional year.

“Iron chelation therapy has markedly improved survival for many regularly transfused patients with beta-thalassemia; however, heart failure due to cardiac iron deposition has been a leading cause of death,” Pennell said. “While the efficacy of chelation in reducing cardiac iron has been demonstrated using myocardial T2* in several prospective clinical trials of up to 1 year, longer term data are needed since T2* normalization may take several years.”

Deferasirox was started at 30 mg/ kg/day and increased to 40 mg/kg/day by the time patients entered the trial’s extension phase. Dose decreases were allowed for safety reasons.

The data showed that continued treatment with monotherapy deferasirox at greater than 30 mg/kg/day for up to 2 years significantly improved cardiac T2* and allowed 57% of patients with moderate-to-mild baseline cardiac siderosis to normalize and 43% of patients with severe baseline cardiac siderosis to achieve moderate-to-mild cardiac T2* values.

The investigators also found that significant improvements in cardiac T2* over 2 years were associated with the maintenance of normal cardiac function.

Deferasirox treatment was well tolerated.

The findings are especially noteworthy considering that all patients had received chelation therapy with other agents for a median of 12.2 years before enrolling in the study, Pennell said.

The study is the first to report 2-year data on cardiac iron removal for any iron-chelating agent, he added. ●

www.theOncologyNurse.com

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Meetings NOVEMBER

SEPTEMBER

9-13

©iStockphoto.com/Dwight Nadig

NEW YORK, NY Chemotherapy Foundation Symposium chemotherapyfoundationsymposium. org

17-19

©iStockphoto.com/David Liu

BALTIMORE, MD Academy of Oncology Nurse Navigators’ Navigation and Survivorship Conference www.aonnonline.org

26-29

©iStockphoto.com/Jeremy Edwards

SAN DIEGO, CA Scripps Cancer Center’s 30th Annual Oncology Nurses Symposium www.scripps.org

Sept 29-Oct 2 ST. LOUIS, MO Association of Community Cancer Centers 27th Annual Oncology Economics Conference www.accc-cancer.org

OCTOBER

5-8 MONTREAL, QUEBEC 18th International Congress on Palliative Care www.pal2010.com

7-10 AMELIA ISLAND, FL The 13th Annual Association of Physician Assistants in Oncology (APAO) Conference apao.cc www.TheOncologyNurse.com

11-13

ORLANDO, FL Oncology Nursing Society’s Advanced Practice Nursing Conference www.ons.org

RITUXAN® (Rituximab) Brief summary—Please consult full prescribing information. counts prior to each Rituxan course. During treatment with Rituxan and chemotherapy, obtain CBC and platelet counts at weekly to monthly intervals and more frequently in WARNING: FATAL INFUSION REACTIONS, TUMOR LYSIS SYNDROME (TLS), patients who develop cytopenias. [See Adverse Reactions]. s The duration of cytopenias SEVERE MUCOCUTANEOUS REACTIONS, and PROGRESSIVE MULTIFOCAL caused by Rituxan can extend months beyond the treatment period. ADVERSE LEUKOENCEPHALOPATHY (PML) REACTIONS The most common adverse reactions of Rituxan (incidence ≥25%) Infusion Reactions: Rituxan administration can result in serious, including observed in clinical trials of patients with NHL were infusion reactions, fever, fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have lymphopenia, chills, infection, and asthenia. The most common adverse reactions of occurred. Approximately 80% of fatal infusion reactions occurred in Rituxan (incidence ≥25%) observed in clinical trials of patients with CLL were: infusion association with the first infusion. Carefully monitor patients during reactions and neutropenia. Clinical Trials Experience in Lymphoid Malignancies infusions. Discontinue Rituxan infusion and provide medical treatment for Because clinical trials are conducted under widely varying conditions, adverse reaction Grade 3 or 4 infusion reactions [see Warnings and Precautions, Adverse rates observed in the clinical trials of a drug cannot be directly compared to rates in the Reactions]. s Tumor Lysis Syndrome (TLS): Acute renal failure requiring clinical trials of another drug and may not reflect the rates observed in practice. The data dialysis with instances of fatal outcome can occur in the setting of TLS described below reflect exposure to Rituxan in 2282 patients, with exposures ranging from a single infusion up to 6–8 months. Rituxan was studied in both single-agent and following treatment of non-Hodgkin’s lymphoma (NHL) patients with Rituxan active-controlled trials (n = 356 and n = 1926). The population included 679 patients [see Warnings and Precautions, Adverse Reactions]. s Severe Mucocutaneous with low-grade follicular lymphoma, 927 patients with DLBCL, and 676 patients with Reactions: Severe, including fatal, mucocutaneous reactions can occur in CLL. Most NHL patients received Rituxan as infusion of 375 mg/m2 per infusion, given as patients receiving Rituxan [see Warnings and Precautions, Adverse a single agent weekly for up to 8 doses, in combination with chemotherapy for up to 8 Reactions]. s Progressive Multifocal Leukoencephalopathy (PML): JC virus doses, or following chemotherapy for up to 16 doses. CLL patients received Rituxan 375 infection resulting in PML and death can occur in patients receiving Rituxan mg/m2 as an initial infusion followed by 500 mg/m2 for up to 5 doses, in combination with [see Warnings and Precautions, Adverse Reactions]. s fludarabine and cyclophosphamide. Seventy-one percent of CLL patients received 6 cycles and 90% received at least 3 cycles of Rituxan-based therapy. Infusion INDICATIONS AND USAGE Non-Hodgkin’s Lymphoma (NHL) Rituxan® (rituximab) is Reactionss In the majority of patients with NHL, infusion reactions consisting of fever, indicated for the treatment of patients with: Relapsed or refractory, low-grade or chills/rigors, nausea, pruritus, angioedema, hypotension, headache, bronchospasm, follicular, CD20-positive, B-cell NHL as a single agent; Previously untreated follicular, urticaria, rash, vomiting, myalgia, dizziness, or hypertension occurred during the first CD20-positive, B-cell NHL in combination with CVP chemotherapy; Non-progressing Rituxan infusion. Infusion reactions typically occurred within 30 to 120 minutes of (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after beginning the first infusion and resolved with slowing or interruption of the Rituxan first-line CVP chemotherapy; Previously untreated diffuse large B-cell, CD20-positive infusion and with supportive care (diphenhydramine, acetaminophen, and intravenous NHL in combination with CHOP or other anthracycline-based chemotherapy regimens. saline). The incidence of infusion reactions was highest during the first infusion (77%) Chronic Lymphocytic Leukemia (CLL) Rituxan® (rituximab) is indicated, in and decreased with each subsequent infusion. [See Boxed Warning, Warnings and combination with fludarabine and cyclophosphamide (FC), for the treatment of patients Precautions.] Infections Serious infections (NCI CTCAE Grade 3 or 4), including sepsis, with previously untreated and previously treated CD20-positive CLL. Limitations of use occurred in less than 5% of patients with NHL in the single-arm studies. The overall Rituxan is not recommended for use in patients with severe, active infections. incidence of infections was 31% (bacterial 19%, viral 10%, unknown 6%, and fungal WARNINGS AND PRECAUTIONS Infusion Reactions Rituxan can cause severe, 1%). [See Warnings and Precautions.] In randomized, controlled studies where Rituxan including fatal, infusion reactions. Severe reactions typically occurred during the first was administered following chemotherapy for the treatment of follicular or low-grade infusion with time to onset of 30–120 minutes. Rituxan-induced infusion reactions and NHL, the rate of infection was higher among patients who received Rituxan. In diffuse sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, large B-cell lymphoma patients, viral infections occurred more frequently in those who pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, received Rituxan. Cytopenias and hypogammaglobulinemiaa In patients with NHL ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death. Premedicate receiving rituximab monotherapy, NCI-CTC Grade 3 and 4 cytopenias were reported in patients with an antihistamine and acetaminophen prior to dosing. Institute medical 48% of patients. These included lymphopenia (40%), neutropenia (6%), leukopenia management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion (4%), anemia (3%), and thrombocytopenia (2%). The median duration of lymphopenia reactions as needed. Depending on the severity of the infusion reaction and the required was 14 days (range, 1–588 days) and of neutropenia was 13 days (range, 2–116 days). interventions, temporarily or permanently discontinue Rituxan. Resume infusion at a A single occurrence of transient aplastic anemia (pure red cell aplasia) and two minimum 50% reduction in rate after symptoms have resolved. Closely monitor the occurrences of hemolytic anemia following Rituxan therapy occurred during the singlefollowing patients: those with pre-existing cardiac or pulmonary conditions, those who arm studies. In studies of monotherapy, Rituxan-induced B-cell depletion occurred in experienced prior cardiopulmonary adverse reactions, and those with high numbers of 70% to 80% of patients with NHL. Decreased IgM and IgG serum levels occurred in 14% circulating malignant cells (≥25,000/mm3). [See Boxed Warning, Warnings and of these patients. Relapsed or Refractory, Low-Grade NHL Adverse reactions in Table 1 Precautions, Adverse Reactions.] Tumor Lysis Syndrome (TLS) Acute renal failure, occurred in 356 patients with relapsed or refractory, low-grade or follicular, CD20-positive, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, B-cell NHL treated in single-arm studies of Rituxan administered as a single agent. [See some fatal, can occur within 12–24 hours after the first infusion of Rituxan in patients Clinical Studies.] Most patients received Rituxan 375 mg/m2 weekly for 4 doses. with NHL. A high number of circulating malignant cells (≥25,000/mm3) or high tumor burden Table 1 confers a greater risk of TLS. Administer aggressive intravenous hydration and anti- Incidence of Adverse Reactions in ≥5% of Patients with Relapsed or Refractory, Lowhyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, Grade or Follicular NHL, Receiving Single-agent Rituxan (N = 356)a,b monitor renal function and fluid balance, and administer supportive care, including dialysis as All Grades (%) Grade 3 and 4 (%) All Grades (%) Grade 3 and 4 (%) indicated. [See Boxed Warning.] Severe Mucocutaneous Reactions Mucocutaneous Any Adverse Events 99 57 Respiratory p y System y 38 4 reactions, some with fatal outcome, can occur in patients treated with Rituxan. These Bodyy as a Whole 86 10 Increased Cough 13 1 Fever 53 1 Rhinitis 12 1 reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid Chills 33 3 Bronchospasm 8 1 dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these Infection 31 4 Dyspnea 7 1 Asthenia 26 1 Sinusitis 6 0 reactions has varied from 1–13 weeks following Rituxan exposure. Discontinue Rituxan Headache 19 1 Metabolic and Nutritional in patients who experience a severe mucocutaneous reaction. The safety of 14 1 Disorders 38 3 Abdominal Pain Pain 12 1 Angioedema 11 1 readministration of Rituxan to patients with severe mucocutaneous reactions has not Back Pain 10 1 Hyperglycemia 9 1 been determined. [See Boxed Warning, Adverse Reactions.] Progressive Multifocal Throat Irritation 9 0 Peripheral Edema 8 0 5 0 LDH Increase 7 0 Leukoencephalopathy (PML) JC virus infection resulting in PML and death can occur HemeFlushing and Lymphatic y p System y 67 48 Digestive g System y 37 2 in Rituxan-treated patients with hematologic malignancies or with autoimmune diseases.

Lymphopenia 48 40 Nausea 23 1 Leukopenia 14 4 Diarrhea 10 1 The majority of patients with hematologic malignancies diagnosed with PML received Neutropenia 14 6 Vomiting 10 1 Rituxan in combination with chemotherapy or as part of a hematopoietic stem cell Thrombocytopenia 12 2 Nervous System y 32 1 Anemia 8 3 Dizziness 10 1 transplant. The patients with autoimmune diseases had prior or concurrent Skin and Appendages pp g 44 2 Anxiety 5 1 immunosuppressive therapy. Most cases of PML were diagnosed within 12 months of Night Sweats 15 1 Musculoskeletal System y 26 3 Rash 15 1Myalgia 10 1 their last infusion of Rituxan. Consider the diagnosis of PML in any patient presenting Arthralgia Pruritus 14 1 10 1 with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited Urticaria 8 1 Cardiovascular System y 25 3 Hypotension 10 1 to, consultation with a neurologist, brain MRI, and lumbar puncture. Discontinue Rituxan Hypertension 6 1 and consider discontinuation or reduction of any concomitant chemotherapy or a b immunosuppressive therapy in patients who develop PML. [See Boxed Warning, Adverse Adverse reactions observed up to 12 months following Rituxan. Adverse reactions graded for severity Reactions.] Hepatitis B Virus (HBV) Reactivation Hepatitis B virus (HBV) reactivation by NCI-CTC criteria. with fulminant hepatitis, hepatic failure, and death can occur in patients with hematologic In these single-arm Rituxan studies, bronchiolitis obliterans occurred during and up to malignancies treated with Rituxan. The median time to the diagnosis of hepatitis was 6 months after Rituxan infusion. Previously Untreated Low-Grade NHL In Study 4, approximately 4 months after the initiation of Rituxan and approximately one month after patients in the R-CVP arm experienced a higher incidence of infusional toxicity and the last dose. Screen patients at high risk of HBV infection before initiation of Rituxan. neutropenia compared to patients in the CVP arm. The following adverse reactions Closely monitor carriers of hepatitis B for clinical and laboratory signs of active HBV occurred more frequently (≥5%) in patients receiving R-CVP compared to CVP alone: infection for several months following Rituxan therapy. Discontinue Rituxan and any rash (17% vs. 5%), cough (15% vs. 6%), flushing (14% vs. 3%), rigors (10% vs. 2%), concomitant chemotherapy in patients who develop viral hepatitis, and institute pruritus (10% vs. 1%), neutropenia (8% vs. 3%), and chest tightness (7% vs. 1%). In appropriate treatment including antiviral therapy. Insufficient data exist regarding the Study 5, the following adverse reactions were reported more frequently (≥5%) in safety of resuming Rituxan in patients who develop hepatitis subsequent to HBV patients receiving Rituxan following CVP compared to patients who received no further reactivation. [See Adverse Reactions.] Infections Serious, including fatal, bacterial, therapy: fatigue (39% vs. 14%), anemia (35% vs. 20%), peripheral sensory fungal, and new or reactivated viral infections can occur during and up to one year neuropathy (30% vs. 18%), infections (19% vs. 9%), pulmonary toxicity (18% vs. following the completion of Rituxan-based therapy. New or reactivated viral infections 10%), hepato-biliary toxicity (17% vs. 7%), rash and/or pruritus (17% vs. 5%), included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, arthralgia (12% vs. 3%), and weight gain (11% vs. 4%). Neutropenia was the only West Nile virus, and hepatitis B and C. Discontinue Rituxan for serious infections and Grade 3 or 4 adverse reaction that occurred more frequently (≥2%) in the Rituxan arm institute appropriate anti-infective therapy. [See Adverse Reactions.] Cardiovascular Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform compared with those who received no further therapy (4% vs. 1%). [See Clinical Studies.]

DLBCLL In Studies 6 and 7, [see Clinical Studies] s the following adverse reactions, cardiac monitoring during and after all infusions of Rituxan for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina. [See regardless of severity, were reported more frequently (≥5%) in patients age ≥60 years receiving R-CHOP as compared to CHOP alone: pyrexia (56% vs. 46%), lung disorder Adverse Reactions.] Renal Severe, including fatal, renal toxicity can occur after Rituxan administration in patients with NHL. Renal toxicity has occurred in patients who (31% vs. 24%), cardiac disorder (29% vs. 21%), and chills (13% vs. 4%). Detailed experience tumor lysis syndrome and in patients with NHL administered concomitant safety data collection in these studies was primarily limited to Grade 3 and 4 adverse cisplatin therapy during clinical trials. The combination of cisplatin and Rituxan is not an reactions and serious adverse reactions. In Study 7, a review of cardiac toxicity approved treatment regimen. Monitor closely for signs of renal failure and discontinue determined that supraventricular arrhythmias or tachycardia accounted for most of Rituxan in patients with a rising serum creatinine or oliguria. Bowel Obstruction and the difference in cardiac disorders (4.5% for R-CHOP vs. 1.0% for CHOP). The Perforation Abdominal pain, bowel obstruction and perforation, in some cases leading following Grade 3 or 4 adverse reactions occurred more frequently among patients in to death, can occur in patients receiving Rituxan in combination with chemotherapy. In the R-CHOP arm compared with those in the CHOP arm: thrombocytopenia (9% vs. postmarketing reports, the mean time to documented gastrointestinal perforation was 6 7%) and lung disorder (6% vs. 3%). Other Grade 3 or 4 adverse reactions occurring (range 1–77) days in patients with NHL. Perform a thorough diagnostic evaluation and more frequently among patients receiving R-CHOP were viral infection (Study 7), institute appropriate treatment for complaints of abdominal pain. [See Adverse neutropenia (Studies 7 and 8), and anemia (Study 8). CLL The data below reflect Reactions.] Immunization The safety of immunization with live viral vaccines following exposure to Rituxan in combination with fludarabine and cyclophosphamide in 676 s The age range was Rituxan therapy has not been studied and vaccination with live virus vaccines is not patients with CLL in Study 9 or Study 10 [see Clinical Studies]. recommended. Laboratory Monitoring In patients with lymphoid malignancies, during 30–83 years and 71% were men. Detailed safety data collection in Study 9 was limited treatment with Rituxan monotherapy, obtain complete blood counts (CBC) and platelet to Grade 3 and 4 adverse reactions and serious adverse reactions. Infusion-related

12-14

ORLANDO, FL Oncology Nursing Society 11th Annual Institutes of Learning www.ons.org

adverse reactions were defined by any of the following adverse events occurring during or within 24 hours of the start of infusion: nausea, pyrexia, chills, hypotension, vomiting, and dyspnea. In Study 9, the following Grade 3 and 4 adverse reactions occurred more frequently in R-FC–treated patients compared to FC-treated patients: infusion reactions (9% in R-FC arm), neutropenia (30% vs. 19%), febrile neutropenia (9% vs. 6%), leukopenia (23% vs. 12%), and pancytopenia (3% vs. 1%). In Study 10, the following Grade 3 or 4 adverse reactions occurred more frequently in R-FC–treated patients compared to FC-treated patients: infusion reactions (7% in R-FC arm), neutropenia (49% vs. 44%), febrile neutropenia (15% vs. 12%), thrombocytopenia (11% vs. 9%), hypotension (2% vs. 0%), and hepatitis B (2% vs. <1%). Fifty-nine percent of R-FC–treated patients experienced an infusion reaction of any severity. Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The observed incidence of antibody (including neutralizing antibody) positivity in an assay is highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Rituxan with the incidence of antibodies to other products may be misleading. Using an ELISA assay, anti-human antichimeric antibody (HACA) was detected in 4 of 356 (1.1%) patients with low-grade or follicular NHL receiving single-agent Rituxan. Three of the four patients had an objective clinical response. The clinical relevance of HACA formation in Rituxan-treated patients is unclear. Postmarketing Experience The following adverse reactions have been identified during post-approval use of Rituxan in hematologic malignancies. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Rituxan. Hematologic: prolonged pancytopenia, marrow hypoplasia, and late-onset neutropenia, hyperviscosity syndrome in Waldenstrom’s macroglobulinemia. Cardiac:: fatal cardiac failure. Immune/ Autoimmune Events: uveitis, optic neuritis, systemic vasculitis, pleuritis, lupus-like syndrome, serum sickness, polyarticular arthritis, and vasculitis with rash. Infection: viral infections, including progressive multifocal leukoencephalopathy (PML), increase in fatal infections in HIV-associated lymphoma, and a reported increased incidence of Grade 3 and 4 infections in patients with previously treated lymphoma without known HIV infection. Neoplasia:: disease progression of Kaposi’s sarcoma. Skin: severe mucocutaneous reactions. Gastrointestinal: bowel obstruction and perforation. Pulmonary: fatal bronchiolitis obliterans and pneumonitis (including interstitial pneumonitis). DRUG INTERACTIONS Formal drug interaction studies have not been performed with Rituxan. In patients with CLL, Rituxan did not alter systemic exposure to fludarabine or cyclophosphamide. USE IN SPECIFIC POPULATIONS Pregnancy Category C: There are no adequate and well-controlled studies of rituximab in pregnant women.

Postmarketing data indicate that B-cell lymphocytopenia generally lasting less than six months can occur in infants exposed to rituximab in-utero. Rituximab was detected postnatally in the serum of infants exposed in-utero. Non-Hodgkin’s lymphoma is a serious condition that requires treatment. Rituximab should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Reproduction studies in cynomolgus monkeys at maternal exposures similar to human therapeutic exposures showed no evidence of teratogenic effects. However, B-cell lymphoid tissue was reduced in the offspring of treated dams. The B-cell counts returned to normal levels, and immunologic function was restored within 6 months of birth.

Nursing Mothers It is not known whether Rituxan is secreted into human milk.

However, Rituxan is secreted in the milk of lactating cynomolgus monkeys, and IgG is excreted in human milk. Published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts. The unknown risks to the infant from oral ingestion of Rituxan should be weighed against the known benefits of breast-feeding. Pediatric Use The safety and effectiveness of Rituxan in pediatric patients have not been established. Geriatric Use Diffuse Large B-Cell NHLL Among patients with DLBCL evaluated in three randomized, active-controlled trials, 927 patients received Rituxan in combination with chemotherapy. Of these, 396 (43%) were age 65 or greater and 123 (13%) were age 75 or greater. No overall differences in effectiveness were observed between these patients and younger patients. Cardiac adverse reactions, mostly supraventricular arrhythmias, occurred more frequently among elderly patients.

Serious pulmonary adverse reactions were also more common among the elderly, including pneumonia and pneumonitis. Low-Grade or Follicular Non-Hodgkin’s Lymphoma Clinical studies of Rituxan in low-grade or follicular, CD20-positive, B-cell NHL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. Chronic Lymphocytic Leukemia Among patients with CLL evaluated in two randomized active-controlled trials, 243 of 676 Rituxan-treated patients (36%) were 65 years of age or older; of these, 100 Rituxan-treated patients (15%) were 70 years of age or older. In exploratory analyses defined by age, there was no observed benefit from the addition of Rituxan to fludarabine and cyclophosphamide among patients 70 years of age or older in Study 9 or in Study 10; there was also no observed benefit from the addition of Rituxan to fludarabine and cyclophosphamide among patients 65 years of age or older in Study 10 [see Clinical Studies]. s Patients 70 years or older received lower dose intensity of fludarabine and cyclophosphamide compared to younger patients, regardless of the addition of Rituxan.

In Study 9, the dose intensity of Rituxan was similar in older and younger patients, however in Study 10 older patients received a lower dose intensity of Rituxan. The incidence of Grade 3 and 4 adverse reactions was higher among patients receiving R-FC who were 70 years or older compared to younger patients for neutropenia [44% vs. 31% (Study 9); 56% vs. 39% (Study 10)], febrile neutropenia [16% vs. 6% (Study 9)], anemia [5% vs. 2% (Study 9); 21% vs. 10% (Study 10)], thrombocytopenia [19% vs. 8% (Study 10)], pancytopenia [7% vs. 2% (Study 9); 7% vs. 2% (Study 10)] and infections [30% vs.

14% (Study 10)]. OVERDOSAGE There has been no experience with overdosage in human clinical trials. Single doses of up to 500 mg/m2 have been administered in clinical trials. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to establish the carcinogenic or mutagenic potential of Rituxan or to determine potential effects on fertility in males or females. PATIENT COUNSELING INFORMATION Patients should be provided the Rituxan Medication Guide and provided an opportunity to read prior to each treatment session. It is important that the patient’s overall health be assessed at each visit and the risks of Rituxan therapy and any questions resulting from the patient’s reading of the Medication Guide be discussed. Rituxan is detectable in serum for up to six months following completion of therapy. Individuals of childbearing potential should use effective contraception during treatment and for 12 months after Rituxan therapy.

Revised 02/2010 (4851501) Jointly Marketed by: Biogen Idec Inc. 5200 Research Place San Diego, CA 92122 Genentech USA, Inc. 1 DNA Way South San Francisco, CA 94080-4990 ©2010 Biogen Idec Inc. and Genentech, Inc. 7140919 February 2010

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ACROSS APPROVED CLL AND NHL INDICATIONS

DRIVING PATIENT OUTCOMES Supporting your central role in patient care

Resources to support pp yyour p patients with NHL and CLL Patients can talk to a nurse educator about RITUXAN, CLL, and NHL 24 hours a day, 7 days a week. Call the RITUXAN Support Center at (888) 455-2220.

You, your patients, and their caregivers can turn to RITUXAN.com for additional resources and materials.

RITUXAN Access Solutions is committed to connecting your patients to RITUXAN, regardless of their ability to pay; for more information, please visit www.RituxanAccessSolutions.com.

Indications

Warnings and Precautions

®

RITUXAN (Rituximab) is indicated for the treatment of patients with: Previously untreated and previously treated CD20positive CLL in combination with fludarabine and cyclophosphamide (FC) Relapsed or refractory, low-grade or follicular, CD20positive, B-cell NHL as a single agent Weekly ×4

Weekly ×8

Bulky disease

Retreatment

Previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP chemotherapy Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after firstline CVP chemotherapy Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracyclinebased chemotherapy regimens RITUXAN is not recommended for use in patients with severe, active infections.

BOXED WARNINGS RITUXAN administration can result in serious, including fatal, adverse reactions. These include infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML)

©2010 Genentech USA, Inc., and Biogen Idec Inc. All rights reserved.

RITUXAN can also result in serious, including fatal, adverse reactions. These include hepatitis B reactivation with fulminant hepatitis and hepatic failure resulting in death; other infections, including bacterial, fungal, new or reactivated viral infections; cardiovascular events; severe, including fatal, renal toxicity; and abdominal pain, bowel obstruction and perforation, in some cases leading to death

Additional Important Safety Information The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with NHL were infusion reactions, fever, lymphopenia, chills, infection, and asthenia. The most frequent Grade 3 or 4 adverse reactions observed in NHL were cytopenias, including lymphopenia The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with CLL were infusion reactions and neutropenia. Most patients treated with R-FC experienced at least one Grade 3 or 4 adverse reaction.

The most frequently reported Grade 3 or 4 adverse reaction was neutropenia In clinical trials, CLL patients 70 years of age or older who received R-FC had more Grade 3 and 4 adverse reactions compared with younger CLL patients who received the same treatment

For additional safety information, please see following page for brief summary of full prescribing information, including BOXED WARNINGS. Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN infusion.

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May 2010