June 2010, Vol 3, No 4 by The Oncology Nurse

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JUNE 2010

www.TheOncologyNurse.com

VOL 3, NO 4

CONFERENCE NEWS

CANCER CENTER PROFILE

35th Annual Congress of the Oncology Nursing Society San Diego, California, May 13-16, 2010. See who was there: page 20.

Back row left to right: Joy Dimagmaliw, RNC; Joann Signorino, RN-BC; Charlotte Bradley, RN, OCN; Robyn Rex, RN, OCN; Debora Velmer, RN, CCM; Patricia Molinelli, MS, RN, APN-C, AOCNS; Rita Messemer, RN; Janet Belmonte, RNC. Bottom row left to right: Amalia Apuzzio, RN-BC; Bozena Owsieniuk, RN; Erica Schermer; Kathy Wagle, PCT.

Aran Levine, Ellie Flores, Laura Spriggs, and Elizabeth Embry of the San Diego ONS chapter display some local character.

VIEWPOINT

Steeplechase Cancer Center Provides Patient-centered Care in Community Setting

No, You Can’t Keep Your Health Plan

By Karen Rosenberg

By Scott Gottlieb, MD

teeplechase Cancer Center at Somerset Medical Center in Somerville, New Jersey, was established in 2007 in response to community needs for easily accessible high-quality cancer care. The center is named for the steeplechase horse race, held each October in the neighboring community of Far Hills, New Jersey. Proceeds from the race are donated to the center and go to support expanded facilities and services. The cancer center occupies a large, state-of-the-art facility and offers a full range of services. “It houses everything you need for diagnosis and treatment of cancer in one place,” notes Joan Perrone, RPh, one of four pharmacists who service the infusion center at Steeplechase. Somerset

Insurers and doctors are already consolidating their businesses in the wake of ObamaCare’s passage. resident Obama guaranteed Americans that after health reform became law they could keep their insurance plans and their doctors. It’s clear that this promise cannot be kept. Insurers and physicians are already reshaping their businesses as a result of Mr. Obama’s plan. The health-reform law caps how much insurers can spend on expenses and take for profits. Starting next year, health plans will have a regulated “floor” on their medical-loss ratios, which is the amount of revenue they spend on medical claims. Insurers can only spend 20% of their premiums on running their plans if they offer policies directly to consumers or to small employers. The spending cap is 15% for policies sold to large employers. This regulation is going to have its biggest impact on insurance sold directly to consumers—what’s referred to as the “individual market.” These policies cost more

Continued on page 8

Journal of Oncology

NAVIGATION & SURVIVORSHIP

™

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

www.AONNonline.org

VOL 1, NO 2

NAVIGATION TRENDS

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

A Conversation with Harold P. Freeman, MD, the “Pioneer of Patient Navigation” By Caroline Helwick

arold P. Freeman, MD, is the founder and president of the Harold P. Freeman Patient Navigation Institute of the Ralph Lauren Center for Cancer Care and Prevention in New York City. He is a past president of the American Cancer Society and for 25 years has served as clinical professor of medicine at Columbia University College of Physicians and Surgeons. Dr Freeman is also a leading authority on the interrelationship of racism, poverty, and cancer. He has been credited with initiating the patient navigation concept based on the movement he began as a young surgeon

at Harlem Hospital Center in the 1980s. In an interview with Journal of Oncology Navigation & Survivorship, Dr Freeman described the seeds of this concept and his personal view of what patient navigation should accomplish. There is now national recognition that patients should be helped to navigate through the maze of cancer care delivery. Dr Freeman, was there an “ah-ha moment” for you that fostered this concept? It started as a way to enhance access to breast cancer screening. Back in the 1970s and 1980s, over and over I wit-

nessed women with breast cancer who could not overcome the barriers to access proper care. This bothered me tremendously. I saw that surgery, my specialty, was not the answer to their problems. They were coming in to Harlem Hospital with late-stage disease, and I began to ask them why. They told me that they went to the emergency department, because they didn’t have a doctor. When they got there, they were told theirs was not an emergency, they needed a medical clinic, but first they needed to go downtown 100 blocks for a Medicaid card, and then come back.

Pain, Fatigue, and Sleep Disruption Common in Cancer Survivors By Jill Stein SAN DIEGO—Nearly 25% of cancer survivors say that they have experienced concurrent pain, fatigue, and sleep disturbance, according to results released at the 35th Annual Congress of the Oncology Nursing Society. “While co-occurring pain, fatigue,

and sleep disturbance are widely recognized as a cancer symptom cluster during treatment, we believe that our findings show preliminary evidence that the cluster may continue into survivorship,” said Kristine Kwekkeboom, PhD, RN, assisContinued on page 4

Kristine Kwekkeboom, PhD, RN

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

First Annual Navigation and Survivorship Conference

Inside Supportive Care A New Advance in Lymphedema Therapy

Continued on page 2

SUPPORTIVE CARE

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

Journal of Oncology Navigation & Survivorship™

between pages 20 and 21

By Wilma Morgan-Hazelwood, OTR/L, CLT-LANA; Jenna Balaicuis, DPT, CLT

CO M PL IM EN TA RY

CE Credit

Active Surveillance as a Management Strategy for Low-risk Prostate Cancer page 14

Fostering a Dialogue to Improve Patient Care & Outcomes

Submit your cases online today at www.myelomacases.com

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When treating patients with HER2+ breast cancer

No one touches their HER2-positive status is associated with more aggressive disease and poorer outcomes than HER2-negative breast cancer. Women who received 1 year of Herceptin had a lower risk of HER2+ breast cancer returning. We applaud you for playing such a critical role in helping patients with HER2+ breast cancer complete the full course of treatment with Herceptin.

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

Metastatic indications Herceptin is indicated: s In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer s As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease 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 6 7% N/A 5% N/A Dysfunctionc a Congestive heart failure or significant asymptomatic decrease in LVEF. b Anthracycline (doxorubicin or epirubicin) and cyclophosphamide c Includes 1 patient with fatal cardiomyopathy. Infusion Reactions Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia. [see Adverse Reactions]. In postmarketing reports, serious and fatal infusion reactions have been reported. Severe reactions which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension, were usually reported during or immediately following the initial infusion. However, the onset and clinical course were variable including progressive worsening, initial improvement followed by clinical deterioration, or delayed post-infusion events with rapid clinical deterioration. For fatal events, death occurred within hours to days following a serious infusion reaction. Interrupt Herceptin infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered, which may include: epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen. Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. Permanent discontinuation should be strongly considered in all patients with severe infusion reactions. There are no data regarding the most appropriate method of identification of patients who may safely be retreated with Herceptin after experiencing a severe infusion reaction. Prior to resumption of Herceptin infusion, the majority of patients who experienced a severe infusion reaction were pre-medicated with antihistamines and/or corticosteroids. While some patients tolerated Herceptin infusions, others had recurrent severe infusion reactions despite pre-medications. Exacerbation of Chemotherapy-Induced Neutropenia In randomized, controlled clinical trials in women with metastatic breast cancer, the perpatient incidences of NCI CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving Herceptin in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was not significantly increased. [see Adverse Reactions]. Pulmonary Toxicity Herceptin use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions [see Warnings and Precautions (5.2)]. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity. HER2 Testing Detection of HER2 protein overexpression is necessary for selection of patients appropriate for Herceptin therapy because these are the only patients studied and for whom benefit has been shown. Assessment for HER2 overexpression and of HER2 gene amplification should be performed by laboratories with demonstrated proficiency in the specific technology being utilized. Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results. Several FDA-approved commercial assays are available to aid in the selection of patients for Herceptin therapy. These include HercepTestTM and Pathway® HER-2/neu (IHC assays) and PathVysion® and HER2 FISH pharmDxTM (FISH assays). Users should refer to the package inserts of specific assay kits for information on the validation and performance of each assay. Limitations in assay precision (particularly for the IHC method) and in the direct linkage between assay result and overexpression of the Herceptin target (for the FISH method) make it inadvisable to rely on a single method to rule out potential Herceptin benefit. A negative FISH result does not rule out HER2 overexpression and potential benefit from Herceptin. Treatment outcomes for metastatic breast cancer (Study 5) as a function of IHC and FISH testing are provided in Table 9. Treatment outcomes for adjuvant breast cancer (Studies 2 and 3) as a function of IHC and FISH testing are provided in Table 7. HER2 Protein Overexpression Detection Methods HER2 protein overexpression can be established by measuring HER2 protein using an IHC method. HercepTest®, one test approved for this use, was assessed for concordance with the Clinical Trial Assay (CTA), using tumor specimens collected and stored independently from those obtained in Herceptin clinical studies in women with metastatic breast cancer. Data are provided in the package insert for HercepTest®. HER2 Gene Amplification Detection Method The presence of HER2 protein overexpression and gene amplification are highly correlated, therefore the use of FISH to detect gene amplification may be employed for selection of patients appropriate for Herceptin therapy. PathVysion®, one test approved for this use, was evaluated in an exploratory, retrospective assessment of available CTA 2+ or 3+ tumor specimens collected as part of patient screening for clinical studies in metastatic breast cancer (Studies 5 and 6). Data are provided in the package insert for PathVysion®. Embryo-Fetal Toxicity (Pregnancy Category D) Herceptin can cause fetal harm when administered to a pregnant woman. Postmarketing case reports suggest that Herceptin use during pregnancy increases the risk of oligohydramnios during the second and third trimesters. If Herceptin is used during pregnancy or if a woman becomes pregnant while taking Herceptin, she should be apprised of the potential hazard to a

fetus. [see Use in Specific Populations]. ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Cardiomyopathy [see Warnings and Precautions] • Infusion reactions [see Warnings and Precautions] • Exacerbation of chemotherapy-induced neutropenia [see Warnings and Precautions] • Pulmonary toxicity [see Warnings and Precautions] The most common adverse reactions in patients receiving Herceptin are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Adverse reactions requiring interruption or discontinuation of Herceptin treatment include CHF, significant decline in left ventricular cardiac function, severe infusion reactions, and pulmonary toxicity [see Dosage and Administration]. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adjuvant Breast Cancer Studies The data below reflect exposure to Herceptin across three randomized, open-label studies, Studies 1, 2, and 3, with (n= 3355) or without (n= 3308) trastuzumab in the adjuvant treatment of breast cancer. The data summarized in Table 3 below, from Study 3, reflect exposure to Herceptin in 1678 patients; the median treatment duration was 51 weeks and median number of infusions was 18. Among the 3386 patients enrolled in Study 3, the median age was 49 years (range: 21 to 80 years), 83% of patients were Caucasian, and 13% were Asian. Table 3 Adverse Reactions for Study 3, All Gradesa: MedDRA (v. 7.1) 1 Year Herceptin Adverse Event Preferred Term (n= 1678) Cardiac Hypertension 64 (4%) Dizziness 60 (4%) Ejection Fraction Decreased 58 (3.5%) Palpitations 48 (3%) Cardiac Arrhythmiasb 40 (3%) Cardiac Failure Congestive 30 (2%) Cardiac Failure 9 (0.5%) Cardiac Disorder 5 (0.3%) Ventricular Dysfunction 4 (0.2%) Respiratory Thoracic Mediastinal Disorders Nasopharyngitis 135 (8%) Cough 81 (5%) Influenza 70 (4%) Dyspnea 57 (3%) URI 46 (3%) Rhinitis 36 (2%) Pharyngolaryngeal Pain 32 (2%) Sinusitis 26 (2%) Epistaxis 25 (2%) Pulmonary Hypertension 4 (0.2%) Interstitial Pneumonitis 4 (0.2%) Gastrointestinal Disorders Diarrhea 123 (7%) Nausea 108 (6%) Vomiting 58 (3.5%) Constipation 33 (2%) Dyspepsia 30 (2%) Upper Abdominal Pain 29 (2%) Musculoskeletal & Connective Tissue Disorders Arthralgia 137 (8%) Back Pain 91 (5%) Myalgia 63 (4%) Bone Pain 49 (3%) Muscle Spasm 46 (3%) Nervous System Disorders Headache 162 (10%) Paraesthesia 29 (2%) Skin & Subcutaneous Tissue Disorders Rash 70 (4%) Nail Disorders 43 (2%) Pruritis 40 (2%) General Disorders Pyrexia 100 (6%) Edema Peripheral 79 (5%) Chills 85 (5%) Aesthenia 75 (4.5%) Influenza-like Illness 40 (2%) Sudden Death 1 (.06%) Infections Nasopharyngitis 135 (8%) UTI 39 (3%) Immune System Disorders Hypersensitivity 10 (0.6%) Autoimmune Thyroiditis 4 (0.3%)

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

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

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

Grade 2–5 occurred at an incidence of at least 2% greater among patients randomized to Herceptin plus chemotherapy as compared to chemotherapy alone: arthralgia (11% vs. 8.4%), myalgia (10% vs. 8%), nail changes (9% vs. 7%), and dyspnea (2.5% vs. 0.1%). The majority of these events were Grade 2 in severity. Safety data from Study 4 reflect exposure to Herceptin as part of an adjuvant treatment regimen from 2124 patients receiving at least one dose of study treatment [AC-TH: n = 1068; TCH: n = 1056]. The overall median treatment duration was 54 weeks in both the AC-TH and TCH arms. The median number of infusions was 26 in the AC-TH arm and 30 in the TCH arm, including weekly infusions during the chemotherapy phase and every three week dosing in the monotherapy period. Among these patients, the median age was 49 years (range 22 to 74 years). In Study 4, the toxicity profile was similar to that reported in Studies 1, 2, and 3 with the exception of a low incidence of CHF in the TCH arm. Metastatic Breast Cancer Studies The data below reflect exposure to Herceptin in one randomized, openlabel study, Study 5, of chemotherapy with (n=235) or without (n=234) trastuzumab in patients with metastatic breast cancer, and one single-arm study (Study 6; n=222) in patients with metastatic breast cancer. Data in Table 5 are based on Studies 5 and 6. Among the 464 patients treated in Study 5, the median age was 52 years (range: 25–77 years). Eighty-nine percent were White, 5% Black, 1% Asian and 5% other racial/ethnic groups. All patients received 4 mg/kg initial dose of Herceptin followed by 2 mg/kg weekly. The percentages of patients who received Herceptin treatment for 6 months and 12 months were 58% and 9%, respectively. Among the 352 patients treated in single agent studies (213 patients from Study 6), the median age was 50 years (range 28–86 years), 100% had breast cancer, 86% were White, 3% were Black, 3% were Asian, and 8% in other racial/ ethnic groups. Most of the patients received 4 mg/kg initial dose of Herceptin followed by 2 mg/kg weekly. The percentages of patients who received Herceptin treatment for 6 months and 12 months were 31% and 16%, respectively. Table 4 Per-Patient Incidence of Adverse Reactions Occurring in 5% of Patients in Uncontrolled Studies or at Increased Incidence in the Herceptin Arm (Studies 5 and 6) (Percent of Patients) Herceptin Single + Paclitaxel Herceptin ACb a Agent Paclitaxel Alone + ACb Alone n = 352 n = 91 n = 95 n = 143 n = 135 Body as a Whole Pain 47 61 62 57 42 Asthenia 42 62 57 54 55 Fever 36 49 23 56 34 Chills 32 41 4 35 11 Headache 26 36 28 44 31 Abdominal pain 22 34 22 23 18 Back pain 22 34 30 27 15 Infection 20 47 27 47 31 Flu syndrome 10 12 5 12 6 Accidental injury 6 13 3 9 4 Allergic reaction 3 8 2 4 2 Cardiovascular Tachycardia 5 12 4 10 5 Congestive 7 11 1 28 7 heart failure Digestive Nausea 33 51 9 76 77 Diarrhea 25 45 29 45 26 Vomiting 23 37 28 53 49 Nausea and 8 14 11 18 9 vomiting Anorexia 14 24 16 31 26 Heme & Lymphatic Anemia 4 14 9 36 26 Leukopenia 3 24 17 52 34 Metabolic Peripheral edema 10 22 20 20 17 Edema 8 10 8 11 5 Musculoskeletal Bone pain 7 24 18 7 7 Arthralgia 6 37 21 8 9 Nervous Insomnia 14 25 13 29 15 Dizziness 13 22 24 24 18 Paresthesia 9 48 39 17 11 Depression 6 12 13 20 12 Peripheral neuritis 2 23 16 2 2 Neuropathy 1 13 5 4 4 Respiratory Cough increased 26 41 22 43 29 Dyspnea 22 27 26 42 25 Rhinitis 14 22 5 22 16 Pharyngitis 12 22 14 30 18 Sinusitis 9 21 7 13 6 Skin Rash 18 38 18 27 17 Herpes simplex 2 12 3 7 9 Acne 2 11 3 3 <1 Urogenital Urinary tract 5 18 14 13 7 infection a Data for Herceptin single agent were from 4 studies, including 213 patients from Study 6. b Anthracycline (doxorubicin or epirubicin) and cyclophosphamide The following subsections provide additional detail regarding adverse reactions observed in clinical trials of adjuvant breast, metastatic breast cancer, or post-marketing experience. Cardiomyopathy Serial measurement of cardiac function (LVEF) was obtained in clinical trials in the adjuvant treatment of breast cancer. In Study 3, the median duration of follow-up was 12.6 months (12.4 months in the observation arm; 12.6 months in the 1-year Herceptin arm); and in Studies 1 and 2, 23 months in

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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.

Letter to the Editor

am the current ONS Chemotherapy SIG Coordinator. I would like to respond to the article, “Nursing Practice—Maintaining Chemotherapy Administration Competency in a Small Hospital,” in the April 2010 issue. The topic of chemotherapy administration in rural areas and small hospitals very much needs to be addressed. The content of the article is well written. The concern that I have, which challenges safe and proficient handling/administration of chemotherapy, is the two photographs that accompany the article. The only reference for this article is the ONS Chemotherapy and Biotherapy Guidelines and Recommendations for Practice, 3rd edition. When someone reads the article and sees the wonderful reference, my concern is that they will conceptualize that chemotherapy gloves, alone, are the only PPE required in administration of chemotherapy. When the nurses are checking the bags (photo on page 22), the chemotherapy is not in a double-sealed bag and does not have a closed system attached to the bag. In the photo, the chemotherapy is being held over the medication paperwork, rather than over the chemotherapy preparation area. When hanging the chemotherapy (cover page), the nurse appears to be getting ready to hang the bag on the IV pole. She has only gloves for PPE, which is not the only PPE advocated for this procedure by the ONS Chemotherapy/Biotherapy Provider program. Where is the second nurse for the two-nurse check, to verify that this is the correct patient and that the patient is receiving the correct agent? I am hopeful that you will relay the need for gown, double gloves, and eye protection to your readers in your next edition, to encourage protection of the healthcare worker. Perhaps, at that time include additional details related to NIOSH Guidelines and have major cancer centers share with your publication the PPE that they advocate and implement at their institutions. At MDACC, our Environmental Health and Safety Department has adjusted policy to the “recent” NIOSH guidelines and, in the near future, nurses will be required to wear goggles and face shields when administering agents that have potential for splash; I would like to encourage an article on closed systems, as well. Mildred “Millie” A. Toth, MS, RN, AOCN Senior Nursing Instructor, U. T. M. D. Anderson Cancer Center, Houston, Texas

Editor’s Response: We appreciate these comments from the ONS Chemotherapy SIG Coordinator. The Oncology Nurse strongly supports the importance of safe handling practices (see article on page 23). In the future, we will make every effort to ensure that all photos are consistent with professional standards. We invite readers to share the safe handling policies and procedures used at their institution.

June 2010 I VOL 3, nO 4

TON_June 2010_FINAL_TON 6/9/10 1:57 PM Page 4

Editorial Board EDITOR-IN-CHIEF

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

Cassandra J. Hammond, RN,

Dolores “Jeff” Nordquist, RN, MS,

Karla Wilson, RN,

MSN, CRNP

CS, FNP

Avid Education Partners, LLC Sharpsburg, MD

Mayo Clinic Rochester, MN

City of Hope National Medical Center Duarte, CA

Patricia Irouer Hughes, RN, MSN,

Melinda Oberleitner, RN,

Nutrition Karen Connelly,

BSN, OCN

DNS, APRN, CNS

RD, CSO

MSN, FNP-C, CPON

Elizabeth Bilotti, RN, MSN, APRN, BC, OCN John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Piedmount Healthcare Rex, GA

Deena Damsky Dell, RN, MSN,

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

Somerset Medical Center Somerville, NJ

AOCN, BC Fox Chase Cancer Center Philadelphia, PA

Wendy DiSalvo,

Taline Khoukaz,

Gary Shelton,

NP, MSN, ACNP-C

MSN, ARNP, AOCN

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

NYU Cancer Institute New York, NY

Managed Care and Pharmaceutical Management Burt Zweigenhaft, BS BioPharma Partners LLC New York, NY

DNP, APRN, AOCN Genentech New London, NH

Denice Economou, RN,

Sandra E. Kurtin,

Lori Stover, RN,

RN, MS, AOCN, ANP-C

BSN

Arizona Cancer Center Tucson, AZ

Pharmacy John F. Aforismo,

Western Pennsylvania Cancer Institute Pittsburgh, PA

BSc Pharm, RPh, FASCP

Pamela Hallquist Viale, RN, MS,

Social Work Carolyn Messner,

CS, ANP, AOCN

DSW, MSW, LCSWR, BCD

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

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

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

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

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

The Cancer Center at Hackensack University Medical Center Hackensack, NJ

Saratoga, CA

Kena C. Miller,

Connie Visovsky,

Isabell Castellano, RN

RN, MSN, FNP

RN, PhD, APRN

Roswell Park Cancer Institute Buffalo, NY

University of Nebraska College of Nursing Omaha, NE

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

CancerCare New York, NY

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

Sharon S. Gentry,

Patricia Molinelli,

Rita Wickham,

RN, MSN, AOCN

MS, RN, APN-C, AOCNS

OCN, PhD, RN

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

June 2010 I VOL 3, nO 4

Somerset Medical Center Somerville, NJ

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

Jeanne Westphal, RN Meeker County Memorial Hospital Litchfield, MN

www.TheOncologynurse.com

TON_June 2010_FINAL_TON 6/9/10 1:58 PM Page 5

“After my balloon kyphoplasty, I’m walking pain-free again.” Tom Callaghan experienced debilitating pain due to spinal fractures caused by multiple myeloma. He underwent a minimally invasive procedure, Balloon Kyphoplasty, to treat the spinal fractures.

KYPHON® Balloon Kyphoplasty

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The complication rate with KYPHON® Balloon Kyphoplasty has been demonstrated to be low. As with all surgical procedures, there are risks associated with the procedure, including serious complications, and though rare, some of which can be fatal. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use included with the product. © 2009 Medtronic Spine LLC. All Rights Reserved. 16003611_001 rev 1

TON_June 2010_FINAL_TON 6/15/10 9:55 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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addressed to EDITORIAL DIRECTOR, The Oncology Nurse® - APN/PA, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. E-mail: karen@greenhillhc.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issues, $17.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. The ideas and opinions expressed in The Oncology Nurse® - APN/PA do not necessarily reflect those of the Editorial Board, the Editorial Director, or the Publisher. Publication of an advertisement or other product mention in The Oncology Nurse® - APN/PA should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the Editorial Board nor the Publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the Editorial Director. ISSN #1944-9798. The Oncology Nurse® - APN/PA is published 8 times a year by Green Hill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2010 by Green Hill Healthcare Communications, LLC. All rights reserved. The Oncology Nurse® - APN/PA logo is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America.

JuNe 2010 I VOL 3, NO 4

prominent theme, with several educational and poster sessions devoted to it, at the just-concluded American Society of Clinical Oncology (ASCO) annual meeting was survivor care. At a session called Cancer Survivors: A Challenge to Healthcare Systems Worldwide, speakers addressed concerns about Beth Faiman, RN, how the growing number of cancer MSN, APRN, BC, survivors will affect healthcare sysAOCN tems. Of particular concern is how Editor-in-Chief to provide the ongoing medical and psychosocial support services this growing population needs in face of the healthcare workforce shortage. As one speaker put it, this is a happy problem, but a challenging one nonetheless. Collaborative practice arrangements in which nurse practitioners (NPs) and physician assistants (PAs) play a prominent role in survivor care is one way to meet this supply/demand imbalance, said Douglas Blayney, MD, ASCO president.

While the role of NPs and PAs and other advanced practitioners in cancer care will undoubtedly expand in coming years, it is important to recognize the contributions of all members of the nursing team in the care of cancer patients and survivors. The addition of “APNs/PAs” to The Oncology Nurse logo signals our commitment to providing information of value to nurses and practitioners with all levels of training and experience who participate in the care of cancer patients and survivors. Another thread that ran throughout the meeting was the need for education of patients and their family members and other caregivers about cancer and its treatment and the importance of good communication with healthcare providers. Nurses are often the ones patients and their caregivers turn to for information about the latest treatment advances. It can be daunting just to keep up with the new information reported at meetings such as ASCO and even more so to interpret how new findings may apply in our own practice. News from ASCO is widely reported. The Oncology Nurse looks at the news reported there from a nurse’s perspective, featuring findings that potentially may affect nursing practice. ●

CONTENTS

JuNe 2010 • VOL 3, NO 4

FEATURE ARTICLES 8 Conference News: ONS Congress Oral care protocol may prevent oral mucositis Follow-up phone call improves patient satisfaction after discharge Oncology nurses play a pivotal role in amyloidosis management

14 Continuing Education Active surveillance as a management strategy for low-risk prostate cancer

20 Faces at the Congress 23 Safe Handling

Journal of Oncology

NAVIGATION & SURVIVORSHIP

™

The Official Journal of the Academy of Oncology Nurse Navigators ®

Increasing compliance with safe handling guidelines: one cancer center’s experience

24 Psychosocial Issues Most oncology nurses unfamiliar with IOM report on caring for the whole patient

JUNE 2010

www.AONNonline.org NAVIGATION TRENDS

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

Anemia management using erythropoiesis-stimulating agents and iron therapy

32 Supportive Care

A Conversation with Harold P. Freeman, MD, the “Pioneer of Patient Navigation” By Caroline Helwick

Sharon Gentry, RN, MSN, AOCN, CBCN Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, North Carolina Nicole Messier, RN Vermont Cancer Center Burlington, Vermont Pamela Matten, RN, BSN, OCN St. Joseph Hospital Orange, California Elaine Sein, RN, BSN, OCN, CBCN Fox Chase Cancer Center Partners Rockledge, Pennsylvania

SUPPORTIVE CARE

Tricia Strusowski MS, RN Helen F. Graham Cancer Center Christiana Care Health System Newark, Delaware Linda Fleisher, MPH, PhD(c) Fox Chase Cancer Center Cheltenham, Pennsylvania Susan M. Gardner, RN, CBEC, CBCN Valley Medical Center Renton, Washington

28 Supportive Care

VOL 1, NO 2

Jay R. Swanson, RN, BSN, OCN Saint Elizabeth Cancer Institute Lincoln, Nebraska Carol Lewis, RN, BSN, OCN, CRNI Memorial Hermann The Woodlands, Texas

Kristine Kwekkeboom, PhD, RN

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

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

First Annual Navigation and Survivorship Conference

Journal of Oncology

NAVIGATION & SURVIVORSHIP

™

A new advance in lymphedema therapy

36 Nursing Life My evidence: a poem Recipe: chilled grilled shrimp over tropical fruit salad with citrus vinaigrette

The Official Journal of the Academy of Oncology Nurse Navigators ®

A conversation with Harold P. Freeman, MD, the “pioneer of patient navigation” Pain, fatigue, and sleep disruption common in cancer survivors

DEPARTMENTS 3 Letter to the Editor

Nurse navigators increase patient satisfaction

25 Oncology Drug Codes

Oncology nurses, social workers play key roles in patient navigation

Lung cancer

34 International News

Physical needs and quality of life among older survivors

37 Meetings

Between pages 20 and 21 www.TheOncologyNurse.com

TON_June 2010_FINAL_TON 6/9/10 1:58 PM Page 7

www.BioOncology.com

Taking a broader view — charting a unique course in cancer care

At Genentech BioOncology, not only are we leading the fight against cancer with innovative science, but we’re also dedicated to supporting patients and others within the oncology community. A commitment to patients — We created Genentech BioOncology™ Access Solutions™, a single source for all access and reimbursement issues, so healthcare providers can remain focused on patient care. Reducing barriers to treatment — We help make treatment possible for patients in financial need through our BioOncology Co-Pay Card Program and ongoing charitable donations to various independent nonprofit organizations in support of co-pay assistance. A commitment to care — Our first product was approved in 1985, and since then we have donated approximately $1.5 billion in medicine to uninsured patients through the Genentech® Access to Care Foundation and other donation programs. Our goal is to fundamentally change the way that cancer is treated by personalizing solutions to patient care.

TON_June 2010_FINAL_TON 6/9/10 1:58 PM Page 8

Cancer Center Profile Steeplechase Cancer Center... Continued from cover

Left to right: radiation oncologist Joel Braver, MD; urologist Joel Fischer, MD, chair of the Prostate Cancer Institute; Kathleen Toomey, MD, medical director of the Steeplechase Cancer Center; and Katrina Losa, RN, director of the Steeplechase Cancer Center.

Medical Center is the only full-service counseling, a cancer registry, clinical trihospital in the county, and “it’s an inte- als, rehabilitation medicine, palliative gral part of the community,” she says. care and pain management, and nutri“We do community fundraisers and are tion counseling. “Besides the clinical triwell supported by the community.” als that are available to patients, there Kathleen Toomey, MD, are four multidisciplinary medical director of the cancer groups [breast, prostate, colcenter, notes that patients are orectal, and lung] that come not only able to get their care together and discuss cases. In close to home but are able to the case of breast and colon continue to see their own doccancer, all new cases are distors. “The doctors who know cussed in a multidisciplinary the patients best are here and forum,” Toomey says. The can help coordinate their care Tobacco Quitcenter is availwith the many specialists.” Joan Perrone, RPh able to help patients stop In addition to medical, radismoking. ation, and surgical oncology, Somerset Medical Center Steeplechase’s services include plastic is a clinical research affiliate of The surgery, a breast care center, genetic Cancer Institute of New Jersey, allowing

patients access to clinical trierators, flat-screen televisions, als. Currently, patients are and DVD/VHS players. enrolled in treatment trials Patricia Molinelli, MS, RN, for breast, prostate, renal, APN-C, AOCNS, is nurse bladder, and colorectal canmanager of the inpatient and cers as well as chemotherapyoutpatient oncology units. She induced peripheral neuropacame to the center from large thy. There are also industry academic medical centers in registry trials in multiple New York and values the intiPatricia Molinelli, myeloma and chronic lymmacy afforded by working in a MS, RN, APN-C, phocytic leukemia and a large smaller setting. “I try to know AOCNS annual screening trial for one thing that is important to prostate cancer. “We accrued every patient,” she says. Care 92 patients to trials last year, 23 on treat- at the center is patient-centered. As ment trials and 69 on the screening trial,” Molinelli describes it, “I am the gateToomey notes. keeper, the coordinator of all these orbits. A complementary medicine suite pro- The patient is the sun.” She views family vides a variety of services including members and other caregivers as “an yoga, meditation, and massage. Other extension of the patient” and takes care resources include a patient library, an to provide for their comfort with a wellonsite wellness boutique, a survivorship stocked pantry, games, and DVDs for visprogram, a healing garden, and educa- itor use. “We try to take a lot of the burtional and support groups for patients den off the family,” she explains. She also and their families. points to the latest technology in eviThe Steeplechase Cancer Center dence throughout the center. “We rush to earned its 3-year Community Com- get whatever is available to reduce medprehensive Cancer Program accredita- ical errors and increase patient safety.” tion from the American College of Her current goal is to incorporate genetSurgeons in 2008, and it ranks in the ics into the cancer program. 99th percentile for patient-satisfaction Other future plans include a new scores in New Jersey. interdisciplinary group for lymphoma, Inpatient services are provided at the myeloma, and leukemias, and a head 35-bed Paul R. Nardoni Oncology and neck group as well as gynecologyPavilion. Patient rooms have sofa beds oncology and palliative care programs, for visitors wishing to stay overnight in and a men’s cancer support group. A addition to amenities such as blanket Day of Hope is planned for cancer surwarmers, lounge chairs, showers, refrig- vivor month. ●

VIEWPOINT

No, You Can’t Keep Your Health Plan Continued from cover to market. They also have higher medical costs, owing partly to selection by less healthy consumers. Finally, individual policies have high start-up costs. If insurers cannot spend more of their revenue getting plans on track, fewer new policies will be offered. This will hit WellPoint, one of the biggest players in the individual market, particularly hard. The insurance company already has a strained relationship with the White House: Earlier this month Mr. Obama accused WellPoint of systemically denying coverage to breast cancer patients, though the facts don’t bear that out. Restrictions on how insurers can spend money are compounded by simultaneous constraints on how they can manage their costs. Beginning in 2014, a new federal agency will standardize insurance benefits, placing minimum actuarial values on medical policies. There are also mandates forcing insurers to cover a lot of expensive primary-care services in full. At the same time, insurers are being blocked from raising premiums—for now

June 2010 I VOL 3, nO 4

by political jawboning, but the threat of legislative restrictions looms. One of the few remaining ways to manage expenses is to reduce the actual cost of the products. In health care, this means pushing providers to accept lower fees and reduce their use of costly services like radiology or other diagnostic testing. To implement this strategy, companies need to be able to exert more control over doctors. So insurers are trying to buy up medical clinics and doctor practices. Where they can’t own providers outright, they’ll maintain smaller “networks” of physicians that they will contract with so they can manage doctors more closely. That means even fewer choices for beneficiaries. Insurers hope that owning providers will enable health policies to offset the cost of the new regulations. Doctors, meanwhile, are selling their practices to local hospitals. In 2005, doctors owned more than two-thirds of all medical practices. By next year, more than 60% of physicians will be salaried

employees. About a third of those will be working for hospitals, according to the American Medical Association. A review of the open job searches held by one of the country’s largest physicianrecruiting firms shows that nearly 50% are for jobs in hospitals, up from about 25% five years ago. Last month, a hospital I’m affiliated with outside of Manhattan sent a note to its physicians announcing a new subsidiary it’s forming to buy up local medical practices. Nearby physicians are lining up to sell—and not just primary-care doctors, but highly paid specialists like orthopedic surgeons and neurologists. Similar developments are unfolding nationwide. Consolidated practices and salaried doctors will leave fewer options for patients and longer waiting times for routine appointments. Like the insurers, physicians are responding to the economic burdens of the President’s plan in one of the few ways they’re permitted to. For physicians, the strains include higher operating costs. The Obama health plan puts expensive new mandates

on doctors, such as a requirement to purchase IT systems and keep more records. Overhead costs already consume more than 60% of the revenue generated by an average medical practice, according to a 2007 survey by the Medical Group Management Association. At the same time, reimbursement under Medicare is falling. Some specialists, such as radiologists and cardiologists, will see their Medicare payments fall by more than 10% next year. Then there’s the fact that medical malpractice premiums have risen by 10%-20% annually for specialists like surgeons, particularly in states that haven’t passed liability reform. The bottom line: Defensive business arrangements designed to blunt ObamaCare’s economic impacts will mean less patient choice. ● Dr. Gottlieb, a former official at the Centers for Medicare & Medicaid Services, is a fellow at the American Enterprise Institute and a practicing internist. He’s partner to a firm that invests in health-care companies. Reprinted with permission. © Scott Gottlieb. Originally printed in Opinion Journal. The Wall Street Journal. May 18, 2010.

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For more information about GEMZAR, please see your Lilly sales professional or visit GEMZAR.com.

TON_June 2010_FINAL_TON 6/9/10 1:58 PM Page 10

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

Oral Care Protocol May Prevent Oral Mucositis By Jill Stein

areful attention to a set of standard doses of chemotherapeutic oral care measures may help agents known to cause oral mucositis. patients avoid chemotherapyWith the oral care protocol, patients induced oral mucositis, according to were given the following instructions. new research. • Brush your teeth and tongue with Results showed that a protocol that toothpaste and a soft toothbrush provides specific instructions on the varat least twice daily. ious components of oral care can reduce • Rinse your mouth with saline the incidence and severity of mucositis (mild salt water) after every meal in patients receiving chemotherapy. As and before bed. Swish for 1 minexamples, the protocol states how often ute, and spit. patients should rinse and brush • Put mouth moisturizer their teeth and what they should on your lips whenever do if they develop mouth sores. they feel dry. “Clinical practice guidelines • If you wear dentures, recommend the implementaclean them after every tion of systematic basic oral meal. care,” said principal investigator • If you usually floss your Jennifer Hester, DNP, APRN, teeth, it is okay to conAOCNS, ACHPN, palliative tinue flossing unless you care advanced practice nurse at bleed or your nurse or Jennifer Hester, The Christ Hospital in Cindoctor tells you to stop. DNP, APRN, cinnati, Ohio. “However, when • Tell your nurse or docAOCNS, ACHPN I looked to the literature for spetor right away if you cific guidance on oral care, inbegin to feel any pain cluding which rinsing agent to use, in your mouth. frequency of brushing and rinsing, • Avoid hot or spicy foods and drinks and escalation of care, I was not able that might irritate your mouth as to find the information I needed to well as commercial mouthwashes. bring evidence-based practice to the The oral care protocol also provided bedside.” instructions for patients who develOral mucositis can lead to infection oped mouth sores. and chemotherapy dose reductions or • Brush your teeth and tongue with delays. Patients may also develop pain, toothpaste and a soft toothbrush nutritional compromise, and difficulty at least twice a day. in communicating, all of which worsen • Rinse your mouth with saline quality of life. (mild salt water) every 2 hours Hester developed an oral care protowhile you are awake and every 4 col, and she and her colleagues evaluathours during the night. Swish for 1 ed its effectiveness in patients receiving minute, and spit.

• Apply mouth moisturizer on your ly. Also, 8% of patients in the interlips whenever they feel dry. vention arm said that mouth sores kept • If you wear dentures, remove them them from eating adequately versus until your mouth heals. 30% of patients in the usual care arm. • If you usually floss your teeth, stop “Current clinical practice guidelines flossing until your mouth heals. tell patients to use bland rinses, brush • Tell your nurse or doctor right their teeth frequently, to floss, and so on away if you have trouble eating or but do not specify how often to brush, drinking. what kind of bland rinses to Twenty-five participants in use, how much salt or baking the study were assigned to folsoda they should use in the low the oral care protocol for 8 rinse, and a way to escalate if weeks, and 24 patients were they have mouth sores,” assigned to usual care. Usual Colleen Bass, BSN, a palliacare meant that patients untive care nurse at The Christ derstood the importance of Hospital, commented in an oral care, but they were not interview. provided with “specifics” as far She added that the results as how often and when to Colleen Bass, BSN of the study are promising brush their teeth and tongue and may represent the first or what to do if a mouth sore developed. step toward standardization of basic Results showed that patients in the oral care for patients receiving stanintervention group were significantly dard-dose chemotherapy. “We are more likely to brush their teeth twice excited by the results, and we believe daily, to rinse at least three times daily, that this protocol is something specific and to rinse with saline rather than harsh that nurses can easily teach and that commercial rinses than those in the patients can easily follow,” Bass said. usual care group. “And, actually all patients in our study As a result, the intervention group felt that they could take good care of had multiple clinical benefits, Hester their mouth. They just needed specifics said. Overall, 4% of patients in the inter- in order to be able to do so effectively.” vention group developed oral mucositis Besides, she noted, the regimen is defcompared with 38% of patients in the initely cost-effective. “It doesn’t cost control group. Oral mucositis was con- them anything,” Bass said. “All patients firmed by a score greater than 4 on the have to do is have the ability to make a Oral Assessment Guide, which is a wide- quart of mild salt water each day.” ly validated tool for establishing the presFinally, Bass said that future research ence of mucositis. should aim to examine how normal Mouth pain was reported in 12% saline mouthwash compares with comand 46% of the two groups, respective- mercial rinses in preventing mucositis. ●

Follow-up Phone Call Improves Patient Satisfaction after Discharge

pilot program whereby the effectiveness of disoncology nurses telecharge instructions in two phone patients shortly groups of patients. One after their hospital discharge group had recently been helps improve patient satisfacdischarged from the hostion with the discharge process pital after surgery for a and discharge instructions, ac gastrointestinal malignancording to early results. cy, and the other group Mary Ann Long, MS, RN, had been discharged after Mary Ann Long, OCN, at Roswell Park Cancer treatment for leukemia. MS, RN, OCN Institute (RPCI) in Buffalo, “Results showed that a New York, and colleagues evaluated phone call to patients within 48 hours

June 2010 I VOL 3, nO 4

of their discharge helped patients feel significantly better equipped about how to manage at home,” said Long, who is director of patient care services. In 2008, a task force was established at RPCI to identify ways to improve the discharge process. Notably, patient satisfaction scores in various surveys at her institution had exceeded 90% on all measures (including the extent to which nurses kept patients informed and the extent to which general staff respected

the patient’s privacy and addressed their emotional needs), except for discharge instructions. The surveys had found that oncology inpatients did not feel that they were prepared to be discharged and that patients did not want to care for themselves. Also, family members were not ready or willing to provide care at home for the patient. The task force developed a pilot Continued on page 12

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ALOXI provides powerful CINV prevention that can’t be ignored. ®

Help support your patients’ treatment goals. • Powerful chemotherapy-induced nausea and vomiting (CINV) prevention in the first 24 hours and up to 5 days following moderately emetogenic chemotherapy1,2 • Powerful acute CINV prevention following highly emetogenic chemotherapy3 • Can be used in multiple-day chemotherapy regimens4* • Eisai offers a variety of support programs and resources * The restriction on repeated dosing of ALOXI within a 7-day interval was removed from the label.5

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 Full Prescribing Information. References: 1. Gralla R, et al. Ann Oncol. 2003;14:1570-1577. 2. Eisenberg P, et al. Cancer. 2003;98:2473-2482. 3. Aapro MS, et al. Ann Oncol. 2006;17:1441-1449. 4. ALOXI® (palonosetron HCl) injection full prescribing information. 5. Data on file. Eisai Inc., Woodcliff Lake, NJ.

STARTS STRONG. LASTS LONG.

ALOXI® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license. Distributed and marketed by Eisai Inc. © 2010 Eisai Inc. All rights reserved. Printed in USA. ALO00036-A 05/10

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Conference News ONS

Follow-up Phone Call Improves Patient Satisfaction... Continued from page 10 project whereby a registered nurse would telephone patients 24 to 48 hours after they had been discharged from his or her unit. The calls were made by the nurse in charge on the 3 PM to 11 PM shift or his 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.

June 2010 I VOL 3, nO 4

or her designee. In addition to questions about their general health status during the postdischarge phone call, patients were asked: 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.

• If they had received information about home healthcare • If a home care nurse had taught them about line or tube care and also whether that information was 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-A 08/09

consistent with the information that they had received from oncology inpatient nurses before their discharge • If they had contact information for the inpatient oncology nurses • If they had any questions or concerns. The researchers compared patient satisfaction scores from before the initiation of the telephone calls with scores taken 1 month after the telephone call process was started. “Responses showed an improvement in all areas for both units,” she said. For example, during the time period before the intervention was implemented, 63% of gastrointestinal surgery patients said they considered themselves to be well informed about whom to call if they had difficulties at home versus 69% afterwards. The responses for leukemia patients were 59% and 63%, respectively. After the intervention, significantly more patients said they considered themselves well informed about activities of daily living including dietary restrictions, lifting and exercise recommendations, and driving restrictions. Also, significantly more patients reported that they were satisfied with the instructions and preparation they received for continuing care at home after the intervention. The investigators also documented an improvement in the extent to which patients felt that their family members (or other caregivers) were ready to provide continuing care at home. Long told The Oncology Nurse that follow-up telephone calls provided benefits to patients as well as to the nurses who completed the calls. “This ‘process’ has identified patient concerns, including constipation and confusion about pain medications or nausea, which the nurse was able to rectify by reviewing the discharge instructions, offering advice such as increasing fluid intake, or contacting the prescriber,” she said. For nurses, the telephone calls provided an opportunity to reconnect with patients to learn how they were doing. “In particular, the nurses loved hearing the comment: ‘Oh, it is so nice of you to call and check up on me.’” Finally, she said that follow-up telephone calls reaffirm the role of the oncology nurse as a liaison between the patient/family and the healthcare team in achieving optimal health. ● —JS Conference News continued on page 16

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CONTINUING EDUCATION EDITORIAL BOARD

PROGRAM TON3 • RELEASE DATE: JUNE 15, 2010 • EXPIRATION DATE: JUNE 15, 2011

Scott E. Eggener, MD

ESTIMATED TIME TO COMPLETE: 1.0 HOUR

Assistant Professor of Surgery/Urology University of Chicago Medical Center 5841 South Maryland Ave MC6038 Chicago, IL 60637

Active Surveillance as a Management Strategy for Low-risk Prostate Cancer

Gary Shelton, MSN, NP, ANP-BC, AOCNP Clinical Research Program Coordinator New York University Cancer Institute 160 East 34th Street 11th Floor New York, NY 10016

By Scott E. Eggener, MD Assistant Professor of Surgery/Urology, University of Chicago Medical Center, Chicago, Illinois STATEMENT OF NEED

With the introduction and widespread use of prostatespecific antigen screening, the number of men being diagnosed with prostate cancer has increased. Almost 50% of these cancers, however, have biological characteristics associated with a low risk of cancer progression. As a result, clinicians are interested in management strategies that offer the possibility of delaying, obviating, or minimizing the impact of treatment to avoid having patients undergo unnecessary treatment. Oncology nurses and pharmacists should be aware of the most recent data regarding one such strategy, active surveillance with selective delayed intervention, so that they may discuss it with patients diagnosed with various types of prostate cancer.

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

Anne L. Finger President 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: • Discuss active surveillance with selective delayed intervention with patients diagnosed with prostate cancer

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 Drive Monroe Twp, NJ 08831 Eileen Koutnik-Fotopoulos 77A Beers Street Keyport, NJ 07735

• Appropriately select candidates for active surveillance based on disease characteristics at diagnosis • Evaluate patient progress to determine if, and, when, treatment may be warranted

he number of American men dying of prostate cancer has decreased 30% over the past 25 years, but it remains the second leading cause of cancer death. In 2009, an estimated 192,280 new cases of prostate cancer were diagnosed and 27,360 men died of the disease.1 There is no universally accepted strategy for screening, diagnosis, and treatment of prostate cancer.2 The introduc-

tion and widespread use of prostate-specific antigen (PSA) screening, however, has led to an increasing number of men being diagnosed with prostate cancer each year. Almost 50% of these cancers have biological characteristics associated with a low risk of cancer progression.3 The challenge facing patients and physicians is accurately determining which men have cancers with a significant risk of progression or metastases whom would benefit from treatment, compared with those unlikely to be impacted by the cancer during their natural lifespan. Although radical prostatectomy (RP) and radiation therapy are effective treatments, they can result in serious long-term side effects such as urinary problems and erectile dysfunction. As a result, clinicians are interested in management strategies that offer the possibility of delaying, obviating, or minimizing the impact of treatment to avoid having patients undergo unnecessary treatment.3 One strategy is active surveillance (AS) with selective delayed intervention.3 AS involves characterizing the cancer using all available tools, determining whether the patient is a good candidate for AS, and frequently evaluating the cancer and overall health of the patient to determine if, and when, treatment may be warranted.2 Current clinical practice guidelines Because many prostate cancers detected through PSA screening may not require immediate treatment, the American Urological Association and National Comprehensive Cancer Network (NCCN) recommend that during discussion of treatment approaches for cancer clinicians include AS as an option for men with low-risk prostate cancer who have a life expectancy of less than 10 years.4,5 In addition, a new “very low risk”

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 Hours. 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 TON3 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.

June 2010 I VOL 3, nO 4

category has been added to the updated NCCN guidelines using a modification of the Epstein criteria for clinically insignificant prostate cancer (Table). AS is offered and recommended for men in this category when life expectancy is less than 20 years.5 Multicenter study examines active surveillance Studies have assessed the safety and efficacy of AS for low-risk localized prostate cancer.2,3,6 One multicenter, retrospective study evaluated the actuarial rates and predictors of remaining on AS, the incidence of disease progression, and the pathologic findings of delayed RP.3 Patient criteria Each man in a cohort of 262 men from four institutions was offered multiple options but ultimately chose AS. All patients met the following criteria for eligibility3: • 75 years of age or younger • PSA 10 ng/mL or less • Clinical stage T1 to T2a • Biopsy Gleason sum 6 or less • Three or fewer positive cores at diagnostic biopsy • No single core with >50% cancer • Repeat biopsy before AS (restaging) • No treatment for 6 months following the repeat biopsy. Patient assessment AS was defined as starting on the date of the second biopsy. Evaluation of patient progress included office visits, review of general health and urinary symptoms, digital rectal examinations, and PSA screenings every 6 to 12 months. Biopsies were routinely recommended within 18 months of starting AS and subsequently every 1 to 3 years or prompted

FINANCIAL DISCLOSURES

Veritas Institute for Medical Education, Inc. is required to disclose to the activity audience 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: • Scott E. Eggener, MD, has nothing to disclose. • Gary Shelton, MSN, NP, ANP-BC, AOCNP, has nothing to disclose. The staffs 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 by a change in clinical status, a sign of possible disease progression. Magnetic resonance imaging (MRI) of the prostate was selectively used at diagnosis and every 1 to 3 years after starting AS. In isolated cases, MRI findings warranted biopsy earlier than was scheduled. Study results Forty-three (16%) patients elected active treatment, with a median followup of 29 months. The 2- and 5-year probabilities of remaining on AS were 91% and 75%, respectively. Of the 43 patients

cryotherapy for one (2%), and androgen deprivation for three (7%). Patients with cancer on the second biopsy (hazard ratio [HR], 2.23; 95% confidence interval [CI], 1.23-4.06, P = .007) and a greater number of cancerous cores from the two biopsies combined (P = .002) were more likely to undergo treatment. Bone metastases developed in one patient 38 months after starting AS. Age, PSA, clinical stage, prostate volume, and the number of total biopsy cores were not predictive of outcome.

Early- to intermediate-term data for appropriately selected AS patients suggest metastasis rates are consistently less than 1%, with follow-ups ranging from 2 to 8 years.

undergoing delayed treatment, 41 (95%) were without disease progression at a median of 23 months following treatment. The most commonly reported reasons for stopping AS included upgrading (35%) or higher volume of cancer (16%) on surveillance biopsy or a change in patient preference (14%). The active treatment choices among the cohort were RP for 26 (61%) patients, radiation therapy for 13 (30%),

Clinical implications of AS This study demonstrates that for select patients with low-risk prostate cancer AS with judicious monitoring appears to be safe, durable, and associated with a low risk of systemic progression within the first 5 years. My colleagues and I strongly recommend a second biopsy before considering AS, because cancer detected at restaging biopsy and a higher number of cores

Table. Modified Epstein Criteria for Clinically Insignificant Prostate Cancer • Clinical stage T1c • Biopsy Gleason score ≤6 • Presence of disease in fewer than three biopsy cores • ≤50% prostate cancer involvement in any core • Prostate-specific antigen density <0.15 ng/mL/g Source: Reference 5.

with cancer are linked with a lower likelihood of remaining on AS.3 The success of any AS program relies on accurate disease characterization at diagnosis. Because this study specified strict clinical and pathologic inclusion criteria and required a second biopsy before starting AS, we were able to identify a cohort of men with a low risk of cancer progression. The rate of discontinuing AS was about 5% per year, lower than that of similar studies, largely due to the strict inclusion criteria. Furthermore, it is crucial that all men participating in an AS program be counseled on the low but real risk of potentially life-threatening cancer progression.3 Early- to intermediate-term data for appropriately selected AS patients suggest metastasis rates are consistently less than 1%, with follow-ups ranging from 2 to 8 years.2 To minimize the risk,

we strongly recommend a restaging biopsy. This proactive approach excludes up to 30% of patients considered for AS based on the initial diagnostic biopsy, minimizes the risk of Gleason grade sampling error, and predicts the likelihood of continuing on AS.3 Studies indicate that AS is used as a treatment strategy in only 10% of patients with newly diagnosed prostate cancer.2,3 Our findings as well as those from other researchers show that AS should be discussed and considered for appropriately selected patients.2,3,6 Multiple limitations of this study, however, warrant consideration. Based on the short-term follow-up of this study (median, 29 months) and of other studies (median, 22-64 months), caution should be exercised in extrapolating these findings to justify AS as a long-term Continued on page 16

COMMENTARY

Active Surveillance as a Management Strategy for Low-risk Prostate Cancer: Wouldn’t It Be Nice…! By Gary Shelton, MSN, NP, ANP-BC, AOCNP Clinical Research Program Coordinator, New York University Cancer Institute, New York

ome would debate that too many men are being diagnosed with prostate cancer, men who do not need to know that they have prostate cancer and, ultimately, are being treated for prostate cancer when they may not have needed to be treated and thus dealing with the side effects of unneeded therapies. Interestingly, for prostate cancer, an option of watchful waiting, or doing nothing after being handed the diagnosis, has been a management strategy offered to men who have been considered at low risk for problems associated with their cancer. However, men who know they have cancer, and consent to wait-

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ing, have the added issues of anxiety, worry, and stress; awaiting and fearing progression and wondering whether they made the right choice. Wouldn’t it be nice, if there could be consensus among men with prostate cancer, their friends, and families, and the healthcare community, that for select men, watchful waiting, or active surveillance (AS) is a viable treatment option? By providing a treatment strategy with built-in judicious monitoring and unambiguous eligibility criteria, all can feel more comfortable agreeing to AS and moving on—less stress and angst, for all. As stated by Eggener, the challenge is to accurately stratify those whose dis-

ease will likely be significant and to separate out those who will unlikely be impacted by their cancer and, thus, are candidates for AS. Guidelines do attempt to qualify patients who are at “very low risk” for disease impact and with whom AS should be discussed. The multicenter study examining active surveillance, discussed here, attempted to further give credence for the viability, safety, and appropriateness of AS. The outcomes stated from this study of low-risk men who opted for AS stress that, under judicious follow-up and closely monitored evaluations, AS appears to be safe and durable, with only a few men progressing to systemic

disease within the 5 years of observation. It must be noted that the men had repeat biopsies before they were allowed to agree to AS and that strict and accurate disease characteristics were documented before discussing treatment options. As with any relatively small study, how one can generalize and translate results is limited, so the results cannot be taken as universal. However, with scrutiny and close adherence to strict eligibility criteria, select cohorts of men can be appropriately offered AS, and all should feel comfortable with allowing this to be a standard of care; thus free of choice angst. Wouldn’t it be nice? ●

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CONTINUING EDUCATION Continued from page 15

Active Surveillance as a Management Strategy...

CASE STUDY

66-year-old man who had been undergoing annual prostate-specific antigen (PSA)-based prostate cancer screening had a normal digital rectal examination (DRE) but a PSA level of 6.4 ng/mL. PSA testing was repeated 1 month later and found to be 6.2 ng/mL. Prostate biopsy revealed two of 12 cores with Gleason 6 prostate cancer, encompassing 20% of each core. He had excellent sexual and urinary function. His medical history showed moderate obesity and medication-controlled hypertension. After meeting with multiple specialists and considering his options, he elected to proceed with active surveillance (AS) and, therefore, underwent a restaging 12-core biopsy. No cancer was identified and he formally entered AS. For 6 years, he underwent evaluations every 6 months without a significant change in health status, DRE, or PSA (range, 4.3-7.1 ng/mL). Surveillance biopsies performed every 12 to 18 months did not show a higher-grade or higher-volume cancer and ranged from zero to two cores with cancer. Seven years following the initiation of AS, the patient experienced a myocardial infarction, underwent the placement of two coronary stents, and was started on clopidogrel and aspirin. He continues routine surveillance of his prostate cancer with annual evaluations.

management strategy. Extended follow-up is mandatory to address this concern.3 The data in this study provide an observational experience, which will continue to provide insights into the natural history of low-risk prostate cancer, generalized rates of delayed treatment given the variable practice patterns, overall cancer-specific success rates, and causes of death.3 Whereas a strength of this study is the multi-institutional cohort, this

ONS

has also led to variations in the intensity of follow-up, diagnostic and restaging strategies, occurrence of surveillance biopsies, pathologic assessment, and indications for treatment.3 Therefore, generalizing of the findings to include other populations should be done with caution. The most common reason for stopping AS in this study was the outcome of a surveillance biopsy; in other AS studies it was patient preference or

increasing PSA alone, underscoring the variable nature of currently available series and need for prespecified study methodology.3 My view on AS is to appropriately select patients, discuss initial observation as an option, monitor frequently (based on serial prostate biopsies), and, if necessary, implement active therapy while the disease is still at a highly curable stage. Most men will not require an intervention, and those who do can

benefit from a period when quality of life and cancer-related outcomes do not appear to be compromised. ● References 1. American Cancer Society. What are the key statistics about prostate cancer? March 3, 2010. www.cancer.org/docroot/CRI/content/CRI_2_4_1 X_What_are_the_key_statistics_for_prostate_can cer_36.asp?sitearea=. Accessed March 12, 2010. 2. Large MC, Eggener SE. Active surveillance for low-risk localized prostate cancer. Oncology (Williston Park). 2009;23:974-979. 3. Eggener SE, Mueller A, Berglund RK, et al. A multi-institutional evaluation of active surveillance for low risk prostate cancer. J Urol. 2009;181:1635-1641. 4. American Urological Association. ProstateSpecific Antigen: Best Practice Statement: 2009 Update. Linthicum, MD: American Urological Association Education and Research Inc; 2009. 5. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Prostate Cancer. V.1.2010. www.nccn.org/professionals/ physician_gls/PDF/prostate.pdf. Accessed March 12, 2010. 6. Klotz L, Zhang L, Lam A, et al. Clinical results of long-term follow-up of a large, active surveillance cohort with localized prostate cancer. J Clin Oncol. 2010;28:126-131. Eileen Koutnik-Fotopoulos contributed to the preparation of this manuscript.

Continued from page 12

Oncology Nurses Play a Pivotal Role in Amyloidosis Management

lthough primary amyloidosis is rare, oncology nurses have a broad range of responsibilities in managing patients who develop this disorder, researchers said. “Oncology nurses educate patients about dietary changes that help prevent edema as well as safety measures that help prevent falls and fractures and additionally teach them which medications to avoid that may cause renal deterioration,” Noel B. Mendez, RN-BC, OCN,

hemisphere, but only approximately 3000 patients in the United States develop the disorder each year. Primary amyloidosis, which may occur in patients with multiple myeloma, is actually a plasma disorder that develops within bone marrow, he said. Bone marrow produces proteins to create protective antibodies against infection. Normally, the protein antibodies are broken down and reabsorb in the body. However in primary amy-

In primary amyloidosis, the protein antibodies are not broken down and instead accumulate in the bloodstream, migrating into multiple organs and leading to an amyloid buildup. clinical nurse in the lymphoma and myeloma inpatient unit at The University of Texas M. D. Anderson Cancer Center in Houston, pointed out. Oncology nurses also monitor cardiac, pulmonary, and renal function and manage chemotherapy-related side effects. Although primary amyloidosis is not a type of cancer, most patients are treated with chemotherapy, he said. There are three types of amyloidosis: primary, secondary, and hereditary, Mendez noted. Primary amyloidosis is the most common form in the western

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loidosis, the protein antibodies are not broken down and instead accumulate in the bloodstream, migrating into multiple organs and leading to an amyloid buildup. Diagnosis is based on clinical symptoms and tissue biopsy. Criteria have been established for determining amyloid-related major organ involvement, Mendez said. • Cardiac involvement is confirmed if an echocardiogram shows increased ventricular wall thickness and thickened valves in the ab-

sence of a history of hypertension or valvular disease. The patient with cardiac involvement also has unexplained low-voltage New York Heart Association class 2 or higher heart failure with or without ischemic heart disease. • Kidney involvement is confirmed by a 24-hour proteinuria output greater than 500 mg. • Peripheral nervous system in volvement is confirmed by the presence of orthostatic hypotension, lower extremity sensory or polyneuropathy, chronic nausea, dysgeusia, early satiety, impotence, diarrhea, or constipation. The primary goals of treatment are elimination of amyloid production in the bone marrow and control of symptoms, which usually involves chemotherapy, Mendez said. Besides chemotherapy, symptom management may also include treatment of underlying illness, such as infection and inflammation. The key responsibilities of the oncology nurse are: • Management of chemotherapy side effects, such as nausea and vomiting, infection, mucositis, pancytopenia, diarrhea and constipation, skin rash, and neuropathy • Prevention and management of graft-versus-host disease after stem

cell transplantation • Patient education about dietary changes. Oncology nurses should make recommendations about diet with particular attention to fat, protein, and salt content depending on which organs are involved • Safety promotion. Oncology nurses should instruct patients with peripheral nerve system involvement to avoid sudden movements that may cause dizziness due to orthostatic hypotension and to curb their salt intake. Because patients may also have amyloid deposits in their bones, physical therapy options should also be discussed • Pain management. Oncology nurses should assess patients routinely for pain that may occur as a result of liver and spleen enlargement. Referral to a specialized pain service or palliative care service may also be necessary • Support services. Oncology nurses should provide emotional and psychological support and should also encourage patients and their families and caregivers to ask questions. Social workers, case managers, chaplains, psychiatrists, and support groups may also be helpful. ● —JS

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NAVIGATING PATIENTS ACROSS THE CONTINUUM OF CANCER CARETM

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

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

Register Online at www.AONNonline.org/reg_2010 CURRENT MEMBERS - $295 Use your exclusive discount code AONN to register. (Save $200 dollars off full registration of $495.)

NEW MEMBERS - $335 Join AONN today when you register with discount code JOIN. (Registration includes member dues.)

NON-MEMBERS - $395 Register with discount code NAV2010 by July 16. (Save $100 dollars off full registration of $495.)

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

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

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

Co-Provided by The Institute for John Hopkins Nursing

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www.AONNonline.org JOIN TODAY $39.95 First Year Membership Member Benefits Include: • • • • •

Best Practices Continuing Education Networking Community Resources Publications

BLOGS

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

RESOURCES

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

PUBLICATIONS

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

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Conference News

Faces at the Congress 35th ANNUAL CONGRESS OF THE ONCOLOGY NURSING SOCIETY San Diego, California, May 13-16, 2010.

Gayle Kerfoot mingles with the local wildlife.

Todd Medley pals around with the AquaGuard mannequin.

Oncology nurses in certification oasis enjoy the perks of certification.

Amanda Murphy demonstrates the PhaSeal system.

Lil Brogdan applies a L’ATHENE pure-nutrient skin care treatment on Maria Lea Almario.

Marjorie Lieberman checks out the exhibit floor.

Kathi Hawes and Linda Dalton do their reading at The Oncology Nurse booth.

Dona Horst explains OncoMed’s service to Andre Metzelaars.

iPod Winner Lynn York, RN, BSN, OCN, of Dominican Hospital in Santa Cruz, CA.

Photos by James Aronovsky • For more photos go to www.TheOncologyNurse.com 20

June 2010 I VOL 3, nO 4

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Journal of Oncology

NAVIGATION & SURVIVORSHIP

™

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

www.AONNonline.org

VOL 1, NO 2

NAVIGATION TRENDS

A Conversation with Harold P. Freeman, MD, the “Pioneer of Patient Navigation” By Caroline Helwick

SUPPORTIVE CARE

Kristine Kwekkeboom, PhD, RN

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

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

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A Conversation with Harold P. Freeman, MD... Continued from cover The bottom line was that the process of becoming diagnosed and treated for cancer was more painful than the painless lump in their breasts. I began to look at their community, and invariably, these patients were black and they were poor. I soon realized these were powerful social variables that affected access to care. That’s when I decided to try to do something to help them. What first steps did you take? We set up a way to get women in Harlem screened for breast cancer so that they didn’t present with late-stage disease, and that’s when I uncovered another set of problems. Just offering free mammograms was not enough. They needed biopsies and treatment, and there were barriers to getting those too. So in 1990, I set up a free Saturday clinic that was, shall I say, “illegal,” because I did not have the authority to establish a new clinic. But the facility was empty on Saturday morning and I was the department head, so I brought in a physician, a nurse, and a clerk who told patients to bypass the admitting office and come directly to the clinic. And we began to have good results, although the hospital administration caught on and forced us to close. Well, I didn’t stop there. I went downtown, visited some corporations, and got funding. We received approval from the Health and Hospitals Corporation, which administered all public hospitals in New York City (including Harlem

Hospital). That free Saturday clinic is still operating today. So, patient navigation grew out of these early attempts to get your patients basic cancer care? Yes. But then we had trouble getting from the screening and examination stage to the next stage, which was treatment. I decided that the crux of the issue was to resolve any abnormal findings quickly. That’s when we trained lay navigators from within the Harlem community. We began to measure outcomes and saw that we reduced the time from mammography to biopsy to 14 days. This was miraculous, because these were the kinds of patients who were previously getting lost within the system and coming back with advanced disease. [Note: The pilot navigation program also compared 5-year survival rates of breast cancer patients who were and were not navigated through the system by a social worker, and demonstrated a survival advantage among patients with navigators.] I didn’t care how well educated these navigators were. I cared how sensitive they were, how well they could communicate. One had a master’s degree in mathematics, another a high school education, but I could not tell the difference in their performance with the patients. We put these navigators in the room with the physician and the patient, and they made sure patients understood everything they needed to know. They also determined whether

there were psychosocial barriers to care. Did the patient have a home? Insurance? A family care system? A way to obtain consultation with other physicians if necessary? So the principal barriers we saw in Harlem were, first, financial, that is, lack of insurance; second, communication, that is, patients did not understand their doctors; third, the complexity of the healthcare system itself, that is, the number of stops required to make it through the system; and fourth, the patients’ psychosocial issues, that is, their worries, concerns, fear, and distrust of the system. Our navigators couldn’t solve all these problems, but they offered a place to start. They helped patients get the help they needed. How did the concept of patient navigation mature from this point? Do you do anything differently now? We ultimately realized that our program was not extensive enough, that we needed “outreach” to start in the community to identify disease even sooner. We now send outreach navigators to identify patients for breast, colon, and prostate cancer screening based on age and risk profile. These navigators actually carry laptop computers that connect with our appointment system. We have found that this helps patients feel committed to screening. Patients promise to come; they feel a sense of obligation to carry through with it. But it’s not enough to make the appointment—the navigator sees that the tests are done.

And we find ways to pay for these screenings for uninsured patients. Next, we have a diagnostics navigator who takes the person from the abnormal screening through diagnosis. Then we have a treatment navigator. And we are developing a plan for a survivorship navigator. The concept is based on our belief that the entire journey of cancer should be navigated. The total journey must be kept in mind, and patient navigation can connect the various systems. As a result of these first experiments with patient navigation, were there larger issues that gained recognition? Yes. We learned that Harlem is not unique. I was not sure of this when we started, but as president of the American Cancer Society, I heard testimonials from poor people with cancer and learned that what I saw in Harlem was universal, irrespective of race. It was an eye-opener. The worst suffering was occurring everywhere among the poor and less educated. Patients all said they were met with barriers when they attempted to get through the healthcare system. They were making sacrifices, losing jobs, losing houses, losing dignity. They essentially were becoming fatalistic. And this was not fatalism that was born in them culturally and demographically, but fatalism that developed out of experience. This is not a local problem but a human problem, and it’s the one we need to solve now. Patient navigation can help. ●

QUALITY IMPROVEMENT

Nurse Navigators Increase Patient Satisfaction

©iStockphoto.com/Jacob Wackerhausen

By Karen Rosenberg

ATLANTA—Ambulatory cancer patients who have a nurse navigator are more satisfied with wait times than those who are not, according to results of a quality improvement study presented at the 16th International Conference on Cancer Nursing. Meghan Richard, MSc(A), and her colleagues at Segal Cancer Center, Jewish General Hospital, Montreal,

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Quebec, Canada, undertook a cross-sectional survey of adult ambulatory cancer patients to identify areas that patients consider priorities for change. “It is our philosophical belief that patients and family members should guide the care they are receiving,” said coinvestigator Monica Parmar, MSc(A). A total of 276 patients (49% men; median age, 62 years) responded to a

21-item patient satisfaction survey. Overall, patient satisfaction with their care was high, 89%. Consistent with previous surveys, length of time spent in the waiting room was one area of lowest satisfaction (70.9%). The other was telephone contact with someone who could answer healthcare questions (79.9%). A subset of patients who were followed by a nurse navigator were more satisfied with wait times than those who were not. “We were a little disappointed to find that time spent in the waiting room continued to be an issue despite esthetic- and systemic-based changes that we had made at the center, but we found it interesting that patients who had a nurse navigator actually had improved satisfaction with waiting times,” Parmar commented. She said that this finding has been used to request funding from the provincial government to allocate more nurse

navigators. In Quebec, she explained, patients are assigned to a nurse navigator who follows them from diagnosis to palliation. “They coordinate services, do symptom management, and provide psychosocial support.” The cancer center plans several quality improvement initiatives to increase patient satisfaction, including supporting the nurse navigator role to provide support, education, and advocacy for patients. “We need to look at system disorganization and time constraints, but really patients need support,” Parmar said. “We find that when patients are feeling more supported and connected to the care they are receiving, they perceive wait times to be less even if they have not changed fundamentally.” She added, “having a nurse navigator is quite effective in terms of increasing continuity of care, reducing the number of tests, and providing support for patients and their families.” ● www.AOnnonline.org

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POSITION PAPER

Oncology Nurses, Social Workers Play Key Roles in Patient Navigation An interview with Pam Murph, LCSW By Karen Rosenberg

he Oncology Nursing Society (ONS), Association of Oncology Social Work (AOSW), and National Association of Social Workers (NASW) recently issued a joint position statement outlining the role of oncology nursing and oncology social work in patient navigation (Oncol Nurs Forum. 2010;37:1-2). The statement resulted from work conducted during a joint ONS-AOSW think tank on patient navigation held in June 2009. Pam Murph, LSCW, co-chaired the think tank with Pamela “P.J.” Haylock, PhD, RN. In this interview, Murph discusses the work leading up to the position paper and talks about the importance of a multidisciplinary approach to patient navigation. Why was it considered necessary to hold a think tank and develop a position paper? Has there been some confusion about the respective roles of nurses and social workers in patient navigation? Yes, there has been. The think thank was actually born out of a conversation that Michele McCorkle (ONS) and I started in November 2008. We were both at a national patient navigator training session held by the American Cancer Society and we were talking about the fact that the memberships of our respective organizations, ONS and AOSW, were struggling with what navigation meant and wanted our organizations to do more to clarify it. We decided to pull together the ONS and AOSW task forces on patient navigation and hold a think tank with key people in our organizations who deal with patient navigation. We had the think-tank meeting last June. We agreed on definitions and on collaborations, but the main thing that we all agreed on is that patient navigation is a process and that patient navigation processes are an integral and necessary component of cancer care. Did you address the role of lay navigators as well as that of nurses and social workers? The lay navigator is a necessary component of patient navigation. If you look at Harold Freeman’s model, they used lay navigators in the communities they were in because they

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understood the culture and the barriers to care in those communities. We support a team approach. Nurses, social workers, and lay persons can all function together to support the needs of cancer patients and their families. I believe the most effective patient navigator programs are the ones that continue to look at barriers in the specific communities and use lay navigators with social workers and nurses in a multidisciplinary team approach, with everybody working together to address what’s happening in that specific community. Is there a need for special certification as a patient navigator and did the think tank look into that issue? It was discussed, and I think that will come in time. Some organizations already offer certification. The National Consortium of Breast Centers offers certification as a breast health navigator, and the Harold Freeman Institute offers certification in navigation, but the issue is that there’s no standard for what certification means. As the position paper states, nurses and social workers who function as navigators do so based on the scope of practice of their respective professions. If we’re going to solidify the role of patient navigation, there needs to be standards for it across all certifications.

If we’re going to solidify the role of patient navigation, there needs to be standards for it across all certifications. another component? One of the things ONS and AOSW are trying to address is how we can define the differences in our skill sets and how we can use each other’s best skills as we work as a team to serve our patients. What future developments do you foresee in patient navigation? Role identity is an issue we must address. Some people may say “If I call myself a patient navigator instead of a nurse or social worker, I’m losing my identity.” But they’re focusing on the title rather than the fact that the patient

navigation processes, the essential components of the care we provide, are part of the skill set we have been using for years and years. Patient navigation is still an emerging field and it’s huge on the national scope right now. Many things still need to happen, such as a clear definition of what navigation means and the development of core competencies, assuming we have a core curriculum. We have an opportunity to show that there are unmet needs, and we need even more people to do the work that still needs to be done. ●

QUALITY OF LIFE

Physical Needs and Quality of Life among Older Survivors By Dawn Lagrosa

Are any other joint ventures by AOSW, ONS, and NASW planned, such as yearly meetings or ongoing research or educational programs? Yes, we have planned educational programs and just completed joint workshops at our respective conferences on patient navigation; this is the first time that ONS and AOSW have done a joint workshop. We’re also looking at whether a white paper beyond the position statement is needed and at how to provide more web-based resources for our memberships and share the findings between the organizations. We’re hoping that we can be very involved in terms of what happens in the future with certification and core curricula. We hope that there will be continued work between all three organizations (AOSW, ONS, and NASW) because we’re trying to answer our members’ needs. If you think about it, nurses and social workers, everyone on the healthcare team, have been working together for a long time and we’ve done it well as a multidisciplinary team. Why should it be different now that we have

he number of physical needs experienced by older survivors moderately to strongly correlates with other aspects of cancer survivorship, according to research presented at the 16th International Conference on Cancer Nursing. Using Survey of Needs data, Maura C. Schlairet, RN, MSN, EdD, assistant professor, Valdosta State University College of Nursing, in Valdosta, Georgia, conducted secondary analyses from a convenience sample of 190 older adults via a descriptive correlational design. Five subscales of survivor needs and associated distress were assessed: 19 physical effects, 10 social issues, 10 emotional aspects, 5 spiritual issues, and 6 other issues. Fatigue (78.9%), fear of recurrence (73.2%), sleep disturbance (67.9%), balance/mobility/walking issues (64.2%), long-term effects of treatment (63.7%), and body changes (63.7%) were the most common needs expressed by study participants. The researchers found significant relationships between older adults’ physical

distress scores and seven aspects of cancer survivorship: well-being, long-term effects, stress, fear of recurrence, living with uncertainty, managing grief/loss, and managing difficult emotions. Schlairet also reported that older adults expressed interest in survivorship education, with 75% requesting education and information on physical effects common in cancer survivorship. The findings of this study of older survivors in the community cancer care settings are supported by existing literature describing the survivorship experience of older adults in a variety of cancer care settings. Schlairet noted that this study suggests that assessment of older adult cancer survivors’ experiences related to physical symptoms, a focus on symptom management, and provision of client education targeting physical effects common to the survivorship experience may allow professionals working in a variety of community cancer center contexts to respond to older adults’ unique survivorship needs. ● JuNe 2010 I VOL 1, NO 2

TON_June 2010_FINAL:TON 6/11/10 1:42 PM Page B4

Pain, Fatigue, and Sleep Disruption... Continued from cover tant professor at the University of Wisconsin School of Nursing in Madison. Kwekkeboom and her colleagues evaluated the frequency of pain, fatigue, and sleep disturbance in a secondary analysis of 560 adult cancer survivors who were drawn from the National Survey of Midlife Development in the United States-II (MIDUS-II). The

MIDUS-II survey examined behavioral, psychological, and social influences on health in nearly 5000 adults. In the secondary analysis, 260 (46%) patients reported pain, 270 (48%) described at least some fatigue, and 440 (79%) cited at least some sleep disturbance. Notably, 132 (24%) patients said that they had developed all three symptoms.

Nearly half (49%) of survivors said that they had used at least one mindbody therapy in the past 12 months for health or wellness. Mind-body therapies included prayer, relaxation/meditation, imagery, biofeedback, and hypnosis. Kwekkeboom noted that the frequency of pain and sleep disturbance in the study population exceeded figures that have been reported for cancer survivors

Journal of Oncology

NAVIGATION & SURVIVORSHIP

™

The Official Journal of the Academy of Oncology Nurse Navigators ®

Author Guidelines Manuscripts submitted to the Journal of Oncology Navigation & Survivorship (JONS) must be original and must not have been published previously, either in print or in electronic form. Manuscripts cannot be submitted elsewhere while under consideration by JONS.

Double space the entire manuscript and number pages consecutively.

To be considered for publication, manuscripts must adhere to the format described in this document. All manuscripts are subject to peer review, and acceptance is based on that review. If accepted, authors will be notified of any recommended revisions, and a revised manuscript should be resubmitted in its entirety, with all changes made.

Images must be saved as individual files, at high resolution (300 dpi), as jpg. Attach an individual file for each image. A copy may be included in the article but cannot substitute for an electronic image file. Images not saved appropriately will delay the peer-review process significantly. For help with images, please contact editorial@greenhillhc.com.

Routine editorial changes will be made to conform to house style, following the AMA Manual of Style, 10th ed. (New York, NY: Oxford University Press; 2007). The edited manuscript is sent to the author for a final review and approval. Time from submission to publication is generally 3 to 5 months. COPYRIGHT/DISCLOSURE Authors are required to sign a Copyright Transfer Form, assigning all copyrights to Green Hill Healthcare Communications, LLC, publisher of JONS, as well as a Financial Disclosure Form. Authors are required to disclose any financial interests—direct or indirect—and any affiliations or involvement (competitive or amiable) with organizations that have a financial interest in the subject matter or materials discussed in the manuscript. PERMISSIONS Authors must secure written permission to reuse or adapt any table or figure from a previously published (online or in print) article or from any source. Provide the letter of permission when submitting the manuscript, or indicate that permission will be provided, and cite the original source with the graphic element in the manuscript. MANUSCRIPT FORMAT Title page: Include a proper title for the article and list the names, titles, and affiliations of all authors. Also list the name, address, telephone number, and e-mail address of the corresponding author. Abstract: Provide a 150- to 250-word abstract that describes the main objectives of the article and why this article is important or what it adds to the literature. Conclusion: The conclusion should add comments that offer the rationale for the article and what the article adds to the literature.

Tables and figures must be cited in the text, but the actual graphics must then be placed at the end of the article. Length: 2500-3000 words, plus tables and figures.

AUTHORS Provide all authors’ highest academic degree and all professional affiliations. Also provide the name, address, telephone number, e-mail, and fax of the corresponding author. If possible, please provide a headshot of the lead author. REFERENCES Cite references consecutively in the text (as superscript numbers), then place each complete reference at the end of the article under heading “References.” Use proper citation format according to the AMA Manual of Style. See examples below. Use the most upto-date, post-1990 references, citing primary sources only. Try to limit the number of references to about 30. Do not use automatic numbering or footnote/endnote features. Reference examples: 1. Peters JL, Sutton AJ, Jones DR, et al. Comparison of two methods to detect publication bias in meta-analysis. JAMA. 2006;295:676-680. 2. McGrath JJ, Murray RM. Risk factors for schizophrenia: from conception to birth. In: Hirsch SR, Weinberger DR, eds. Schizophrenia. Oxford, England: Blackwell Press; 2003. 3. Waters R, Pettypiece S. Drug sales in the US grow at slower pace as generic use surges. Bloomberg news, March 12, 2008. www.bloomberg.com/apps/news?pid=newsarchive&sid= aLfUw7_sYMRY. Accessed March 13, 2008. HOW TO SUBMIT MANUSCRIPTS Save the entire manuscript as a Word file and attach individual files for each image. Save images individually as an image file (jpg). Digital graphics must be saved at a high resolution of at least 300 dpi. Submit the manuscript to editorial@greenhillhc. com. For assistance with the submission, call 732-992-1890. REPRINTS Reprints may be ordered at a nominal fee by contacting editorial@greenhillhc.com.

in a large, ongoing survey of roughly 40,000 American households known as the National Health Interview Survey (NHIS) as well as in the general public. “The discrepancy,” she said, “may be related to differences in how the two surveys worded their questions or in the ‘cutoff’ used to indicate symptom frequency, that is, at least sometimes versus regularly.” The present study also revealed that greater use of mind-body therapies was associated with higher control belief, which, in turn, was associated with fewer complaints of pain, fatigue, and sleep disturbance. “In other words, the more mind-body therapies a patient used, the more control he/she perceived, and the less pain, fatigue, and sleep disturbance he/she experienced,” Kwekkeboom said.

Greater use of mind-body therapies was associated with higher control belief, which, in turn, was associated with fewer complaints of pain, fatigue, and sleep disturbance. An especially interesting finding was that the most frequently used mindbody therapies were prayer and relaxation/distraction, “which are easily learned in lay settings (from friends, in magazines, etc),” she pointed out. “Patients using these therapies may not be fully aware of their therapeutic potential, and they may obtain more benefit through additional training from a clinician or therapist who can explain how these treatments are thought to influence the symptom experience.” Finally, the Wisconsin investigator cautioned that the use of cross-sectional data from a secondary analysis is a study limitation and added that a prospective study is needed to definitively determine the frequency of the pain, fatigue, and sleep disturbance symptom cluster in cancer survivors and better define the impact of mindbody therapies in this population. ●

Did You Know? The average oncology nurse navigator salary for job postings nationwide is $59,000, 9% lower than average salaries for all job postings nationwide. Source: indeed.com

June 2010 I VOL 1, nO 2

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TON_June 2010_FINAL_TON 6/9/10 2:00 PM Page 21

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

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

First and only FDA approved treatment for anthracycline extravasation. Supplied as a convenient and accessible complete three day treatment kit for single patient use, which should be proactively stocked on-site and infused as soon as possible and within 6 hours of an anthracycline extravasation. Demonstrates 98% overall eﬃcacy based on two biopsy-confirmed clinical trials1,2 in reducing or avoiding surgical intervention (i.e., surgical debridement, plastic surgery and their related costs), thereby reducing postponement of a patient’s chemotherapy treatments and the avoidance of long-term consequences. Cited in nursing guidelines3,4 and oncology safety standards5.

For more information, call 866-478-8274 or visit our website at www.totect.com To order Totect®, contact one of our authorized distributors. ASD Healthcare Cardinal Specialty McKesson/OTN Oncology Supply US Oncology (800) 746-6273 (866) 677-4844 (800) 482-6700 (800) 633-7555 (888) 987-6679 1

Mouridsen HT et al. Treatment of anthracycline extravasation with savene (dexrazoxane). Results from two prospective clinical multicentre studies. Ann Oncol 2007; 18:546-550. 2 Totect® package insert. 3 Polovich M, White JM, Olsen, M (eds.). Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (ed 3). Pittsburgh, PA, Oncology Nursing Society, 2009. 4 Alexander M, Corrigan A, Gorski L, Hankins J, Perucca R. (eds). Infusion Nurses Society Infusion Nursing an Evidence-Based Approach (ed 3). Boston, MA, Infusion Nurses Society, 2009. 5 Jacobsen J., et al. American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards. Oncology Nursing Forum, 2009; 36:651-658. © 2010 TopoTarget USA. All rights reserved. TOT0112/4-10 Totect and its logo mark are registered trademarks of TopoTarget A/S

TON_June 2010_FINAL_TON 6/9/10 2:00 PM Page 22

Totect® – Brief prescribing information Please refer to the package insert for full prescribing information. Each Totect carton contains 10 vials of Totect® (dexrazoxane for injection) 500 mg and 10 vials of 50 mL diluent. Indication: Treatment of extravasation resulting from IV anthracycline chemotherapy. Dosage and administration: Totect is a cytotoxic drug. Vial contents must be mixed and diluted before use. Totect should not be mixed or administered with any other drug during the infusion. Administration of Totect should begin as soon as possible and within 6 hours following the anthracycline extravasation. Totect should be given as an intravenous (IV) infusion once daily for 3 consecutive days. The dose of Totect is based on the patient’s body surface area: day one, 1000 mg/m2; day two, 1000 mg/m2; day three, 500 mg/m2. For patients with a body surface area of > 2 m2, a dose of 2000 mg should be given on days 1 and 2, and a dose of 1000 mg should be given on day 3. Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the first day. The Totect dose should be reduced 50% for patients with creatinine clearance values of <40 mL/minute. Cooling procedures such as ice packs should be removed from the affected area at least 15 minutes prior to Totect administration. Totect (dexrazoxane for injection) must be reconstituted with diluent supplied in the carton. The patient’s Totect dose is diluted in 0.9% 1000 mL NaCl prior to administration. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.3-5 Direct contact of Totect® with the skin or mucous membranes prior to and following reconstitution should be avoided. If contact occurs, wash immediately and thoroughly with water. Contraindications: None. Warnings and Precautions: Myelosuppression: treatment with Totect is associated with leukopenia, neutropenia, and thrombocytopenia. Hematological monitoring should be performed. Use in Pregnancy: Pregnancy Category D. Totect can cause fetal harm when administered to a pregnant woman. There is no adequate information about the use of Totect in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Adverse reactions: The most common adverse reactions (≥ 16%) are nausea, pyrexia, injection site pain and vomiting.

www.totect.com

Rx only

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

Drug Interactions: No drug interactions have been identified. Based on anecdotal reports concurrent use of topical dimethyl sulfoxide (DMSO) at the site of tissue injury may reduce the benefit of Totect. Additionally, nonclinical studies using a mouse model that simulates extravasation of anthracyclines has shown that concomitant treatment with topical DMSO decreases the efficacy of systemic dexrazoxane. Use in Specific Populations: Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of drug to the mother. Renal Impairment: Reduce the Totect dose by 50% In patients with creatinine clearance values <40 mL/min. Pediatric Use: The safety and effectiveness of Totect in pediatric patients have not been established. Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Overdosage: There are no data on overdosage. There is no known antidote for dexrazoxane. Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of dexrazoxane has not been investigated. Nevertheless, a study by the National Cancer Institute has reported that long term dosing with razoxane (the racemic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malignancies in rats and possibly in mice. Dexrazoxane was not mutagenic to bacteria in vitro (Ames assay), but caused significant chromosomal aberrations in mammalian cells in vitro. It also increased the formation of micronucleated polychromatic erythrocytes in mice. Thus, dexrazoxane is mutagenic and clastogenic. The possible adverse effects of Totect on the fertility of humans and experimental animals, male or female, have not been adequately studied. Testicular atrophy was seen with dexrazoxane administration at doses as low as 30 mg/kg weekly for 6 weeks in rats (about 1/5 the human dose on a mg/m2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs (about half the human dose on a mg/m2 basis).

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

Manufactured for: TopoTarget A/S Symbion Science Park Fruebjergvej 3 DK-2100 Copenhagen Denmark

TON_June 2010_FINAL_TON 6/15/10 9:52 AM Page 23

Safe Handling

Increasing Compliance with Safe Handling Guidelines: One Cancer Center’s Experience By Karen Rosenberg

pril 2010 was the second National Safe Handling Month, a campaign designed to further education about the risks associated with handling hazardous drugs and safety measures that can prevent exposure to these agents. The initiative was supported by an unrestricted educational grant provided by Carmel Pharma, Inc, the maker of the PhaSeal closed-system drug transfer device (CSTD), and included regional and national educational activities. The Oncology Nurse recently spoke with oncology nurse Shannon Hazen, RN, BSN, OCN, about efforts to increase awareness and compliance

with safety standards in her own institution and their experience with implementing a CSTD. Hazen is the regional oncology education coordinator at Presbyterian Cancer Center, Charlotte, North Carolina. Are there gaps in compliance with safe handling guidelines issued by the Oncology Nursing Society (ONS), the National Institute for Occupational Safety and Health, and other groups? There are lots of gaps in compliance. In certain facilities, they may not have a champion who is seeking to put these guidelines in place. We have a habit of

Before the research is published…

Before the guideline is issued…

Before the drug is approved……

You read it first in

www.TheOncologyNurse.com www.TheOncologyNurse.com

just doing what we have always dence-based model. We were done if there is not a champion looking for a product that in place to make sure we are could demonstrate its efficacy following the guidelines to the through evidence. Our best letter and, if there are new practices team included repupdates, to make sure we have resentatives from the three updated our practice as well. facilities and had nursing and Across the country, there are pharmacy representation. We still people who have had that also asked for input from corShannon Hazen, “a-ha moment” during safe porate colleagues in our facilRN, BSN, OCN handling education when they ity and elsewhere about their realized there was so much experiences with these systhey didn’t know and that there is room tems. We chose the PhaSeal product for improvement in their practice. because we were very impressed with the data the manufacturer presented to What led to the decision to imple- us from unbiased studies showing that ment a CSTD in your institution? it was truly a closed system (Wick C, et At Presbyterian Cancer Center, al. Am J Health Syst Pharm. 2003; 60: which is part of Novant Health, we 2314-2320). have a primary cancer center in downtown Charlotte and two community How did you go about implementing hospitals with oncology services. As the the device? service line grew in the community hosWe had done upfront education pitals, we saw the need to get everyone about safe handling, and everyone on the same page and make sure that understood that a CSTD was the next the education and practices were the piece. Once we decided to implement same in all places. About 4 years ago, we the system, we did a lot of staff training. began a superenforcement campaign We got demo kits and went to the difand did a lot of education about the use ferent nursing units and had them come of personal protective equipment and up with questions for the company what the recommendations were for trainers, thinking of scenarios where handling chemotherapy. We observed they might have issues. We did this practice in different units and did spot before trainers from the company came checks to make sure they were comply- so we could maximize our time with ing with safe handling recommenda- them. We organized our training very tions. The other educator and I who specifically so that everyone got training worked on this were dubbed “the chemo from the official trainer from the manucops” because we called people on vari- facturer, including clinical coordinators ations in practice that were not compli- and people who worked night and weekant with what our policy said was best end shifts. We also established “supepractice. For about 1 year, we did a lot of rusers” to help train staff. We had a realintensive monitoring, educating, and ly good response from staff. tracking to create a safety culture Before we implemented the system, change in our oncology areas. Our staff we had wipe studies done in pharmacy is also required to attend the ONS and nursing areas, and they demonstratchemotherapy and biotherapy course. ed some contamination. After impleThe next step was to implement a mentation, pharmacy areas showed draCSTD. When nurses are knowledgeable matic improvements. about safe handling, they begin to ask The nursing staff has expressed apprefor evidence-based practice changes, ciation that the administration was willlike using a CSTD. ing to support the product, and they say We have a best practices team in they feel much safer because they were place that looks at chemotherapy issues. trained properly in how to use it. We We had relationships with a number of really did change the culture in areas vendors, and we got permission from that administer chemotherapy. ● our materials management department to compare different products to decide For more information on safe handling of which would work best for us. hazardous drugs, please view the archived The goal of the best practice team Safe Handling Awareness Day CE webinar at was to make an evidence-based pracwww.carmelpharmausa.com/CE. Free CE tice change to improve saftey. Novant credit for this archived webinar is available Presbyterian Hospitals have achieved for pharmacists, pharmacy technicians, Magnet designation, and decision nurses, and risk managers. making has moved toward the evi-

JuNe 2010 I VOL 3, NO 4

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Psychosocial Issues

Most Oncology Nurses Unfamiliar with IOM Report on Caring for the Whole Patient By Caroline Helwick NEW ORLEANS—A 2007 report by the Institute of Medicine (IOM) concluded that psychosocial issues created

or exacerbated by cancer are “palpable, important, and potentially crippling” but can be effectively addressed by serv-

ices and interventions. The report, Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs, also

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acknowledged that appropriate psychosocial care is the “exception rather than the rule in cancer care today,” and a study by the Oncology Nursing Society (ONS) bore this out. The ONS research, presented at the annual meeting of the American Psychosocial Oncology Society, found that almost two thirds of oncology nurses were unfamiliar with the IOM report and its recommendations (Table 1), according to Tracy Gosselin, RN, MSN, AOCN, director of oncology services at Duke University Hospital, Durham, North Carolina. “Although nurses may assess patients’ needs, multiple barriers pertaining to individuals and institutions still exist related to communication, knowledge of IOM recommendations, and resources,” Gosselin said. “These barriers may impair their ability to provide the necessary psychosocial care to patients and their families.” The web-based survey was developed by the ONS Psychosocial Project and the ONS Research Team. Questions were aligned with recommendations from the IOM report. The 34-item survey was pilot-tested on 76 ONS members, more than half of whom had a master’s degree in nursing and were advanced practice nurses. The pool of candidates has since been expanded to 400 nurses, but the presentation was based on the 76 in the pilot study. Seventy-one percent were aged 45 to 59 years, 97% worked with adults, 56% worked in the outpatient setting, 31%

Table 1. Institute of Medicine’s Standard of Care for Meeting Psychosocial Health Needs All cancer care should ensure the provision of appropriate psychosocial health services by: • Facilitating effective communication between patients and care providers

For insurance verification…prior authorization…patient assistance program information…and billing and claims processing support. Amgen Assist™ and Amgen Inc. do not guarantee success in obtaining reimbursement. Third party payment for medical products and services is affected by numerous factors, not all of which can be anticipated or resolved by our Amgen Assist™ staff. ©Amgen. All rights reserved. MC48319 11/09

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• Identifying each patient’s psychosocial health needs • Designing and implementing a plan that links the patient with needed psychosocial services, coordinates biomedical and psychosocial care, and engages and supports patients in managing their illness and health • Systematically following up on, reevaluating, and adjusting plans Continued on page 36

June 2010 I VOL 3, nO 4

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

Medications Used for the Treatment of Lung Cancer Lung cancer forms in tissues of the lung, usually in the cells lining the air passages. The two main types are small-cell lung cancer and non– small-cell lung cancer. The following section will assist healthcare professionals and payers by providing appropriate coding, billing, and reimbursement information associated with the management of lung cancer. The following sections include: • Associated ICD-9-CM codes used for the classification of lung cancer • Drugs that have been FDA-approved in the treatment of lung cancer • Drugs that are compendia listed for off-label use for lung cancer based on clinical studies that suggest beneficial use in some cases. Please note: if a check mark appears in the FDA column, it will NOT appear in the compendia off-label use column • Corresponding HCPCS/CPT codes and code descriptions • Current Code Price (AWP-based pricing) • Most recent ASP plus 6% (Medicare allowable), if applicable • Possible CPT Administration Codes for each medication

generic (Brand) name

HCPCS code: code description

amifostine (Ethyol) bevacizumab (Avastin) carboplatin (Paraplatin) cetuximab (Erbitux) cisplatin (Platinol AQ) cisplatin (Platinol AQ) cyclophosphamide (Cytoxan) cyclophosphamide (Cytoxan)

J0207: injection, amifostine, 500mg J9035: injection, bevacizumab, 10 mg J9045: injection, carboplatin, 50 mg J9055: injection, cetuximab, 10 mg J9060: cisplatin, powder or solution, per 10 mg J9062: cisplatin, 50 mg

cyclophosphamide (Cytoxan)

J8530: cyclophosphamide, oral, 25 mg J9070: cyclophosphamide, 100 mg (All 100 mg NDCs inactive—500 mg NDCs used to calculate code price) J9080: cyclophosphamide, 200 mg (All 200 mg NDCs inactive—500 mg NDCs used to calculate code price) J9090: cyclophosphamide, 500 mg

Associated ICD-9-CM Codes Used for Lung Cancer 162 Malignant neoplasm of trachea, bronchus, and lung 162.0 Trachea Cartilage of trachea Mucosa of trachea 162.2 Main bronchus Carina Hilus of lung 162.3 Upper lobe, bronchus or lung 162.4 Middle lobe, bronchus or lung 162.5 Lower lobe, bronchus or lung 162.8 Other parts of bronchus or lung Malignant neoplasm of contiguous or overlapping sites of bronchus or lung whose point of origin cannot be determined 162.9 Bronchus and lung, unspecified

FDAapproved for lung cancer

Compendia listed off-label use for lung cancera

✓

Current code price (AWP-based pricing), effective 6/1/10

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

CPT administration codes

$564.95

$327.96

$66.99

$57.57

✓

$48.55

$5.31

✓

$57.60

$49.73

✓

$4.33

$1.98

96409, 96413, 96415

✓

$21.66

$9.91

96409, 96413, 96415

✓

$2.09

$0.84

✓

$10.57

$4.35

96409, 96413, 96415

✓

$21.15

$8.69

96409, 96413, 96415

✓

$52.87

$21.73

96409, 96413, 96415

✓

96374 96413, 96415 96409, 96413, 96415 96413, 96415

N/A

Continued on page 26 www.TheOncologyNurse.com

JuNe 2010 I VOL 3, NO 4

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems Continued from page 25

generic (Brand) name

HCPCS code: code description

cyclophosphamide (Cytoxan) cyclophosphamide (Cytoxan) docetaxel (Taxotere) doxorubicin HCl (Adriamycin) erlotinib (Tarceva)

J9091: cyclophosphamide, 1.0 gram J9092: cyclophosphamide, 2.0 gram J9171: injection, docetaxel, 1 mg J9000: injection, doxorubicin hydrochloride, 10 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified J8560: etoposide, oral, 50 mg J9181: injection, etoposide, 10 mg J8565: gefitinib, oral, 250 mg J9201: injection, gemcitabine hydrochloride, 200 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0176: hydroxyurea, oral, 500 mg

etoposide (Vepesid) etoposide (Toposar) gefitinib (Iressa) gemcitabine (Gemzar) hydroxyurea (Hydrea) hydroxyurea (Hydrea) ifosfamide (Ifex) irinotecan (Camptosar) mechlorethamine HCl (Mustargen)

J9208: injection, ifosfamide, 1 gram J9206: injection, irinotecan, 20 mg J9230: injection, mechlorethamine hydrochloride (nitrogen mustard), 10 mg methotrexate J8610: methotrexate, oral, 2.5 mg methotrexate sodium J9250: methotrexate sodium, 5 mg methotrexate sodium J9260: methotrexate sodium, 50 mg mitomycin J9280: mitomycin, (Mutamycin) 5 mg mitomycin J9290: mitomycin, (Mutamycin) 20 mg mitomycin J9291: mitomycin, (Mutamycin) 40 mg paclitaxel J9265: injection, (Taxol) paclitaxel, 30 mg paclitaxel J9264: injection, protein-bound paclitaxel protein-bound particles particles, 1 mg (Abraxane) panitumumab J9303: injection, (Vectibix) panitumumab, 10 mg

June 2010 I VOL 3, nO 4

FDAapproved for lung cancer

Compendia listed off-label use for lung cancera

Current code price (AWP-based pricing), effective 6/1/10

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

CPT administration codes

✓

$95.21

$43.46

96409, 96413, 96415

✓

$171.35

$86.92

96409, 96413, 96415

✓

$23.87

$17.85

96413

✓

$13.20

$3.04

96409

✓

N/A

✓

NDC level pricing $47.64

$28.26

N/A

✓

$0.53

$0.49

✓

$68.08

✓

$173.83

✓

none reported $145.10

96413, 96415 N/A 96413

✓

NDC level pricing $1.28

✓

$56.40

NDC level pricing S0176 not payable by Medicare $30.76

✓

$31.50

$9.15

✓

$178.71

$154.50

96409

✓

$3.61

$0.16

N/A

✓

$0.29

$0.21

✓

$2.86

$2.10

✓

$67.20

$20.36

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

✓

$218.40

$81.43

96409

✓

$300.00

$162.87

96409

$16.50

$11.46

✓

$11.20

$9.43

✓

$101.85

$87.23

✓

N/A

96413, 96415 96413, 96415

96413, 96415 96413

96413, 96415

www.TheOncologynurse.com

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

generic (Brand) name

HCPCS code: code description

pemetrexed (Alimta) porfimer sodium (Photofrin) procarbazine (Matulane)

J9305: injection, pemetrexed, 10 mg J9600: injection, porfimer sodium, 75 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0182: procarbazine HCl, oral, 50 mg

procarbazine (Matulane) tamoxifen (Nolvadex) tamoxifen (Nolvadex) teniposide (Vumon) topotecan (Hycamtin) topotecan (Hycamtin) trastuzumab (Herceptin) vinBLAStine vinCRIStine (Vincasar) vinCRIStine (Vincasar) vinCRIStine (Vincasar) vinorelbine tartrate (Navelbine) a

FDAapproved for lung cancer

Compendia listed off-label use for lung cancera

Current code price (AWP-based pricing), effective 6/1/10

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

CPT administration codes

✓

$60.67

$50.63

96409

✓

$3,317.04

$2,934.28

96409

✓

N/A

J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0187: tamoxifen citrate, oral, 10 mg

✓

NDC level pricing $1.89

Q2017: injection, teniposide, 50 mg J8705: topotecan, oral, 0.25 mg J9350: injection topotecan, 4 mg J9355: injection, trastuzumab, 10 mg J9360: injection, vinblastine sulfate, 1 mg J9370: vincristine sulfate, 1 mg J9375: vincristine sulfate, 2 mg J9380: vincristine sulfate, 5 mg J9390: injection, vinorelbine tartrate, per 10 mg

✓

$376.55

NDC level pricing S0182 not payable by Medicare NDC level pricing S0187 not payable by Medicare $324.55

✓

$89.73

$74.66

N/A

✓

$1,306.10

$1,058.90

96413

✓

$78.26

$66.42

✓

$3.18

$1.02

96409

✓

$7.22

$4.31

96409

✓

$14.44

$8.62

96409

✓

$36.10

$21.54

96409

$42.60

$10.05

96409

✓

NDC level pricing $55.68

N/A

96413, 96415

Compendia references available upon request.

When billing a non-classified medication using a CMS 1500 claim form you must include both the HCPCS code (ie, J8999 for Tarceva) 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 • Current Procedural Terminology (CPT) 2010 • ICD-9-CM for Professionals Volumes 1 & 2 2010 • The Drug Reimbursement Coding and Pricing Guide by RJ Health Systems International, LLC, Volume 7, Number 2, 2nd Quarter 2010 • FDA-approved indication (from product’s prescribing information) • National Cancer Institute® • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Wethersfield, Connecticut • CMS (Centers for Medicare and Medicaid Services)—Medicare Allowable 2nd Quarter 2010 (effective dates 4/1/106/30/10). Prices listed herein are effective as of June 1, 2010. ASP indicates average sales price; AWP, average wholesale price; CMS, Centers for Medicare & Medicaid Services; CPT, Current Procedural Terminology; FDA, US Food and Drug Administration; HCPCS, Healthcare Common Procedure Coding System; NDC, National Drug Code.

This information was supplied by:

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

www.TheOncologyNurse.com

JuNe 2010 I VOL 3, NO 4

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Supportive Care

Anemia Management Using Erythropoiesisstimulating Agents and Iron Therapy: Development and Implementation of an Evidence-based Learning Needs Assessment By Melissa Grimm, RN, CNS Mercy Medical Center Canton, Ohio

Kathryn Spiegel, RN, PhD Watson Laboratories, Inc Morristown, New Jersey

Table. Iron Indices in Screened Anemic Cancer Patientsa

Patients with TSAT <20%

Ferritin <100 ng/mL

Ferritin ≥100 ng/mL

Total

13% (absolute iron deficiency)

46% (functional iron deficiency)

59% (both)

TSAT indicates transferrin saturation. a

Data collected from 260 screened anemic cancer patients prior to the start of a chemotherapy cycle.

Source: Reference 12.

Jo Sclafani, PharmD Watson Laboratories, Inc Morristown, New Jersey

dvance practice nurses play a critical role in the assessment and management of patients with chemotherapy-induced anemia. Although the use of erythropoiesis-stimulating agents (ESAs) has been very effective in treating chemotherapyinduced anemia, approximately 30% to 50% of cancer patients receiving ESAs do not achieve a clinically meaningful hematologic response.1 Recent prospective, controlled trials have demonstrated the benefits and marked synergy of the addition of intravenous (IV) iron supplementation to ESA therapy in patients with documented iron deficiency and chemotherapy-induced anemia.2-5 The 2001 Medicare data show that measured iron parameters and the use of IV iron supplementation both increased significantly in nephrology patients over the previous decade. In oncology, however, the approach to identifying and treating iron deficiency is far less evolved. In fact, the same 2001 Medicare data show that the use of IV iron remained stagnant, and obtaining iron parameters regressed considerably in oncology patients.6 In response to these reported discrepancies, a Learning Needs Assessment was developed to assess the knowledge of oncology and nephrology nurses re garding iron indices and treatment of iron-deficiency anemia to identify potential barriers to anemia management in current oncology practices. Learning Needs Assessment The Learning Needs Assessment was conducted by administering an Iron Knowledge Nursing Questionnaire to evaluate several aspects of the practices of both nephrology and oncology nurses who identify and manage patients with iron-deficiency anemia. The ques-

June 2010 I VOL 3, nO 4

tionnaire assessed education background and work setting, laboratory markers utilized to determine iron status, treatment of anemia and iron deficiency, and challenges associated with IV iron administration. Nephrology nurses were used as a comparator, because nephrology practices have extensive experience managing anemia, especially using IV iron in conjunction with ESA therapy.7 Survey data were collected from 165 nurses attending Oncology Nursing Society (n = 85) and American Nephrology Nursing Association (n = 80) chapter meetings. Iron Knowledge Nursing Questionnaires were distributed at these meetings between June 2007 and June 2008. Data are reported as the number and percent of respondents selecting each answer. Survey results The survey results show the largest disparity between oncology and nephrology nurses in the following areas: • Understanding and appropriate use of iron indices to assess iron deficiency, including interpreting laboratory values for functional and absolute iron deficiency • Use of IV versus oral iron supplementation in conjunction with ESA therapy for iron-deficiency anemia • Perception of safety and administration challenges with the use of IV iron. Oncology nurses most commonly report and assess iron deficiency using serum ferritin, total iron-binding capacity (TIBC), and/or serum iron. However, less than 50% of the oncology nurses correctly defined these measurements. Nephrology nurses most commonly report and assess iron deficiency using transferrin saturation (TSAT) and serum ferritin, and they had a greater ability to correctly define these terms (Figure 1). Approximately one third of

oncology nurses reported that iron studies are ordered before ESA therapy, whereas nephrology nurses generally order iron studies on admission and monthly thereafter. Treatment interventions differ among the practices of oncology and nephrology nurses. About 47% of oncology nurses reported that their anemic, ESA-treated patients receive oral iron or no iron supplementation at all. Only 18% reported that their patients are treated with the addition of IV iron therapy only. This is in contrast to nephrology nurses; 79% reported that treatment for anemic, ESA-treated patients is with IV iron only (Figure 2). When iron deficiency is diagnosed, the most commonly prescribed treatment for cancer patients is oral iron (54% of oncology nurse respondents), whereas IV iron is frequently ordered for nephrology patients (91% of nephrology nurse respondents). Approximately 87% of nephrology nurses versus 20% of oncology nurses treat functional iron deficiency with ESA and IV iron therapy combined. Oncology nurses are more likely to use ESA therapy alone (35%) or ESA plus oral iron therapy (31%). The perception of the challenges surrounding IV iron use differs between nephrology and oncology nurses. In oncology, adverse reactions and administration of IV iron were reported as the biggest concerns (54% and 40%, respectively). Nephrology nurses reported iron markers and guidelines as the biggest challenges to using IV iron therapy. The results from this survey demonstrate a significant need for oncology nursing educational programs. To optimize the care of oncology patients, it is crucial that educational programs focus on the following areas: • Anemia assessment with laboratory values and iron indices • Anemia management with emphasis on the clinical advantages of IV iron in cancer patients

• Anemia treatment monitoring in accordance with current practice guidelines for timely evaluation of iron studies. Iron indices A strong working knowledge of iron indices is essential in the proper assessment and subsequent treatment of irondeficiency anemia. The survey results showed that less than half of the oncology nurses surveyed could properly define iron laboratory terms. TSAT and serum ferritin are commonly used iron indices to assess anemic patients. However, recognizing their limitations is essential in understanding the clinical status of a patient. Iron exists in the body either in storage or as a labile form, ready to be used in the production of red blood cells (RBCs). Transferrin is an iron transport protein, which brings iron from its stored areas in the reticuloenthothelial system (RES) to the bone marrow to be available for incorporation into RBCs. TIBC describes how much transferrin is available to which iron can bind. TSAT represents functional iron, estimating how saturated transferrin is with iron. TSAT levels provide clinicians with an idea of how much iron is readily available to the bone marrow for erythropoiesis. It is calculated using serum iron levels and TIBC ([serum iron divided by TIBC] ¥ 100). Serum ferritin is used as an indirect marker of iron stores. Tissue ferritin is the major iron-storage protein found primarily in the RES. Tissue ferritin is a protein shell made of polypeptide units surrounding an iron core. It acts as part of the mechanism to regulate iron status by storing iron in the RES when too much iron exists in the blood or releasing iron into the blood when iron deficiency occurs. When iron binds to tissue ferritin to be stored, serum ferritin is released into the plasma. Although the relationContinued on page 30

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TON_June 2010_FINAL_TON 6/9/10 2:00 PM Page 30

Supportive Care Anemia Management Using Erythropoiesis-stimulating Agents... Continued from page 28

Transferrin

Total iron-binding capacity

Serum Ferritin

Absolute iron Deficiency

Functional iron Deficiency

Figure 1. Knowledge of respondents about the definitions of terms used in the detection and assessment of iron-deficiency anemia.

Oral iron only

IV iron only

Figure 2. Use of iron supplement in addition to ESA therapy. Comparison of oncology nurses to nephrology nurses. ship of iron stores and tissue ferritin is well defined, the relationship of serum ferritin and iron status is not as clear. The small quantities of ferritin found in the serum do not play a role in the storage of iron. Unlike tissue ferritin, serum ferritin contains little to no iron, making it a less than perfect indicator of iron stores.8-10 The key to proper interpretation of iron indices is understanding the role of inflammation and ESA therapy itself. Inflammatory cytokines, which can be chronically present in malignancy and other chronic diseases such as kidney disease, alter the production of transferrin and serum ferritin.8 Serum ferritin reflects iron in storage. In the presence of inflammation, however, serum ferritin levels can be elevated, requiring a review of the overall clinical picture of the patient to determine if the elevated ferritin level reflects high storage levels or inflammation.11 Low serum ferritin (<100 ng/mL) is indicative of absolute iron deficiency

June 2010 I VOL 3, nO 4

or depleted iron stores. However, the impact of inflammation on ferritin can often be seen in functional iron deficiency, in which TSAT is low (<20%) but serum ferritin is elevated (>100 ng/dL). Oftentimes, IV iron is not considered in these patients, because the elevated serum ferritin is attributed to adequate or excess iron in storage. Inflammationâ&#x20AC;&#x2122;s impact on serum ferritin needs to be part of the assessment. The low TSAT in these patients reflects inadequate amounts of iron for erythropoiesis. In addition, ESA therapy drives the need for iron, which can also contribute to functional iron deficiency. In one study, almost two thirds of anemic patients about to start a cycle of chemotherapy had either functional or absolute iron deficiency at the time of enrollment (Table).12 The American Society of Hematology/American Society of Clinical Oncology Clinical Practice Guidelines recommend conducting baseline and

periodic monitoring of iron studies.13 The National Comprehensive Cancer Network (NCCN) Guidelines for Cancer- and Chemotherapy-Induced Anemia recommend conducting iron studies as part of the screening evaluation for anemia and prior to the initiation of ESA therapy.14 Despite these guidelines, only one third of oncology nurses surveyed stated that iron indices are evaluated prior to ESA therapy, and just 23% revealed that iron studies are checked on admission and periodically thereafter. Educating oncology nurses on the proper assessment and follow-up monitoring of their anemic patients could help to ensure adequate identification of iron-deficiency anemia in cancer patients. Use of IV iron Several prospective, randomized, controlled trials have been conducted to evaluate the efficacy of IV iron supplementation in combination with ESA therapy in treating iron deficiency in oncology patients.2-5 In patients with iron-deficiency and chemotherapy-related anemia, these studies demonstrated that the addition of IV iron to ESA therapy results in increased hemoglobin responsiveness,2-4 faster time to response,4 decreased transfusion requirements,4,5 and improved quality of life, energy, and O activity.3 In all of these studies, oral iron was used in the control arm and IV iron demonstrated superior efficacy compared with oral iron. The effect of oral iron on hemoglobin was shown to be similar to using no iron at all in cancer patients.2,3 The NCCN and European Organisation for Research and Treatment of Cancer guidelines recommend the use of IV iron products for iron repletion in cancer patients with absolute iron deficiency. These guidelines further state that IV iron should be considered for the treatment of functional iron deficiency for patients receiving ESAs. They also recognize that oral iron is less effective, supported by recent studies demonstrating that IV iron is superior to oral iron. In addition to poor efficacy, the gastrointestinal side effects of oral iron are often intolerable for patients.14,15 Despite this clinically significant information, 47% of oncology nurses surveyed treat anemic ESA-treated patients with oral or no iron. Recognizing the substantial benefit of IV iron over oral iron in the oncology setting could optimize treatment strategies and clinical outcomes in iron-deficient, anemic cancer patients. Conclusion This Learning Needs Assessment

compared the practice patterns of nephrology nurses with oncology nurses to reveal areas of opportunity for education and optimization of anemia management in oncology. Lessons learned from nephrology nurses include the need for increased understanding of iron indices, proper use of IV versus oral iron, and education regarding safety and administration. â&#x2014;? References 1. Mano M, Butzberger P, Reid A, et al. Current role of erythropoietin in the management of patients with haematological and solid malignancies. Cancer Ther. 2005;3A:41-56. 2. Henry DH, Dahl NV, Auerbach M, et al. Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Oncologist. 2007;12:231-242. 3. Auerbach M, Ballard H, Trout JR, et al. Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial. J Clin Oncol. 2004;22:1301-1307. 4. Bastit L, Vandebroek A, Altintas S, et al. Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alfa administered every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. J Clin Oncol. 2008;26: 1611-1618. 5. Pinter T, Mossman T, Suto T, Vansteenkiste J. Effects of intravenous (IV) iron supplementation on responses to every-3-week (Q3W) darbepoetin alfa (DA) by baseline hemoglobin in patients (pts) with chemotherapy-induced anemia (CIA). J Clin Oncol. 2007;25(18S):Abstract 9106. 6. Collins A. Trend in iron testing and IV iron dosing in cancer patients receiving chemotherapy and ESA versus dialysis patients. Presented at: American Society of Hematology 45th Annual Meeting and Exposition; December 6-9, 2003; San Diego, CA. 7. Yee J, Henry DH. Using IV iron and ESAs effectively to manage anemia: translating lessons learned in nephrology to oncology. Hematology & Oncology News & Issues. April 2008:30-32. 8. Ponka P, Beaumont C, Richardson DR. Function and regulation of transferrin and ferritin. Semin Hematol. 1998;35:35-54. 9. Cavill I. Iron status as measured by serum ferritin: the marker and its limitations. Am J Kidney Dis. 1999;34(4 suppl 2):S12-S17. 10. Hudson JQ, Comstock TJ. Considerations for optimal iron use for anemia due to chronic kidney disease. Clin Ther. 2001;23:1637-1671. 11. Henry DH. Supplemental iron: a key to optimizing the response of cancer-related anemia to rHuEPO? Oncologist. 1998;3:275-278. 12. Henry DH, Dahl NV; for the Ferrlecit Cancer Study Group. Iron or vitamin B12 deficiency in anemic cancer patients prior to erythropoiesisstimulating agent therapy. Commun Oncol. 2007;4:95-101. 13. Rizzo JD, Somerfield MR, Hagerty KL, et al. Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Hematology/ American Society of Clinical Oncology clinical practice guideline update. Blood. 2008;111:25-41. 14. National Comprehensive Care Network. Clinical Practice Guidelines in Oncology: Cancer- and Chemotherapy-Induced Anemia. V.3.2.2010. www. nccn.org/professionals/physician_gls/PDF/ane mia.pdf. Accessed May 30, 2010. 15. Bokemeyer C, Aapro MS, Courdi A, et al; for the European Organisation for Research and Treatment of Cancer (EORTC) Taskforce for the Elderly. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer. 2007;43:258-270.

www.TheOncologynurse.com

TON_June 2010_FINAL_TON 6/9/10 2:00 PM Page 31

value-focused www.ValueBasedCancer.com www.ValueBasedCancer.com

New NewTools ToolsArriving ArrivingtotoMeasure Measureand and NCCN NCCNRoundtable: Roundtable:Clinical Clinicaland and Manage Economic ManageChemotherapy ChemotherapyCare Care EconomicIssues IssuesImpacting Impacting Business, Cancer Business,clinical clinicalconcerns concernsnow nowconnected connectedinin CancerCare CareDelivery Delivery value-focused value-focusedapproach approach ByBy Daniel Denvir Daniel Denvir

payers

Baltimore, MDâ&#x20AC;&#x201D;A long-held business Baltimore, MDâ&#x20AC;&#x201D;A long-held business truism is is that â&#x20AC;&#x153;ifâ&#x20AC;&#x153;if you canâ&#x20AC;&#x2122;t measure it, it, truism that you canâ&#x20AC;&#x2122;t measure you it.â&#x20AC;?it.â&#x20AC;? The application youcanâ&#x20AC;&#x2122;t canâ&#x20AC;&#x2122;tmanage manage The application ofofthis thisbelief beliefto tothetheoncology oncologysetting setting was of of thethe wasdemonstrated demonstratedat ata session a session Association AssociationofofCommunity CommunityCancer Cancer Cen tersâ&#x20AC;&#x2122; 36th Annual National Cen tersâ&#x20AC;&#x2122;(ACCC) (ACCC) 36th Annual National Meeting. Kimberly Bergstrom, PharmD, Meeting. Kimberly Bergstrom, PharmD, chief chiefclinical clinicalofficer officerforforMcKesson McKesson Specialty Care Solutions, told attendees Specialty Care Solutions, told attendees ofof thethe growing importance of of developing growing importance developing and andusing usingstandardized standardizedchemotherapy chemotherapy treatment regimens, and of of thethe tools that treatment regimens, and tools that

cost control

clinical practice guidelines

â&#x20AC;&#x153;Collision â&#x20AC;&#x153;Collisioncourseâ&#x20AC;? courseâ&#x20AC;?ininsight sight cancan benchmark performance andand foster benchmark performance foster compliance with treatment guidelines. Dr DrGoodman Audrey Andrews Goodman compliance with treatment guidelines. By By Audrey Andrews Public and private payers areare movalluded to atolevel Public and private payers movalluded a level ingingto tocontrol exploding healthcare thatthat of frustration control exploding healthcare Hollywood, Hollywood,FLâ&#x20AC;&#x201D;Clinical FLâ&#x20AC;&#x201D;Clinicalpractice practice of frustration has never been costs, Dr Bergstrom told attendees, guidelines issued by the National costs, Dr Bergstrom told attendees, guidelines issued by the National has never been and control in in cancer andbecause becauseincreased increasedcost cost control Comprehensive ComprehensiveCancer CancerNetwork Network higher higher cancer was areare followed by by conscienâ&#x20AC;&#x153;Too many wasinevitable, inevitable,it itis isin inprovidersâ&#x20AC;&#x2122; providersâ&#x20AC;&#x2122; (NCCN) (NCCN) followed conscien- care. care. â&#x20AC;&#x153;Too many interest to get a seat at the table. tious oncologists in their everyday patients are still interest to get a seat at the table. tious oncologists in their everyday patients are still â&#x20AC;&#x153;Itâ&#x20AC;&#x153;It is is anan important topic, because areare developed young. WeWe important topic, because practice, practice,butbutthey they developed dying dying young. this is one of of those things, if we donâ&#x20AC;&#x2122;t on on clinical efficacy andand without innovations andand a cure,â&#x20AC;? he said. this is one those things, if we donâ&#x20AC;&#x2122;t based based clinical efficacy without need need innovations a cure,â&#x20AC;? he said. getget a handle on it, itâ&#x20AC;&#x2122;s going to happen regard to to costs. At At a roundtable held thethe inadequacy of current treatinadequacy of current treata handle on it, itâ&#x20AC;&#x2122;s going to happen regard costs. a roundtable held ButBut to to us,â&#x20AC;? she said. â&#x20AC;&#x153;People and groups during the NCCNâ&#x20AC;&#x2122;s 15th Annual ments for cancer is no the the main us,â&#x20AC;? she said. â&#x20AC;&#x153;People and groups during the NCCNâ&#x20AC;&#x2122;s 15th Annual ments for cancer is longer no longer main Equally challenging, he sugand organizations areare going to to start and organizations going start Conference, Conference, moderator moderator Clifford Clifford problem. problem. Equally challenging, he sugdictating how wewe provide cancer care, PhD, Senior Vice President is finding a means to pay for for Goodman, PhD, Senior Vice President gested, gested, is finding a means to pay dictating how provide cancer care, Goodman, and we canâ&#x20AC;&#x2122;t let that happen.â&#x20AC;? at The Lewin Group, predicted, â&#x20AC;&#x153;The the ever-costlier care that threatens to and we canâ&#x20AC;&#x2122;t let that happen.â&#x20AC;? at The Lewin Group, predicted, â&#x20AC;&#x153;The the ever-costlier care that threatens to appropriate use of evidence-based bankrupt the healthcare system. Continued on page 8 appropriate use of evidence-based bankrupt the healthcare system. Continued on page 8 guidelines is on a collision course As society struggles to find soluAs society struggles to find soluguidelines is on a collision course with the financial nonsustainability of tions, â&#x20AC;&#x153;the ground is shaking beneath with the financial nonsustainability of tions, â&#x20AC;&#x153;the ground is shaking beneath the healthcare system.â&#x20AC;? us,â&#x20AC;? Dr Goodman commented. the healthcare system.â&#x20AC;? us,â&#x20AC;? Dr Goodman commented.

Value-Based Value-BasedCancer CancerCare Care will willbebeatatthe theASCO ASCOAnnual Annual Meeting, June 4-8, in Chicago. Meeting, June 4-8, in Chicago.

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Breast Cancer Conference (EBCC7). Breast Cancer Conference (EBCC7). This improvement, the researchers By Rosemary Frei, MSc This improvement, the researchers By Rosemary Frei, MSc Barcelonaâ&#x20AC;&#x201D;Survival for patients with suggest, is due to increased use of The 2010 Genitourinary Cancers Barcelonaâ&#x20AC;&#x201D;Survival for patients with suggest, is due to rise increased use of San Francisco, CAâ&#x20AC;&#x201D;The popularity of The 2010 Progress Genitourinary Cancers metastatic breast cancer has improved anthracyclines and the of targeted Symposium: in Multi San Francisco, CAâ&#x20AC;&#x201D;The metastatic breast cancer has improved anthracyclines and the rise of targeted minimally Symposium: Progresswas in held Multidramatically in the last 20 years, espe- therapies. Management invasive radical popularity prostatec- of disciplinary minimally radical prostatec- March dramatically in the last 20 years,with espe- â&#x20AC;&#x153;There therapies. disciplinary Management cially in the subgroup of patients is no doubt that trastuzu- tomy 5-7 in San Francisco. Allwas ses-held (MIRP),invasive intensity-modulated tomy (MIRP), cially in the subgroup patients with is no which doubt that trastuzu March 5-7 in San Francisco. All sesHER2-positive tumors, of according to mab â&#x20AC;&#x153;There (Herceptin), targets the - radiation sions emphasized a multidisciplinary therapy intensity-modulated (IMRT), and of radiation therapy (IMRT), and of approach HER2-positive mab gene, (Herceptin), which important targets the brachytherapy sions emphasized a multidisciplinary research presentedtumors, at the 7thaccording European to HER2 is the most to care; a number of them combined with IMRT research presented at the 7th European HER2 gene, is the most important forbrachytherapy approach to cost care;and a number of them brought out the value issues prostate cancercombined started towith take IMRT off Continued on page 27 for 2002, prostate cancer started analysis to take off associated broughtwith out the cost for andgenitourivalue issues Continued on page 27 after caring a new database after 2002, a new database analysis associated with caring for genitourinary cancers. has confirmed. hasthe confirmed. nary cancers. At American Society of Clinical At the American Society of Can Clinical Oncologyâ&#x20AC;&#x2122;s 2010 Genitourinary - and Womenâ&#x20AC;&#x2122;s Hospital, Harvard Oncologyâ&#x20AC;&#x2122;s 2010Paul Genitourinary Can- Medical and Womenâ&#x20AC;&#x2122;s Hospital, Harvard School, Boston, and his cocers Symposium, L. Nguyen, cerspresented Symposium, Nguyen, Medical School, his coMD, the Paul resultsL. of his investigators foundBoston, MIRP and jumped investigators found MIRP jumped MD, analysis presentedof the teamâ&#x20AC;&#x2122;s dataresults from of thehis from 1.5% of radical prostatectomies teamâ&#x20AC;&#x2122;s analysis of dataand from from of 28.7% radicalinprostatectomies Surveillance, Epidemiology Endthe (RPs) in 1.5% 2002 to 2005. They Surveillance, Epidemiology and End also(RPs) in 2002 28.7% in 2005. They Results (SEER)-Medicare database. found that to IMRT soared from Results (SEER)-Medicare also found that IMRT treatments soared from Dr Nguyen, director of database. Prostate 8.7% of external radiation Dr Nguyen, director of Prostate for 8.7% of external radiation treatments prostate cancer to 81.7%. In addiBrachytherapy, Dana-Farber/Brigham Brachytherapy, Dana-Farber/Brigham for prostate cancer to 81.7%. In 24 addiContinued on page

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Continued on page 24

A new publication for your new vocabulary

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TON_June 2010_FINAL_TON 6/9/10 2:00 PM Page 32

Supportive Care

A New Advance in Lymphedema Therapy By Wilma Morgan-Hazelwood, OTR/L, CLT-LANA; Jenna Balaicuis, DPT, CLT Fox Chase Cancer Center, Philadelphia, Pennsylvania

Wilma Morgan-Hazelwood, OTR/L, CLT-LANA

Jenna Balaicuis, DPT, CLT

ymphedema, an excess of fluid and protein caused by impaired lymph flow from the tissue, is a common and debilitating complication of cancer surgery and radiation treatment.1 Depending on which area and lymph nodes are affected, the areas of edema or swelling can be the arms, legs, head and neck, trunk, abdomen, or groin. Lymphedema is not a life-threatening condition but is one that has no cure. According to the American Cancer Society, complete decongestive therapy (CDT) is the recommended standand of care.1 CDT is a combination of four elements: compression (including bandaging and garments), skin care, exercise, and manual lymph drainage. Developed in the 1930s, manual lymph drainage is a gold standard for care, and the same techniques are still used today. Although this technique is effective, research continues into newer methods for treating lymphedema. The newest device is the low-level laser. In 2006, the US Food and Drug Administration (FDA) approved low-level laser therapy (LLLT) for professional and self-treatment of lymphedema in postmastectomy breast cancer patients. Laser therapy and applications LLLT has been found to affect fibroblasts and collagen synthesis, influencing

June 2010 I VOL 3, nO 4

the tissue repair process.2 This application could be used in the treatment of surgical scars that restrict movement, cause pain, and impede lymph flow, such as those after mastectomy. Some research suggests that LLLT also stimulates lymphatic motoricity and lymphangiogenesis through an invisible wavelength penetrating into tissue, where it is absorbed by cells and converted into energy used to reduce tissue swelling.2 Other research has shown an increase in microcirculation and acceleration of collateral circulation after tissue injury. Specifications of the laser The LTU-904 (RianCorp) is a class I laser per FDA regulations and its use is approved for the treatment of postmastectomy lymphedema. The LTU-904 is a handheld, battery-powered, nonthermal, infrared laser, operating at a wavelength of 904 nm with a controlled series of 200-ns bursts of pulses along this spectrum.3 At this wavelength, tissue penetration is up to 3 cm to 5 cm deep.3 Treatment with the LTU-904 may be used in conjunction with manual lymph drainage and occurs directly in contact with the skin, on areas of lymph nodes or surgical scars, or on the limb in areas of textural change (ie, fibrosis). Its use requires a physician prescription and, initially, it should be used only under the supervision of a trained clinician. Because of its portability and ease of use, however, in the future, LLLT could be used at home by patients with lymphedema, including the elderly or those lacking dexterity for self-massage. Although there are no known contraindications to LLLT, its safety and effectiveness in treating postmastectomy lymphedema in pregnant women or those under 18 have not been evaluated.3 If an affected limb becomes infected or if metastatic cancer develops, treatment should be discontinued. Should dizziness, nausea, or increased discomfort occur, the patient should reduce treatment and seek medical guidance. Safety and effectiveness of the device when used consistently beyond two 3-week treatment blocks (three times per week, every 2 days) has not been evaluated.3 Research that paved the way Credited for the initial studies using LLLT in breast cancer patients, the School of Medicine at Flinders Medical Centre in South Australia laid the groundwork for LLLT in the United States. In 1998, Piller and Thelander

studied 10 patients with unilateral arm lymphedema following mastectomy and radiation. These patients all received 16 treatment sessions of LLLT over a period of 10 weeks, and seven of the 10 patients received long-term follow-up, up to 3 years.4 Immediately posttreatment, volumetrics decreased, tissue softened, and patients reported improvement in sensation of aching, tightness, and heaviness. Although long-term follow-up subjective responses trended toward pretreatment values, arm circumference showed continued reduction patterns, and the affected forearm and chest areas lacked progressive induration.4 In 2003, Carati and colleagues published results of the first double-blind, placebo-controlled trial of the use of LLLT to treat postmastectomy lymphedema.2 The study, conducted over a 1year period, included 64 patients, randomly assigned to a laser or placebo-laser group. It included a parallel study (within-group comparison) aimed to assess one cycle versus two cycles of laser treatment. All treatment was directed to the axillary region of the affected arm, using a grid to demarcate 17 treatment points to guide application. Each laser treatment lasted 17 minutes, 1 minute per treatment point, and a cycle of treatment included nine sessions (three times per week for 3 weeks). Following two cycles

of active LLLT, arm volume, tissue hardness, and extracellular fluid levels were significantly reduced on both 1- and 3month follow-up. One cycle of active treatment or placebo treatment had no significant effect on limb volume, nor did any group show significant improvement in arm range of motion. Present research Although research into the use of LLLT in the postmastectomy lymphedema population continues, there have been few studies that compare with the design and magnitude of those of Carati and colleagues. Recently, a randomized controlled trial of 64 participants looked at volume reduction and pain, comparing 1 month of LLLT (20 minutes, three times per week) to 1 month of pneumatic compression pump therapy (twenty 2-hour sessions).5 Although initial follow-up at 1, 3, and 6 months posttreatment showed a reduction in arm volume in both groups, only the LLLT group continued to show a significant decrease after 12 months. Likewise, both groups noted reduction in pain immediately after treatment, but this reduction remained significant only in the LLLT group at 3-, 6-, and 12month follow-up. Another study with a small sample Continued on page 34

Table. Patient Profiles Patient A

Patient B

Patient C

59 years

57 years

69 years

22 years after lumpectomy

4 years after mastectomy followed by transflap

3 years after lumpectomy, with 1 positive node

Volume of involved arm

3473 mL

4177 mL

2665 mL

Difference between uninvolved arm

414 mL or 14%

443 mL or 12%

136 mL or 5%

Number of first treatment sessions

First treatment results

141 mL or 5%

188 mL or 5%

194 mL or 7%

Break between treatments

1 month

Number of second treatment sessions

Second treatment results

123 mL or 4%

46 mL or 1%

85 mL or 4%

Total loss

264 mL or 9%

233 mL or 6%

279 mL or 11%

Age Surgery

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Chronic Lymphocytic Leukemia The Essentials of Patient Care LOG ON TODAY TO PARTICIPATE www.coexm.com/ace02.asp Release Date: April 29, 2010 Expiration Date: April 28, 2011

TARGET AUDIENCE This activity is intended for hematologists, oncologists and others who are involved with the care of patients with Chronic Lymphocytic Leukemia (CLL).

STATEMENT OF NEED CLL is the most common type of leukemia in the United States, with over 15,000 new cases per year, characterized by the accumulation of monoclonal B cells in the bone marrow, peripheral blood, and lymphoid tissue. Primarily a disease of the elderly, the median survival for CLL varies substantially: many patients survive more than 10 years after diagnosis, but a subset of symptomatic patients have shorter life expectancies—in the range of 1.5 to 6 years. The clinical/research body of knowledge in CLL is rapidly changing and represents a challenge for the whole treatment team.

FACULTY Neil E. Kay, MD Professor Department of Medicine Mayo Clinic Rochester, Minnesota

Michael Keating, MD Course Chair Professor of Medicine Deputy Department Chairman Department of Leukemia M.D. Anderson Cancer Center Houston, Texas

EDUCATIONAL OBJECTIVES On completion of this activity, participants should be able to: • List the essential steps in diagnosis and treatment planning of the CLL patient • Select CLL treatment regimens based on patient characteristics • Define data supporting the benefit/risk ratio of upfront, relapsed, and refractory CLL setting • Define strategies to manage fludarabine-resistant CLL • Describe emerging therapies in CLL

This activity is supported by an educational grant from Genentech BioOncology and Biogen Idec.

This activity has been approved for 1.5 AMA PRA Category 1 Credits™. For further information and to participate, please go to: www.coexm.com/ace02.asp

In collaboration with

TON_June 2010_FINAL_TON 6/9/10 2:01 PM Page 34

International News

Reports from the European Association of Urology Congress, European Breast Cancer Conference, UK National Health Service High BMI Is No Reason to Exclude Prostate Cancer Patients from Minimally Invasive Surgery BARCELONA—Minimally invasive prostate cancer surgery known as robotic-assisted laparoscopic prostatectomy (RALP) is an effective and safe treatment option in obese patients, investigators announced at the 25th Anniversary European Association of Urology Congress. David Samadi, MD, and colleagues at Mount Sinai Medical Center in New York presented results in 1112 men who underwent RALP by a single surgeon. Of the study population, 870 patients had a low body mass index (BMI; <30) and 242 patients had a high BMI (≥30). The results showed similar perioperative, pathologic, oncologic, and functional outcomes in the two groups. Continence and potency rates were also similar. Samadi noted that surgeons have voiced concern that obese patients might develop worse outcomes than

nonobese patients because surgery is technically more challenging in this population. “Surgeons should approach these cases with more confidence,” he said.

Breast Cancer Patients Prefer “Buddy System” to Photographs When Discussing Reconstruction BARCELONA—Women with breast cancer say they would rather meet with other patients who have undergone breast reconstructive surgery than view clinical photographs before they decide on the particulars of their procedure, new data show. Clinical photographs are the surgeons’ preferred method for showing patients preoperatively the outcomes of various types of breast reconstruction. Anushka Chaudhry, MD, with Frenchay Breast Care Centre in Bristol, United Kingdom, interviewed 30 women who were planning to undergo reconstructive procedures at her institution. All patients were seen

at the center’s dedicated breast reconstruction clinic. In addition to viewing clinical photographs of their surgeon’s breast reconstruction procedures, patients were offered the opportunity to meet face-toface with other women who had undergone similar procedures or talk to them by telephone or e-mail. Contact between the women was made by the breast cancer nurse. Twenty-five women reported that they preferred meeting other patients to “simply seeing clinical photographs.” The other five women said that they, too, preferred meeting other women who had undergone reconstructive surgery but that contact by phone or e-mail was best for them. “A key part of the decision-making process is support, and patients are often the best advocates for others at this time of great personal anguish,” Chaudhry said. She reported the findings at the Seventh European Breast Cancer Conference.

Foreign Nurses Have Poor Grasp of English LONDON—Nurses recruited from overseas may be able to “manage” the basics of the English language, but they often have difficulty understanding common phrases used on hospital wards, according to a report from the United Kingdom’s National Health Service. As a result, the government agency has started paying for 10-week English classes to help them become more proficient. Although physicians recruited from outside the European Union are required to pass an English language test before being allowed to practice, other hospital workers including nurses are exempt from such tests. The term “nil by mouth,” meaning that the patient is not allowed to eat or drink, is among the most commonly misunderstood terms. Other poorly understood terms include “bleeping a doctor” (which is “beeping a doctor” in the United States) and “doing the rounds” (which is “making the rounds” in the United States). ●

SUPPORTIVE CARE

A New Advance in Lymphedema Therapy Continued from page 32 size and a 1-month follow-up period did attempt to measure quality of life along with arm volume and tissue resistance.6 Disabilities of Arm, Shoulder, and Hand (DASH) outcome measure scores showed improvement in the LLLT treatment group, which continued to the 1month follow-up. Currently, Ridner and associates of Vanderbilt University School of Nursing are studying the impact of different types of lymphedema treatment, including LLLT and manual lymph drainage, on patient symptoms, arm volume, and quality of life under a grant from the Oncology Nursing Society (ONS). The study will include 90 participants at a Florida clinic over the course of 2 years.7 Patients will be randomized into three groups: laser only, manual lymph drainage only, and a combination of the two. The study also aims to determine what treatment dose of laser therapy is effective. Laser trial at Fox Chase Cancer Center Before purchasing the device, our clinic had the opportunity to test the laser and determine its effectiveness in our population to justify the cost of purchase. Because of a lack of broad-based re-

June 2010 I VOL 3, nO 4

search, we conducted case studies to determine its effectiveness. Even in “Putting Evidence into Practice,” the ONS lymphedema management team ranked LLLT as “evidence not established.”8 Our clinic followed the treatment protocol for upper limb secondary lymphedema and treatment frequency in the manufacturer’s manual.3 For the case studies, we used three patients (Table) with similar criteria: • Breast cancer in remission • Chronic moderate, but stable, lymphedema • Successfully completed one to two courses in CDT • Followed a dedicated home program of exercise, skin care, self-massage, and compression therapy. We applied LLLT to the axillary region of the affected arm, covering approximately 17 points (each point covering a 2-cm area). Each point received 1 minute of laser treatment. We also expanded our area to cover scar tissue and fibrotic tissue for the affected arm, chest, trunk, or hand. The maximum dose received in an individual treatment session was 36 points to the affected quadrant, with only 25 minutes of laser therapy. Following the manufacturer’s guidelines, some points were

held for only 30 seconds. While performing LLLT, the therapist also provided manual lymph drainage massage, specifically to the lasered area as well as the affected quadrant. Throughout the LLLT sessions, patients continued to follow their previous home maintenance program of skin care, exercise, and compression therapy. Findings Each of the three patients lost more than 200 mL (233-279 mL), which is a 6% to 11% change in the affected limb. The patients’ skin quality improved throughout the entire limb, but each of the areas treated for scar or fibrotic tissue showed marked improvement with softening and pliability. In Patient B, the effects were evident after the second treatment, with a 203-mL decrease (a 6% change). In Patient A, however, the effects went unnoticed until the sixth treatment, with a 141-mL decrease (a 5% change). The patients found it easier to put on their compression garments and looser areas of compression. All three needed new custom compression garments at the end of treatment. Surprisingly, even during the monthlong treatment break, patients noted improvement in skin texture and a 0%

to 3% decrease in volume. Each patient will be followed at 3-month intervals for reassessment of the affected limb and volumetrics. Although LLLT is not a cure for lymphedema, it is a tool that can contribute to patients’ treatment programs and further enhance their progress. From this limited study, all three patients demonstrated positive results without any side effects or contraindications. ● References 1. Lawenda BD, Mondry TE, Johnstone PAS. Lymphedema: a primer on the identification and management of a chronic condition in oncologic treatment. CA Cancer J Clin. 2009;59:8-24. 2. Carati JC, Anderson SN, Gannon BJ, Piller NB. Treatment of postmastectomy lymphedema with low-level laser therapy: a double blind, placebocontrolled trial. Cancer. 2003;98:1114-1122. 3. LTU-904 portable laser therapy unit [user manual]. Richmond, South Australia: RianCorp; 1998. 4. Piller NB, Thelander A. Treatment of chronic postmastectomy lymphedema with low level laser therapy: a 2.5 year follow-up. Lymphology. 1998; 31:74-86. 5. Ridner SH. An assessment of the role of low-level laser therapy in the treatment of lymphedema. NLN LymphLink. 2009;21:8-9,31. 6. Lau RWL, Cheing GLY. Managing postmastectomy lymphedema with low-level laser therapy. Photomedicine and Laser Surgery. 2009;27:763-769. 7. Hast L. Laser treatment studied to ease lymphedema. Vanderbilt-Ingram Cancer Center News. November 10, 2009. www.vicc.org/news/?p= 1013. Accessed January 20, 2010. 8. Poage E. Case study: low-level laser therapy in complicated post-breast cancer lymphedema. NLN LymphLink. 2009;21:5-6.

www.TheOncologynurse.com

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CONTINUING EDUCATION CREDITS

Current activities at www.COEXM.com include:

TON_June 2010_FINAL_TON 6/10/10 12:23 PM Page 36

Nursing Life Chilled Grilled Shrimp over Tropical Fruit Salad with Citrus Vinaigrette

he following recipe is a great way to celebrate summer and incorporate beneficial cruciferous veggies, fruits, and a varitey of phytonutrients into a great tasting salad. Sprinkle some ground flax seed on top for an added bonus.

Ingredients Large shrimp, 20 1 tablespoon olive oil 3 tablespoons salt-free herbal seasoning

My Evidence

By Cortney Davis, NP

When I saw dust settling, the road black and gritty, and noticed the air shimmering as it lowered closer to the earth

just before the hospital phoned to say that Mother had called my name, familiar syllables caught in her throat, I’d already detected her leaving in my own body

like a soft blanket suffocating the damp September mornings that had morphed seamlessly into November’s

and so while she paused at the end of her journey, which was also the beginning, I rushed to her,

crowded table of berries, sweets, and yellow corn, (First published online at www.pulsemagazine.org)

hurrying as I’d never hurried before.

½ cup orange juice ¼ cup lemon juice 3 tablespoons canola oil ½ teaspoon salt

PSYCHOSOCIAL ISSUES

2 papayas

Most Oncology Nurses Unfamiliar with IOM... Continued from page 24

2 mangos 1 quart strawberries 8 ounces spring mix ½ cup shredded carrot 12 cherry tomatoes

Directions • Combine shrimp, olive oil, and herb seasoning. Marinate for 1 hour. • Grill shrimp and set aside in refrigerator to cool. • In a small bowl, whisk together orange juice, lemon juice, canola oil, and salt. Set aside. • Peel and thinly slice papaya and mango. Slice strawberries in half. • In a separate bowl, toss spring mix with carrots and dressing. • On the top of the plate, shingle together papaya and mango. Place salad mix in center of plate. • Garnish front and sides of the plate with strawberries and cherry tomatoes. • Arrange shrimp on top of salad mix. Serves 4

Nutritional Information Each serving provides: 400 calories, 19 g fat, 2.5 g saturated fat, 60 mg cholesterol, 122 mg sodium, 51 g carbohydrate, 9 g dietary fiber, 12 g protein. Recipe courtesy of Peter Pascale, CCC Executive Chef, Somerville, New Jersey.

June 2010 I VOL 3, nO 4

worked in the inpatient setting, and 74% worked in frontline patient care. Regarding their knowledge of the IOM report, 64% were “not at all” or “not very” familiar with the report, whereas only 34% were “somewhat” or “very” familiar with it, she reported. It is important to note that only 12% reported that someone in their work setting had communicated or taken action based on the IOM recommendations. Forty-two percent had not taken action, and 41% were unsure if any action had been taken. The responsibility for the provision of psychosocial health services typically fell to a social worker (43%), followed by a nurse (17%), an advanced practice nurse (17%), a behavioral health professional (9%), a physician (3%), a pastor or spiritual care counselor (3%), or another individual (7%). The nurses used a variety of methods for assessing and identifying the psychosocial issues and needs of their patients, but discussion with the patient was by far the most common (Table 2). Thirty-six percent said they applied evidence-based resources for psychosocial care to their practices. “They used a variety of assessments, but the best evidence for this is from the NCCN [National Comprehensive Cancer Network], which developed the Distress Thermometer. This incorporates symptomatology, spirituality, economics, transportation, and other elements of stress and coping. Only 13% were using this,” Gosselin pointed out.

Perhaps some of the insufficiency in psychosocial service can be attributed to the multiple barriers faced by healthcare providers, including lack of time at work (49%), lack of patient and family access to providers (41%), lack of insurance coverage or high cost of services (41%), and lack of community resources (29%), she added. “The key barriers were related to having time to assess and provide these services, to lack of insurance coverage, and to access to suitable providers,” she noted. “We know that the bulk of cancer patients are not treated in academ-

ic medical centers like ours. If you are a rural healthcare provider, do you have someone to refer these patients to? This is another important issue.” Only 20% cited a lack of experience in assessment or screening tools for distress as a barrier to the delivery of psychosocial care. These results were incorporated into a 3-year plan that has been submitted to the ONS, which includes recommendations for advocacy, education, and research related to the integration of evidence-based practices into psychosocial care delivery. ●

Table 2. Tools and Methods Used to Assess Psychosocial Needs (n = 76) Method

N (%)

Interview and discussion

59 (78)

Numeric, Likert, or visual analog scale

20 (26)

Activities of daily living scale

15 (20)

No specific instrument

15 (20)

National Comprehensive Cancer Network Distress Thermometer

10 (13)

Depression scale

9 (12)

Anxiety scale

3 (4)

Social support scale

3 (4)

Acculturation scale

2 (3)

Caregiver strain index

2 (3)

Other

6 (8)

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TON_June 2010_FINAL_TON 6/9/10 2:01 PM Page 37

Meetings OCTOBER

JUNE/JULY

1-3

WASHINGTON, DC Breast Cancer Symposium www.asco.org

June 30-July 3 BARCELONA, SPAIN 12th World Congress on Gastrointestinal Cancer www.esmo.org

SEPTEMBER

15-17

BORDEAUX, FRANCE Congress of the European Society of Surgical Oncology www.ecco-org.eu

17-19 BALTIMORE, MD

Academy of Oncology Nurse Navigators’ Navigation and Survivorship Conference www.aonnonline.org

26-29

SAN DIEGO, CA Scripps Cancer Center’s 30th Annual Oncology Nurses Symposium www.scripps.org

www.TheOncologynurse.com

5-8 MONTREAL, QUEBEC 18th International Congress on Palliative Care www.pal2010.com

RITUXAN® (Rituximab) Brief summary—Please consult full prescribing information. counts prior to each Rituxan course. During treatment with Rituxan and chemotherapy, obtain CBC and platelet counts at weekly to monthly intervals and more frequently in WARNING: FATAL INFUSION REACTIONS, TUMOR LYSIS SYNDROME (TLS), patients who develop cytopenias. [See Adverse Reactions]. s The duration of cytopenias SEVERE MUCOCUTANEOUS REACTIONS, and PROGRESSIVE MULTIFOCAL caused by Rituxan can extend months beyond the treatment period. ADVERSE LEUKOENCEPHALOPATHY (PML) REACTIONS The most common adverse reactions of Rituxan (incidence ≥25%) Infusion Reactions: Rituxan administration can result in serious, including observed in clinical trials of patients with NHL were infusion reactions, fever, fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have lymphopenia, chills, infection, and asthenia. The most common adverse reactions of occurred. Approximately 80% of fatal infusion reactions occurred in Rituxan (incidence ≥25%) observed in clinical trials of patients with CLL were: infusion association with the first infusion. Carefully monitor patients during reactions and neutropenia. Clinical Trials Experience in Lymphoid Malignancies infusions. Discontinue Rituxan infusion and provide medical treatment for Because clinical trials are conducted under widely varying conditions, adverse reaction Grade 3 or 4 infusion reactions [see Warnings and Precautions, Adverse rates observed in the clinical trials of a drug cannot be directly compared to rates in the Reactions]. s Tumor Lysis Syndrome (TLS): Acute renal failure requiring clinical trials of another drug and may not reflect the rates observed in practice. The data dialysis with instances of fatal outcome can occur in the setting of TLS described below reflect exposure to Rituxan in 2282 patients, with exposures ranging from a single infusion up to 6–8 months. Rituxan was studied in both single-agent and following treatment of non-Hodgkin’s lymphoma (NHL) patients with Rituxan active-controlled trials (n = 356 and n = 1926). The population included 679 patients [see Warnings and Precautions, Adverse Reactions]. s Severe Mucocutaneous with low-grade follicular lymphoma, 927 patients with DLBCL, and 676 patients with Reactions: Severe, including fatal, mucocutaneous reactions can occur in CLL. Most NHL patients received Rituxan as infusion of 375 mg/m2 per infusion, given as patients receiving Rituxan [see Warnings and Precautions, Adverse a single agent weekly for up to 8 doses, in combination with chemotherapy for up to 8 Reactions]. s Progressive Multifocal Leukoencephalopathy (PML): JC virus doses, or following chemotherapy for up to 16 doses. CLL patients received Rituxan 375 infection resulting in PML and death can occur in patients receiving Rituxan mg/m2 as an initial infusion followed by 500 mg/m2 for up to 5 doses, in combination with [see Warnings and Precautions, Adverse Reactions]. s fludarabine and cyclophosphamide. Seventy-one percent of CLL patients received 6 cycles and 90% received at least 3 cycles of Rituxan-based therapy. Infusion INDICATIONS AND USAGE Non-Hodgkin’s Lymphoma (NHL) Rituxan® (rituximab) is Reactionss In the majority of patients with NHL, infusion reactions consisting of fever, indicated for the treatment of patients with: Relapsed or refractory, low-grade or chills/rigors, nausea, pruritus, angioedema, hypotension, headache, bronchospasm, follicular, CD20-positive, B-cell NHL as a single agent; Previously untreated follicular, urticaria, rash, vomiting, myalgia, dizziness, or hypertension occurred during the first CD20-positive, B-cell NHL in combination with CVP chemotherapy; Non-progressing Rituxan infusion. Infusion reactions typically occurred within 30 to 120 minutes of (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after beginning the first infusion and resolved with slowing or interruption of the Rituxan first-line CVP chemotherapy; Previously untreated diffuse large B-cell, CD20-positive infusion and with supportive care (diphenhydramine, acetaminophen, and intravenous NHL in combination with CHOP or other anthracycline-based chemotherapy regimens. saline). The incidence of infusion reactions was highest during the first infusion (77%) Chronic Lymphocytic Leukemia (CLL) Rituxan® (rituximab) is indicated, in and decreased with each subsequent infusion. [See Boxed Warning, Warnings and combination with fludarabine and cyclophosphamide (FC), for the treatment of patients Precautions.] Infections Serious infections (NCI CTCAE Grade 3 or 4), including sepsis, with previously untreated and previously treated CD20-positive CLL. Limitations of use occurred in less than 5% of patients with NHL in the single-arm studies. The overall Rituxan is not recommended for use in patients with severe, active infections. incidence of infections was 31% (bacterial 19%, viral 10%, unknown 6%, and fungal WARNINGS AND PRECAUTIONS Infusion Reactions Rituxan can cause severe, 1%). [See Warnings and Precautions.] In randomized, controlled studies where Rituxan including fatal, infusion reactions. Severe reactions typically occurred during the first was administered following chemotherapy for the treatment of follicular or low-grade infusion with time to onset of 30–120 minutes. Rituxan-induced infusion reactions and NHL, the rate of infection was higher among patients who received Rituxan. In diffuse sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, large B-cell lymphoma patients, viral infections occurred more frequently in those who pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, received Rituxan. Cytopenias and hypogammaglobulinemiaa In patients with NHL ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death. Premedicate receiving rituximab monotherapy, NCI-CTC Grade 3 and 4 cytopenias were reported in patients with an antihistamine and acetaminophen prior to dosing. Institute medical 48% of patients. These included lymphopenia (40%), neutropenia (6%), leukopenia management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion (4%), anemia (3%), and thrombocytopenia (2%). The median duration of lymphopenia reactions as needed. Depending on the severity of the infusion reaction and the required was 14 days (range, 1–588 days) and of neutropenia was 13 days (range, 2–116 days). interventions, temporarily or permanently discontinue Rituxan. Resume infusion at a A single occurrence of transient aplastic anemia (pure red cell aplasia) and two minimum 50% reduction in rate after symptoms have resolved. Closely monitor the occurrences of hemolytic anemia following Rituxan therapy occurred during the singlefollowing patients: those with pre-existing cardiac or pulmonary conditions, those who arm studies. In studies of monotherapy, Rituxan-induced B-cell depletion occurred in experienced prior cardiopulmonary adverse reactions, and those with high numbers of 70% to 80% of patients with NHL. Decreased IgM and IgG serum levels occurred in 14% circulating malignant cells (≥25,000/mm3). [See Boxed Warning, Warnings and of these patients. Relapsed or Refractory, Low-Grade NHL Adverse reactions in Table 1 Precautions, Adverse Reactions.] Tumor Lysis Syndrome (TLS) Acute renal failure, occurred in 356 patients with relapsed or refractory, low-grade or follicular, CD20-positive, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, B-cell NHL treated in single-arm studies of Rituxan administered as a single agent. [See some fatal, can occur within 12–24 hours after the first infusion of Rituxan in patients Clinical Studies.] Most patients received Rituxan 375 mg/m2 weekly for 4 doses. with NHL. A high number of circulating malignant cells (≥25,000/mm3) or high tumor burden Table 1 confers a greater risk of TLS. Administer aggressive intravenous hydration and anti- Incidence of Adverse Reactions in ≥5% of Patients with Relapsed or Refractory, Lowhyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, Grade or Follicular NHL, Receiving Single-agent Rituxan (N = 356)a,b monitor renal function and fluid balance, and administer supportive care, including dialysis as All Grades (%) Grade 3 and 4 (%) All Grades (%) Grade 3 and 4 (%) indicated. [See Boxed Warning.] Severe Mucocutaneous Reactions Mucocutaneous Any Adverse Events 99 57 Respiratory p y System y 38 4 reactions, some with fatal outcome, can occur in patients treated with Rituxan. These Bodyy as a Whole 86 10 Increased Cough 13 1 Fever 53 1 Rhinitis 12 1 reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid Chills 33 3 Bronchospasm 8 1 dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these Infection 31 4 Dyspnea 7 1 Asthenia 26 1 Sinusitis 6 0 reactions has varied from 1–13 weeks following Rituxan exposure. Discontinue Rituxan Headache 19 1 Metabolic and Nutritional in patients who experience a severe mucocutaneous reaction. The safety of 14 1 Disorders 38 3 Abdominal Pain Pain 12 1 Angioedema 11 1 readministration of Rituxan to patients with severe mucocutaneous reactions has not Back Pain 10 1 Hyperglycemia 9 1 been determined. [See Boxed Warning, Adverse Reactions.] Progressive Multifocal Throat Irritation 9 0 Peripheral Edema 8 0 5 0 LDH Increase 7 0 Leukoencephalopathy (PML) JC virus infection resulting in PML and death can occur HemeFlushing and Lymphatic y p System y 67 48 Digestive g System y 37 2 in Rituxan-treated patients with hematologic malignancies or with autoimmune diseases. Lymphopenia 48 40 Nausea 23 1 Leukopenia 14 4 Diarrhea 10 1 The majority of patients with hematologic malignancies diagnosed with PML received Neutropenia 14 6 Vomiting 10 1 Rituxan in combination with chemotherapy or as part of a hematopoietic stem cell Thrombocytopenia 12 2 Nervous System y 32 1 Anemia 8 3 Dizziness 10 1 transplant. The patients with autoimmune diseases had prior or concurrent Skin and Appendages pp g 44 2 Anxiety 5 1 immunosuppressive therapy. Most cases of PML were diagnosed within 12 months of Night Sweats 15 1 Musculoskeletal System y 26 3 Rash 15 1 Myalgia 10 1 their last infusion of Rituxan. Consider the diagnosis of PML in any patient presenting Arthralgia Pruritus 14 1 10 1 with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited Urticaria 8 1 Cardiovascular System y 25 3 Hypotension 10 1 to, consultation with a neurologist, brain MRI, and lumbar puncture. Discontinue Rituxan Hypertension 6 1 and consider discontinuation or reduction of any concomitant chemotherapy or a b immunosuppressive therapy in patients who develop PML. [See Boxed Warning, Adverse Adverse reactions observed up to 12 months following Rituxan. Adverse reactions graded for severity Reactions.] Hepatitis B Virus (HBV) Reactivation Hepatitis B virus (HBV) reactivation by NCI-CTC criteria. with fulminant hepatitis, hepatic failure, and death can occur in patients with hematologic In these single-arm Rituxan studies, bronchiolitis obliterans occurred during and up to malignancies treated with Rituxan. The median time to the diagnosis of hepatitis was 6 months after Rituxan infusion. Previously Untreated Low-Grade NHL In Study 4, approximately 4 months after the initiation of Rituxan and approximately one month after patients in the R-CVP arm experienced a higher incidence of infusional toxicity and the last dose. Screen patients at high risk of HBV infection before initiation of Rituxan. neutropenia compared to patients in the CVP arm. The following adverse reactions Closely monitor carriers of hepatitis B for clinical and laboratory signs of active HBV occurred more frequently (≥5%) in patients receiving R-CVP compared to CVP alone: infection for several months following Rituxan therapy. Discontinue Rituxan and any rash (17% vs. 5%), cough (15% vs. 6%), flushing (14% vs. 3%), rigors (10% vs. 2%), concomitant chemotherapy in patients who develop viral hepatitis, and institute pruritus (10% vs. 1%), neutropenia (8% vs. 3%), and chest tightness (7% vs. 1%). In appropriate treatment including antiviral therapy. Insufficient data exist regarding the Study 5, the following adverse reactions were reported more frequently (≥5%) in safety of resuming Rituxan in patients who develop hepatitis subsequent to HBV patients receiving Rituxan following CVP compared to patients who received no further reactivation. [See Adverse Reactions.] Infections Serious, including fatal, bacterial, therapy: fatigue (39% vs. 14%), anemia (35% vs. 20%), peripheral sensory fungal, and new or reactivated viral infections can occur during and up to one year neuropathy (30% vs. 18%), infections (19% vs. 9%), pulmonary toxicity (18% vs. following the completion of Rituxan-based therapy. New or reactivated viral infections 10%), hepato-biliary toxicity (17% vs. 7%), rash and/or pruritus (17% vs. 5%), included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, arthralgia (12% vs. 3%), and weight gain (11% vs. 4%). Neutropenia was the only West Nile virus, and hepatitis B and C. Discontinue Rituxan for serious infections and Grade 3 or 4 adverse reaction that occurred more frequently (≥2%) in the Rituxan arm institute appropriate anti-infective therapy. [See Adverse Reactions.] Cardiovascular Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform compared with those who received no further therapy (4% vs. 1%). [See Clinical Studies.] DLBCLL In Studies 6 and 7, [see Clinical Studies] s the following adverse reactions, cardiac monitoring during and after all infusions of Rituxan for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina. [See regardless of severity, were reported more frequently (≥5%) in patients age ≥60 years receiving R-CHOP as compared to CHOP alone: pyrexia (56% vs. 46%), lung disorder Adverse Reactions.] Renal Severe, including fatal, renal toxicity can occur after Rituxan administration in patients with NHL. Renal toxicity has occurred in patients who (31% vs. 24%), cardiac disorder (29% vs. 21%), and chills (13% vs. 4%). Detailed experience tumor lysis syndrome and in patients with NHL administered concomitant safety data collection in these studies was primarily limited to Grade 3 and 4 adverse cisplatin therapy during clinical trials. The combination of cisplatin and Rituxan is not an reactions and serious adverse reactions. In Study 7, a review of cardiac toxicity approved treatment regimen. Monitor closely for signs of renal failure and discontinue determined that supraventricular arrhythmias or tachycardia accounted for most of Rituxan in patients with a rising serum creatinine or oliguria. Bowel Obstruction and the difference in cardiac disorders (4.5% for R-CHOP vs. 1.0% for CHOP). The Perforation Abdominal pain, bowel obstruction and perforation, in some cases leading following Grade 3 or 4 adverse reactions occurred more frequently among patients in to death, can occur in patients receiving Rituxan in combination with chemotherapy. In the R-CHOP arm compared with those in the CHOP arm: thrombocytopenia (9% vs. postmarketing reports, the mean time to documented gastrointestinal perforation was 6 7%) and lung disorder (6% vs. 3%). Other Grade 3 or 4 adverse reactions occurring (range 1–77) days in patients with NHL. Perform a thorough diagnostic evaluation and more frequently among patients receiving R-CHOP were viral infection (Study 7), institute appropriate treatment for complaints of abdominal pain. [See Adverse neutropenia (Studies 7 and 8), and anemia (Study 8). CLL The data below reflect Reactions.] Immunization The safety of immunization with live viral vaccines following exposure to Rituxan in combination with fludarabine and cyclophosphamide in 676 s The age range was Rituxan therapy has not been studied and vaccination with live virus vaccines is not patients with CLL in Study 9 or Study 10 [see Clinical Studies]. recommended. Laboratory Monitoring In patients with lymphoid malignancies, during 30–83 years and 71% were men. Detailed safety data collection in Study 9 was limited treatment with Rituxan monotherapy, obtain complete blood counts (CBC) and platelet to Grade 3 and 4 adverse reactions and serious adverse reactions. Infusion-related

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NEW YORK, NY NCCN 5th Annual Congress: Hematologic Malignancies www.nccn.org

adverse reactions were defined by any of the following adverse events occurring during or within 24 hours of the start of infusion: nausea, pyrexia, chills, hypotension, vomiting, and dyspnea. In Study 9, the following Grade 3 and 4 adverse reactions occurred more frequently in R-FC–treated patients compared to FC-treated patients: infusion reactions (9% in R-FC arm), neutropenia (30% vs. 19%), febrile neutropenia (9% vs. 6%), leukopenia (23% vs. 12%), and pancytopenia (3% vs. 1%). In Study 10, the following Grade 3 or 4 adverse reactions occurred more frequently in R-FC–treated patients compared to FC-treated patients: infusion reactions (7% in R-FC arm), neutropenia (49% vs. 44%), febrile neutropenia (15% vs. 12%), thrombocytopenia (11% vs. 9%), hypotension (2% vs. 0%), and hepatitis B (2% vs. <1%). Fifty-nine percent of R-FC–treated patients experienced an infusion reaction of any severity. Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The observed incidence of antibody (including neutralizing antibody) positivity in an assay is highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Rituxan with the incidence of antibodies to other products may be misleading. Using an ELISA assay, anti-human antichimeric antibody (HACA) was detected in 4 of 356 (1.1%) patients with low-grade or follicular NHL receiving single-agent Rituxan. Three of the four patients had an objective clinical response. The clinical relevance of HACA formation in Rituxan-treated patients is unclear. Postmarketing Experience The following adverse reactions have been identified during post-approval use of Rituxan in hematologic malignancies. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Rituxan. Hematologic: prolonged pancytopenia, marrow hypoplasia, and late-onset neutropenia, hyperviscosity syndrome in Waldenstrom’s macroglobulinemia. Cardiac:: fatal cardiac failure. Immune/ Autoimmune Events: uveitis, optic neuritis, systemic vasculitis, pleuritis, lupus-like syndrome, serum sickness, polyarticular arthritis, and vasculitis with rash. Infection: viral infections, including progressive multifocal leukoencephalopathy (PML), increase in fatal infections in HIV-associated lymphoma, and a reported increased incidence of Grade 3 and 4 infections in patients with previously treated lymphoma without known HIV infection. Neoplasia:: disease progression of Kaposi’s sarcoma. Skin: severe mucocutaneous reactions. Gastrointestinal: bowel obstruction and perforation. Pulmonary: fatal bronchiolitis obliterans and pneumonitis (including interstitial pneumonitis). DRUG INTERACTIONS Formal drug interaction studies have not been performed with Rituxan. In patients with CLL, Rituxan did not alter systemic exposure to fludarabine or cyclophosphamide. USE IN SPECIFIC POPULATIONS Pregnancy Category C: There are no adequate and well-controlled studies of rituximab in pregnant women. Postmarketing data indicate that B-cell lymphocytopenia generally lasting less than six months can occur in infants exposed to rituximab in-utero. Rituximab was detected postnatally in the serum of infants exposed in-utero. Non-Hodgkin’s lymphoma is a serious condition that requires treatment. Rituximab should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Reproduction studies in cynomolgus monkeys at maternal exposures similar to human therapeutic exposures showed no evidence of teratogenic effects. However, B-cell lymphoid tissue was reduced in the offspring of treated dams. The B-cell counts returned to normal levels, and immunologic function was restored within 6 months of birth. Nursing Mothers It is not known whether Rituxan is secreted into human milk. However, Rituxan is secreted in the milk of lactating cynomolgus monkeys, and IgG is excreted in human milk. Published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts. The unknown risks to the infant from oral ingestion of Rituxan should be weighed against the known benefits of breast-feeding. Pediatric Use The safety and effectiveness of Rituxan in pediatric patients have not been established. Geriatric Use Diffuse Large B-Cell NHLL Among patients with DLBCL evaluated in three randomized, active-controlled trials, 927 patients received Rituxan in combination with chemotherapy. Of these, 396 (43%) were age 65 or greater and 123 (13%) were age 75 or greater. No overall differences in effectiveness were observed between these patients and younger patients. Cardiac adverse reactions, mostly supraventricular arrhythmias, occurred more frequently among elderly patients. Serious pulmonary adverse reactions were also more common among the elderly, including pneumonia and pneumonitis. Low-Grade or Follicular Non-Hodgkin’s Lymphoma Clinical studies of Rituxan in low-grade or follicular, CD20-positive, B-cell NHL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. Chronic Lymphocytic Leukemia Among patients with CLL evaluated in two randomized active-controlled trials, 243 of 676 Rituxan-treated patients (36%) were 65 years of age or older; of these, 100 Rituxan-treated patients (15%) were 70 years of age or older. In exploratory analyses defined by age, there was no observed benefit from the addition of Rituxan to fludarabine and cyclophosphamide among patients 70 years of age or older in Study 9 or in Study 10; there was also no observed benefit from the addition of Rituxan to fludarabine and cyclophosphamide among patients 65 years of age or older in Study 10 [see Clinical Studies]. s Patients 70 years or older received lower dose intensity of fludarabine and cyclophosphamide compared to younger patients, regardless of the addition of Rituxan. In Study 9, the dose intensity of Rituxan was similar in older and younger patients, however in Study 10 older patients received a lower dose intensity of Rituxan. The incidence of Grade 3 and 4 adverse reactions was higher among patients receiving R-FC who were 70 years or older compared to younger patients for neutropenia [44% vs. 31% (Study 9); 56% vs. 39% (Study 10)], febrile neutropenia [16% vs. 6% (Study 9)], anemia [5% vs. 2% (Study 9); 21% vs. 10% (Study 10)], thrombocytopenia [19% vs. 8% (Study 10)], pancytopenia [7% vs. 2% (Study 9); 7% vs. 2% (Study 10)] and infections [30% vs. 14% (Study 10)]. OVERDOSAGE There has been no experience with overdosage in human clinical trials. Single doses of up to 500 mg/m2 have been administered in clinical trials. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to establish the carcinogenic or mutagenic potential of Rituxan or to determine potential effects on fertility in males or females. PATIENT COUNSELING INFORMATION Patients should be provided the Rituxan Medication Guide and provided an opportunity to read prior to each treatment session. It is important that the patient’s overall health be assessed at each visit and the risks of Rituxan therapy and any questions resulting from the patient’s reading of the Medication Guide be discussed. Rituxan is detectable in serum for up to six months following completion of therapy. Individuals of childbearing potential should use effective contraception during treatment and for 12 months after Rituxan therapy. Revised 02/2010 (4851501) Jointly Marketed by: Biogen Idec Inc. 5200 Research Place San Diego, CA 92122 Genentech USA, Inc. 1 DNA Way South San Francisco, CA 94080-4990 ©2010 Biogen Idec Inc. and Genentech, Inc. 7140919 February 2010

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ACROSS APPROVED CLL AND NHL INDICATIONS

DRIVING PATIENT OUTCOMES Supporting your central role in patient care

Resources to support pp yyour p patients with NHL and CLL Patients can talk to a nurse educator about RITUXAN, CLL, and NHL 24 hours a day, 7 days a week. Call the RITUXAN Support Center at (888) 455-2220. You, your patients, and their caregivers can turn to RITUXAN.com for additional resources and materials.

RITUXAN Access Solutions is committed to connecting your patients to RITUXAN, regardless of their ability to pay; for more information, please visit www.RituxanAccessSolutions.com.

Indications

Warnings and Precautions

RITUXAN (Rituximab) is indicated for the treatment of patients with: Previously untreated and previously treated CD20positive CLL in combination with fludarabine and cyclophosphamide (FC) Relapsed or refractory, low-grade or follicular, CD20positive, B-cell NHL as a single agent Weekly ×4

Weekly ×8

Bulky disease

Retreatment

Previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP chemotherapy Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after firstline CVP chemotherapy Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracyclinebased chemotherapy regimens RITUXAN is not recommended for use in patients with severe, active infections.

BOXED WARNINGS RITUXAN administration can result in serious, including fatal, adverse reactions. These include infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML)

RITUXAN can also result in serious, including fatal, adverse reactions. These include hepatitis B reactivation with fulminant hepatitis and hepatic failure resulting in death; other infections, including bacterial, fungal, new or reactivated viral infections; cardiovascular events; severe, including fatal, renal toxicity; and abdominal pain, bowel obstruction and perforation, in some cases leading to death

Additional Important Safety Information The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with NHL were infusion reactions, fever, lymphopenia, chills, infection, and asthenia. The most frequent Grade 3 or 4 adverse reactions observed in NHL were cytopenias, including lymphopenia The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with CLL were infusion reactions and neutropenia. Most patients treated with R-FC experienced at least one Grade 3 or 4 adverse reaction. The most frequently reported Grade 3 or 4 adverse reaction was neutropenia In clinical trials, CLL patients 70 years of age or older who received R-FC had more Grade 3 and 4 adverse reactions compared with younger CLL patients who received the same treatment

For additional safety information, please see following page for brief summary of full prescribing information, including BOXED WARNINGS. Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN infusion.

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