April 2010, Vol 3, No 2 by The Oncology Nurse

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APRIL 2010

www.TheOncologyNurse.com

CANCER CENTER PROFILE

VOL 3, NO 2

NURSING PRACTICE

Maintaining Chemotherapy Administration Competency in a Small Hospital

Desert Regional Comprehensive Cancer Center Provides Variety Marianne Bunce-Houston, RN, MS, AOCNS, CRNI of Services Under Oncology Clinical Nurse Specialist, IHI TCAB Public Hospital Faculty, One Roof Martinez, California By Karen Rosenberg

Holly Longmuir, RN, OCN, CRNI Charge Nurse Medical Unit, Contra Costa Regional Medical Center, Martinez, California

ealthcare is in a state of crisis across the nation. This, coupled with the impending nursing shortage and regulatory pressures, creates tension as well as an overall awareness for the need for change. Oncology patients admitted to Contra Costa Regional Medical Center (CCRMC) for chemotherapy treatments, as in many

pened in 1989, the Comprehensive Cancer Center (CCC) at Desert Regional Medical Center was the first multidisciplinary outpatient cancer program in the Palm Springs, California, area. The CCC represents the collaboration of the multispecialty regional medical center with Aptium Oncology, a national provider of oncology management and consulting services. The CCC now employs 120 healthcare professionals and provides a full range of services, including screening, diagnosis, treatment, and follow-up care under one roof. The 60,000-square-foot center houses a medical oncology infusion center, physician offices and examination rooms, a radiation oncology treatment area, outpatient surgery facilities, a laboratory, a pharmacy, a research department, a comprehensive breast center, and a patient resource center. Continued on page 16

The Journal of Oncology

NAVIGATION & SURVIVORSHIP

™

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

www.AONNonline.org

VOL 1, NO 1

Empowering Oncology Nurses

I Leadership Council Lillie Shockney, RN, BS, MAS University Distinguished Service Associate Professor of Breast Cancer Administrative Director Johns Hopkins Breast Center Associate Professor Dept of Surgery & Dept of Gynecology JHU School of Medicine Baltimore, Maryland Sharon Gentry, RN, MSN, AOCN, CBCN Breast Health Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, North Carolina Jay R. Swanson, RN, BSN, OCN Oncology Nurse Navigator Saint Elizabeth Cancer Institute Lincoln, Nebraska Susan M. Gardner, RN, CBEC, CBCN Oncology Nurse Navigator Valley Medical Center Renton, Washington Carol Lewis, RN, BSN, OCN, CRNI Oncology Nurse Navigator Memorial Hermann The Woodlands, Texas Nicole Messier, RN Nurse Navigator Vermont Cancer Center Burlington, Vermont Pamela Matten, RN, BSN, OCN Nurse Navigator Thoracic Oncology Program The Center for Cancer Prevention and Treatment St. Joseph Hospital Orange, California Elaine Sein, RN, BSN, OCN, CBCN Senior Project Manager Fox Chase Cancer Center Partners Rockledge, Pennsylvania Linda Fleisher, MPH, PhD(c) Assistant Vice President Health Communications and Health Disparities Fox Chase Cancer Center Cheltenham, Pennsylvania

n the past several years, the concepts of patient navigation and survivorship care have come to the forefront in oncology. Given the growing interest in these topics, the Leadership Council of the Academy of Oncology Nurse Navigators has chosen to embark on a path to empower all oncology nurses to enhance their understanding of relevant issues and their ability to implement strategies in patient navigation and survivorship care. For the remainder of 2010, this publication will run within the pages of The Oncology Nurse; in addition we

invite manuscripts on all issues relevant to these two exciting areas within oncology patient care, again in order to expand this publication into a peer-reviewed journal in 2011. For more information regarding submitting a manuscript please e-mail our team at editorial@greenhillhc.com. For your reference, complete author guidelines can be found on page 3. Thank you for your continued interest in these and other topics critical to improving the care our patients receive and their treatment experience. l

SURGICAL NAVIGATION

The Role of Patient Navigation in the Breast Surgical Oncology Setting By Lillie Shockney, RN, BS, MAS University Distinguished Service Associate Professor of Breast Cancer Administrative Director, Johns Hopkins Breast Center Associate Professor, Department of Surgery & Department of Gynecology JHU School of Medicine Baltimore, Maryland

reast cancer remains a feared disease among women. The incidence for 2009 in the United States has been estimated at 194,280 individuals.1 Although treatment has improved over the decades, women still carry an image of the Halsted radical mastectomy when thinking about this disease. Empowering women with information so that they can actively participate in decision making about their disease is critically important for those diagnosed with breast cancer.2 Without appropriate patient education, coordination of care, efficient management of resources, and removal of barriers to care, a patient may blunder through the healthcare system not receiving the treatment she needs to become a survivor. In many breast centers, navigation begins at the point of diagnosis; and in

some breast centers, the breast imaging facility begins the navigation as part of its recruitment process for mammography screening. Whether initiating the navigation process at time of a screening mammogram or implementing navigation at the time of a diagnosis, providing guidance and direction for a patient with breast cancer can ease her anxiety and help ensure she receives appropriate care in a timely manner. Step 1: Educate the patient about the roles and responsibilities of the breast cancer nurse navigator Explain to the patient the functions that will be performed on her behalf. Also provide her information about the rest of the oncology team who will be directly involved in her care. Review the process of how decisions will be made regarding her treatment, and the

order in which the decisions and subsequent treatment will occur. Step 2: Identify barriers that may affect efficient and effective delivery of cancer treatment As should be with any initial navigation assessment, interview the patient to determine her needs, identifying any barriers that may impact her ability to receive treatment. These barriers include financial and economic; language and cultural; communication; healthcare system; transportation; bias based on culture, race, or age; and/or fear.3 Step 3: Expedite appointment with the correct oncology specialist Once breast cancer is diagnosed, an appointment with an oncology specialist is needed to determine the plan of care.

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

Continued on page 2

First Annual Navigation and Survivorship Conference

hospitals across the country, are sent to the medical/surgical unit. The caseload of patients receiving chemotherapy can vary week to week and month to month. As a result, maintaining competency and safe practice are challenging for the nursing staff. Located in northern California and serving a population of 1 million resi-

between pages 20 and 21

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BREAST CANCER

CONFERENCE NEWS

High-dose Vitamin D May Relieve Joint Pain from AIs

16th Annual International Conference on Cancer Care

By Caroline Helwick

igh doses of vitamin D can relieve musculoskeletal pain associated with aromatase inhibitors (AIs) in women with breast cancer, according to a study presented at the 32nd Annual San Antonio Breast Cancer Symposium in San Antonio, Texas. “Our pilot data suggest that high-dose vitamin D significantly improves muscle and joint tenderness associated with anastrozole, and that this beneficial effect disappears once vitamin D is given monthly rather than weekly,” said principal investigator Antonella

Rastelli, MD, an internist with the survivorship program of the Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri. Musculoskeletal pain is a class effect of AIs, and breast cancer patients have been found to have deficient or insufficient levels of 25-OH vitamin D, she said. The randomized, double-blind, placebo-controlled study evaluated high-dose vitamin D supplementation versus placebo for 6 months in 60 early breast cancer patients taking anastrozole as hor-

Atlanta, Georgia, March 7-11, 2010 See who was there: page 10.

Continued on page 20

Inside

Introducing The Journal of Oncology Navigation & Survivorship™

dents, Contra Costa Health Services consists of an integrated health delivery system and was the first federally qualified, publicly sponsored health plan in the country. As the safety net for the county, CCRMC is a 166-bed acutecare facility with the mission to provide healthcare for all people, paying special

Oncology Nursing Month

CO M PL IM EN TA RY

CE Credit

Compassion fatigue: can nurses live happily ever after?

Aspirin therapy and survival in patients with colorectal cancer

page 36

page 14

r fo ay E d o e C om T er Fre xm.c t is ur coe g Re Yo ww. w

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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 ÂŠ2009 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

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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 N/A 5% N/A 6 7% 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 64 (4%) Hypertension Dizziness 60 (4%) Ejection Fraction Decreased 58 (3.5%) Palpitations 48 (3%) b Cardiac Arrhythmias 40 (3%) 30 (2%) Cardiac Failure Congestive 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%) 70 (4%) Influenza Dyspnea 57 (3%) URI 46 (3%) Rhinitis 36 (2%) Pharyngolaryngeal Pain 32 (2%) 26 (2%) Sinusitis Epistaxis 25 (2%) Pulmonary Hypertension 4 (0.2%) Interstitial Pneumonitis 4 (0.2%) Gastrointestinal Disorders Diarrhea 123 (7%) Nausea 108 (6%) 58 (3.5%) Vomiting 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

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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

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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.

News Notes Nurses Should Have Greater Voice in Health Policy, Thought Leaders Say Thought leaders in academia, insurance, health services, government, industry, and the corporate world believe that nurses should have a greater say in health policy, planning, and management, a new Gallup survey shows. Ninety percent of 1504 survey respondents said nurses should have more influence in improving the quality of healthcare and reducing medical errors, and about 85% said nurses should have more influence in promoting wellness and preventive care, improving healthcare efficiency and cost, coordinating medical care, and adapting care to meet the needs of an aging population. Seventy-two percent of those surveyed believed that greater nurse influence would help the healthcare system adapt to greater ethnic, racial, and cultural diversity in patient populations (Robert Wood Johnson Foundation, Jan 20, 2010).

Annual Report to the Nation Finds Continued Declines in New Diagnoses and Deaths Rates of new diagnoses and rates of death from all cancers combined declined significantly for men and women and for most racial and ethnic populations in the United States, according to the latest annual report issued by the National Cancer Institute, the American Cancer Society, and the North American Association of Central Cancer Registries. New diagnoses for all types of cancers decreased, on average, 1% per year from 1999 to 2006. Cancer deaths decreased 1.6% per year from 2001 to 2006. These decreases are attributed to the reduction of new cases and deaths for the three most common cancers in men—lung, prostate, colorectal—and for two of the three leading cancers in women— breast, colorectal. Among racial/ethnic groups, cancer death rates were highest in black men and women and lowest in Asian/Pacific Islander men and women. Trends in death rates were similar for most cancer sites. The complete report was published online in Cancer (7 Dec 2009. Epub ahead of print).

New Treatment Guidelines for Brain Metastases The nation’s first formal evidence-based, multidisciplinary treatment guidelines for patients with brain metastases are available from the American Association of Neurological Surgeons and the Congress of Neurological Surgeons. With the advancements in technology, physicians have many new options to treat metastases to the brain. To provide uniform, accepted treatment protocols, a 20-member panel in conjunction with the McMasters Evidence-based Practice Center reviewed 25,000 studies and then used 400 of them to reach a multidisciplinary consensus for different treatments. The new guidelines are available in a special issue of the Journal of Neuro-Oncology (4 Dec 2009. Epub ahead of print). ●

April 2010 I VOl 3, NO 2

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Editorial Board EDITOR-IN-CHIEF

Sharon S. Gentry, RN, MSN, AOCN

Dolores “Jeff” Nordquist, RN, MS, CS, FNP

Karla Wilson, RN, MSN, FNP-C, CPON

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

Mayo Clinic Rochester, MN

City of Hope National Medical Center Duarte, CA

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

Cassandra J. Hammond, RN, MSN, CRNP

Nutrition Karen Connelly, RD

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Avid Education Partners, LLC Sharpsburg, MD

Melinda Oberleitner, RN, DNS, APRN, CNS

Deena Damsky Dell, RN, MSN, AOCN, BC

Taline Khoukaz, NP, MSN, ACNP-C

Gary Shelton, MSN, ARNP, AOCN

Fox Chase Cancer Center Philadelphia, PA

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

NYU Cancer Institute New York, NY

Wendy DiSalvo, BSN, MSN, FNP, AOCN

Sandra E. Kurtin, RN, MS, AOCN, ANP-C

Lori Stover, RN, BSN

Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center Lebanon, NH

Arizona Cancer Center Tucson, AZ

Western Pennsylvania Cancer Institute Pittsburgh, PA

Denice Economou, RN, MN, AOCN

Ann McNeill, MSN, RN, NP-C, OCN

Pamela Hallquist Viale, RN, MS, CS, ANP, AOCN

City of Hope National Medical Center Duarte, CA

The Cancer Center at Hackensack University Medical Center Hackensack, NJ

Saratoga, CA

Beth Faiman, RN, MSN, APRN, BC, AOCN Cleveland Clinic Taussig Cancer Institute Cleveland, OH

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

Somerset Medical Center Somerville, NJ

Pharmacy John F. Aforismo, BSc Pharm, RPh, FASCP R. J. Health Systems, LLC Wethersfield, CT

Susan Goodin, PharmD, FCCP, BCOP Cancer Institute of New Jersey New Brunswick, NJ

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

Lyssa Friedman, RN, MPA, OCN Constance Engelking, RN, MS, OCN The CHE Consulting Group, Inc. Mt. Kisco, NY

Kena C. Miller, RN, MSN, FNP

Connie Visovsky, RN, PhD, APRN

Roswell Park Cancer Institute Buffalo, NY

University of Nebraska, College of Nursing Omaha, NE

Veracyte, Inc South San Francisco, CA

Jeanne Westphal, RN Meeker County Memorial Hospital Litchfield, MN

Amy Ford, RN, BSN, OCN Innovex Dallas, TX

April 2010 I VOl 3, NO 2

Patricia Molinelli MS, RN, NP, APN-C, AOCNS Somerset Medical Center Somerville, NJ

Rita Wickham, OCN, PhD, RN Rush University College of Nursing Rush-Presbyterian-St. Luke’s Medical Center Chicago, IL

Social Work Barbara Savage, LISW Cleveland Clinic Taussig Cancer Institute Cleveland, OH

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April marks the Second Annual

Did yo ou know: The World Health Organization predicts a 50% increase of cancer cases over the next 20 years, meaning increased hazardous drug use Two separate studies studi investigating the toxicity in healthcare personnel who handle hazardous drugs revealed a 40–50% increased risk for miscarriage A national survey showed links between nurses’ hazardous drug exposure and health problems such uch as cancerr,, asthma, asthm miscarriages and children’s birth defects Learn more about how you can protect yourself from hazardous drug exposure during the

Awareness Webinar ebinar on Second Annual National Safe Handling A wareness Day CE W Tu uesda ay y, April 20, at 1pm 1p and d 3pm EST T.. Tuesday, EST. To regis register ster now w,, visit www www.carmelpharmausa.com/aware .carmelpharmausa.com/aware This program is supported by an unrestricted educational grant provided by Carmel Pharma. For more information on how to prevent hazardous drug exposure, contact a safe handling representative at 866-487-9250, and take advantage of additional safe handling CE programs all year long at www www.carmelpharmausa.com/CE .carmelpharmausa.com/CE

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TON_April2010_TON 4/8/10 9:42 AM Page 6

FROM THE EDITOR

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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n recognition of Oncology Nursing Month, which will be celebrated in May, this issue features stories about nurses who exemplify the commitment, compassion, and creativity oncology nurses bring to their work and their communities. Comments from coworkers and patients attest to the vital role nurses play in cancer care and the special relationships they Beth Faiman, RN, MSN, APRN, BC, often develop with patients and their families. As one nurse puts it, AOCN “nurses are a special breed,” and Editor-in-Chief their contributions go beyond the hospital, clinic, or classroom. The recent International Conference on Cancer Nursing in Atlanta gave those of us in the United States a chance to connect with colleagues from around the world and share experiences and ideas. As Sancha Aranda, president of the International Society of Nurses in Cancer Care, said, nurses from developed countries

can learn much from our peers in less developed areas, who often have to use ingenuity and creativity to accomplish what we may take for granted. Although in some parts of the world, there are few cancer specialists, here in the United States, new specialties within oncology nursing are emerging. The Journal of Oncology Navigation & Survivorship, contained within these covers, has been established to provide in-depth coverage of these two areas of increasing interest in oncology practice. As you see on the cover, The Oncology Nurse has an enhanced logo as well, based on feedback from our advisory board members and readers, to demonstrate our commitment to providing content relevant to readers at different levels of experience and expertise in oncology and to reflect the close working relationships between members of the cancer care team in hospitals, clinics, and physician practices. The Oncology Nurse and The Journal of Oncology Navigation & Survivorship will continue to bring you up-to-date information on all areas of interest to oncology practitioners. We invite your contributions to both publications. ●

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CONTENTS

April 2010 • VOl 3, NO 2

FEATURE ARTICLES 8 Conference News: ISNCC ISNCC seeks to be voice of oncology nursing around the world Distinguished merit award winner calls upon nurses to promote cancer prevention Faces at the conference

14 Continuing Education Aspirin therapy and survival in patients with colorectal cancer

18 Psychosocial Issues New CancerCare CEO looks ahead

32 Breast Cancer National press coverage can boost clinical trial enrollment

33 Hematologic Cancers Strong responses seen with bortezomib-based therapy after relapse in multiple myeloma Bendamustine–rituximab combo an effective first-line therapy for CLL

36 Nursing Life Mother and daughter helping oncology patients in a unique way Nurses are a special breed An oncology nurse with a special ability to empathize Nurse’s poetry reflects her work Compassion fatigue: can nurses live happily ever after? Advance your education: become a leader of tomorrow

DEPARTMENTS 3 News Notes 25 Oncology Drug Codes Lymphomas

41 International Oncology News

THE JOURNAL OF ONCOLOGY NAVIGATION & SURVIVORSHIP™

The role of patient navigation in the breast surgical oncology setting York Cancer Center takes team approach to patient navigation

Between pages 20 and 21

April 2010 I VOl 3, NO 2

www.TheOncologyNurse.com

TON_April2010_TON 4/7/10 9:54 AM Page 7

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Conference News

ISNCC Seeks to Be Voice of Oncology Nursing Around the World By Karen Rosenberg

urses from around the world met in Atlanta, Georgia, in March to attend the 16th International Conference on Cancer Nursing, cosponsored by the International Society of Nurses in Cancer Care (ISNCC) and the National Headquarters and South Atlantic Division of the American Cancer Society. The theme of the conference was Enhancing Knowledge, Promoting Quality. The Oncology Nurse spoke with Prof. Sancha Aranda of the University of

individual members and associate members, such as cancer hospitals. Currently, we represent about 60,000 cancer nurses around the world, but with our links, the numbers are probably considerably higher. What are the goals of ISNCC? One of our key missions is to be the voice of cancer nursing around the world. The other is supporting the development of cancer nursing in places where it is underdeveloped.

“In our work with nurses in developing countries, one challenge is that many countries don’t recognize cancer as a health problem or cancer nursing as a specialist field.” —Prof. Sancha Aranda

Melbourne, president of ISNCC, about the goals of the organization and what oncology nurses can gain by involvement in international organizations as well as their own national associations. What is the membership of ISNCC? ISNCC is an international federation of national and regional cancer nursing societies. About 22 national cancer nursing societies are members of ISNCC, and we have links to other nursing organizations. There are also

In the international arena, we work with many other health organizations, including the International Council of Nurses, the World Health Organization, and the International Union Against Cancer (UICC). Our job is to bring the voice of nurses into those organizations’ agendas, which is not a small task. The UICC, for instance, has a World Cancer Declaration, which includes about 15 target areas to address the coming cancer pandemic. The aim is to reduce cancer incidence and

deaths. There has been little nursing engagement in this effort, yet many actions will need to involve nurses. We aim to get nurses at the table in some of these plans. In our work with nurses in developing countries, one challenge is that many countries don’t recognize cancer as a health problem or cancer nursing as a specialist field. In some parts of the world, there are very few cancer specialists, whether doctors or nurses. It is difficult to develop expertise or build a knowledge base under those circumstances, but we are working with individuals in these countries to do that. Given the differences in practice and available treatments, what can nurses from developed and developing countries learn from each other? Meetings such as this expose nurses from developed countries to a wider picture of the cancer problem worldwide. From my own contact with Australian nurses, I think they begin to realize that their own practices have certain privileges. Also, often these meetings interest them in prevention, early detection, and palliative care,

which they may not be exposed to in their own practices. For nurses from less developed countries, these meetings provide access to educational materials and updates that they may not have access to in their own countries. I am always struck to see the innovation that comes from poverty. One of the things that has always inspired me in developing countries is how people manage to do something with very little. A good example is the rollout of visual inspection for early detection of cervical cancer, which can be done without pathology labs or specific expertise and is pretty much as effective as standard screening. Nurses are at the forefront of the visual inspection rollout in developing countries. ●

Did You Know? In the first 6 months of 2009, 51% of US adults used the Internet to find health information, a survey by the National Center for Health Statistics found. Only 5%, however, communicated with their physician via e-mail.

Distinguished Merit Award Winner Calls upon Nurses to Promote Cancer Prevention

hat a different world is possible,” said Vernice Ferguson, RN, MA, FAAN, FRCN, accepting the Distinguished Merit Award at the opening session of the 16th International Conference on Cancer Nursing in Atlanta, Georgia. She spoke of the importance of preventive medicine and the critical role nurses play in promoting healthy lifestyles, which she said could prevent the occurrence of up to one third of all cancers. Cancer prevention is a neglected area, she said. “We do very well in cancer care with diagnosis and treatment, but we do too little with pre-

April 2010 I VOl 3, NO 2

vention. I was trying to emphasize the need for more attention by nurses to

“I was trying to emphasize the need for more attention by nurses to prevention of cancer and helping people to develop healthier lifestyles.” —Vernice Ferguson, RN, MA, FAAN, FRCN

prevention of cancer and helping people to develop healthier lifestyles.”

She called upon nurses of the world to unite and “to include prevention prominently in your life’s work.” The prevention of cancer is “a useful goal,” she added. Ferguson spent most of her career in federal services as chief nurse at two Veterans Affairs Medical Centers affiliated with universities and as chief of the Nursing Department at the National Institutes of Health Clinical Center. She served for 12 years as assistant chief medical director for nursing programs at the Department of Veterans Affairs. Prior to her retirement, Ferguson was senior fellow at the University of Pennsylvania School

of Nursing, where she held the Fagin Family Chair in Cultural Diversity from 1993 to 1996. ● —KR

www.TheOncologyNurse.com

TON_April2010_TON 4/7/10 9:55 AM Page 9

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Conference News

Faces at the Conference INTERNATIONAL CONFERENCE ON CANCER NURSING Atlanta, Georgia, March 7-11, 2010

From left: Cristina Fabbruzzo, Lisa Wayment, Penny Dooks

From left: Luz Esperanza, Sylvia Rodriguez

From left: Glory Etube, Irene Riedman, Ellen Scott

From left: Lynn Kachuilk, A. Robin Morash, Marlene Mackey, Mary Smytle

Janice Stewart

From left: Lorraine Trebilock, Elizabeth Thomas

From left: Mei Chen, Pien Wang

Photos by John Campbell Photographers â&#x20AC;˘ For more photos go to www.TheOncologyNurse.com 10

April 2010 I VOl 3, NO 2

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CONTINUING EDUCATION CREDITS

Current activities at www.COEXM.com include:

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Identification of patients with lower-risk MDS * and a poor prognosis

Clinical challenge: MDS treatment selection Approximately two-thirds of patients with myelodysplastic syndromes (MDS) have lowerrisk disease, defined as Low- and Intermediate-1–risk per IPSS.* However, existing prognostic tools for MDS do not differentiate those patients with lower-risk disease who have a poor prognosis.1

The International Prognostic Scoring System (IPSS) The IPSS helps to estimate the overall survival of patients with MDS. One limitation of the IPSS is that it does not identify patients with lower-risk MDS and poor prognosis who may be candidates for early therapeutic intervention. Certain patients classified with lower-risk MDS by the IPSS system may benefit from the “wait and watch” approach currently used by many physicians; but some patients with lower-risk MDS have a worse prognosis and may benefit from active therapy.1

A proposed prognostic scoring system for patients with lower-risk MDS This scoring system stratified patients with lower-risk MDS into 3 risk categories and evaluated the characteristics associated with survival.1 Following a multivariate analysis, the parameters below were found to be associated with decreased survival1: • Platelets (<50 x 109/L; 50–200 x 109/L) • Age (≥60 years) • Unfavorable cytogenetics† • Hemoglobin (<10 g/dL-1) • Percent of marrow blasts (≥4%–10%) The authors recommend the validation of this model by confirming the results in another patient population. Until these results are validated, the main use of this model will be to assign patients with poor prognoses to investigational clinical trials.1

Benefit of proposed scoring system This scoring system may help to identify those patients with lower-risk MDS who may benefit from early active therapy. Using this system, the authors determined that of the 673 patients in Risk Categories 2 and 3, 80% had a poor prognosis if untreated. They believed that the need to treat this population was further supported by the number of patients who died (90%) before their disease transformed to acute myelogenous leukemia.1 Results from 856 patients showed 31% of patients with a median survival of 14.2 months (1.2 years) (Risk Category 3), 48% with a median survival of 26.6 months (2.2 years) (Risk Category 2), and 21% with a median survival of 80.3 months (6.7 years) (Risk Category 1).1‡

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Estimated Survival of Lower-risk MDS Patients by Risk Category1

Assigned Score‡ 0-2 3-4 ≥5

Cumulative Proportion Alive

1.0

Survival Total (%) Dead (No.) Median (mo) 4-yr (%) 182 (21) 408 (48) 265 (31)

43 212 173

80 27 14

65 33 7

0.8 0.6 0.4 0.2 0 0

Months from Referral Reprinted with permission from Garcia-Manero et al (2008).1

A study indicated that it is possible to identify those lower-risk MDS patients with a poor prognosis (those in Risk Categories 2 and 3) who may benefit from active therapy. The proposed prognostic tool based on the IPSS classification of this specific patient type may have a significant impact on1: • MDS treatment approaches • Benefits of different therapies for lower-risk MDS • Clinical trial development • Targeted interventions

This proposed model may have significant implications for clinical trial design and ultimately for the treatment decision process for patients with lower-risk MDS.1

*MDS, myelodysplastic syndromes; lower-risk MDS, Low- and Intermediate-1–risk per International Prognostic Scoring System. †In this scoring system, only diploid and 5q were considered favorable cytogenetics; all others were considered unfavorable.1 ‡Category scoring based on: Category 1 = score 0-2, Category 2 = score 3-4, Category 3 = ≥5. Assigned score: age (≥60 years) = 2; platelets (<50 x 109/L) = 2, platelets (50–200 x 109/L) = 1; hemoglobin (<10 g/dL-1) = 1; bone marrow blasts (≥4%–10%) = 1; unfavorable cytogenetics = 1.1 Reference: 1. Garcia-Manero G, Shan J, Faderl S, et al. A prognostic score for patients with lower risk myelodysplastic syndrome. Leukemia. 2008;22(3):538-543.

CELG08070T

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CONTINUING EDUCATION EDITORIAL BOARD

PROGRAM TON2 • RELEASE DATE: APRIL 15, 2010 • EXPIRATION DATE: APRIL 15, 2011

Andrew T. Chan, MD, MPH

ESTIMATED TIME TO COMPLETE: 1.0 HOUR

Gastrointestinal Unit Massachusetts General Hospital 55 Fruit Street GRJ 724 Boston, MA 02114

Aspirin Therapy and Survival in Patients with Colorectal Cancer

Pamela Hallquist Viale, RN, MS, CS, ANP, AOCNP Oncology Nurse Practitioner and Consultant Saratoga, CA 95970

By Andrew T. Chan, MD, MPH Gastrointestinal Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts STATEMENT OF NEED

Because colorectal cancer (CRC) remains the third most frequently diagnosed cancer in both men and women and the third leading cause of cancer-related death for both sexes, there is great interest in reducing both the incidence and mortality associated with this disease. However, data regarding aspirin use and survival after a diagnosis of CRC are unknown. Therefore, the most recent data regarding aspirin and CRC are met with great interest. Oncology nurses should be aware of the most recent data in order to be able to discuss results with patients diagnosed with CRC.

Assistant Clinical Professor Department of Physiological Nursing University of California San Francisco 2 Koret Way San Francisco, CA 94143

PLANNING COMMITTEE Gloria Mui Medical Director Veritas Institute for Medical Education, Inc. 611 Route 46 West Hasbrouck Heights, NJ 07604

TARGET AUDIENCE

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

Julie Ann Tagliareni CME Director Veritas Institute for Medical Education, Inc. 611 Route 46 West Hasbrouck Heights, NJ 07604

LEARNING OBJECTIVES

After completing this activity, the reader should be better able to: • Explain the rationale for use of aspirin to protect against colorectal cancer

Anne L. Finger President Veritas Institute for Medical Education, Inc. 611 Route 46 West Hasbrouck Heights, NJ 07604 Dawn Lagrosa Associate Editor Green Hill Healthcare Communications, LLC 241 Forsgate Drive Monroe Twp, NJ 08831 Karen Rosenberg Editorial Director Green Hill Healthcare Communications, LLC 241 Forsgate Drvie Monroe Twp, NJ 08831 Jill Stein 22 rue Malher Paris, France 75004

• Describe the effects of prediagnosis and postdiagnosis use of aspirin on survival in patients with diagnosed colorectal cancer • Discuss potential indications and contraindications for aspirin use in patients at risk for colorectal cancer

lthough aspirin is best known for its uses as an analgesic, anti-inflammatory, or cardiovascular prophylactic, regular aspirin use also may prevent colorectal adenoma and colorectal cancer (CRC).1 Aspirin’s ability to inhibit colorectal tumor growth is probably due, in part, to its inhibition of cyclooxygenase-2 (COX2).2,3 The COX-2 enzyme is overexpressed

in most CRC, and is known to inhibit natural cell death, encourage growth of tumor blood vessels, and increase tumor invasiveness.4-6 Despite aspirin’s protective effect against colorectal neoplasia, it is not recommended as a CRC chemopreventive agent due to concern over its potential harmful effects, including an increased risk for hemorrhagic stroke and gastrointestinal bleeding. However, there may be a role for aspirin use in CRC prevention among those at extremely high risk of dying from the disease. One such subgroup is patients diagnosed with nonmetastatic CRC. Although their prognosis is generally more favorable compared with patients who present with metastatic disease, patients with, for example, stage III disease have as high as a 40% chance of recurrent cancer and death.7 Thus, if an inexpensive, widely used medication such as aspirin could improve survival when added to conventional surgery and chemotherapy, it would represent a significant advance in the treatment of CRC. CRC is the third most common type of cancer in men and women. It is also the second most common cause of cancer-related death in men and the third most common cause of cancer-related death in women. According to estimates from the National Cancer Institute, almost 50,000 patients will die of CRC in 2009.8 Study analyzes data from two large prospective cohorts Although a role for aspirin in reducing CRC incidence is well-established, it is not clear whether aspirin can influence prognosis in patients with confirmed CRC. To determine the effect of aspirin use after diagnosis of CRC on survival, my colleagues and I conducted a prospective cohort study of 1279 patients with nonmetastatic (stage I, II, and III) CRC.9 Our patients were drawn

CONTINUING NURSING EDUCATION ACCREDITATION AND CONTACT HOURS STATEMENT

Veritas Institute for Medical Education, Inc. approved by the California Board of Registered Nursing, Provider #13986 for 1.0 Contact Hour. METHOD OF PARTICIPATION

1. Read the article in its entirety 2. Log on to www.TheOncologyNurse.com 3. Click on “CE Credits” 4. Click on “Click here to complete the posttest and obtain a CE certificate online” 5. Register to participate 6. Enter program number TON2 7. Complete and submit the CE posttest and CE Activity Evaluation and Request for Credit Form online 8. Print your Statement of Completion This activity is provided free of charge to participants. FINANCIAL DISCLOSURES

Veritas Institute for Medical Education, Inc. is required to disclose to the activity audi-

April 2010 I VOl 3, NO 2

from two large, ongoing prospective studies—the Nurses’ Health Study and the Health Professionals Follow-up Study. At the time of enrollment in these two studies, no patient had been diagnosed with CRC. Of the 1279 patients, 560 used aspirin regularly before the diagnosis of CRC and 549 used it after the diagnosis. Because patients were asked to provide information on their use of aspirin every 2 years, we were able to determine the effect of prediagnosis and postdiagnosis aspirin use on survival in patients with established CRC. We also assessed whether the effect of aspirin varied according to levels of tumoral expression of COX-2. Results show reduced mortality with aspirin After a median follow-up of 11.8 years, there were 193 (35%) total deaths and 81 (15%) deaths due to CRC among the 549 patients who took aspirin regularly after being diagnosed with CRC. Among aspirin nonusers, there were 287 (39%) total deaths and 141 (19%) deaths due to CRC. Overall 5-year survival for the entire cohort was 88% for aspirin users compared with 83% for nonusers; 10-year survival rates were 74% and 69%, respectively. Multivariate analysis showed that patients who used aspirin regularly after being diagnosed with CRC had a 29% lower risk of death from CRC than those who did not take aspirin (multivariate hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.53-0.95) and a 21% lower risk of overall mortality (multivariate HR, 0.79; 95% CI, 0.65-0.97). Prediagnosis use of aspirin, in contrast, was not associated with either CRC-specific or overall mortality. Aspirin’s benefit was most pronounced in patients whose primary tumors overexpressed

ence the relevant financial relationships of the planners and faculty involved in the development of CE content. An individual has a relevant financial relationship if he or she has a financial relationship in any amount occurring in the last 12 months with a commercial interest whose products or services are discussed in the CE activity content over which the individual has control. In addition, all faculty are expected to openly disclose any unlabeled/unapproved/investigational uses of drugs or devices discussed in this activity. Disclosures are as follows: • Andrew T. Chan, MD, MPH, has nothing to disclose. • Pamela Hallquist Viale, RN, MS, CS, ANP, AOCNP, has received honoraria for speaking from Amgen, Bristol-Myers Squibb, IMER Institute for Medical Education and Research, Meniscus Educational Institute, Merck & Co, and Norvartis. The staff of Veritas Institute for Medical Education, Inc. and Green Hill Healthcare Communications, LLC have nothing to disclose. DISCLAIMER

The opinions expressed in this activity are those of the presenters and do not necessarily reflect the opinions or recommendation of Veritas Institute for Medical Education, Inc. Copyright © 2010 Veritas Institute for Medical Education, Inc. All rights reserved.

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www.TheOncologyNurse.com COX-2; these patients were 61% less likely to die of CRC if they took aspirin after their diagnosis than patients with similar COX-2 levels who did not take aspirin (multivariate HR, 39; 95% CI, 0.20-0.76). Patients with COX-2–positive tumors also had a 38% lower risk of overall mortality (multivariate HR, 0.62; 95% CI, 0.42-0.93). The findings, which are consistent with those of other human and experimental data, suggest that COX-2–positive tumors may be relatively sensitive to the effects of aspirin whereas COX-2–negative tumors may be relatively aspirin-resistant. Among study subjects who had not used aspirin regularly before diagnosis, the association between postdiagnosis aspirin use and survival was found to be modestly dose-responsive. Compared with subjects who used any aspirin, the multivariate-adjusted HR for CRC-specific mortality was 0.57 (95% CI, 0.32-

0.99) for those who used 0.5 to 5 standard aspirin tablets and 0.49 (95% CI, 0.181.35) for those who used six or more tablets per week (P for trend = .04). Study strengths and limitations We believe that our study has several notable strengths. For example, we used prospective data on aspirin use, which allowed us to minimize the possibility that patients would be inaccurate in their recollection of their aspirin use. Also, we compiled data on aspirin use both before and after patients had been diagnosed with CRC, which enabled us to clearly distinguish the effect of aspirin use after diagnosis from that of aspirin use before diagnosis. Notably, all study participants were health professionals, and health professionals are presumably more likely to provide an accurate report of aspirin use. Perhaps the key study limitation is its

Patients with CRC who take aspirin may reduce their risk of dying from the disease by nearly 30%. observational design. We examined aspirin use in individuals who had either decided on their own to take aspirin or in whom aspirin had been prescribed for some other condition. Observational studies are generally less reliable than placebo-controlled studies. Our results thus need to be confirmed in placebocontrolled trials of aspirin or associated agents as adjuncts to other standard CRC treatments. Summary and conclusion What we now know • Patients with CRC who take aspirin may reduce their risk of dying from the disease by nearly 30%.

• Aspirin use after rather than before the development of stage I, II, or III cancer is associated with improved survival. • Aspirin appears to primarily benefit only those patients whose primary tumors test positive for the COX-2 enzyme. • Patients with stage III disease at the time of diagnosis derive as much benefit from aspirin use as patients who have stage I or II disease at diagnosis. • Former aspirin users obtain less benefit from subsequent aspirin use than former nonusers. Continued on page 16

COMMENTARY

A Nurse’s Perspective Pamela Hallquist Viale, RN, MS, CS, ANP, AOCNP Oncology Nurse Practitioner and Consultant, Saratoga, California; Assistant Clinical Professor, Department of Physiological Nursing, University of California, San Francisco

he role of aspirin and non steroidal anti-inflammatory drugs (NSAIDs) and colorectal cancer (CRC) has been examined in multiple studies. Because CRC remains the third most frequently diagnosed cancer in both men and women and the third leading cause of cancerrelated death for both sexes,1 there is great interest in reducing both the incidence and mortality associated with this disease. Numerous studies have demonstrated that individuals who use aspirin regularly have a lower risk of colorectal adenoma or cancer.2 However, long-term therapy with aspirin is not without risks. A systematic review of aspirin as a primary prevention of CRC was prepared for the US Preventive Services Task Force and published in the Annals of Internal Medicine in 2007.3 The report utilized comprehensive data sources, including the Cochrane Database of Systematic Reviews and included randomized controlled trials (RCTs), case-control studies, and cohort studies of aspirin chemoprophylaxis. The authors noted that the data synthesis showed that regular use of aspirin reduced the incidence of colonic adenomas in all reviewed studies and in the cohort studies and its use was associated with a relative risk reduction of 22% for the incidence of CRC. Two of the RCTs failed to show a protective effect of aspirin against

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CRC, and the benefits were notably more evident when aspirin was used at a high dose (14 or more standard aspirin tablets per week) and for periods longer than 10 years; additionally it should be noted that gastrointestinal complications were higher with the use of aspirin.3 The authors of the review stressed that further study of the costeffectiveness of chemoprevention compared with and in combination with a screening strategy should be conducted. An additional report by Rostom and colleagues examined the use of NSAIDs and cyclooxygenase-2 (COX2) inhibitors for primary prevention of CRC in a review for the US Preventive Services Task Force.4 The study found that these agents reduced the incidence of colonic adenomas and CRC; however, the review found that the associated side effects (cardiovascular events and gastrointestinal harms) were sufficient enough to prevent chemopreventive use in average-risk individuals.4 Although the optimal duration and dose of this agent is not yet known, the benefit of aspirin in the potential prevention of CRC is established and it appears that long-term use is needed to derive a protective effect against the disease.5 However, data regarding aspirin use and survival after a diagnosis of CRC are unknown. Therefore, the most recent data regarding aspirin and CRC are met with great

interest. Chan and colleagues examined aspirin use after CRC to determine its effects on overall survival in a prospective cohort study of men and women with stage I, II, and III CRC. The study results showed that aspirin use after a diagnosis of nonmetastatic CRC was associated with a decreased risk of CRC-specific mortality and was strongest among those study participants whose tumors overexpressed COX-2.2 Because personalized medicine continues to evolve, the results of this study are important and contribute to understanding of the biology of established CRC tumors. It may be possible to use COX-2 or other markers to specifically tailor the use of aspirin in patients with newly diagnosed CRC to improve survival. The authors point out that routine use of aspirin cannot yet be recommended in this setting because the data are observational, but future studies should continue to address the use of aspirin as an adjunct to standard therapies for patients diagnosed with CRC. It may be that aspirin has a significant role when combined with routine therapies for this common tumor type as well as a role as a chemoprevention strategy for the development of CRC. Oncology nurses have a key part in the education of patients regarding CRC. Aspirin therapy is not without

side effects, and patients should be taught about the use of this agent. Oncology nurses should be aware of the updated information regarding aspirin in chemoprevention, including doses and duration of aspirin use studied. The dose for chemoprevention in CRC is higher than the doses patients are familiar with and those recommended for cardioprotection.2 Although the use of aspirin in conjunction with recommended therapy for CRC is not yet standard, oncology nurses should be aware of the most recent data in order to be able to discuss results with patients diagnosed with CRC. References 1. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2009. CA Cancer J Clin. 2009;59:225-249. 2. Chan AT, Ogino S, Fuchs CS. Aspirin use and survival after diagnosis of colorectal cancer. JAMA. 2009;302:649-658. 3. Dubé C, Rostom A, Lewin G, et al; for the US Preventive Services Task Force. The use of aspirin for primary prevention of colorectal cancer: a systematic review prepared for the US Preventive Services Task Force. Ann Intern Med. 2007;146:365-375. 4. Rostom A, Dubé C, Lewin G, et al; for the US Preventive Services Task Force. Nonsteroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors for primary prevention of colorectal cancer: a systematic review prepared for the U.S. Preventive Services Task Force. Ann Intern Med. 2007;146:376-389. 5. Friis S, Poulsen AH, Sørensen HT, et al. Aspirin and other non-steroidal anti-inflammatory drugs and risk of colorectal cancer: a Danish cohort study. Cancer Causes Control. 2009;20:731-740.

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CONTINUING EDUCATION Continued from page 15

Aspirin Therapy... • Our data suggest that aspirin may alter the biology of established colorectal tumors (ie, reduce the risk of recurrence among patients with cancer) in addition to preventing their occurrence (ie, reduce the risk of developing an initial cancer). At

what roles that factors other than aspirin may have played in decreasing cancer deaths. • We do not know yet whether all patients with CRC will benefit from aspirin so we cannot make recommendations yet about who should

Patients with stage III disease at the time of diagnosis derive as much benefit from aspirin use as patients who have stage I or II disease at diagnosis. this time, it is unclear exactly how aspirin interacts with the tumor to improve survival. • Our data demonstrate the potential for using COX-2 as a marker to tailor aspirin use in patients with newly diagnosed CRC. What we do not know • Because the study was observational, we were not able to determine

take it and how often and at what dose. All these questions require additional research, including placebocontrolled trials of aspirin as adjuvant therapy for CRC. An ongoing study being conducted in Asia is comparing aspirin with placebo in patients with nonmetastatic CRC.10 At this time, we cannot make broad recommendations about the use of aspirin in patients with CRC. Some

patients may already be taking aspirin for other reasons, such as heart attack prevention. However, the risk of serious side effects with long-term exposure means that physicians should not prescribe aspirin to treat CRC until the evidence in favor of a significant benefit is definitive and until there is proof that its benefits outweigh its risks. For now, the best treatments for CRC are surgery, chemotherapy, and radiation therapy. References 1. Dubé C, Roston A, Lewin G, et al; for the US Preventive Services Task Force. The use of aspirin for primary prevention of colorectal cancer: a systematic review prepared for the U.S. Preventive Services Task Force. Ann Intern Med. 2007;146:365-375. 2. Chan AT, Ogino S, Fuchs CS. Aspirin and the risk of colorectal cancer in relation to the expression of COX-2. N Engl J Med. 2007;356: 2131-2142. 3. Markowitz SD. Aspirin and colon cancer—targeting prevention? N Engl J Med. 2007;356: 2195-2198. 4. Brown JR, DuBois RN. COX-2: a molecular target for colorectal cancer prevention. J Clin Oncol. 2005;23:2840-2855. 5. Eberhart CE, Coffey RJ, Radhika A, et al. Up-

regulation of cyclooxygenase 2 gene expression in human colorectal adenomas and adenocarcinomas. Gastroenterology. 1994;107:1183-1188. 6. Soumaoro LT, Uetake H, Higuchi T, et al. Cyclooxygenase-2 expression: a significant prognostic indicator for patients with colorectal cancer. Clin Cancer Res. 2004;10:8465-8471. 7. Goldberg RM. Intensive surveillance after stage II or III colorectal cancer: is it worth it? J Clin Oncol. 2006;24:330-331. 8. Surveillance, Epidemiology and End Results. SEER Stat Fact Sheets: colon and rectum. Based on November 2008 SEER data submission, posted to the SEER website, 2009. http://seer.can cer.gov/statfacts/html/colorect.html. Accessed November 25, 2009. 9. Chan AT, Ogino S, Fuchs CS. Aspirin use and survival after diagnosis of colorectal cancer. JAMA. 2009;302:649-659. 10. National Cancer Institute. Clinical trials (PDQ): phase III randomized study of acetylsalicylic acid (aspirin) in patients with completely resected Dukes stage C colon or rectal cancer, Dukes stage B rectal cancer, or high-risk Dukes stage B colon cancer. January 30, 2009. www.cancer.gov/search/viewclinicaltrials. aspx?cdrid=577892&version=healthprof. Accessed November 25, 2009.

Jill Stein contributed to preparation of this manuscript.

CANCER CENTER PROFILE

Desert Regional Comprehensive Cancer Center... Continued from cover new responsibilities, Elg has found. “You get a lot of support from Administration and the medical staff. It is a very collaborative practice here and definitely an enjoyable place to work.”

Multidisciplinary staff of Desert Regional Comprehensive Cancer Center.

The center employs a multidisciplinary team of physicians with expertise in all the major types of cancer and offers a variety of treatment options, including chemotherapy, radiation therapy, gene therapy, and surgery. Patients have access to on-site psychosocial, nutritional support, and financial counseling services. In addition, the CCC provides genetic testing for women at high risk for breast or ovarian cancer, a hospice program, a pain management program, support groups, and volunteer services. Because of its excellent reputation, patients come from far away to be treated at Desert Regional CCC, and social workers help arrange housing for patients and their families; translators are available to assist foreign visitors.

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Pharmacist plays many roles Through its affiliation with Aptium Oncology–managed cancer centers throughout the country, the CCC offers patients the opportunity to participate in phase 1 to 4 clinical trials. Oncology pharmacist Craig Elg, PharmD, BCOP, coordinates clinical trials in addition to his other responsibilities. “At any given time, we have 40 to 50 clinical trials open and running,” he says. “One of my responsibilities is to make sure that the pharmacy portion of those trials is running smoothly and correctly. I go to the site initiation visits and meet with the monitors to make sure that the protocol is being followed properly, the drugs are being stored in the correct manner, destruction policies are being followed, and all the

paperwork is done. Since we implemented our electronic medical record (EMR), I’m also involved in building the protocols for all the new research trials. Once we sign on to do something, those order sets are put into the EMR so that the physicians have easy access to them.” In addition to their more traditional responsibilities for counseling patients and providing support to medical staff on a variety of supportive care issues, such as fatigue and pain management, Elg and his fellow pharmacists at the center have the ability through special California law to prescribe controlled substances to help manage patients with cancer pain. Desert Regional CCC provides an environment in which employees are encouraged to do new things and take on

Nurse appreciates range of specialties Oncology nurse Kristin Rupp, RN, BSN, OCN, agrees, saying, “We feel as if we are a family here. Coming here as a transplant from Indiana, it has been very welcoming.” Rupp previously worked on the oncology floor of a local hospital in Indiana and in private oncology practices in Indiana and California. In her previous jobs, she says the nurses had to take on other responsibilities, such as mixing chemotherapy, in addition to their nursing duties. “We wore all hats. We were the nurse; we administered chemotherapy in our office; we ran the lab; we were the social worker; the dietitian, everything.” At the CCC, she says, “I can rely on all the different professions—the pharmacists, the dietitians, social workers, and others—to add their knowledge and expertise to taking care of the patient as a whole. This allows me to focus on my nursing role.” There are also advantages for patients. “We have everything here under one roof,” making it possible for patients to see different specialists in one visit, she notes. “The level of expertise that I am surrounded by every day makes care of the patient top notch.” ●

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Metastatic Colorectal Cancer: Sound Strategies for Selecting First-Line Therapies

LOG ON TODAY TO PARTICIPATE www.coexm.com/ace01.asp FACULTY

Release Date: November 25, 2009 Expiration Date: November 24, 2010

Neal P. Christiansen, MD Assistant Professor of Medicine Medical University of South Carolina Division of Hematology/Oncology Charleston, South Carolina

TARGET AUDIENCE This activity is intended for hematologists, oncologists, oncology nurses, oncology/specialty pharmacists, and others who are involved with the care of patients with metastatic colorectal cancer (mCRC).

STATEMENT OF NEED Colorectal cancer (CRC) is the third most commonly diagnosed malignancy and the second leading cause of cancer death in the United States. Approximately 149,000 new cases are diagnosed each year. At the time of presentation, about 20% of patients with CRC will have metastatic disease. Cure at this stage is rarely possible, although some patients whose metastases are limited (especially if to the liver or lung) may be “cured” by surgical means. For most sufferers of mCRC, however, treatment is palliative, offering prolonged survival, improvement in symptoms, and enhanced quality of life.

EDUCATIONAL OBJECTIVES On completion of this activity, participants should be able to: • Evaluate and assess current findings in the management of mCRC • Identify current first-line therapies, both chemotherapeutic and biologic agents, and practices in mCRC • Tailor a therapeutic regimen to meet the needs of the individual patient with mCRC • Employ select strategies to minimize exposure to ineffective therapies and their toxicities

INSTRUCTIONS To receive a statement of credit, you must: • Review the content of the activity • Successfully complete the post-test (70% or higher) • Complete the evaluation at the end of the activity Your statement of credit will be issued immediately upon successful completion of the post-test and submission of the evaluation

ACCREDITATION STATEMENT This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the University of California, Irvine School of Medicine (UCI) and Center of Excellence Media, LLC. The University of California, Irvine School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT The University of California, Irvine School of Medicine designates this educational activity for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity. This activity is complimentary.

FACULTY INFORMATION AND DISCLOSURES Dr Christiansen has received consultancy fees from sanofi-aventis and Genentech. Off-label use of cetuximab (in patients in whom irinotecan has not failed) and bevacizumab (continuing after first-line therapy) will be discussed in this presentation. Conflict resolution: This presentation has been peer reviewed for evidence base and fair balance.

GENERAL DISCLOSURE STATEMENT It is the policy of the University of California, Irvine School of Medicine and the University of California CME Consortium to ensure balance, independence, objectivity, and scientific rigor in all CME activities. Full disclosure of conflict resolution will be made in writing via handout materials or syllabus. Bonnie Carroll, Director, CME, UC Irvine School of Medicine, has no financial or other relationship to products or devices with commercial interests related to the content of this CME/CE activity. Center of Excellence Media, LLC: The planners and managers have nothing to disclose related to the content of this activity. Erica Johansson, RN, Astute CE, LLC, has nothing to disclose related to the content of this activity. Dr. Randall F. Holcombe, University of California, Irvine School of Medicine, peer-reviewed the content for evidence base and fair balance. Dr Holcombe has no real or apparent conflicts of interest related to this activity. Conflict resolution: This presentation has been peer reviewed for evidence base and fair balance. This activity is in compliance with California Assembly Bill 1195, which requires continuing medical education components to include curriculum in the subjects of cultural and linguistic competency. For specific information regarding Bill 1195 and definitions of cultural and linguistic competency, please visit the CME web site at http://www.cme.uci.edu. This activity is supported by an educational grant from Genentech BioOncology.

In collaboration with

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Psychosocial Issues

New CancerCare CEO Looks Ahead An interview with Helen H. Miller, LCSW By Karen Rosenberg

elen H. Miller, LCSW, recently assumed the position of chief executive officer of CancerCare. The Oncology Nurse spoke with Ms Miller about the role of CancerCare in helping patients and their significant others cope with the practical and emotional challenges associated with a diagnosis of cancer.

What services does CancerCare provide and how do its services complement the services provided by hospitals and clinics? CancerCare is a 65-year-old nonprofit agency that provides free counseling, education, support groups, and financial assistance for patients and others affected by cancer. Last year, we provided services to more than 100,000 individuals. These services complement those provided by hospitals or cancer centers. When I worked in a hospital setting, I often referred patients to CancerCare for additional help with psychosocial issues. We are located in New York City, but people who don’t live in the metropolitan area can get our services through websites and over Helen H. Miller, the telephone. For LCSW instance, we offer Connect Education Workshops, in which oncology experts provide free 1hour workshops on various cancerrelated topics over the phone or as podcasts. We offer health education credit for healthcare professionals who participate in these workshops. Our services are available to anyone affected by cancer, including patients, family members, and caregivers. We even had an employer come to us for counseling to learn how to deal with the business, personal, and professional issues presented by an employee with cancer. We also provide free educational materials and resources for healthcare professionals, and we have social workers with expertise in specific types of cancer who are available for consultation. Do you find that people with different types of cancer have different psychosocial issues and different needs? They absolutely do. Being even more specific, people’s needs reflect what stage they are at in the course of the disease. Are they recently diagnosed or have they been through treatment for an ongoing period? Are they in the end stage of life or are we dealing with bereavement for a family? For many

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types of cancer, there is a genetic component, and one issue is what can be done from a preventive standpoint if there is a

family history of the disease. It’s very important to have trained social work professionals who are familiar with the

different types of cancer because of the complexity of the medical system and the rapid advances in treatment.

Neulasta® (pegfilgrastim) 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.

Important Safety Information SPLENIC RUPTURE, INCLUDING FATAL CASES, HAS BEEN REPORTED. IF PATIENTS REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN, THEY SHOULD BE EVALUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE. Acute respiratory distress syndrome (ARDS) has been reported. Evaluate patients who develop fever, lung infiltrates, or respiratory distress for ARDS. If patient is diagnosed with ARDS, discontinue and/or withhold Neulasta® until resolution. Allergic reactions to Neulasta®, manifesting as anaphylaxis, angioedema, or urticaria have been reported. The majority of these reactions occurred upon initial exposure. However, in rare cases, allergic reactions, including anaphylaxis, recurred within days after discontinuing anti-allergic treatment. Severe sickle cell crises have been associated with the use of Neulasta® in patients with sickle cell disorders. Only physicians qualified by specialized training or experience in the treatment of patients with sickle cell disorders should prescribe Neulasta® for such patients.

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Psychosocial Issues How can nurses and social workers work together to best meet a patient’s psychosocial needs? My emphasis has been the team approach. I firmly believe that the nurse or nurse practitioner is the core person from the medical standpoint because she is the one who often spends time with the patient than the physician. I think one

reason nurses have always made so many of the referrals here is that they know that we understand that you can’t talk to a patient without taking into account the doctor’s role and the nurse’s role. What are your personal goals as CEO? CancerCare is already a well-respected

resource for people affected by cancer. I hope to continue to expand that resource and make it more of a household word. It’s important for everyone in the cancer community to know about us and for us to continue to work with nurses and expand. I am looking at outcomes in terms of what we are doing, how we are doing,

and what the results are of what we are doing. It is especially important to continue to deliver high-quality, efficient care in these changing times. Where can we be better or how can we reach more people? How do we continue to do what we have done and not overburden our staff when there are economic challenges? ●

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

Neulasta® should not be administered in the period between 14 days before and 24 hours after administration of cytotoxic chemotherapy. The use of Neulasta® has not been studied in patients receiving chemotherapy associated with delayed myelosuppression (eg, nitrosoureas, mitomycin C). In a placebo-controlled trial, bone pain occurred at a higher incidence in patients treated with Neulasta®, as compared to placebo-treated patients. The most common adverse events reported in either placebo- or active-controlled trials were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain. Please see brief summary of Neulasta® Prescribing Information on the adjacent page. *Regimens associated with ≥ 17% risk of febrile neutropenia.

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Breast Cancer High-dose Vitamin D... Continued from cover monal therapy for hormone receptor–positive disease. Patients were required to have serum calcium ≤10.3 mg/dL, marginal 25-OH vitamin D levels (10 ng/mL-29 ng/mL), 24-hour urinary calcium excretion ≤250 mg/g, and a history of generalized musculoskeletal pain that developed or

worsened since starting anastrozole. All patients received calcium (1000 mg/day) and standard vitamin D supplementation (400 IU/day). The active group also received highdose vitamin D (50,000 IU/week), administered for 8 weeks if they had 25-OH vitamin D ≥20 ng/mL and

<30 ng/mL or for 16 weeks if they had 25-OH vitamin D ≥10 ng/mL and <20 ng/mL. Patients were given questionnaires for pain and impairment at baseline and at 2, 4, and 6 months, including the Brief Pain Inventory (BPI), the Fibromyalgia Impact Questionnaire

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;

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April 2010 I VOl 3, NO 2

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%

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”

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 Filgrastim treated 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

(FIQ), and the Health Assessment Questionnaire-Disability Index (HAQDI). Bone mineral density (BMD) measurements of the lumbar spine and proximal femur were taken at baseline and at 6 months. Pain relieved in high-dose group At the 2-month follow-up visit, subjects in the high-dose vitamin D group experienced a significant reduction in pain, compared with those in the placebo arm, on both the BPI questionnaire (P = .009) and the FIQ (P = .01). Significantly better scores were also reported for walking on flat ground and climbing steps (P = .04) in the HAQ-DI. Rastelli also reported favorable trends on the BPI-interference score, the FIQ total score, and the HAQ-DI total score. Patients in the placebo group also derived some improvements in pain. “They were getting some vitamin D, and they seemed to be getting some relief,” she said. For patients in the active groups, most of the beneficial effects disappeared at 4 and 6 months after the dosing was cut back from weekly to monthly. Subjects receiving high-dose vitamin D supplementation also showed a trend for maintaining BMD of the femoral neck, compared with those in the placebo group, she added. Need to monitor urine Although high-dose vitamin D was well tolerated, some patients showed a propensity for higher urinary calcium excretion, which can lead to kidney stones, Rastelli reported. Four of the 30 active-treatment patients were excluded at 2 months because of this, as was one patient in the control group. “You have to monitor for urinary calcium when you are giving 50,000 IU/week of vitamin D long-term, which is very potent,” she emphasized. Secondary hyperparathyroidism was also observed in a few patients. At baseline, 6 patients (10%) had secondary hyperparathyroidism from low 25-OH vitamin D levels, which resolved for two patients during treatment but persisted in four (8.5%). Secondary hyperparathyroidism can lead to bone loss. The group hopes to conduct a multicenter trial to confirm their findings, and perhaps using cholecalciferol, which keeps serum levels more stable than ergocalciferol. “We used ergocalciferol and weekly dosing,” she noted. “We don’t know if alternative forms of vitamin D, such as cholecaleiferal, and daily dosing would similarly improve muscle–joint pain and BMD.” ●

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The Journal of Oncology

NAVIGATION & SURVIVORSHIP

™

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

www.AONNonline.org

VOL 1, NO 1

Empowering Oncology Nurses

I Leadership Council Lillie Shockney, RN, BS, MAS University Distinguished Service Associate Professor of Breast Cancer Administrative Director Johns Hopkins Breast Center Associate Professor Dept of Surgery & Dept of Gynecology Johns Hopkins University School of Medicine Baltimore, Maryland Sharon Gentry, RN, MSN, AOCN, CBCN Breast Health Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, North Carolina Jay R. Swanson, RN, BSN, OCN Oncology Nurse Navigator Saint Elizabeth Cancer Institute Lincoln, Nebraska Susan M. Gardner, RN, CBEC, CBCN Oncology Nurse Navigator Valley Medical Center Renton, Washington Carol Lewis, RN, BSN, OCN, CRNI Oncology Nurse Navigator Memorial Hermann The Woodlands, Texas Nicole Messier, RN Nurse Navigator Vermont Cancer Center Burlington, Vermont Pamela Matten, RN, BSN, OCN Nurse Navigator Thoracic Oncology Program The Center for Cancer Prevention and Treatment St. Joseph Hospital Orange, California Elaine Sein, RN, BSN, OCN, CBCN Senior Project Manager Fox Chase Cancer Center Partners Rockledge, Pennsylvania Linda Fleisher, MPH, PhD(c) Assistant Vice President Health Communications and Health Disparities Fox Chase Cancer Center Cheltenham, Pennsylvania

invite manuscripts on all issues relevant to these two exciting areas within oncology patient care, again in order to expand this publication into a peer-reviewed journal in 2011. For more information regarding submitting a manuscript please e-mail our team at editorial@greenhillhc.com. For your reference, complete author guidelines can be found on page 4. Thank you for your continued interest in these and other topics critical to improving the care our patients receive and their treatment experience. ●

SURGICAL NAVIGATION

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

breast centers, the breast imaging facility begins the navigation as part of its recruitment process for mammography screening. Whether initiating the navigation process at the time of a screening mammogram or implementing navigation at the time of a diagnosis, providing guidance and direction for a patient with breast cancer can ease her anxiety and help ensure she receives appropriate care in a timely manner. Step 1: Educate the patient about the roles and responsibilities of the breast cancer nurse navigator Explain to the patient the functions that will be performed on her behalf. Also provide her information about the rest of the oncology team who will be directly involved in her care. Review the process of how decisions will be made regarding her treatment, and the

First Annual Navigation and Survivorship Conference 17-19, 2010 • Baltimore, Maryland www.AONNonline. org

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The Role of Patient Navigation... Continued from cover To triage the patient appropriately, glean information from the biopsy results and breast imaging studies. Descriptions of the size of the mass and type of breast cancer diagnosed can help in determining the first phase of treatment most likely to be recommended. For example, a patient diagnosed with a 0.8-cm invasive ductal carcinoma that was found on a routine screening mammogram is usually a good candidate for lumpectomy with sentinel node biopsy; therefore, she would need an appointment with a breast surgical oncologist. However, a patient diagnosed with inflammatory breast cancer based on the redness of the breast and a biopsy of the breast skin that showed the presence of cancer cells in the dermal lymphatics would be guided to a medical oncologist for neoadjuvant chemotherapy. The urgency of an appointment is usually driven by the patient’s anxiety, not by a change in clinical outcome if her

appointment is scheduled several weeks from the time the diagnosis is confirmed. Ideally, arranging for consultation within a few days will help in reducing her anxiety and fear of the unknown. Step 4A: Provide educational information to the patient based on stage of disease and anticipated treatment plan Early on, provide the patient with an overview of what to expect regarding each phase of her treatment. Take care not to overwhelm the patient with information. For example, providing details about the surgical treatment would be appropriate for patients having lumpectomy or mastectomy as their first treatment. Touching on adjuvant therapy and how decisions will be made regarding what adjuvant therapy will be needed is sufficient at the navigation appointment following initial consultation with the doctor. Whenever possible, the navigator

Example of Patient Navigation during Surgical Oncology Care Action 1. Patient is informed that biopsy is positive for breast cancer 2. Patient is contacted by nurse navigator a. Barrier assessment b. Roles and responsibilities c. Patient scheduled for consultation with surgical oncologist

Date 4/1/2010

4/1/2010

3. Surgical consultation 4/4/2010 a. Patient is educated about surgical treatment plan b. Preoperative tests and physical examination are arranged c. Scheduled for preoperative teaching d. Surgery scheduled e. Postoperative appointment with surgeon, 5 to 7 days after surgery f. Postoperative consultation with medical oncologist, 10 to 14 days after surgery g. Postoperative consultation with radiation oncologist, 15 to 18 days after surgery

4. Review of preoperative tests

4/12/2010

5. Preoperative teaching performed

4/12/2010

6. Surgery performed

4/15/2010

7. Assessment of recovery process by phone

4/16/2010

8. Postoperative appointment with breast surgical oncologist

4/21/2010

9. Consultation with medical oncologist

4/26/2010

10. Consultation with radiation oncologist

4/30/2010

Barriers identified Transportation for postoperative appointment

Action taken Taxi voucher provided

April 2010 I VOl 1, NO 1

Whenever possible, the navigator should be present with the patient during that consultation so that she has a clear understanding of the information stated by the physician. should be present with the patient during that consultation so that she has a clear understanding of the information stated by the physician. By doing so, the treatment plan can be accurately reiterated to the patient and family. In addition to verbal consultation, provide information in writing. Step 4B: Provide emotional support to the patient and family This disease affects the patient and those who love her; it can be a lifealtering experience, whether diagnosed early or at an advanced stage. Providing the patient an opportunity to express her fears, ascertaining her previous knowledge base of breast cancer (particularly any misinformation she may have), and assessing the family’s needs should also take place early in the care-delivery process. Whenever possible, provide the patient an opportunity to be matched with a volunteer who is a survivor with training specifically designed to provide support to others newly diagnosed with a similar treatment plan and stage of disease. The patient may experience anxiety about changes to her body image that will happen as a result of surgery and systemic treatment.4 She may also have concerns about job security if she needs to be off from work for an extended period of time. She may be concerned about how to tell her children about her diagnosis. She may also be anxious about her sexuality as well as her chances of surviving this disease.5 A variety of resources are available to patients and their families. Even for patients who do not appear to be struggling emotionally, it is helpful to provide them a list of resources in case they wish to access them now or in the future. Step 5: Schedule the patient for surgery After the surgical treatment plan is known, arrangements can be made to schedule the patient for surgery. Assess comorbid conditions that may impact surgical management to determine whether an anesthesia consultation is warranted or other special consultations are needed. Immediately notify the patient’s primary care physician so that a physical examination and preoperative tests can be conducted, allowing enough time for results to be reviewed before the surgery date. Also review any medications the patient is

currently taking to determine whether any drug (eg, an anticoagulant) needs to be discontinued before surgery. Step 6: Teach preoperatively In some breast centers, the nurse navigator will conduct preoperative education classes to prepare a patient for the specific type of surgery she will soon be having. This education may include: • Drain management • Wound care/dressing changes • Body image (photographs to show her immediate incisional appearance and scar healing over time) • Activities of daily living • Sexual activity • Exercises • Coping with fatigue • Coping with anxiety/addressing psychological well-being • Pain management • Urgent care needs—signs of infection or surgical complication. The procedures to be reviewed depend on the specific type of surgery the patient will be undergoing. These procedures include wire localization, sentinel node biopsy, axillary node dissection, lumpectomy, mastectomy, skinsparing mastectomy, insertion of tissue expander, transverse rectus abdominis myocutaneous (TRAM) flap reconstruction, deep inferior epigastric perforator (DIEP) flap reconstruction, superior gluteal artery perforator (S-GAP) reconstruction, latismuss dorsi flap reconstruction, or transverse gracilis/ inner thigh (TUG) flap reconstruction. Step 7: Review preoperative tests and readiness for surgery Review all preoperative tests to ensure that the patient’s laboratory values, chest film, and any other tests are within normal limits and do not require intervention. These can include additional imaging studies that were performed (such as breast magnetic resonance imaging) to ensure that no additional workup is needed that may impact the type of surgery planned.6 Step 8: Contact patient and assess after surgery Some institutions follow a protocol in which the recovery room nurse contacts the patient who had ambulatory surgery; in other institutions, the navigator may contact the patient. If in line with the surgical protocol for the institution, contact the patient the morning after Continued on page 3 www.AONNonline.org

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NAVIGATION MODELS

York Cancer Center Takes Team Approach to Patient Navigation An Interview with Diane McElwain, RN, OCN, MEd, and Deana Albright, MSW, LSW By Karen Rosenberg

s the role of patient navigator continues to evolve, questions have arisen about the respective roles of oncology nurses and oncology social workers in providing support and guidance for patients with cancer. In this interview, oncology nurse Diane McElwain, RN, OCN, MEd, and oncology social worker Deana Albright, MSW, LSW, of York Cancer Center, York, Pennsylvania, describe the team approach used at their cancer center to provide assistance with their patients’ myriad health, emotional, and practical issues.

oncology nurse and an oncology social worker. Little did we know then that we were actually setting up a navigator program. I was seeing a lot of breast cancer patients at that time and started a breast cancer support group and then also special events for breast cancer patients. It soon became clear that since we see at least 400 breast cancer patients a year, that was a group that needed special attention. We have since hired another oncology nurse— Sue Bowman—to be a breast cancer navigator, but Deana and I continue to navigate other patients. We have also hired another oncology social worker, Kathy Allen. Only Sue has the title of navigator, but we all act as navigators.

When and how did you start your navigation program at York? DM: The cancer center in York was started in 1993. A business director was hired first and she recruited an

The Oncology Nursing Society and the Association of Oncology Social Work (AOSW) recently held a meeting to discuss the respective professions’ role in patient navigation. At

your center, how do you divide your responsibilities for patient navigation? DM: In York, we have a building with three departments: cancer support services, radiation therapy, and a private practice in medical oncology. It is rather unusual to have a private practice integrated within the cancer center, and one of the reasons the medical oncology office decided to come to our building was that we provide extra staff to enhance patient care—the patient navigators as well as a financial counselor and dietitian. At the same time, having the private practice means that there are more oncology nurses added to our team because they have 12 or 15 oncology certified nurses within their practice. A patient may enter through the chem o therapy office and be referred to us for additional services, whether it be a dietitian or a mental health or financial counselor. The same thing happens in

the radiation department; the nurses there refer patients for the services we provide. We have a very fluid system of finding patients without a lot of boundaries, and sometimes more than one team member is working with the same patient. We do, of course, have some boundaries. I clearly do not handle money issues or mental health. Often it is the nurse who has the initial conversation with the patient and identifies a problem, such as depression or a financial issue, and then we interact with the other navigators based on the patient’s needs. Based on your own experience, do you feel that there is a need for special credentialing for oncology nurse navigators? DM: There are nurses and social workers who are very skilled in inpatient and outpatient care. I think that if you Continued on page 4

The Role of Patient Navigation... Continued from page 2 discharge from the surgical facility. For women undergoing lumpectomy or mastectomy without reconstruction, this usually is the morning after the ambulatory surgery procedure. A woman undergoing simultaneous reconstruction may be hospitalized 1 to 3 days. If someone other than the navigator contacts the patient, clear communication with the navigator is essential to ensure that information regarding how the patient is faring both physically and emotionally is documented so that the appropriate next steps for coordination of her care can be arranged. Step 9: Schedule postoperative appointment with the breast surgical oncologist Ideally, the postoperative appointment should be arranged at the time the surgery is scheduled. During this appointment, the nurse navigator should be present to hear how the pathology results are explained by the surgeon and interpreted by the patient. The navigator should review the pathology results before the consultation to be prepared for questions and determine what follow-up appointments will be needed. The ease of access to appointments with the medical oncologist and the radiation oncolwww.AONNonline.org

ogist will influence the amount of prearrangements needed to deliver care efficiently. For example, if the wait time for a medical oncology consultation is usually 3 weeks, it would be advisable to preschedule the medical oncology consultation by arranging it at the time of surgery. By doing so, the patient can have her surgery, be seen for her postoperative appointment with her surgeon 5 to 7 days after surgery, and be seen by the medical oncologist 10 to 14 days after surgery. Any patient having a lumpectomy or who has known nodal involvement or a T3 tumor should also be automatically scheduled to see a radiation oncologist. In most cases, patients who have drains will be able to have the drains removed at the time of this postoperative consultation as well. Wound care should be reviewed to ensure the patient is keeping the area dry, knows the signs of infection, and has information on wound-healing. Information from the pathology report to review with the patient should include: size of the invasive portion of the tumor; status of all six margins; grade; Ki-67; presence of angiolymphatic invasion; nodal status; hormone receptors; and human epidermal growth factor receptor type 2. Provide the patient with information

as to how these pathology results will be used to determine the next steps in her treatment. Step 10: Transition the patient to medical oncology and radiation oncology nurse navigators In some institutions, the nurse navigator is responsible for the patient across the entire continuum of care. It is more common, however, for a navigator to be responsible for navigating the patient during specific phases of her treatment. In these cases, the initial navigator must provide detailed information to the next navigator who will be responsible for overseeing the patient, starting with the barrier assessment information collected initially. Clinical outcome may be impacted by adherence to the National Comprehensive Cancer Network treatment guidelines, based on stage of disease and prognostic factors.7 The medical oncology navigator should provide the patient with an overview of her role and responsibilities and begin the patient education process as it relates to what to expect at the time of her medical oncology consultation and how decisions will be made about systemic therapy. The radiation oncology nurse navigator will do the same.

Tracking the information collected and the steps taken along the navigation process is important to assess the patient’s position across the continuum of care and to help ensure that no delays occur or the patient does not fall through the cracks. This can be accomplished electronically using a software program or via an electronic medical record. If relying solely on a paper process, be sure that this documentation becomes part of the patient’s permanent medical record. References 1. Cancer Facts & Figures, 2009. Atlanta, GA: American Cancer Society; 2009. 2. Lally RM. In the moment: women speak about surgical treatment decision making days after a breast cancer diagnosis. Oncol Nurs Forum. 2009;36:E257-E258. 3. Shockney LD. Becoming a Breast Cancer Nurse Navigator. Baltimore, MD: Jones & Bartlett Publishers; 2009. 4. Biglia N, Moggio G, Peano E, et al. Effects of surgical and adjuvant therapies for breast cancer on sexuality, cognitive functions, and body weight. J Sex Med. March 2, 2010. Epub ahead of print. 5. Fallowfield LJ, Hall A. Psychosocial and sexual impact of diagnosis and treatment of breast cancer. Br Med Bull. 1991;47:388-399. 6. McCaffery KJ, Jansen J. Pre-operative MRI for women with newly diagnosed breast cancer: perspectives on clinician and patient decisionmaking when evidence is uncertain. Breast. 2010;19:10-12. 7. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Breast Cancer. V.2.2010. www.nccn.org/professionals/ physician_gls/PDF/breast.pdf. Accessed March 15, 2010.

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York Cancer Center... Continued from page 3 have someone who has a lot of inpatient and outpatient experience, you don’t need that special credentialing. In the real world, however, where there are lots of job applicants, it’s safer to get the credentials. Many people already have credentials offered by the Oncology Nursing Certification Corporation and the AOSW, so I’m not sure that any additional credentials are necessary.

What I do think is needed are educational programs for people who are seeking more specialized training. If new navigators do not have oncology nurse practitioners or oncology social workers available to help them, linkage to an organization that could help them learn some of the skills necessary for patient navigation would be very helpful. DA: Kathy Allen and I are both

board-certified oncology social workers and are required to get a certain number of credits each year in psychosocial care or end-of-life issues. We both attend our national conferences and also participate in an online program where we can communicate with other professionals across the country on a daily basis. Do you find that there are different

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psychosocial issues associated with different types of cancers and is there a need for a designated navigator for different types of cancer? DA: That has been our experience, and it’s one of the reasons Diane branched off into head and neck cancer when we hired a breast navigator. That population has so many special needs. Kathy and I tend to see anybody under treatment for brain cancer because of that population’s special needs in terms of ambulation problems, cognitive problems, and memory problems. Another population with special needs is patients who are having concurrent treatments in the chemotherapy and radiation offices, who often need a navigator help coordinate their care. DM: Patients with preexisting mental health issues, such as those with depression or schizophrenia, are another population for whom a team approach is especially important. We rely on the social workers and outside mental health practitioners to keep those patients in treatment and on schedule. Do you offer services for survivors after they’ve completed their treatment? DA: Yes. We have several support groups up and running now because of voiced patient needs. Patients come to these groups for new information, to talk to other patients, and to get referrals. We also have special events during the year, including an annual survivor day that has grown so large we now hold it in a ball stadium. What are some of the greatest challenges navigators are facing? DM: One of the biggest challenges we are facing right now are the average working class patients whose treatment is demanding and are not able to work their full hours. They are financially at a disadvantage, and they may have to make serious choices about whether to get their prescriptions filled because they have lost half their income. They are not eligible for public assistance because they make a little too much money, and they are not eligible for Social Security disability benefits because they may go back to work within the next year. We have patients who have lost their insurance and are facing losing everything they have in the bank to pay for their healthcare. The other limit for us is time. We work long hours, and even though we love what we do, we have to make personal decisions about working long hours to help our patients. Time management is a very important issue for us. ●

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Nursing Practice Maintaining Chemotherapy Administration... Continued from cover attention to those who are most vulner- related continuing education course able to health problems. This health annually, and administer a minimum of Nurses proctored on the medical unit are assigned a system provides the physical three chemotherapy infusions facilities and system strucannually to maintain compe- light patient load to allow them time to focus on the tures that reach into a medtency. Many registered nurses chemotherapy. ically underserved commuvolunteered to go through nity and provides services to this process to become those who otherwise may be approved by CCRMC to to refuse to administer chemotherapy, tion with the training because they are without care. The outpaadminister chemotherapy. as they no longer felt competent. This able to focus on chemotherapy administient cancer center and infuOver the next decade, made staffing to accommodate 24-hour tration safety processes without having sion clinic handles the vast most chemotherapy admin- infusion support for oncology patients a patient load. majority of cancer patients istration gradually shifted a challenge. As a result of this training program, and their chemotherapy from the inpatient to the each shift has developed a core group Marianne Bunceadministrations. However, outpatient setting. As a con- Fulfilling the need of nurses who administer chemotheraHouston, RN, MS, Since 2007, all registered nurses on py, as well as serve as resources to initial conditions leading to sequence, inpatient staff AOCNS,CRNI diagnosis, surgical recovery, nurses had inconsistent op- the CCRMC medical unit are required other staff members on the medical long-term infusions, and portunities to administer to maintain a current ONS chemother- unit and in other departments in the treatment of side effects may occur in the chemotherapy, and maintaining compe- apy and biotherapy provider card. New hospital. In addition, the other medinpatient setting. In addition, some tency in a low-volume, high-risk proce- hires to the unit are required to success- ical unit staff nurses have better patients may require hospitalization for dure became a challenge. However, some fully attend the ONS course and pass preparation to proactively prevent treatment because of a nonexistent or oncology patients continued to be the posttest within 6 months of hire. The and/or treat oncology-related side unstable home environment or a lack of admitted to the hospital for chemothera- ONS Chemotherapy and Biotherapy effects and handle discharge considersupport services (eg, home health nurse py treatment or for other reasons, such as Guidelines and Recommendations for ations. As a group, the staff has develvisits or a significant other to assist in treatment-related side effects and can- Practice has specific recommendations oped preprinted chemotherapy orders for nursing education and specific to inpatient processes. Inthe home). cer-related complications. demonstration of competency.1 patient oncology staff meetings adMany staff members felt The need Completion of an acceptable dress patient care concerns. In addiill-prepared to handle the In the late 1980s, CCRMC nurses assessment and managedidactic component and clini- tion, the staff nurses have enhanced interested in chemotherapy adminis- ment of oncology patientsâ&#x20AC;&#x2122; cal practicum has become stan- teamwork and communication with tration were encouraged to attend a needs. The emotional imdardized nationally through the the pharmacy and outpatient oncolochemotherapy course developed by pact of working with ONS course. CCRMC has pro- gy staff, streamlining patient care. one author and were mentored in safe patients coping with canvided the ONS 2-day course for administration practice. In the 1990s, cer cannot be underestiits staff and the community for Conclusion Safe and competent administration the Oncology Nursing Society (ONS) mated for staff members several years to ensure consisChemotherapy and Biotherapy course unfamiliar with expected tency and quality of education. of chemotherapy and biotherapy in the Holly Longmuir, RN, became the standard coursework, and and unexpected presenOn successful completion of inpatient setting of small hospitals can OCN, CRNI its clinical practicum evaluation tool tations, treatment needs, the course and posttest, partici- be challenging and stressful for staff became the standard competency and psychosocial issues. Staff members pants receive an ONS chemotherapy nurses. Competency can be developed checklist for registered nurses new to unprepared for the emotional toll and biotherapy provider card. This card through standardized education and chemotherapy administration. In the became stressed as a result of concern is renewable every 2 years by successful- mentoring, with required updates to late 1990s, it became a requirement about not being prepared to adequately completing an online renewal course ensure continued competency. By profor CCRMC nurses to have a current ly handle their patientsâ&#x20AC;&#x2122; needs in a safe, that covers updates related to oncology viding the ONS chemotherapy and biotherapy course, CCRMC has develONS chemotherapy and biotherapy timely, and supportive fashion. Even- nursing clinical practice. provider card, attend an oncology- tually, many staff nurses felt the need Each month, an oncology clinical oped a medical unit team with a basenurse specialist teaches the ONS chemo- line knowledge of chemotherapy treattherapy and biotherapy course, which ment and side effects, who feel better allows all the medical unit nurses to take prepared to handle the special needs of the course without adversely affecting oncology patients. â&#x2014;? staffing levels. Nurses who want to become competent in chemotherapy ad- Reference ministration are proctored through a 1. Oncology Nursing Society. ONS Chemotherapy and Biotherapy Guidelines and Recommendations minimum of three successful chemotherfor Practice. 3rd ed. Pittsburgh, PA: Oncology apy administrations, including calculaNursing Press; 2009:343-344. tion of dosages, evaluation of laboratory data, patient and family education, venipuncture/central-line access, safe and proficient handling/administration/ disposal, and documentation. These nurses are given the option of being proctored on the unit by an experienced The risk of developing cancer could be CCRMC chemotherapy-approved nurse, reduced by 40% if people used vaccines or spending a day in the cancer center and other measures to protect themselves infusion clinic and working directly with against infections that can lead to cancer, the outpatient oncology nurses. Nurses such as HPV and hepatitis C, and made simple lifestyle changes, such as quitting proctored on the medical unit are smoking and avoiding sun exposure, assigned a light patient load to allow according to a report by the International them time to focus on the chemotheraUnion Against Cancer. py. Nurses rotating through the infusion Nurses double-check a chemotherapy order. clinic tend to express a greater satisfac-

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First and only FDA approved treatment for anthracycline extravasation. Supp Supplied as a convenient and accessible complete three day emergency treatment kit, ld be proactively stocked on-site and infused as soon as possible e and a which should within 6 hours of an anthracycline extravasation. Demonstrates 98% overall efficacy based on two biopsy-confirmed clinical trails1,2 in preventing the need for: o Surgical debridement, plastic surgery and related healthcare costs o Postponement of a patient’s chemotherapy treatments o Rehabilitation, follow-up and avoidance of long-term consequences

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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: 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. 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. Contraindications: None known. Warnings: Pregnancy Category D. Dexrazoxane was toxic to pregnant rats at doses of 2 mg/kg (1/80 the human dose on a mg/m2 basis) and embryotoxic and teratogenic at 8 mg/kg when given daily during the period of organogenesis. Teratogenic effects in the rat included imperforate anus, microphthalmia, and anophthalmia. In offspring allowed to develop to maturity, fertility was impaired in the male and female rats treated in utero during organogenesis at 8 mg/kg. In rabbits, doses of 5 mg/kg daily during the period of organogenesis caused maternal toxicity and doses of 20 mg/kg were embryotoxic and terato-

genic. Teratogenic effects in the rabbit included several skeletal malformations such as short tail, rib and thoracic malformations, and soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, as well as agenesis of the gallbladder and of the intermediate lobe of the lung. 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. Precautions: Totect is a cytotoxic drug. When administered to patients receiving anthracycline-containing cytotoxic therapy, additive cytotoxicity may occur. Treatment with Totect is associated with leukopenia, neutropenia, and thrombocytopenia. Reversible elevations of liver enzymes may occur. Blood counts and liver enzymes should be monitored. Greater exposure to dexrazoxane may occur in patients with compromised renal function. The Totect dose should be reduced by 50% in patients with creatinine clearance values <40 mL/min. Dimethyl sulfoxide (DMSO) should not be used in patients who are receiving dexrazoxane to treat anthracycline-induced extravasation. Women who have the potential to become pregnant should be advised that Totect might cause fetal harm. There are no known drug interactions. No carcinogenicity studies have been done with Totect in animals. The carcinogenic potential of dexrazoxane has not been investigated. 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. 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. The effect of dexrazoxane on labor and delivery in humans has not been studied. It is not known whether dexrazoxane or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from dexrazoxane, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The safety and effectiveness of Totect in pediatric patients have not been established. No differences in safety or efficacy were observed between older and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older patients has been observed. 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. Adverse reactions: Adverse reactions of nausea/vomiting, diarrhea, stomatitis, bone marrow suppression (neutropenia, thrombocytopenia), altered liver function (increased AST/ALT), and infusion site burning have been observed. These adverse reactions have been reversible.

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

Medications Used for the Treatment of Lymphomas The following sections include: • Associated ICD-9-CM codes used for the classification of lymphomas • Drugs that have been FDA-approved in the treatment of lymphomas. Please note: if a check mark appears in the FDA column it will NOT appear in the Compendia section even if a drug is included in the NCCN (National Comprehensive Cancer Network) Drugs & Biologics Compendium • Drugs included in the NCCN Drugs & Biologics Compendium for off-label use in lymphomas. NCCN is recognized by the Centers for Medicare & Medicaid Services (CMS) as a referencing source • Corresponding HCPCS/CPT codes and code descriptions • Current Code Price (AWP-based pricing) • Most recent ASP plus 6% (Medicare allowable) • Possible CPT Administration Codes for each medication

generic (Brand) name

HCPCS code: code description

alemtuzumab (Campath) asparaginase (Elspar) bendamustine (Treanda) betamethasone (Celestone Soluspan)

J9010: injection, alemtuzumab, 10 mg J9020: injection, asparaginase, 10,000 units J9033: injection, bendamustine HCl, 1 mg J0702: injection, betamethasone acetate, 3 mg and betamethasone sodium phosphate, 3 mg

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Associated ICD-9-CM Codes Used for Lymphomas The following fifth-digit subclassification is for use with categories 200-202: 0 unspecified site, extranodal and solid organ sites 1 lymph nodes of head, face, and neck 2 intrathoracic lymph nodes 3 intra-abdominal lymph nodes 4 lymph nodes of axilla and upper limb 5 lymph nodes of inguinal region and lower limb 6 intrapelvic lymph nodes 7 spleen 8 lymph nodes of multiple sites 200 Lymphosarcoma and reticulosarcoma and other specified malignant tumors of lymphatic tissue 200.0 Reticulosarcoma 200.1 Lymphosarcoma 200.2 Burkitt’s tumor or lymphoma 200.3 Marginal zone lymphoma 200.4 Mantle cell lymphoma 200.5 Primary central nervous system lymphoma 200.6 Anaplastic large cell lymphoma 200.7 Large cell lymphoma 200.8 Other named variants Lymphoma (malignant): lymphoplasmacytoid type mixed lymphocytic-histiocytic (diffuse) Lymphosarcoma, mixed cell type (diffuse) Reticulolymphosarcoma (diffuse) 202 Other malignant neoplasms of lymphoid and histiocytic tissue 202.0 Nodular lymphoma 202.1 Mycosis fungoides 202.2 Sézary’s disease 202.3 Malignant histiocytosis 202.4 Leukemic reticuloendotheliosis 202.5 Letterer-Siwe disease 202.6 Malignant mast cell tumors 202.7 Peripheral T-cell lymphoma 202.8 Other lymphomas Lymphoma (malignant): not otherwise specified diffuse Excludes: benign lymphoma (229.0) 202.9 Other and unspecified malignant neoplasms of lymphoid and histiocytic tissue Follicular dendritic cell sarcoma Interdigitating dendritic cell sarcoma Langerhans cell sarcoma Malignant neoplasm of bone marrow not otherwise specified

FDAapproved for lymphomas

NCCN Drugs & Biologics Compendium off-label use for lymphomas

Current code price (AWP-based pricing), effective 4/1/10

Medicare allowable (ASP + 6%), effective 4/1/10-6/30/10

CPT administration codes

✓

$680.73

$578.01

96413, 96415

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96401, 96413

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96413

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$6.55

11900, 11901, 20600, 20605, 20610, 96372

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TON_April2010_TON 4/7/10 12:08 PM Page 26

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

generic (Brand) name

HCPCS code: code description

bexarotene (Targretin)

J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified J9040: injection, bleomycin sulfate, 15 units J9041: injection, bortezomib, 0.1 mg J9045: injection, carboplatin, 50 mg J9050: injection, carmustine, 100 mg J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified J9060: cisplatin, powder or solution, per 10 mg J9062: cisplatin, 50 mg J9065: injection, cladribine, per 1 mg J8530: cyclophosphamide, oral, 25 mg

bleomycin (Blenoxane) bortezomib (Velcade) carboplatin (Paraplatin) carmustine (BiCNU) chlorambucil (Leukeran)

FDAapproved for lymphomas

NCCN Drugs & Biologics Compendium off-label use for lymphomas

✓

Current code price (AWP-based pricing), effective 4/1/10

Medicare allowable (ASP + 6%), effective 4/1/10-6/30/10

CPT administration codes

✓

NDC level pricing $45.30

NDC level pricing $26.08

96401, 96409

✓

$45.43

$38.24

96409

$48.55

$5.31

✓

$205.69

$176.41

✓

NDC level pricing $4.33

NDC level pricing $1.98

96409, 96413, 96415

✓

$21.66

$9.91

96409, 96413, 96415

✓

$58.20

$28.22

✓

$2.09

$0.84

J9070: cyclophosphamide, 100 mg

✓

$7.55

$4.35

96409, 96413, 96419

J9080: cyclophosphamide, 200 mg

✓

$15.10

$8.69

96409, 96413, 96415

J9090: cyclophosphamide, 500 mg

✓

$37.76

$21.73

96409, 96413, 96415

J9091: cyclophosphamide, 1.0 gram

✓

$68.00

$43.46

96409, 96413, 96415

J9092: cyclophosphamide, 2.0 grams

✓

$122.39

$86.92

96409, 96413, 96415

$2.31

$1.51

$22.21

$7.37

96409, 96413, 96415, 96450 96409, 96413

$25.20

$19.46

96409, 96413

✓

$1,756.80

$1,494.82

96409, 96413, 96415

✓

$0.15

$0.09

✓

$0.09

$0.38

11900, 11901, 20600, 20605, 20610, 96372, 96374 N/A

✓

$13.20

$3.04

96409

cisplatin (Platinol-AQ) cisplatin (Platinol-AQ) cladribine (Leustatin) cyclophosphamide, oral (Cytoxan) cyclophosphamide, injection (Cytoxan) cyclophosphamide, injection (Cytoxan) cyclophosphamide, injection (Cytoxan) cyclophosphamide, injection (Cytoxan) cyclophosphamide, injection (Cytoxan) cytarabine (Cytosar-U) dacarbazine (DTIC-Dome) daunorubicin (Cerubidine) denileukin diftitox (Ontak) dexamethasone (Decadron)

J9100: injection, cytarabine, 100 mg J9140: dacarbazine, 200 mg J9150: injection, daunorubicin, 10 mg J9160: injection, denileukin diftitox, 300 micrograms J1100: injection, dexamethasone sodium phosphate, 1 mg

dexamethasone (Decadron) doxorubicin HCl (Adriamycin)

J8540: dexamethasone, oral, 0.25 mg J9000: injection, doxorubicin hydrochloride, 10 mg

✓

✓ ✓ ✓

N/A

96409, 96413, 96415 96413, 96415 N/A

96413, 96415 N/A

Continued on page 28

April 2010 I VOl 3, NO 2

www.TheOncologyNurse.com

TON_April2010_TON 4/7/10 9:59 AM Page 27

NHL Mantle Cell Trial Now Recruiting Investigators and Enrolling Study Participants Celgene CC-5013-MCL-001

A Phase 2 Study for Patients With Relapsed/Refractory Mantle Cell Non-Hodgkin’s Lymphoma Primary Investigator André Goy, MD Primary Objective To determine the tumor response and duration of response of lenalidomide monotherapy in subjects with mantle cell lymphoma (MCL) who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib Key Eligibility Criteria* • Individuals with MCL previously treated with all of the following (alone or in combination): – Bortezomib† – An anthracycline or mitoxantrone – Rituximab – Cyclophosphamide • Individuals must have documented relapse after bortezomib treatment or be refractory to bortezomib • Excluding individuals who are candidates for high-dose chemotherapy/allogeneic stem cell transplant *Additional criteria apply. †Note: When the agent bortezomib is mentioned this also includes ANY BORTEZOMIB-CONTAINING REGIMEN.

Study Design

Pretreatment Phase (4 Weeks)

N=133

• MCL diagnosis conﬁrmed by local pathological review

Treatment Phasea (until disease progression)

• Lenalidomide starting dose 25 mg po once dailyb

Lenalidomide will be dosed po once daily on days 1-21 of each 28-day cycle. Subjects with creatinine clearance ≥30 mL/min but <60 mL/min will receive a lower starting dose of lenalidomide 10 mg po once daily. Dose may be escalated to 15 mg po once daily if no dose-limiting toxicities occur during the ﬁrst 2 cycles.

Investigational use of lenalidomide. For more information contact Deborah Ingenito, Celgene Study Manager dingenito@celgene.com (908) 673-9581 www.clinicaltrials.gov (NCT00737529)

TON_April2010_FINAL_TON 4/8/10 11:27 AM Page 28

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems Continued from page 26

generic (Brand) name

HCPCS code: code description

FDAapproved for lymphomas

doxorubicin liposome J9001: injection, doxorubicin (Doxil) hydrochloride, all lipid formulations, 10 mg etoposide J9181: injection, (Etopophos, Toposar) etoposide, 10 mg etoposide J8560: etoposide, (Vepesid) oral, 50 mg fludarabine J9185: injection, fludarabine phosphate phosphate, 50 mg (Fludara) gemcitabine J9201: injection, gemcitabine (Gemzar) hydrochloride, 200 mg hydrocortisone J1720: injection, hydrocortisone ✓ (Solu-Cortef) sodium succinate, up to 100 mg ibritumomab A9542: indium In-111 ✓ tiuxetan ibritumomab tiuxetan, diagnostic, (Zevalin) per study dose, up to 5 millicuries ibritumomab A9543: yttrium Y-90 ibritumomab ✓ tiuxetan tiuxetan, therapeutic, per (Zevalin) treatment dose, up to 40 millicuries ifosfamide J9208: injection, (Ifex) ifosfamide, 1 gram ✓ interferon J9214: injection, interferon, alfa-2b alfa-2b, recombinant, (Intron-A) 1 million units interferon gamma 1-b J9216: injection, interferon, (Actimmune) gamma 1-b, 3 million units isotretinoin J8499a: prescription drug, (Accutane) oral, non-chemotherapeutic, not otherwise specified lenalidomide J8999a: prescription drug, (Revlimid) oral, chemotherapeutic, not otherwise specified ✓ lomustine J8999a: prescription drug, (CeeNU) oral, chemotherapeutic, not otherwise specified ✓ lomustine S0178: lomustine, (CeeNu) oral, 10 mg mechlorethamine (Mustargen) melphalan (Alkeran) melphalan (Alkeran) mesna (Mesnex) mesna (Mesnex) methotrexate

J9230: injection, mechlorethamine hydrochloride (nitrogen mustard), 10 mg J8600: melphalan, oral, 2 mg J9245: injection, melphalan hydrochloride, 50 mg J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified J9209: injection, mesna, 200 mg J8610: methotrexate, oral, 2.5 mg

April 2010 I VOl 3, NO 2

NCCN Drugs & Biologics Compendium off-label use for lymphomas

Medicare allowable (ASP + 6%), effective 4/1/10-6/30/10

CPT administration codes

✓

$578.88

$472.01

✓

$0.53

$0.49

✓

$47.64

$28.26

N/A

✓

$309.70

$205.81

96413

✓

$173.83

$145.10

96413

$2.46

$3.14

✓

96413

96413, 96415

$4,200.00

N/A

96365, 96366, 96372, 96374 96374

$37,800.00

N/A

79403

$56.40

$30.76

96413, 96415

$21.90

$15.84

96372, 96401

✓

$517.89

$430.93

✓

NDC level pricing NDC level pricing NDC level pricing $10.59

✓

$178.71

96372

NDC level pricing NDC level pricing NDC level pricing S0178: not payable by Medicare $154.50

N/A

96409

N/A

✓

$5.68

$4.83

✓

$1,922.50

$1,500.32

✓

NDC level pricing $10.44

NDC level pricing $4.26

96409

$3.61

$0.16

N/A

✓ ✓

Current code price (AWP-based pricing), effective 4/1/10

96409, 96413 N/A

www.TheOncologyNurse.com

TON_April2010_TON 4/7/10 12:08 PM Page 29

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

FDAapproved for lymphomas

NCCN Drugs & Biologics Compendium off-label use for lymphomas

Current code price (AWP-based pricing), effective 4/1/10

Medicare allowable (ASP + 6%), effective 4/1/10-6/30/10

CPT administration codes

generic (Brand) name

HCPCS code: code description

methotrexate sodium

J9250: methotrexate sodium, 5 mg

✓

$0.29

$0.21

96372, 96374, 96401, 96409, 96450

methotrexate sodium methoxsalen (Oxsoralen, 8-MOP, Oxsoralen Ultra) methylprednisolone (Depo-Medrol)

✓

$2.86

$2.10

✓

NDC level pricing $5.70

NDC level pricing $3.40

96372, 96374, 96401, 96409, 96450 N/A

✓

$10.20

$6.64

11900, 11901, 20600, 20605, 20610, 96372

✓

$2.36

$2.28

96365, 96366, 96372, 96374

✓

$4.15

$3.06

96365, 96366, 96372, 96374

methylprednisolone (Medrol) mitoxantrone (Novantrone) nelarabine (Arranon) ofatumumab (Arzerra) ofatumumab (Arzerra):

J9260: methotrexate sodium, 50 mg J8499a: prescription drug, oral, non-chemotherapeutic, not otherwise specified J1030: injection, methylprednisolone acetate, 40 mg J1040: injection, methylprednisolone acetate, 80 mg J2920: injection, methylprednisolone sodium succinate, up to 40 mg J2930: injection, methylprednisolone sodium succinate, up to 125 mg J7509: methylprednisolone, oral, per 4 mg J9293: injection, mitoxantrone hydrochloride, per 5 mg J9261: injection, nelarabine, 50 mg C9260: injection, ofatumumab, 10 mg J9999a: not otherwise specified, antineoplastic drugs

✓

$0.61

$0.08

$109.60

$45.27

96409, 96413

$123.19

$105.91

96413, 96415

✓

$52.80

N/A

96413, 96415

✓

J9263: injection, oxaliplatin, 0.5 mg J9268: injection, pentostatin, per 10 mg C9259: injection, pralatrexate, 1 mg J9999a: not otherwise classified, antineoplastic drugs

✓

NDC level pricing $6.83

96413, 96415

oxaliplatin (Eloxatin) pentostatin (Nipent) pralatrexate (Folotyn) pralatrexate (Folotyn)

NDC level pricing $8.25

✓

$2,182.80

$1,246.38

96409, 96413

prednisolone (Millipred, Orapred, Veripred) prednisone

J7510: prednisolone, oral, per 5 mg

methylprednisolone (Depo-Medrol) methylprednisolone (Solu-Medrol) methylprednisolone (Solu-Medrol)

✓

✓ ✓

✓

$187.50

✓

11900, 11901, 20600, 20605, 20610, 96372

N/A

96413, 96415

N/A

96409

NDC level pricing $0.02

96409

✓

NDC level pricing $0.66

✓

$0.05

$0.04

N/A

✓

NDC level pricing $55.68

rituximab (Rituxan)

J9310: injection, rituximab, 100 mg

✓

$664.32

NDC level pricing S0182: not payable by Medicare $578.40

N/A

procarbazine (Matulane)

J7506: prednisone, oral, per 5 mg J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified S0182: procarbazine HCl, oral, 50 mg

procarbazine (Matulane)

www.TheOncologyNurse.com

N/A

96413, 96415

April 2010 I VOl 3, NO 2

TON_April2010_TON 4/7/10 12:08 PM Page 30

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

generic (Brand) name

HCPCS code: code description

romidepsin (Istodax)

C9399a: unclassified drugs or biologicals (This code should only be used for new drugs and biologicals that are approved by the FDA on or after January 1, 2004) J9999a: not otherwise classified, antineoplastic drugs

romidepsin (Istodax) temozolomide, injection (Temodar) temozolomide, oral (Temodar) temsirolimus (Torisel) thalidomide (Thalomid) thiotepa (Thioplex) tositumomab (Bexxar) tretinoin (Vesanoid) vinBLAStine vinCRIStine (Vincasar PFS) vinCRIStine (Vincasar PFS) vinCRIStine (Vincasar PFS) vorinostat (Zolinza)

FDAapproved for lymphomas

J9328: injection, temozolomide, 1 mg (For billing prior to 1/1/10, use J9999 or C9253) J8700: temozolomide, oral, 5 mg J9330: injection, temsirolimus, 1 mg J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified J9340: injection, thiotepa, 15 mg A9545: iodine I-131 tositumomab, therapeutic, per treatment dose J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified J9360: injection, vinblastine sulfate, 1 mg J9370: vincristine sulfate, 1 mg J9375: vincristine sulfate, 2 mg J9380: vincristine sulfate, 5 mg J8999a: prescription drug, oral, chemotherapeutic, not otherwise specified

NCCN Drugs & Biologics Compendium off-label use for lymphomas

✓

Current code price (AWP-based pricing), effective 4/1/10 NDC level pricing

Medicare allowable (ASP + 6%), effective 4/1/10-6/30/10

CPT administration codes

NDC level pricing

96413, 96415

NDC level pricing $4.90

96413, 96415

✓

NDC level pricing $5.66

✓

$10.65

$8.83

N/A

✓

$58.72

$49.83

96413

✓

NDC level pricing

N/A

✓

NDC level pricing $138.00

$113.53 51720, 96409

✓

$34,873.19

N/A

NDC level pricing $1.02

N/A

✓

NDC level pricing $3.18

✓

$8.12

$4.31

96409

✓

$16.24

$8.62

96409

✓

$40.60

$21.54

96409

✓

NDC level pricing

N/A

✓

96413, 96415

79403

96409

When billing a nonclassified medication using a CMS 1500 claim form you must include both the HCPCS code (ie, J9999 for Folotyn) in Column 24D and the drug name, strength, and National Drug Code (NDC) in Box 19 in order to ensure appropriate reimbursement.

References • HCPCS Level II Expert 2010 • CPT 2010 • ICD-9-CM for Professionals Volumes 1 & 2; 2010 • The Drug Reimbursement Coding and Pricing Guide, Vol 7, No 2; RJ Health Systems International LLC; 2nd Quarter 2010 • FDA-approved indication (from products’ prescribing information) • NCCN Drugs & Biologics Compendium; 2010. National Comprehensive Cancer Network, Inc. Available at: www.nccn.org. Accessed February 15, 2010. To view the most recent and complete version of the NCCN compendium, go online to www.nccn.org • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Wethersfield, Connecticut • CMS-Medicare allowable 2nd Quarter 2010 (effective dates 4/1/10-6/30/10). Prices listed herein are effective as of April 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; NCCN, National Comprehensive Cancer Network.

This information was supplied by:

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

April 2010 I VOl 3, NO 2

www.TheOncologyNurse.com

TON_April2010_TON 4/7/10 9:59 AM Page 31

STRONG. FROM THE START.

HELP ESTABLISH A SUCCESSFUL CINV PREVENTION STRATEGY FROM THE FIRST CYCLE When your patients experience acute chemotherapyinduced nausea and vomiting (CINV) during their first cycle of chemotherapy, they may have an increased risk of CINV on subsequent days and in subsequent cycles.1-3 ALOXI®: Starts strong to prevent CINV4 A single IV dose lasts up to 5 days after MEC4,5* Can be used with multiple-day chemotherapy regimens6† * Moderately emetogenic chemotherapy. † Based on sNDA approval in August 2007, the restriction on repeated dosing of ALOXI (palonosetron HCl) injection within a 7-day interval was removed.

Indication ALOXI® (palonosetron HCl) injection 0.25 mg is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy. Important Safety Information • ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components • Most commonly reported adverse reactions in chemotherapy-induced nausea and vomiting include headache (9%) and constipation (5%) Please see the following brief summary of prescribing information. REFERENCES: 1. The Italian Group for Antiemetic Research. Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy. N Engl J Med. 2000;342:1554-1559. 2. Hickok JT, Roscoe JA, Morrow GR, et al. 5-hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: a URCC CCOP randomised controlled trial. Lancet Oncol. 2005;6:765-772. Epub September 13, 2005. 3. Cohen L, de Moor CA, Eisenburg P, Ming EE, Hu H. Chemotherapy-induced nausea and vomiting: incidence and impact on patient quality of life at community oncology settings. Support Care Cancer. 2007;15:497-503. Epub November 14, 2006. 4. Gralla R, Lichinitser M, Van der Vegt S, et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol. 2003;14:1570-1577. 5. Eisenberg P, Figueroa-Vadillo J, Zamora R, et al. Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist: results of a phase III, single-dose trial versus dolasetron. Cancer. 2003;98:2473-2482. 6. ALOXI® (palonosetron HCl) injection full prescribing information.

www.ALOXI.com

TON_April2010_TON 4/7/10 10:00 AM Page 32

Breast Cancer

National Press Coverage Can Boost Clinical Trial Enrollment By Jill Stein

ncology nurses who are involved in clinical trials should consider exposure in the “popular press” as a means of increasing patient recruitment, investigators said at the 32nd Annual Breast Cancer Symposium in San Antonio, Texas. ALOXI® (palonosetron HCl) injection BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE Chemotherapy-Induced Nausea and Vomiting ALOXI is indicated for: • Moderately emetogenic cancer chemotherapy – prevention of acute and delayed nausea and vomiting associated with initial and repeat courses • Highly emetogenic cancer chemotherapy – prevention of acute nausea and vomiting associated with initial and repeat courses DOSAGE AND ADMINISTRATION Recommended Dosing Chemotherapy-Induced Nausea and Vomiting Dosage for Adults - a single 0.25 mg I.V. dose administered over 30 seconds. Dosing should occur approximately 30 minutes before the start of chemotherapy. Instructions for I.V. Administration ALOXI is supplied ready for intravenous injection. ALOXI should not be mixed with other drugs. Flush the infusion line with normal saline before and after administration of ALOXI. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit. CONTRAINDICATIONS ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components. [see Adverse Reactions (6) in full prescribing information ] WARNINGS AND PRECAUTIONS Hypersensitivity Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other 5-HT 3 receptor antagonists. ADVERSE REACTIONS 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 reported in practice. In clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 1374 adult patients received palonosetron. Adverse reactions were similar in frequency and severity with ALOXI and ondansetron or dolasetron. Following is a listing of all adverse reactions reported by ≥ 2% of patients in these trials (Table 1). Table 1: Adverse Reactions from ChemotherapyInduced Nausea and Vomiting Studies ≥ 2% in any Treatment Group ALOXI Ondansetron Dolasetron Event 0.25 mg 32 mg I.V. 100 mg I.V. (N=410) (N=633) (N=194) Headache 60 (9%) 34 (8%) 32 (16%) Constipation 29 (5%) 8 (2%) 12 (6%) Diarrhea 8 (1%) 7 (2%) 4 (2%) Dizziness 8 (1%) 9 (2%) 4 (2%) Fatigue 3 (< 1%) 4 (1%) 4 (2%) Abdominal Pain 1 (< 1%) 2 (< 1%) 3 (2%) Insomnia 1 (< 1%) 3 (1%) 3 (2%) In other studies, 2 subjects experienced severe constipation following a single palonosetron dose of approximately 0.75 mg, three times the recommended dose. One patient received a 10 mcg/kg oral dose in a postoperative nausea and vomiting study and one healthy subject received a 0.75 mg I.V. dose in a pharmacokinetic study. In clinical trials, the following infrequently reported adverse reactions, assessed by investigators as treatment-related or causality unknown, occurred following administration of ALOXI to adult patients receiving concomitant cancer chemotherapy: Cardiovascular: 1%: non-sustained tachycardia, bradycardia, hypotension, < 1%: hypertension, myocardial ischemia, extrasystoles, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles and QT prolongation. In many cases, the relationship to ALOXI was unclear. Dermatological: < 1%: allergic dermatitis, rash. Hearing and Vision: < 1%: motion sickness, tinnitus, eye irritation and amblyopia. Gastrointestinal System: 1%: diarrhea, < 1%: dyspepsia, abdominal pain, dry mouth, hiccups and flatulence.

April 2010 I VOl 3, NO 2

“Clinical trial enrollment of cancer patients is low,” said Nicole E. Bates, BA, a research coordinator for the Tumor Vaccine Group at the University of Washington in Seattle’s Center for Translational Medicine in Women’s Health. “In fact, only about General: 1%: weakness, < 1%: fatigue, fever, hot flash, flu-like syndrome. Liver: < 1%: transient, asymptomatic increases in AST and/or ALT and bilirubin. These changes occurred predominantly in patients receiving highly emetogenic chemotherapy. Metabolic: 1%: hyperkalemia, < 1%: electrolyte fluctuations, hyperglycemia, metabolic acidosis, glycosuria, appetite decrease, anorexia. Musculoskeletal: < 1%: arthralgia. Nervous System: 1%: dizziness, < 1%: somnolence, insomnia, hypersomnia, paresthesia. Psychiatric: 1%: anxiety, < 1%: euphoric mood. Urinary System: < 1%: urinary retention. Vascular: < 1%: vein discoloration, vein distention. Postmarketing Experience The following adverse reactions have been identified during postapproval use of ALOXI. 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. Very rare cases (<1/10,000) of hypersensitivity reactions and injection site reactions (burning, induration, discomfort and pain) were reported from postmarketing experience of ALOXI 0.25 mg in the prevention of chemotherapy-induced nausea and vomiting. DRUG INTERACTIONS Palonosetron is eliminated from the body through both renal excretion and metabolic pathways with the latter mediated via multiple CYP enzymes. Further in vitro studies indicated that palonosetron is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C9, CYP2D6, CYP2E1 and CYP3A4/5 (CYP2C19 was not investigated) nor does it induce the activity of CYP1A2, CYP2D6, or CYP3A4/5. Therefore, the potential for clinically significant drug interactions with palonosetron appears to be low. Coadministration of 0.25 mg I.V. palonosetron and 20 mg I.V. dexamethasone in healthy subjects revealed no pharmacokinetic drug-interactions between palonosetron and dexamethasone. In an interaction study in healthy subjects where palonosetron 0.25 mg (I.V. bolus) was administered on day 1 and oral aprepitant for 3 days (125 mg/80 mg/80 mg), the pharmacokinetics of palonosetron were not significantly altered (AUC: no change, Cmax: 15% increase). A study in healthy volunteers involving single-dose I.V. palonosetron (0.75 mg) and steady state oral metoclopramide (10 mg four times daily) demonstrated no significant pharmacokinetic interaction. In controlled clinical trials, ALOXI injection has been safely administered with corticosteroids, analgesics, antiemetics/antinauseants, antispasmodics and anticholinergic agents. Palonosetron did not inhibit the antitumor activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C) in murine tumor models. USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Category B Teratology studies have been performed in rats at oral doses up to 60 mg/kg/day (1894 times the recommended human intravenous dose based on body surface area) and rabbits at oral doses up to 60 mg/ kg/day (3789 times the recommended human intravenous dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to palonosetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, palonosetron should be used during pregnancy only if clearly needed. Labor and Delivery Palonosetron has not been administered to patients undergoing labor and delivery, so its effects on the mother or child are unknown. Nursing Mothers It is not known whether palonosetron is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants and the potential for tumorigenicity shown for palonosetron in the rat carcinogenicity study, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

3% of adult cancer patients ever enroll in a clinical trial.” It is especially difficult to recruit patients at academic centers because academic research groups usually do not have budgets to fund large-scale recruitment efforts, she added. Pediatric Use Safety and effectiveness in patients below the age of 18 years have not been established. Geriatric Use Population pharmacokinetics analysis did not reveal any differences in palonosetron pharmacokinetics between cancer patients ≥ 65 years of age and younger patients (18 to 64 years). Of the 1374 adult cancer patients in clinical studies of palonosetron, 316 (23%) were ≥ 65 years old, while 71 (5%) were ≥ 75 years old. No overall differences in safety or effectiveness were observed between these subjects and the younger subjects, but greater sensitivity in some older individuals cannot be ruled out. No dose adjustment or special monitoring are required for geriatric patients. Of the 1520 adult patients in ALOXI PONV clinical studies, 73 (5%) were ≥65 years old. No overall differences in safety were observed between older and younger subjects in these studies, though the possibility of heightened sensitivity in some older individuals cannot be excluded. No differences in efficacy were observed in geriatric patients for the CINV indication and none are expected for geriatric PONV patients. However, ALOXI efficacy in geriatric patients has not been adequately evaluated. Renal Impairment Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters. Total systemic exposure increased by approximately 28% in severe renal impairment relative to healthy subjects. Dosage adjustment is not necessary in patients with any degree of renal impairment. Hepatic Impairment Hepatic impairment does not significantly affect total body clearance of palonosetron compared to the healthy subjects. Dosage adjustment is not necessary in patients with any degree of hepatic impairment. Race Intravenous palonosetron pharmacokinetics was characterized in twenty-four healthy Japanese subjects over the dose range of 3 – 90 mcg/kg. Total body clearance was 25% higher in Japanese subjects compared to Whites, however, no dose adjustment is required. The pharmacokinetics of palonosetron in Blacks has not been adequately characterized. OVERDOSAGE There is no known antidote to ALOXI. Overdose should be managed with supportive care. Fifty adult cancer patients were administered palonosetron at a dose of 90 mcg/kg (equivalent to 6 mg fixed dose) as part of a dose ranging study. This is approximately 25 times the recommended dose of 0.25 mg. This dose group had a similar incidence of adverse events compared to the other dose groups and no dose response effects were observed. Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for palonosetron overdose. A single intravenous dose of palonosetron at 30 mg/kg (947 and 474 times the human dose for rats and mice, respectively, based on body surface area) was lethal to rats and mice. The major signs of toxicity were convulsions, gasping, pallor, cyanosis and collapse. PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (17.2) in full prescribing information Instructions for Patients • Patients should be advised to report to their physician all of their medical conditions, any pain, redness, or swelling in and around the infusion site [see Adverse Reactions (6) in full prescribing information]. • Patients should be instructed to read the patient insert. Rx Only Mfd by OSO Biopharmaceuticals, LLC, Albuquerque, NM, USA or Pierre Fabre, Médicament Production, Idron, Aquitaine, France and Helsinn Birex Pharmaceuticals, Dublin, Ireland.

ALOXI® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license. Distributed and marketed by Eisai Inc., Woodcliff Lake, NJ 07677. © 2009 Eisai Inc. All rights reserved. Printed in USA. AL449 08/09

Bates presented data showing that a brief segment about an ongoing vaccine trial for breast cancer that aired on national television produced highquality screening candidates that ultimately increased patient enrollment. Since 2006, the University of Washington has been recruiting patients for a phase 2 HER-2/neu peptide vaccine trial for stage IIIB, IIIC, and IV breast cancer. The 2.5-minute news story that aired nationwide included details about the vaccine’s purpose and the trial’s design and eligibility requirements along with comments from the principal investigator and information on how to access Nicole E. Bates, BA the trial’s website. Most of the segment focused on the personal history and experience of one patient participating in the trial. At the end of the segment, viewers were directed to a two-page online article about the vaccine, which provided a direct link to the Tumor Vaccine Group’s website. “As soon as the story aired, we were flooded with phone calls and hits on our website, and we felt that this response provided a good opportunity to determine whether media exposure conferred a tangible impact,” Bates observed. In the month following the broadcast, the trial investigators received 125 new clinical trial inquiries as a result of the feature, a seven-fold increase in new inquiries compared with the same month in the preceding year. The geographic diversity of website visitors increased both within the United States and internationally. Of the new inquiries, more than half were potentially eligible for a clinical trial based on an initial screening. Nearly one third of all clinical trial enrollments that have occurred in the 13 months since the segment aired can be attributed to the news story. “Our results are very impressive,” Bates said. “We were only able to recruit 12 women over the first 2 years of the study. And now, 1 year later, a total of 31 women have enrolled.” Importantly, she noted, it was not primarily the information that was provided by the news segment that explains the increased interest in the trial. “We believe that it’s the connection with the patient because most women who contacted us said that they felt that they were just like the woman featured in the segment,” Continued on page 33

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Hematologic Cancers

Strong Responses Seen with Bortezomib-based Therapy after Relapse in Multiple Myeloma By Caroline Helwick

NEW ORLEANS—For patients with relapsed or refractory multiple myeloma (MM), bortezomib-based therapy is effective after lenalidomide plus dexamethasone (LD), according to a Canadian study that evaluated sequencing of novel agents presented at the 51st Annual Meeting and Exposition of the American Society of Hematology. “The optimal sequencing of novel agents in MM is not certain. Due to limitations in provincial drug funding in Ontario, Canada, we had a unique opportunity to evaluate the efficacy of bortezomib in patients who progressed after treatment with lenalidomide plus dexamethasone, provided through expanded access programs and clinical trials for relapsed or refractory disease,” said principal investigator Donna Reece, MD, associate professor and director of the program for multiple myeloma and related diseases at Princess Margaret Hospital, Toronto. Outcomes were analyzed for 49 patients who received LD for recurrent MM (first- to fourth-line), followed by bortezomib-based regimens for their next relapse, without any interim therapy. Thirty-nine (80%)

had also undergone autologous stemcell transplantation. Patients received bortezomib alone (33%), bortezomib plus steroids (47%), bortezomib plus prednisone and cyclophosphamide (8%), bortezomib plus thalidomide and dexamethasone (4%), or bortezomib plus another agent (8%).

bortezomib-based treatment, median follow-up was 6.5 months and the best responses to those regimens included complete response or nCR in 2%, VGPR in 16%, PR in 26%, MR in 14%, SD in 16%, and PD in 24%. Median progression-free survival (PFS) was 4.0 months, with a 12%

“The PFS and OS observed after bortezomib-based therapy is not dependent on the response to lenalidomide plus dexamethasone.” —Donna Reece, MD

The median treatment duration of LD was 5.3 months. For that regimen, the best clinical response included near-complete response (nCR) in 6%, very good partial response (VGPR) in 6%, partial response (PR) in 51%, minimal response (MR) in 12%, stable disease (SD) in 19%, and progressive disease (PD) in 25%. After relapse, when patients began a

median 1-year PFS rate. Median overall survival (OS) was 9.5 months, with a 31% median 1-year survival rate, Reece reported. Investigators assessed a number of factors for their prognostic effects on PFS and OS, including age at diagnosis, gender, subtype, duration of initial therapy, and response to LD, but only the patient’s response to the bortez-

Bendamustine-Rituximab Combo an Effective First-line Therapy for CLL By Wayne Kuznar

NEW ORLEANS—One third of patients with newly diagnosed, advanced chronic lymphocytic leukemia (CLL) who received the combination of bendamustine and rituximab achieved a complete response, according to researchers from the German CLL Study Group. Another 56% of the patients treated with this combination had partial responses, said principal investigator Kirsten Fischer, MD, Center of Integrated Oncology, University of Cologne, Germany, at the annual meeting and exposition of the American Society of Hematology. Bendamustine had already been shown to have considerable activity as monotherapy in CLL and many other lymphoid cancers, as well as in combination with rituximab in patients with relapsed or refractory CLL. This new study examined bendamustine in combination with rituximab as

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first-line therapy in 117 patients, 48% of whom had Binet stage C disease and 41% of whom had Binet stage B. Rituximab was given as four 6-week cycles with two doses of bendamustine in each cycle. Some 72% of patients in the study were treated with all six cycles of therapy. The median observation time was 15.4 months, and the overall response rate was 90.9%. A complete response was observed in 32.7% and a partial response in 55.5%. All other patients (9.1%) had stable disease, and none of the patients had progressive disease. With up to 26 months of follow-up, 75.8% of the patients were still in remission, and median progression-free survival has not been reached. Objective response rates of approximately 90% were achieved among the different genetic subgroups, except for del(17p), a high-risk subgroup in which the partial response rate was 42.9%.

Complete responses occurred most often in patients with unmutated immunoglobulin variable region heavy chain. The overall response rate in this group was 88.9%. Hematologic toxicities were grade 3/4 anemia in 4.9%, grade 3/4 leukopenia in 14.6%, grade 3/4 neutropenia and thrombocytopenia in 6.5% and 6.1% of all given courses, respectively. Twenty-nine episodes of common toxicity criteria grade ≥3 infections were documented (5.1% of all courses). There were two treatment-related deaths during the study: one fatal pneumonia and one case of sepsis related to neutropenia. Based on these encouraging data, the group is now conducting a phase 3 trial in which the efficacy of bendamustine/ rituximab is being compared with fludarabine-based immunochemotherapy in the first-line treatment of CLL, said Fischer. ●

omib-based therapy was significant (P <.0001 for PFS and P = .002 for OS). “The PFS and OS observed after bortezomib-based therapy is not dependent on the response to lenalidomide plus dexamethasone,” Reece said. Patients who achieved at least a PR to bortezomib had a median PFS of 7.3 months, compared with 2.0 months for patients with MR or less. One-year PFS was 29% versus 13%, respectively. Similarly, for OS, a response of PR or better was associated with a median OS of 14.3 months, versus 3.9 months for a lesser response, and 1-year OS was observed in 12% and 14%, respectively. “We concluded that treatment of sequential multiple myeloma relapses with bortezomib-based therapy after progression on LD produces partial responses or better in 44% of patients, results in a median PFS similar to the 6.2 months seen with bortezomib in less heavily pretreated patients in the APEX trial [Richardson PG, et al. N Engl J Med. 2005;352(24): 24872498], and demonstrates the effectiveness of bortezomib even after exposure to the potent LD combination,” Reece said. ●

National Press Coverage... Continued from page 32

she said. Finally, Bates said that health professionals, particularly oncology nurses, can play an important role in “triaging” information from the media to patients. “Not only can oncology nurses encourage responsible reporting of medical information, but they can also serve as a trusted source of information for patients who inquire about new trials or treatments they see in the news,” she noted. “We were very fortunate that a national news network approached us for this story and were thrilled to have the national exposure along with an unexpected boost in trial enrollment,” she added. “However, it is important to emphasize that our doctors and research nurse conscientiously worked with the reporters to ensure that the medical details were correct and that our vaccine was accurately described as experimental. The last thing we wanted was for the story to make false promises or overstate the vaccine’s success.” ●

April 2010 I VOl 3, NO 2

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Nursing Life

ONCOLOGY NURSING MONTH

To celebrate Oncology Nursing Month, this issue features stories about the personal side of nursing and about how nurses’ own lives and experiences add dimension to their nursing careers. The comments from patients, their spouses, and colleagues are ample evidence of the high regard in which oncology nurses are held.

Mother and Daughter Helping Oncology Patients in a Unique Way By John Schieszer

Julie and Marilyn Ross work side by side at Roswell Park Cancer Institute.

SEATTLE—In Buffalo, New York, there is a special type of continuity of care going on thanks to Marilyn and Julie Ross. This mother and daughter, both oncology nurses, treat a variety of patients on a daily basis at the same center. “I take care of a lot of Julie’s patients and so we really get to know the patients well because when they come to me they say ‘I saw your daughter today and now I get to see you,’” said Marilyn Ross, who is 55 years old. Marilyn, who has been a registered

Medical assistant’s comments am a medical assistant. I have had the pleasure to work with a great team, but the most incredible person would be a nurse practitioner, GS. He is a very dedicated, hardworking, and dedicated person.… He takes his time with every patient and is an inspiration to every patient and staff member.… He makes you feel that you are in the right place and the right hands. The patient is going to get better because he gives his everything to making sure that the patient is comfortable and so is the family. ●

—JR Nursing assistant

April 2010 I VOl 3, NO 2

nurse for more than 30 years, has three grown daughters. She became interested in treating oncology patients after her husband died of lung cancer at only 48 years old. He was diagnosed in March 2003 and died in December of the same year. Marilyn said those 9 months changed her life. She said what astounded her was the incredible care her husband received during those months of treatment. Today, Marilyn believes she has the best job she could possibly have. She is able to help patients and their families

in a way other nurses can’t because she has been in their shoes. “I know what they are going through,” Marilyn told The Oncology Nurse. “It is truly rewarding. I never thought I could be so happy at a job. I absolutely love my job. This outpatient setting is just perfect for me. I truly feel like I am making a difference.” She said that one of the things that can be the most challenging about her job is that every day is completely different. She said that is also what makes her job so interesting and fulfilling. Working in the infusion center at Roswell Park Cancer Institute lets her see a variety of patients for many different types of treatment. “It is very individualized, and you never know what your day is going to be like,” explained Marilyn. “I like a challenge. I never know what an individual’s therapy is going to be or what their prognosis is going to be.” Marilyn said she raised her children with the philosophy of treat others the way you want to be treated. That is how she treats her patients and the same is true of her daughter Julie Ross, who is a nurse practitioner at Roswell. Julie, who is 28 years old, said she always wanted to be a nurse because of her mom. “Ever since I was a little girl, I wanted to be a nurse. My mom is a special person, and I always admired her compassion toward her patients,” Julie said.

“I chose oncology because my father had lung cancer and we came here for his treatment. I liked the atmosphere here and the people.” Julie said there is also something else unique and special about working with cancer patients. She said oncology patients are different from most other patients in one key way. “People who have cancer or have experienced cancer view life in a special way. They are usually more positive and appreciate all of the small things in life that I think a lot of us forget about each day in our busy lives. That is probably the most rewarding part of my job. The strength I see in patients and their positive attitudes can be contagious,” Julie said. Julie and Marilyn readily admit that their jobs can be very challenging and especially difficult when a patient is not doing well. Like many oncology nurses, they often become very close to their patients and form a special relationship with the patients and their families. “I treat them like they are a loved one because they are someone’s loved one. I may be the last relationship they have, and I want it to be a positive relationship. Some of the patients may go into hospice and never come back to the infusion clinic, and I would never want their last day to not be a good experience,” said Marilyn. ●

Nurses Are a Special Breed

espite their demanding jobs, the school motto “Men and Women in Patricia Irouer Hughes, RN, Service of Others.” MSN, BSN, OCN, and her colHughes has also done volunteer work leagues on the oncology unit for an organization that proof Piedmont Healthcare in vides training for women the Atlanta, Georgia, metroaged 18 to 35 years to prepare politan area find time to volthem for employment and unteer in their community. currently volunteers in two “We are a special breed even personal care homes, assistthough we cannot all be ing the owner to maintain Florence Nightingale or Clara records for state inspection. Barton,” she says. Service She is also planning to assist learning or volunteerism was the homes with activities one of the requirements for using the mind and body. Patricia Irouer acquiring her MSN degree Her nursing colleagues Hughes, RN, MSN, from Regis University in have also provided services BSN, OCN Colorado, in keeping with above and beyond their reg-

ular full-time jobs. Ernestine for many years volunteered at her church adult day care center while being a single parent. Judy has done mission work in thirdworld countries as well as at home. Xia has used her annual vacations to volunteer for medical service trips and mission trips to Thailand and China, and this year she will volunteer as a nurse in India. Krupa has done mission work in Bulgaria and says, “It was a grateful, spiritual, holistic, and emotional experience.… I went there thinking I would help the people, but I learned more from them than I could have ever given them.” ●

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Nursing Life

An Oncology Nurse with a Special Ability to Empathize SEATTLE—Dessie Brown, LPN, works with a lot of cancer patients and loves doing it because she is able to help them in a unique way. Brown has been diagnosed with breast cancer twice,

first in 1992 and then again in August 2009. This February she finished her last round of chemotherapy. “I still feel a little sluggish, and I am still trying to get over my last

Nurse’s Poetry Reflects Her Work

ortney Davis is a nurse practitioner specializing in women’s health and a published poet and essayist. Davis says she often incorporates her nursing experience, including time spent as head nurse on a cancer unit, into her writing. “My own voice as a writer has been informed by my nurse’s training,” she

says. She has written and edited books of poetry and essays and serves on the editorial board of the Institute for Poetic Medicine and the NYU Literature, Arts and Medicine Database. The following selection from one of her publications reflects the deep connection nurses often feel with their patients. ●

I Want to Work in a Hospital By Cortney Davis

where it’s okay to climb into bed with patients and hold them— pre-op, before they lose their legs or breasts, or after, to tell them they are still whole. Or post-partum, when they have just returned from that strange garden, or when they are dying,

as if somehow because I stay they are free to go, taking with them the color of my eyes. I want the daylight I walk out into to become the flashlight they carry, waving it so God might find them as we go together into their long night.

(First published in “Bellevue Literary Review,” Vol. 7, No. 1, spring 2007)

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treatment,” said Brown, who has once you are diagnosed with cancer. been a nurse for more than 21 years. Because she has been a nurse for so The mother of a grown son and three long and has seen so many changes in small grandchildren, Brown considers the field of oncology, Brown can bring herself pretty lucky, and believes she has a special kind of comfort to her a special ability to help patients being patients. She usually explains to them treated for cancer. The psychological how therapies have dramatically imissues facing patients are proved in recent years and something that many nurses how the side effects from may not understand in the their medications can be same way as Brown. managed so much more “With my life history, I effectively. “Things have have been in their shoes,” really improved a lot in the said Brown in an interview past 20 years,” said Brown. with The Oncology Nurse. “The treatments are much “A lot of people don’t know better. Now, you have so about cancer and they have many new medications that a great deal of fear. If you help with side effects.” haven’t been there, you Dessie Brown, LPN Brown has been married just don’t know what that for 36 years, and she knows fear is like. My first reaction was that I the importance of having someone to was going to die, until I realized the care for and the importance of receiving treatment I could get would help me. care. Every day she has to deal with her That was just a common reaction. A lot own battle with breast cancer. Instead of of people who come in feel like it is a letting that hold her back, however, it death sentence.” actually allows her to bring a special type Brown said counseling and helping of caring and understanding to her patients with their care allows her to patients. ● show them that it is not a death sen—JS tence. Brown works at the Medical College of Georgia Health Care Center in Augusta. She sees many cancer patients in a given week and many have advanced disease. However, she brings a little bit of sunshine to her The number of cases of nonmelanoma patients every day no matter how skin cancers in the US population reached poorly they are feeling. Brown knows a record 3.5 million cases a year in 2006, according to a report in the March 2010 from firsthand experience what the issue of Archives of Dermatology. emotional roller-coaster ride is like

Did You Know?

April 2010 I VOl 3, NO 2

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Nursing Life

Compassion Fatigue: Can Nurses Live Happily Ever After?

ith all the stresses and demands of their jobs, can oncology nurses live happily ever after? Yes, according to Jennifer Kenderski, BSN, RN, OCN, who presented a poster on building resiliency to compassion fatigue at the 16th International Conference on Cancer Nursing in Atlanta. Kenderski, a radiation oncology clinical nurse at the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Ohio State University Medical Center, Columbus, has the unique perspective of an oncology nurse who herself has been an oncology patient. “I thought I was a good nurse before I had cancer, but after going through cancer, you feel more connected to your

“By learning and using strategies to transcend compassion fatigue, it is possible for nurses to have a happy professional and personal life.” —Jennifer Kenderski, BSN, RN, OCN

patients,” she said. Although she calls oncology nursing “the most fulfilling job I have ever had,” she realized that the realities of working with very sick patients and their families can take a toll on nurses and lead to compassion fatigue, which she defines as “physical, emotional, and

happily

@Copyright iStockphotos.com/Lukasz Laska

We are living

ever after.

spiritual fatigue that develops over time and takes over a person, causing a decline in the ability to experience joy or to care for others.” Sometimes, she says, nurses are not prepared to face the challenges and emotional tolls when they find that the reality of nursing does not measure up to the ideals they had while in school. She maintains that by learning and using strategies to transcend compassion fatigue, it is possible for nurses to have a happy professional and personal life and has developed steps for building resiliency (Sidebar). “Self-help is the most important thing in this field so that you don’t get angry and resentful and don’t carry all that hurt inside yourself,” she advised. She says continuing education is important to learn to set boundaries and not get overly involved with patients’ lives. “Journaling is helpful because you are able to go back and reflect on the things that you did that day, what brought you joy today, what brought you sadness. That helps relieve stress,” she says. ●

Dos and Don’ts for Recovery Engage in practices to discover what is important to you in life and set intentions and goals.

Do: Recognize the symptoms Find someone to talk with Understand what you feel is normal Learn to let go Learn the word “NO,” use whenever necessary Recognize when you need help and ask for it Give yourself credit for what you do Give others credit for what they do Exercise and eat properly Get enough sleep Take some time off Develop interests outside work Use humor to relieve tension and anxiety Manage stress Think powerfully See a counselor Read—knowledge is power Keep a log of your time, add structure Reserve your life for worthy causes, choose your battles Learn mindfulness meditation Understand what you feel is normal

Don’t: Blame others Make life-changing decisions Continually complain to others Work harder and longer Self-medicate Neglect your own needs and interests

—KR

Patient’s comments have been dealing with cancer for 3 years now. During this sometimes frightening and overwhelming ordeal, my husband and I found our oncology nurses to be absolutely invaluable. The nurses we have met have been calm, cheerful, and professional. They explained the drugs to us, told us what side effects to watch for, relayed messages to my doctor when required, made sure our follow-up appointments were scheduled, and, most important of all, they tried to make us comfortable during our frequent and long stays for chemotherapy. They have become an important part of our support team.

—LV 48-year-old woman with metastatic colon cancer

t is difficult for me to overstate the effect nurses have on patient and family member experiences during treatment. The nurses we have worked with have been instrumental in helping us to deal with, and understand, any and all of the issues and concerns that have presented themselves to us. In fact, they have seen to it that we have become a part of their family, and they of ours. The understanding and compassion that our nurses provide to us has given us the added strength and knowledge we have needed to continue to progress and improve. We will be forever indebted to our nurses. —PV LV’s husband

Build Resiliency to Compassion Fatigue

April 2010 I VOl 3, NO 2

Advance Your Education: Become a Leader of Tomorrow

he Patient Protection and Affordable Care Act, known to most as the Healthcare Reform Bill, will change the US healthcare system. But this bill contains much more than just new insurance options. For nurses, nursing workforce development programs have been reauthorized. Advanced education grants to nursing schools and academic health centers will make education more available for nurses pursuing master’s and post-master’s degrees. The bill also removed the cap on grants for doctoral programs. In addition, nursing student and faculty loans programs

have been established. These loans will be available to those working toward graduate level degrees. After graduating, students will be required to teach at a nursing school, for which they will receive an 85% discount on their loan. For California residents, University of California at Davis is offering full tuition coverage to nurse returning to school for master’s level education. Supported by a $100 million donation from the Gordon and Betty Moore Foundation, master’s degree students will receive $33,500 over five quarters. Out-of-state students will need to pick up the balance. ●

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International News

Reports from International Meetings and Researchers By Jill Stein

Zoledronic Acid Cuts Fracture Risk in Men with Advanced Prostate Cancer BARCELONA—Men with prostate cancer and malignant bone metastases who are treated with intravenous (IV) zoledronic acid are significantly less likely to sustain bone fractures than men not receiving an IV bisphosphonate, researchers announced at the 25th Anniversary European Association of Urology Congress. Henry Henk, PhD, with i3 Innovus in Eden Prairie, Minnesota, and colleagues presented data in 4976 men with prostate cancer and bone metastases who were treated in managed care practices. “Prostate cancer patients with malignant bone metastases frequently experience skeletal-related events including pathologic fracture, spinal cord compression, and hypercalcemia of malignancy, which are associated with significant morbidity and mortality,” Henk said. Patients enrolled in the trial between January 1, 2001, and December 31, 2006, and remained in the study until they died or the study ended (December 31, 2007). Men treated with zoledronic acid developed fewer fractures (vertebral fractures, nonvertebral hip fractures, and nonvertebral non-hip fractures) than men who did not. Overall, there were 5.9 fractures per 100 person-years in patients treated with zoledronic acid compared with 8.5 per 100 person-years in the placebo group (P = .0003). The data also showed that longer treatment with the bisphosphonate was associated with a lower fracture risk.

Women Should Maintain Ovarian Cancer Symptom Diary CARDIFF, UK—Women should keep a diary that records how often they have symptoms that may be associated with ovarian cancer, doctors have advised. The “Ovarian Cancer Symptom Diary” was developed to help women monitor the common symptoms that are sometimes linked with ovarian cancer, Bryan Beattie, MD, with Spire Cardiff Hospital, said. “The diary will provide doctors with a snapshot record of a woman’s health and may result in an earlier diagnosis of ovarian cancer,” he added. The diary should be used by women who experience the following symptoms on most days of the month: stomach or pelvic pain, persistent abdominal bloating, difficulty eating, feeling full quickly, frequent urination, a change in bowel habits, excessive fatigue, and back pain. Most women do not know that such symptoms may signal ovarian cancer,

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Beattie commented. According to Beattie, women over 50 years of age should keep a symptom diary for 1 month each year. The widespread availability of screen-

ing for ovarian cancer is the optimal method of detecting ovarian cancer; however, an ovarian cancer symptom diary is useful in the absence of screening, he noted.

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 Abdominal Pain 14 1 Disorders 38 3 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 Flushing 5 0 LDH Increase 7 0 Leukoencephalopathy (PML) JC virus infection resulting in PML and death can occur Heme 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 8 3 Dizziness 10 1 transplant. The patients with autoimmune diseases had prior or concurrent Skin Anemia 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 1 Myalgia 10 1 their last infusion of Rituxan. Consider the diagnosis of PML in any patient presenting Pruritus 14 1 Arthralgia 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 immunosuppressive therapy in patients who develop PML. [See Boxed Warning, Adverse aAdverse reactions observed up to 12 months following Rituxan. bAdverse 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 s the following adverse reactions, cardiac monitoring during and after all infusions of Rituxan for patients who develop Studies.] DLBCLL In Studies 6 and 7, [see Clinical Studies] 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). CLLL 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

Finally, although these symptoms will in most cases not “turn out to be” ovarian cancer, it is important that patients who experience them on most days share their concerns with their physician. ● 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 NHL 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 Fertilityy 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 your 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 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 and Additional Important Safety Information RITUXAN therapy can result in serious, including fatal, adverse reactions. These include infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B reactivation with fulminant hepatitis, other infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation. The most common adverse reactions of RITUXAN (incidence ≥25%) observed in 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. 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. 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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