October 2010, Vol 3, No 7 by The Oncology Nurse

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OCTOBER 2010

www.TheOncologyNurse.com

VOL 3, NO 7

Breast Cancer Awareness Month CANCER CENTER PROFILE

Nurse Navigators Learn from Reducing Disparities in Cancer Care: Each Other St. Luke’s Mountain States Tumor First Annual Navigation and Survivorship Conference Helps Advance the Patient Navigation Profession

Institute Embraces NCCCP Pillar By Dawn Lagrosa

t. Luke’s Mountain States Tumor Institute (MSTI) provides advanced cancer care to patients at clinics in Boise, Fruitland, Meridian, Nampa, and Twin Falls, Idaho. Spanning more than 180 miles across southwestern Idaho, MSTI cares for patients from rural areas and from metropolitan areas. Because of geographic isolation, many people in rural areas present at later

stages of disease. In addition, large Hispanic populations in the rural counties of the state are not getting screened for cancers on recommended timelines. “Reduce cancer healthcare disparities” is the first of seven pillars with which National Cancer Institute Community Cancer Centers Program (NCCCP) sites are tasked. These inequalities of care Continued on page 20

BREAST CANCER

ore than 400 navigators came together for 2 days of education, networking, and professional development, all with the goal of improving oncology patient care and quality of life. At its First Annual Navigation and Survivorship Conference, the Academy of Oncology Nurse Navigators (AONN) welcomed all team members involved in these crucial aspects of patient care—nurses, social workers, lay navigators, navigation and survivorship program administrators—from throughout the country and around the world. From providing nurses with tips for incorporating best practices into their navigation to detailing procedures to prove the value and impact of navigation services to implementing survivorship clinics and navigation programs, the conference kept navigators engaged and interacting with the speakers and among themselves. From more than 50 nominations, the Academy recognized three outstanding programs and three nurse navigators for the contributions to the field. To read why they were chosen, see the Journal of Oncology Navigation & Survivorship (between pages 12 and 13).

In-depth coverage of the material presented will be available in a special issue of the Journal of Oncology Navigation & Survivorship and online at www.AONNonline.org.

Journal of Oncology

NAVIGATION & SURVIVORSHIP

™

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

www.AONNonline.org CONFERENCE NEWS

Launching the Navigation Program that Is Best for You. Part 2: Justifying Your Program

First Annual Conference Honors Excellence in Navigation

By Dawn Lagrosa

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

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

VOL 1, NO 5

GETTING STARTED

our cancer center offers patient navigation. You are guiding patients through the healthcare system, overcoming barriers as they present themselves. Regardless of the navigation model you are using, you will need to track and report clinical outcomes and the financial impact of patient navigation. You will have to show a return on investment, as well as sustainability and patient satisfaction. Most important—you will need to show that navigation is making an impact on the bottom line. Strategies to justify a navigation program were presented by a panel of nurses and administrators at the third annual Oncology Update of the American College of Oncology Administrators. Because each presenter’s navigation program was designed for its community’s specific needs, the outcomes measures tracked and the methods of doing so vary. Continued on page 2

FINANCIAL CHALLENGES

As a key part of the inaugural conference, the Academy presented the Excellence in Navigation & Survivorship Awards. Recognizing excellence in patient navigation and survivorship care, six recipients were selected from more than 50 nominations.

Navigator of the Year Lung Cancer Navigator of the Year— Laura Hunnibell, RN, MSN, ARNP, AOCN, of the Veterans Affairs (VA) Connecticut Healthcare System West Haven Campus works to develop and implement the navigator role, and assists her facility in improving the stage at diagnosis for patients with lung cancer. She speaks nationally and leads an advisory group to develop a standard position description for cancer care coordinators/navigators in the VA Healthcare System.

Oncology Social Workers Can Help Patients with Financial Challenges of Treatment inancial challenges are a key issue for patients with cancer and can interfere with treatment protocols and patient adherence. According to a study presented at the 2010 annual meeting of the American Society of Clinical Oncology, however, only about one third of patients turn to oncology social workers to help them overcome these barriers. In a collaborative project by Kelton Research, Los Angeles, and the Association of Oncology Social Workers (AOSW), Martin Eichholz and his associates surveyed newly diagnosed cancer patients, caregivers, and AOSW members about the financial impact of cancer treatment. Surveys were completed Continued on page 2

Inside Breast Cancer Support Groups Helpful for Young Breast Cancer Patients Page 10

Gastrointestinal Cancer Navigator of the Year—Julie Pope, RN, BSN, of the Derrick L. Davis Forsyth Regional Cancer Center, Winston-Salem, North Carolina, empowers patients and their families with knowledge about their care and resources. In addition, she supports them through her caring and compassion.

By Karen Rosenberg

Journal of Oncology Navigation & Survivorship™

Breast Cancer Navigator of the Year—Susan Bowman, RN, OCN, MSW, of Wellspan Health at York Cancer Center, York, Pennsylvania, has been a nurse navigator for nearly 10 years. She offers information, support, and clinical coordination for her patients. She has also extended her role into survivorship care by developing a curriculum to support survivors with their lifelong recovery process. Continued on page 2

GUIDE OUR PATH Start a Local, State, or Regional Affiliate, Join a Committee

between pages 12 and 13

Managing Metastatic Breast Cancer Patients Page 14

Reconstructive Surgery for Patients with Cancer Part 1: Breast Reconstruction By Deena Damsky Dell, MSN, RN-BC, AOCN; Linda Schiech, MSN, RN, AOCN-R Clinical Nurse Specialists, Fox Chase Cancer Center, Philadelphia

s early as 3000 BC, descriptions can be found on Egyptian papyruses documenting reconstructive techniques used by priest doctors to restore altered appearances to normality. The upper echelons of Egyptian society placed great importance on appearance, and this seems to have been the stimulus for development of modern-day plastic surgery. From a beginning of simply reducing fractures and transferring local skin,

plastic surgery today encompasses free-tissue transfers and microvascular surgery, allowing great strides in the ability to restore not only appearance but function as well.1 In patients with cancer, the goals of reconstructive surgery are to allow for adequate resection of tumor with clear margins, facilitate initiation of adjuvant therapy, maximize quality of life by improving function and esthetics, and Continued on page 8

Identifying Newly Diagnosed Individuals with Breast Cancer at Risk for Hereditary Breast Cancer

Fostering a Dialogue to Improve Patient Care & Outcomes

Page 34

Continuing Education Bar Coding: An Eﬀective Strategy for Preventing Medication Errors Page 40

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.

News Notes Patient Navigators Discuss Enhancing their Profession “The largest ever gathering of patient navigators was a major step in institutionalizing best practices and empowering attendees to implement changes to improve patient care,” said Sean T. Walsh, executive director, Academy of Oncology Nurse Navigators. The First Annual Navigation and Survivorship Conference covered all aspects of navigation— program implementation and maintenance, proving value, community outreach, and survivorship care—and was geared to all types of navigators— nurses, social workers, lay persons. Breakout sessions on prostate, lung, breast, and gastrointestinal cancers focused on the specific challenges in providing optimal patient care. Through interactive discussions and learnings from panels of experts, attendees sought ways to expand and enhance the role of navigation in all cancer types. Afterward, 55% of attendees indicated that expanding the scope of their program was the number one priority.

Final Rule on Safety Information During Clinical Trials The US Food and Drug Administration issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. The rule requires certain safety information that previously had not been required to be reported: • Findings from clinical or epidemiologic studies that suggest a significant risk to study participants • Serious suspected adverse reactions that occur at a rate higher than expected • Serious adverse events from bioavailability studies.

NCCN Guidelines for Patients The National Comprehensive Cancer Network (NCCN) offers a series of NCCN Guidelines for Patients, consumer-friendly translations of the NCCN Clinical Practice Guidelines in Oncology. The first two guidelines released cover breast and lung cancers. “While there are a number of good resources available to these women, only the NCCN Guidelines for Patients provide the level of highly specific, current information that patients want and need,” said Diana Rowden, Survivorship and Outcomes Vice President at Susan G. Komen for the Cure, which supported the breast cancer guidelines through grant funding. “When my sister, Dana, was diagnosed with lung cancer, I assumed, as a physician, that we would be able to find the information we needed to sort through all the various treatment options,” said Deborah Morosini, MD, sister of Dana Reeve, for whom the lung cancer guidelines are named. “It turned out to be much more difficult than I thought. These guidelines will fill a huge gap for patients and the people who are supporting them and will be an incredibly valuable tool in making them more knowledgeable partners in their own treatment.” The NCCN Guidelines for Patients are available at NCCN.com, which also features enhanced content for patients and caregivers. ●

OctOber 2010 I VOL 3, NO 7

TON_October 2010_v6_TON 10/15/10 2:58 PM Page 4

Editorial Board EDITOR-IN-CHIEF

Sharon S. Gentry,

Kena C. Miller,

Rita Wickham,

Beth Faiman,

RN, MSN, AOCN

RN, MSN, FNP

OCN, PhD, RN

RN, MSN, APRN, BC, AOCN

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

Roswell Park Cancer Institute Buffalo, NY

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

Cassandra J. Hammond, RN,

Patricia Molinelli,

Karla Wilson, RN,

Cleveland Clinic Taussig Cancer Institute Cleveland, OH

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

MS, RN, APN-C, AOCNS

MSN, FNP-C, CPON

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Avid Education Partners, LLC Sharpsburg, MD

Somerset Medical Center Somerville, NJ

City of Hope National Medical Center Duarte, CA

Catherine S. Bishop, DNP, NP,

Shannon Hazen,

Dolores “Jeff” Nordquist, RN, MS,

Pharmacy John F. Aforismo,

AOCNP

Novant Health Presbyterian Cancer Center Chapel Hill, NC

CS, FNP

Hematology-Oncology Associates of Fredericksburg Fredericksburg, VA

BSc Pharm, RPh, FASCP

Deena Damsky Dell, RN, MSN,

Patricia Irouer Hughes, RN, MSN,

Melinda Oberleitner, RN,

Nutrition Karen Connelly,

MSN, CRNP

RN, BSN, OCN

Mayo Clinic Rochester, MN

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

AOCN, BC

BSN, OCN

DNS, APRN, CNS

RD, CSO

Fox Chase Cancer Center Philadelphia, PA

Piedmount Healthcare Rex, GA

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

Somerset Medical Center Somerville, NJ

Wendy DiSalvo,

Taline Khoukaz,

Gary Shelton,

DNP, APRN, AOCN

NP, MSN, ACNP-C

Genentech New London, NH

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

MSN, ARNP, AOCN

Patient Advocate Peg Ford

Denice Economou, RN,

Sandra E. Kurtin,

Lori Stover, RN,

RN, MS, AOCN, ANP-C

BSN

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

Arizona Cancer Center Tucson, AZ

Constance Engelking, RN,

Elizabeth Lima,

MS, CNS, OCN

Cleveland Clinic Taussig Cancer Institute Cleveland, OH

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

PA-C

Coronado, CA

NYU Cancer Institute New York, NY

Social Work Carolyn Messner,

Western Pennsylvania Cancer Institute Pittsburgh, PA

DSW, MSW, LCSW-R, BCD

Pamela Hallquist Viale, RN, MS,

Managed Care and Pharmaceutical Management Burt Zweigenhaft,

CS, ANP, AOCN Saratoga, CA

CancerCare New York, NY

BS BioPharma Partners LLC New York, NY

Amy Ford, RN,

Ann McNeill,

Connie Visovsky,

Isabell Castellano, RN

BSN, OCN

MSN, RN, NP-C, OCN

RN, PhD, APRN

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

Innovex Dallas, TX

The Cancer Center at Hackensack University Medical Center Hackensack, NJ

University of Nebraska College of Nursing Omaha, NE

Jeanne Westphal, RN Meeker County Memorial Hospital Litchfield, MN

OctOber 2010 I VOL 3, NO 7

www.theOncologyNurse.com

TON_October 2010_v6_TON 10/15/10 2:58 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

To learn more about Balloon Kyphoplasty, visit our website at www.kyphon.com.

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_October 2010_v6_TON 10/18/10 10:07 AM Page 6

FROM THE EDITOR PUBLISHING STAFF Publisher Philip Pawelko phil@greenhillhc.com

e’re going pink this month in recognition of National Breast Cancer Awareness Month and our continuing commitment to providing our readers with up-to-date information on this still overwhelming problem. A recent survey showed that 43% of women who are candidates for reconstruction after breast cancer Beth Faiman, RN, surgery are not informed about their MSN, APRN, options at the time of diagnosis. BC, AOCN The article by Deena Damsky Dell Editor-in-Chief and Linda Schiech in this issue describes the many types of breast reconstruction surgery now available, and women need

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

to be informed about for them so that they can make informed decisions about treatment. The Patient’s Voice article profiles two young breast cancer patients who decided early on to take a proactive role in their own treatment and are now working hard to share the knowledge they gained with other women. New medical therapies have become available recently too. The Clinical Nursing Review by Una Hopkins provides detailed guidance on educating and managing patients treated with one of the newer breast cancer agents, ixabepilone. Provisions of the Affordable Care Act will make breast cancer screening and treatment available to a greater number of people. We hope the articles in this issue will help you provide the information and guidance your patients need. ●

Circulation Department circulation@greenhillhc.com Editorial Contact: Telephone: 732-992-1891 Fax: 732-656-7938

CONTENTS

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The Oncology Nurse®-APN/PA, ISSN 1944-9798 (print); ISSN 1944-9801 (online) 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. EDITORIAL CORRESPONDENCE should be

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.

OcTOber 2010 I VOL 3, NO 7

THE PATIENT’S VOICE

10 Young breast cancer patients find support

OcTOber 2010 • VOL 3, NO 7 NURSING EDUCATION AND TRAINING

44 Doctor of Nursing Practice: an oncology

groups good source of information, advice

nurse practitioner’s journey Residency programs for nurses surging in popularity

CLINICAL NURSING REVIEW

14 Managing metastatic breast cancer patients treated with ixabepilone: practical guidance

BREAST CANCER

46 Targeted intraoperative radiotherapy may be as good as whole breast radiotherapy at reducing breast cancer recurrence

LUNG CANCER

28 In metastatic NSCLC, early palliative care improves survival as well as QOL

HEMATOLOGIC CANCERS

28 New “tip sheets” help NHL patients communicate with the oncology team 29 More cycles of decitabine equals better MDS outcomes

DEPARTMENTS

3 22 30 38 48 49

News Notes Oncology Drug Codes International News Recent FDA Approval Nursing Life Meetings

GENETICS

34 Identifying newly diagnosed individuals with breast cancer at risk for hereditary breast cancer 34 Genetic profiling changing clinical practice in some areas of oncology

NURSING PRACTICE

36 Split scheduling for chemotherapy increases efficiency, reduces costs

CONTINUING EDUCATION

40 Bar coding: an effective strategy for preventing medication errors SUPPORTIVE CARE

42 Palonosetron demonstrates benefits over other 5-HT3 receptor antagonists in lung cancer patients

Journal of Oncology

NAVIGATION & SURVIVORSHIP

™

The Official Journal of the Academy of Oncology Nurse Navigators ®

Between pages 12 and 13 FEATURE ARTICLES

1 Launching the navigation program that is best for you. Part 2: justifying your program 1 Oncology social workers can help patients with financial challenges of treatment 1 First annual conference honors excellence in navigation 4 Targeting young survivors

www.TheOncologyNurse.com

TON_October 2010_v6_TON 10/15/10 2:58 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_October 2010_v6_TON 10/15/10 2:58 PM Page 8

Breast Cancer Reconstructive Surgery for Patients with Cancer... Continued from cover minimize donor site complications. Therefore, considerations for timing and type of reconstruction include patient age, sex, and body habitus; tumor stage and prognosis; functional status of patient; available donor sites; and psychosocial state. The patient de fect should be matched with the most appropriate reconstructive methods. Part 1 of this article will focus on breast reconstruction surgery. Breast reconstruction In 2007, only 29.3% of patients in California undergoing mastectomy had reconstructions. Insurance status (public), race (African American), and hospital type (community) are all significant limiting factors.2 Surgical options for breast reconstruction include the use of tissue expanders, implants, and autologous tissue. Reconstruction can be done at the time of the mastectomy or after completion of cancer treatment. The goal is to produce symmetry by matching the remaining breast in contour, dimension, and position. Even the best reconstruction, however, cannot replace the natural breast. In general, implant-based reconstructions require less surgery initially but have limitations and are not always trouble free. Quality of long-term results is directly related to implant tolerability. The esthetic results from autologous reconstruction are considered superior because of their versatility, more natural appearance, and durability. They can also better withstand radiotherapy.3 Contraindications to breast reconstruction include uncontrolled and nonresectable chest wall disease, rapidly progressing systemic disease, serious comorbidity, and psychological instability. Relative contraindications are smoking and obesity (body mass index

>30-35). The National Comprehensive Cancer Network guidelines state that “Smoking increases the risk of complications for all types of reconstruction… patients should be made aware of the increased rates of wound healing complications and partial or complete flap failure among smokers.”4 The best cosmetic result is achieved with a skin-sparing mastectomy (SSM). This procedure takes only the skin that must be removed to prevent cancer recurrence: the nipple, areola, and biopsy sites. The incision is smaller, and the resulting skin tone is more even. Evidence suggests that the risk of local and regional recurrence with SSM is equivalent to that with traditional mastectomy when performed by an experienced breast surgeon.4 Some surgeons are performing nipple-areolar complex (NAC)-sparing mastectomies, but current data are insufficient to support their use in oncologic

Linda Schiech, MSN, RN, AOCN-R

surgery.4 Nipple function is not salvaged in these procedures. Tissue expansion/implant reconstruction In this simple method of reconstruction, an inflatable silicone balloon (the

Photograph courtesy of Neal Topham, MD.

Figure. Free TRAM Flap Breast Reconstruction

OctOber 2010 I VOL 3, NO 7

Table Circulatory Assessment of Reconstructed Flap Venous circulation occlusion Redness and dusky Rapid; <1 second

Arteriole circulation occlusion Pale or mottled Slow; >3 seconds

Clinical assessment Color Time for capillary refill

Normal assessment Pink 1-3 seconds

Doppler reading

Positive for normal Weak or absent arterial circulation; Doppler reading positive for normal venous circulation

Weak or absent Doppler reading

Temperature

Warm

Warm to cool

Cool

Flap or tissue fullness

Full

Swollen or taut

Depressed or hollow

Sources: References 13 and 14.

expander) is placed in a submuscular pocket deep to the pectoralis major muscle. The expander is only partially inflated when inserted to allow safe closure of the overlying muscle and skin. It is expanded by a series of postoperative saline injections. The “fills” start 1 to 4 weeks postoperatively and are done every 1 to 2 weeks until the desired size is reached. Reconstruction can be done in a one-stage surgery if a combination volume expander–implant is placed. Most surgeons, however, believe that a better cosmetic result is achieved if the tissue expander is replaced by a permanent implant in a second outpatient procedure. Alternatively, surgeons may be able to insert a fixed-volume implant without an expander in some small-breasted women. Acellular dermal matrix (ADM) can be used to support expanders or implants, which allows more volume to be instilled at the time of mastectomy. This process allows some patients to bypass the use of an expander and others to receive fewer fills.5,6 Operating time for the initial surgery is short, approximately 1 hour. Hospital stay is between 1 and 3 days. Candidates for this type of reconstruction are women with small nonptotic breasts; those having bilateral reconstruction; those who will accept a mastoplexy procedure on the opposite breast if necessary; those who desire minimal scarring; and those unable to tolerate extensive surgery. Contraindications include chest wall tissues that are thin or damaged, radical mastectomy, and extensive infraclavicular tissue deformity. The main complications are capsular contraction, implant rupture, and wound infections. Recovery time is generally 4 to 6 weeks.7,8 The US Food and Drug Administration has approved four breast implants. Two of these are silicone implants that were approved in 2006 for breast reconstruction in women of any age. All other silicone implants, including the more cohesive “gummy bear” implants, are considered investigational devices,

and women must be enrolled in a clinical trial to receive them.7 Postoperatively, patients will have one or two drains and moderate pain, fatigue, and discomfort. Each surgeon has his or her individual preferences, but generally patients are told not to lift more than 5 lb for 4 weeks and not to raise the arm above the shoulder or reach straight out to the side for 1 to 2 weeks. It is also important for patients to know that they should not undergo magnetic resonance imaging while the expander is in place because in most devices the ports are metal. Autologous reconstruction Musculocutaneous flaps, which consist of a segment of vascularized muscle with the overlying skin and fat, form the foundation for autologous reconstructions (Figure). In pedicle flaps, the vascular origin remains intact, so a microvascular surgeon is not required for the procedure. Two types of pedicle flaps are used in breast reconstruction. The latissimus dorsi (LD) flap contains the thoracodorsal artery and vein and is tunneled under the axilla to create a breast mound. It may be combined with an implant to create a larger breast. The transverse rectus abdominis myocutaneous (TRAM) pedicle flap contains the entire rectus muscle and the superior epigastric artery and vein. It is tunneled under the skin and subcutaneous tissue of the diaphragm.9,10 Free flaps require a microvascular surgeon. This flap is harvested along with its blood supply. The flap’s artery and vein are then anastomosed to local vessels in the breast by microvascular techniques. Less muscle is used, resulting in less donor site morbidity (hernias, bulging, abdominal weakness). Although a free TRAM flap is the most common, the transverse upper gracilis free flap is another option. Skilled microvascular reconstructive surgeons are now performing perforator flaps. These flaps harvest the blood vessels that traverse the muscle and perforate the fascia to supply the skin and fat above

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Breast Cancer it. No muscle is removed. Perforator flaps can use the deep inferior epigastric perforator (DIEP) artery, the superficial inferior epigastric artery, the superior gluteal artery, and the inferior gluteal artery. Stacked DIEP flaps can be used to create a very large breast mound.11,12 Operating time for these surgeries is 4 to 8 hours per breast. Perforator flaps take the most time. Hospitalization is usually 3 days with an LD flap and 4 to 5 days with the other flaps. Candidates are women who desire a breast mound with a more natural appearance and texture; want to match a large ptotic breast; have sufficient donor tissue; and are healthy enough to tolerate a longer operating time and a more strenuous recovery. Contraindications include lack of trained nursing staff to monitor for vessel thrombosis, previous liposuction or surgery to donor site, active smoking (within 1 month), and, possibly, diabetes and obesity. Major complications include flap loss (2%-3% for high-volume surgeons), flap necrosis, abdominal hernia, and infections. Recovery time is generally 6 to 8 weeks.5,8,11,12

structed first. Nipple placement is extremely important in producing a satisfying outcome. Nipple reconstruction is most commonly accomplished by a local flap. The surgeon elevates one or two flaps of skin and fat from the breast mound to create a projecting hub. The donor sites are generally closed by suturing the opposing edges together. A major

problem can be loss of projection over time, so some surgeons will use an ADM injection or a piece of rib to maintain projection over time.5,8 The reconstructed nipple needs to be protected and supported for about 2 weeks. A standard maternity plastic nipple shield, a plastic medicine cup, or the last inch of a 10-mL syringe can be secured with tape over the

nipple to protect it. Areola reconstruction can be done via a full-thickness skin graft. However, this is painful and expensive. Excellent results are obtained today by tattooing, because of the wide variety of pigments available. This quick and simple process has minimal morbidity. In fact, it has been reported that in a skilled

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Postoperatively, it is important to check the flaps for perfusion (Table).13,14 Free flaps require hourly checks initially, whereas pedicle flaps can be checked every 4 hours. Patients having abdominal flaps are kept in a flexed position postoperatively to prevent strain on the abdominal incision. This position plus surgical tightening of the abdominal wall may result in diaphragmatic restriction and the potential for ineffective gas exchange, making pulmonary toilet very important. Adequate hydration is necessary to ensure adequate perfusion of the flap. If the patient becomes hypotensive, fluid boluses, not vasopressors, should be used. Tightness, pulling, numbness in abdominal and rib cage areas, and back pain are common complaints in addition to postoperative mastectomy pain.9,15

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NAC reconstruction NAC reconstruction leads to increased patient satisfaction with the results. It is usually a secondary procedure performed 2 to 3 months after the initial surgery. This allows time for the swelling to subside and the breast mound to “settle.” The nipple is recon-

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-B 06/10

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Continued on page 10

Making Access easier.

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OcTOber 2010 I VOL 3, NO 7

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The Patient’s Voice

Young Breast Cancer Patients Find Support Groups Good Source of Information, Advice By Karen Rosenberg

fter coping with the initial shock of a cancer diagnosis, many women decide to take a proactive approach and seek sound information and advice so that they can make informed decisions about their healthcare. The Oncology Nurse recently spoke with two young women who found that support groups were a valuable resource for obtaining information and forming bonds with other patients and survivors. One went on to create her own group to help women with specific needs she felt were not being met based on her own experience.

lump in her breast, she was diagnosed with stage II breast cancer. Sharishta was grateful that her doctor took her concerns seriously, took immediate action, and helped coordinate her treatment. But right from the start, she felt it was important to take a proactive role in her care. She researched the disease and the treatment options and interviewed oncologists and surgeons until she found ones who she felt were the right fit. “I had a gut feeling that I should see different doctors. I learned that getting multiple opinions is essential for making the correct treatment decision,” she says. “These were doctors Breast reconstruction that I was going to be workan option for some ing with very closely for quite Sharishta Shourie was a long time. I was able to find just 25 years old when she doctors that I knew I would detected a lump in her be able to work with and right breast on self-examiwould provide the informanation. She consulted her tion I needed.” Sharishta Shourie primary care physician, In addition to her own who arranged referrals to a medical research and the information provided oncologist and surgical oncologist. Less by her doctors, Sharishta learned a lot than a month after she detected the about the disease and the available

Reconstructive Surgery for Patients with Cancer... Continued from page 9 tattoo artist’s hands, a 3-dimensional NAC can be created. Summary Breast reconstruction can maximize quality of life for patients who have undergone mastectomy. The patient and the healthcare team has numerous options for reconstruction, which can improve appearance, increase functional ability, and enhance patient well-being. ● References 1. Lin SJ, Rabie AN. Head and neck cancer—reconstruction. March 9, 2009. emedicine.medscape.com/arti cle/1289799-overview. Accessed September 15, 2010. 2. Holt A, Duan L, Hendersen K, et al. Disparities in reconstruction rates after mastectomy. Presented at: American Society of Breast Surgeons Proceedings 2010; April 28, 2010; Las Vegas, NV. 3. Berry T, Brooks S, Sydow N, et al. Complication rates of radiation on tissue expander and autologous tissue breast reconstruction. Presented at: American Society of Breast Surgeons Proceedings 2010; April 28, 2010; Las Vegas, NV. 4. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Breast Cancer. V.2.2010. www.nccn.org/professionals/physician_gls/PDF/ breast.pdf. Accessed September 15, 2010. 5. Weiler-Mithoff E. Breast reconstruction. In: Dixon JM, ed. Breast Surgery. The Netherlands: Elsevier Limited; 2006:117-132. 6. Sbitany H, Sandeen S, Amalfi A, et al. Acellular dermis-assisted prosthetic breast reconstruction versus sub-

OctOber 2010 I VOL 3, NO 7

muscular coverage: a head-to-head comparison of outcomes. Plast Reconstr Surg. 2009;124:1735-1740. 7. US Food and Drug Administration. Breast implant questions and answers. May 20, 2009. www.fda.gov/ MedicalDevices/ProductsandMedicalProcedures/Implant sandProsthetics/BreastImplants/ucm063719.htm. Accessed September 15, 2010. 8. Wilkins E, Atisha D. Breast reconstruction in women with breast cancer. May 2010. www.uptodate.com/online/ content/topic.do?topicKey=br_surg/2258&selectedTitl=1 %7E63&source=search_result. Accessed September 15, 2010. 9. Dell DD, Weaver C, Kozempel J, Barsevick A. Recovery after transverse rectus abdominis myocutaneous flap breast surgery. Oncol Nurs Forum. 2008;35:189-196. 10. Kim J, Bullocks JM, Armenta A. Breast reconstruction, latissimus flap. June 15, 2009. emedicine.com/plas tic/topic137.htm. Accessed September 15, 2010. 11. Granzow JW, Levine JL, Chiu ES, Allen RJ. Breast reconstruction using perforator flaps. J Surg Oncol. 2006;94:441-445. 12. Horton KM. Reconstruction of the breast after cancer: an overview of procedures and options. www.breast cancerawareness.com/files/BreastCancerAwareness.com _Reconstruction%20of%20the%20Breast%20Afte% 20Cancer_An%20Overview.pdf. Accessed September 15, 2010. 13. Nahabedian MY. Flaps, free tissue transfer. July 7, 2010. emedicine.medscape.com/article/1284841-over view. Accessed September 15, 2010. 14. Flint PW, Haughey BH, Lund VL, et al. Free tissue transfer. In: Cummings Otolaryngology: Head & Neck Surgery. 5th ed. Philadelphia, PA: Mosby; 2010. 15. Dell D. Postoperative recovery after TRAM flap surgery. Perspectives: Recovery Strategies from the OR to Home. 2004;5:1-8.

Part 2 of this article will focus on surgery for head and neck cancer reconstruction.

there. She set out to inform herself about the disease and the available treatments by reading about it and talking to friends and relatives. She sought out several support groups but found that she was always one of the youngest people in the group and, unlike most of the others she met there, had had a lumpectomy instead of a mastectomy or double mastectomy. “I noticed there were some differences in what was being talked about, and how I was feeling versus how they were feeling and different questions that I wanted to have answered that the women in the support group couldn’t answer.” She came up with the idea for an online forum that would allow a woman to search a database and connect with a survivor who had a similar breast cancer profile or had had her specific type of treatment. “That’s how Pink-Link was born [www.pink-link.org]. The initial thought behind it was to be able to have survivors connect with each other, online, 24/7, on their own.” She points out that although there are other supports that will match patients and survivors, with “Pink-Link it is the survivor herself that’s searching the database, viewing other members’ profiles, and then deciding who she wants to connect with.” Pink-Link is a nonprofit membership-based organization and its services are free to members. Vicki explains that “a member can set up their personal journal and have it completely private so she can use it as a diary or it can be public to Pink-Link members. It can also be password protected so that she can give that password to family and friends and they can log on to Pink-Link and read her entries. So if she wants to keep them updated on a weekly basis, she can do that.” In addition, five experts donate their time to run forums that answer members’ questions about nutrition, physical exercise, skin care, lymphedema, and holistic health. Since the group was started 4 years ago, about 4000 members have signed up and more than 1000 connections have been made. Vicky hopes one day to have a Pink-Link conference so that members can meet in person and to set up similar sites for patients with other kinds of Vicki Tashman cancers. ●

treatment options from the women she met through the West Los Angeles affiliate of the Cancer Support Community (CSC). She joined a breast cancer support group and soon formed strong bonds with the patients and survivors she met there. “As much as family and friends are there for you, there is something unique about having a conversation with a woman who understands exactly what you’re going through, who understands the fears and the questions. There’s a unique bond that we all share,” she says. Sharishta found that being diagnosed with breast cancer was “like having a second full-time job.” She explains, “You’re busy making appointments dealing with the insurance, doing research, and talking with the doctors. It’s very time-consuming and very draining. I was lucky to have the women in the support group who I could ask questions and go to for support.” Sharishta’s surgeon referred her to a breast reconstruction surgeon, and she ultimately decided on a bilateral mastectomy followed by breast reconstruction. She’s learned from other women, however, that not everyone is given enough information about reconstruction options to make an informed decision, as was shown in a recent CSC survey. She thinks that Frankly Speaking about Cancer: Spotlight on Breast Reconstruction, a CSC educational program being launched in January with support from Mentor Worldwide, LLC, in 2011 will help to fill this gap (www.cancersupportcom munity.org). “Lots of factors go into deciding what options are right for any particular patient, and knowing up front what doctors are able to do is hugely important,” she says. Sharishta is doing well 1 year after her diagnosis and she continues her involvement with the West Los Angeles affiliate of CSC, working to raise awareness of breast cancer and to empower women to take an active part in their treatment. Pink-Link grows out of personal experience Vicki Tashman was 44 years old when her breast cancer was detected on a routine mammogram 6 years ago. Like Sharishta, she consulted several surgeons until she found the one she felt most comfortable with. And also like Sharishta, she did not stop

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

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

First and only FDA approved treatment for anthracycline extravasation. Supplied as a convenient and accessible complete three day treatment kit for single patient use, which should be proactively stocked on-site and infused as soon as possible and within 6 hours of an anthracycline extravasation. Demonstrates 98% overall efficacy based on two biopsy-confirmed clinical trials1,2 in reducing or avoiding surgical intervention (i.e., surgical debridement, plastic surgery and their related costs), thereby reducing postponement of a patient’s chemotherapy treatments and the avoidance of long-term consequences. Cited in nursing guidelines.3,4 Extravasation management is now a chemotherapy administration safety standard.5

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

Mouridsen HT et al. Treatment of anthracycline extravasation with savene (dexrazoxane). Results from two prospective clinical multicentre studies. Ann Oncol 2007; 18:546-550. 2 Totect® package insert. 3 Polovich M, White JM, Olsen, M (eds.). Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (ed 3). Pittsburgh, PA, Oncology Nursing Society, 2009. 4 Alexander M, Corrigan A, Gorski L, Hankins J, Perucca R. (eds). Infusion Nurses Society Infusion Nursing an Evidence-Based Approach (ed 3). Boston, MA, Infusion Nurses Society, 2009. 5 Jacobsen J., et al. American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards. Oncology Nursing Forum, 2009; 36:651-658. © 2010 Topotarget USA. All rights reserved. TOT0112/7-10 Totect and its logo mark are registered trademarks of Topotarget A/S 10:55:02 AM

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Totect® – Brief prescribing information Please refer to the package insert for full prescribing information. Each Totect carton contains 10 vials of Totect® (dexrazoxane for injection) 500 mg and 10 vials of 50 mL diluent. Indication: Treatment of extravasation resulting from IV anthracycline chemotherapy. Dosage and administration: 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.

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

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

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

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Journal of Oncology

NAVIGATION & SURVIVORSHIP

™

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

www.AONNonline.org GETTING STARTED

CONFERENCE NEWS

Launching the Navigation Program that Is Best for You. Part 2: Justifying Your Program

First Annual Conference Honors Excellence in Navigation

By Dawn Lagrosa

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

VOL 1, NO 5

FINANCIAL CHALLENGES

Oncology Social Workers Can Help Patients with Financial Challenges of Treatment

By Karen Rosenberg

inancial challenges are a key issue for patients with cancer and can interfere with treatment protocols and patient adherence. According to a study presented at the 2010 annual meeting of the American Society of Clinical Oncology, however, only about one third of patients turn to oncology social workers to help them overcome these barriers. In a collaborative project by Kelton Research, Los Angeles, and the Association of Oncology Social Workers (AOSW), Martin Eichholz and his associates surveyed newly diagnosed cancer patients, caregivers, and AOSW members about the financial impact of cancer treatment. Surveys were completed Continued on page 2

GUIDE OUR PATH Start a Local, State, or Regional Affiliate, Join a Committee

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Launching the Navigation Program that Is Best for You... Continued from cover Regardless of the model of navigation implemented, it is important to measure the program’s impact, noted Bonnie Miller, RN, BSN, OCN, administrative director of the Women’s Cancer Center at Fox Chase, Philadelphia, who chaired the panel. Miller began the presentation by listing the basic measures that will help reveal the impact of a navigation program. The other presenters provided more detail on how such measures can be tracked. Miller noted that tracking need not be difficult; it can be done in an Excel spreadsheet or through navigation software, such as Nursenav Oncology. Miller listed the basic measures they capture at Fox Chase. • Improvement in coordination of care • Enhancement of access to service for patients • Barriers removed • Outcomes improved • Resources shared, internal or external • Enhancement of relationships within the community • Increase in referrals into the system. Fox Chase also tracks:

be navigated, which needs to be identified up front • Education provided • Barriers and their resolutions.

“Regardless of the model of navigation implemented, it is important to measure the program’s impact.” —Bonnie Miller, RN, BSN, OCN

• Demographics, looking at stage and diagnosis • Whether appointments are laid down, kept or missed and why, and whether the navigators have an impact in that • Whether patients accept navigation, as some patients don’t want to

First Annual Conference Honors Excellence in Navigation Continued from cover

Outstanding Community Outreach Initiative Lynn Lutwin, BSN, MA, OCN, CBCN, of Steeplechase Cancer Center at Somerset Medical Center, Somerville, New Jersey, raises awareness among senior citizens about the importance of screening mammograms even later in life. Her “Pink Parties” were a great success and are being conducted for a second year.

Outstanding Survivorship Initiative The Survivor PLACE (Programs for Living After the Cancer Experience) initiative of Lehigh Valley Health Network in Allentown, Pennsylvania, provides multidisciplinary care in the form of a clinic and enables survivors to visit with a variety of allied healthcare professionals. Kathleen Sevedge, BSN, MA, AOCN, accepted the award on behalf of the team, which continues to strive to provide superior survivorship care for all those in their area affected by cancer.

Outstanding Program Saint Thomas Health Services Centers for Breast Health Nurse Navigation in Nashville, Tennessee, continues to grow in its ability to provide care for breast cancer patients and acts as a model for those beginning other navigation programs. The award was accepted by Kim Parham, RN, BSN, CBPN.

OctOber 2010 I VOL 1, NO 5

ume climbing, we look at the level of navigation,” said DeAntonio. What they found is that as volume increased, the time a navigator can spend with each patient has decreased. PCMH is not just Pitt County Memorial Hospital tracking this information because it Greenville, North Carolina can. DeAntonio is using the informaAt Pitt County Memorial Hospital tion to keep the program on target. “In (PCMH), part of University Health these tight economic times, my goal is Systems of Eastern Carolina, patient to maintain a level of service and supsatisfaction, physician satisfaction, and port that helps to meet the needs of the patient volume are used to gauge the patient, so we’re currently looking at program’s success at reaching its main how a navigator functions and whether goals: improved illness status, im- there are some duties that can be deleproved coordination of services for gated even more to social workers, patients, increased patient other clinical staff, or addiadaptation to their illness, tional secretarial and regisand timelier delivery of tration support.” services, explained Phyllis Some outcome measures DeAntonio, RN, MSN, are captured and used to FAAMA, the cancer servbenchmark PCMH’s proices administrator who pregram against others. These sented the outcome measinclude referrals to the canures used at her center. cer program because of the PCMH has 861 licensed patient navigator, and in beds and serves a 29-counthe future, looking at time Phyllis DeAntonio, ty referral area. The navireductions from mammoRN, MSN, FAAMA gation program DeAntonio gram to biopsy and then discussed serves gynecology and breast from biopsy to surgery. cancer patients. Financial measures Quality measures Other measures are tracked annually A patient satisfaction survey is to show PCMH’s administration the mailed semiannually with a self- return on investment for the navigator addressed envelope. DeAntonio recom- position. Most important is to look at mended making the survey as simple as the underinsured and uninsured, and possible. “We use a scale from 1 to 5. It whether state-based or federally funded asks the patient how well the nurse nav- programs helped cover the cost of their igator addressed or listened to their con- treatment, according to DeAntonio. cerns and provided them with informa- “Our navigator does an excellent job tion about their diagnosis and treatment with trying to link patients with these and any support groups and programs. It programs.” In addition, the program also asks how well the navigator man- tracks each patient’s length of stay in aged side effects if any, and worked as a the hospital, charges, costs, and payliaison between them and the physicians. ments to note how the navigator’s The patients also are asked to rate the efforts connected with coordination of nurse navigator overall and how they care correlate to decreased length of think their navigator helped them to stay, keeping patients out of the emercope better with these treatments. Then gency department, and preventing we ask an open-ended question about unnecessary admissions to the hospital. the nurse navigator, how she cared about you and your well-being.” At PCMH Marketing At PCMH, multiple marketing oppormost patients rate the navigators as “very tunities help the navigation program good” or “excellent.” Physician satisfaction is also impor- thrive. To educate the community about tant to measure. Using the same scale, a the program, the breast/gynecologic physician survey asks oncology physi- oncology navigator was highlighted in cians whether they use the navigator, to an insert to the Sunday paper’s health rate her overall and, most importantly, section. The navigator’s role was exwhether she is eliminating barriers, plained, and one of her breast cancer helping patients understand and cope patients told her story. “You will find that better, and providing patients the your satisfied patients are the best way to appropriate resources. An open-ended market your navigation program, so, if question on the benefits of having a they’re willing, use them to market your navigator is also included. The physi- program,” DeAntonio noted. In addicians’ ratings have been in the “very tion, the hospital website places patient navigation on its home page. That page good” to “excellent” range as well. Another outcome measured is patient then links to a navigation page that volume. “Our patient volume has explains the role of the nurse navigator climbed quite a bit through the past sev- and what services are available through eral years, and basically as we see the vol- the navigator. The navigation program www.AONNonline.org

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also is highlighted in Cancer Services’ annual reports. Crozer-Keystone Health System Delaware County, Pennsylvania; New Castle County, Delaware; Gloucester County, New Jersey Crozer-Keystone Health System (CKHS), a five-hospital health system, also began its navigation program for their breast cancer patients. This past year, it has also launched navigation for lung and colon cancer patients. CKHS has two main campuses for cancer care, at which they diagnose about 2000 cancer cases per year. The measures tracked directly relate to the goals of the navigation program—quality care, inpatient referrals, increased patient satisfaction, decreased hospital costs, and decreased outmigration for treatment. Quality indicators Metrics are tracked for all three disease sites with navigation services. In addition to patient satisfaction, metrics are monitored in conjunction with Fox Chase Cancer Center, with which CKHS has a partnership that provides patients access to clinical trials and programs. Marie DeStefano, RN, MSN, FAAMA, administrative director of oncology, who presented the CKHS model for navigation services, explained how breast cancer data are gathered using the American College of Surgeons’ Commission on Cancer database metrics. For example, the number of core biopsies as well as the number of incisional biopsies are captured and then used to determine a ratio. In addition, CKHS looks at the length of time from screening mammogram to traditional start of treatment, whether the patients were offered radiation therapy, and if the patients were given tamoxifen, according to DeStefano. For lung and colon cancer, CKHS looks at the numbers for screening colonoscopy, pathology, radiation, patients referred to CyberKnife treatments, patients contacted, and in- and outmigration. Gaining accreditation not only indicates quality, but also can help justify a program. “Both breast navigators were integral in helping us to obtain National Accreditation Program for Breast Centers accreditation, which is very important for our institution,” DeStefano said. Financial indicators Because of its location in a competitive market CKHS needs to financially justify every hire. Every month, DeStefano sends data to the hospital’s presidents, including the number of screening mammograms, the number of diagnostic mammograms, the number of breast pathologies, and the number of fractions of radiation for breast. www.AONNonline.org

“All of those are revenue generating, and we capture those from year to year to see, for example, if fiscal year 2009 is the same as fiscal year 2010, if it’s up or if it’s down,” explained DeStefano. CKHS also monitors outmigration for treatments. To do this, the navigators send the number of breast patients they contacted to DeStefano, who also receives diagnostic statistics from the radiology and pathology departments, and fractions radiated from the radiation department. If there is an outmigration, the navigators must supply her with the reason. “Sometimes it’s a very good reason; sometimes we assist with the referral out; sometimes the patient will say ‘My mother is a nurse at the hospital up the street and I want to be where my mother is,’ or ‘I have this doctor who operated on me 5 years ago, and I want to go back to the same surgeon,’” DeStefano said. It is important to track why the patients leave to clarify the numbers for the hospital’s presidents, she noted. “Since we’ve put our breast nurse navigators in place, we’ve gone from 16% outmigration to 2% outmigration overall. So, do those positions justify themselves? Absolutely,” DeStefano exclaimed.

“Since we’ve put our breast nurse navigators in place, we’ve gone from 16% outmigration to 2% outmigration overall. So, do those positions justify themselves? Absolutely.” —Marie DeStefano, RN, MSN, FAAMA

Community Cancer Center Normal, Illinois Located in a community of about 120,000 people, the Community Cancer Center is a joint venture of the two healthcare systems in its community that houses outpatient cancer services and offers a full complement of supportive services. With a goal of affecting patient care both inside and outside of its facility, the center implemented patient navigation to help the continuum of breast care services.

Outcome measures “We can make very timely decisions and be monitoring how we’re doing with care looking at the community not just the people we serve,” said Barb Nathan, executive director, who presented her center’s model. This is because the Community Cancer Center holds a common database for its community. This database houses a multitude of useful information to direct the navigation program toward success.

its direction. Using the database, the Community Cancer Center found that in 2008, 57% of eligible women had a screening mammogram, but in 2009 that percentage dropped to 51%. In addition, among the Hispanic population, only 7% of the eligible women had a mammogram in 2009. Working with the administration, the navigator is spearheading an effort to add some lay navigators to work in this specific population, noted Nathan.

“Our days for abnormal mammogram to biopsy have been cut in half; they are now at 15. And our consults to medical oncology and radiation oncology have been growing by 18% per year.” —Barb Nathan

The Community Cancer Center tracks the reduction in the number of days to definitive diagnosis. In addition, it tracks the increase in the number of consults seen in medical oncology and radiation oncology, as well as the number of screening mammograms. “We have seen double-digit per-year growth in the number of cases. Our core biopsy rate has improved. Our days for abnormal mammogram to biopsy have been cut in half; they are now at 15. And our consults to medical oncology and radiation oncology have been growing by 18% per year,” said Nathan. This information is used for more than just financial justification. It helps improve the program and to set

Continuing your commitment to patient care Once again, “One Size Does Not Fit All.” The metrics captured must directly relate to the goals of your navigation program and the financial needs of your center’s administration. Showing your program’s clinical quality, financial sustainability, and positive impact on the bottom line should help all nurses continue to deliver the essential service of patient navigation. ●

To read about how these navigation programs were designed and launched, see Part 1 of this series, which appeared in the August 2010 issue of the Journal of Oncology Navigation & Survivorship.

FINANCIAL CHALLENGES

Oncology Social Workers Can Help Patients... Continued from cover by 169 cancer patients and 131 caregivers identified from national research panels and 153 AOSW members. Patients’ and caregivers’ responses were aggregated. Fifty-seven percent of patients said they had experienced a serious financial hardship related to bills for cancer treatment, including depleted bank accounts (40%) and bankruptcy (6%). Of those who had experienced a financial hardship, 87% reported that treatment costs had had a negative impact on their ability to focus on recovery, and 75% said they were constantly worried about financial problems. Among the social workers, 73% reported discussing financial issues with all or most of their patients, and 58% believed that discussing financial issues

with patients always or frequently leads to a positive outcome. Although 62% of patients said they were familiar with the treatment options covered by their health plan, social workers reported that only 4% of their newly diagnosed cancer patients were aware of these options. Sixty-nine percent of social workers perceived themselves to be their patients’ primary resource for dealing with financial issues. Only 34% of patients, however, said they had interacted with a social worker, and 55% indicated that they were comfortable discussing financial matters with a social worker. Moreover, 61% of patients with a major catastrophic financial burden said they had never seen a social worker. ● OctOber 2010 I VOL 1, NO 5

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SURVIVORSHIP

Targeting Young Survivors By Daniel Denvir

dolescent and young adult (AYA) survivors of cancer are, like their older counterparts, a growing population. And like most other cancer survivors, many are not receiving necessary survivorship care, as outlined by the Institute of Med icine’s (IOM) 2005 report on the subject. Youth issues were the subject of a number of presentations and abstracts at the 5th Biennial Cancer Survivorship Research Conference. Top AYA issues include communication about longterm care, and interventions to promote exercise and discourage risk-taking behavior. Researchers at the University of California Los Angeles assessed the state of AYA survivorship information provided at community-based organizations (CBOs), because accurate knowledge can empower people to seek needed care. The study relied on qualitative analysis of interviews with CBO leaders, including CEOs, program directors, and founders. The researchers found that CBO leaders were knowledgeable and interested in providing survivorship education. CBO leaders suggested that such communication should begin before the end of treatment and that communication with young people be positively framed and sensitive to youth

“culture” to help prevent the survivor from tuning it out. AYA survivors are often “lost in transition” when they cease treatment and begin a lifetime of survivorship. A survey of 376 survivors recruited from LIVESTRONG Survivorship Centers of Excellence found that 33% lacked copies of medical records, 48% lacked a written treatment study, and another 48% lacked a survivorship care plan.

“A greater support from parents is related to fewer symptoms of depression, withdrawal, and aggressive behavior, better school performance, and more involvement in social activities for siblings.” —Melissa Alderfer, PhD

The lack of a survivorship care plan and nonwhite ethnicity were found to be associated with less confidence in seeking survivorship care. The University of Colorado Denver and its affiliate, the Children’s Hospital, are collaborating, “with a unique emphasis on transitioning into primary care.” Each patient is seen by a multidiscipli-

Journal Journalof ofOncology Oncology

NAVIGATION & SURVIVORSHIP

™ ™

The TheOfficial OfficialJournal Journalofofthe theAcademy AcademyofofOncology OncologyNurse NurseNavigators Navigators®®

Submit a Manuscript Today! The ONLY journal focused on patient navigation and survivorship care in oncology patients. Academy of Oncology Nurse Navigators (AONN) is pleased to announce the extension of its official publication into 2011. If you have ever wanted to be a published author or have simply been looking for the right journal to publish your work, regarding these two specific topic areas, the wait is over.

Please submit manuscripts online at www.AONNonline.org/manuscripts Want to get more involved? Submit your CV/Bio to be considered for expert advisory board positions to editorial@greenhillhc.com. If you have any questions about AONN or the Journal of Oncology Navigation & Survivorship, please contact Sean T. Walsh, Executive Director of AONN, at sean@AONNonline.org.

OctOber 2010 I VOL 1, NO 5

nary team trained in survivorship care, including a primary care internal medicine physician, a pediatric oncologist, a health psychologist, and an oncology nurse. Each patient receives a survivorship care plan that outlines a strategy for life after cancer, with the goal of promoting comprehensive preventive and follow-up care. Feedback from participating survivors has been highly positive. “As childhood cancer survivors become

young adults, it is imperative to assist in their successful transitioning to an adult care venue in which their complete healthcare needs can be met,” the researchers concluded. Researchers at Oslo University Hospital, Norway, found that survivors of childhood malignant lymphoma are well informed about their diagnoses and treatment, but mostly unaware of the potential for long-term medical risks. These survivors are at risk for infertility, fatigue, reduced memory or concentration, heart problems, breast cancer, dental caries, reduced muscle growth, and reduced metabolism. Based on interviews with 129 adult survivors of childhood cancer, the study points to the need for more and longer term communication with survivors. A team at MassGeneral Hospital for Children, Boston, is developing a tool to assess the health-related quality of life (QOL) of AYA survivors of central nervous system (CNS) cancer. Much research has focused on survivors of pediatric CNS cancer, but AYA survivors face different social, physical, emotional, and school/work outcomes. In addition, CNS cancer survivors have worse health-related QOL than survivors of other cancers and chronic conditions. A team from British Columbia found low levels of adherence among childhood cancer survivors to long-term follow-up guidelines developed by the Children’s Oncology Group. The researchers followed a cohort (n = 976) of 5-year survivors of childhood cancer, and found that only 13.4% received all advocated tests, 49.7% some, and 36.9% none. Male and older survivors had particularly low rates of adherence. The researchers suggested that future

research examine major barriers to follow-up care and surveillance. A study of decision making and substance use in 243 adolescent survivors of childhood cancer relied on interviews with survivors who had been disease-free for at least 5 years. The study found that the rate of cigarette use was slightly higher among those surveyed than in the general population. Rates of alcohol use were slightly lower, and marijuana use was higher. The findings suggest that risk-taking behaviors among survivors of childhood cancer are still high, pointing to the need for further educational interventions. Childhood cancer can have a major impact on parents and families, including siblings. Siblings of childhood cancer patients can experience a heightened sense of responsibility and independence, but they are also at a higher risk of emotional and behavioral problems, including posttraumatic stress disorder. A study of the importance of social support for siblings of children with cancer found that siblings identified friends as providing more support than parents, and cited support from friends as most important. But the study found that parental support had a greater impact on sibling adjustment. According to lead researcher Melissa Alderfer, PhD, Children’s Hospital of Philadelphia, “greater support from parents is related to fewer symptoms of depression, withdrawal, and aggressive behavior, better school performance, and more involvement in social activities for siblings.” Researchers in New York and Texas explored the possibility of involving parents and young survivors in joint programs to encourage physical activity and a healthy diet. The researchers examined 87 minor survivors and their parents, and found a strong intraclass correlation between survivor and parent level of physical activity and body mass index. The next step is designing interventions that promote healthy lifestyles for parents and child survivors alike. Of those surveyed, 80% of survivors and parents expressed interest in web-based exercise and diet programs. Researchers at Copenhagen University, Denmark, are taking a more direct approach to exercise, recruiting 12 survivors of AYA cancer aged 22 through 39 years to train for an “extreme sport event” called The KiliMAN Adventure Challenge. The event consists of a 6-day summit of Mt. Kilimanjaro, followed by a bike race around the mountain and a marathon run. The study found that “goal-directed exercise may enable adherence to physical activity and stimulate empowering and mutual supportive networks.” ● www.AONNonline.org

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Clinical Nursing Review

Managing Metastatic Breast Cancer Patients Treated with Ixabepilone: Practical Guidance By Una Hopkins, FNP Montefiore Medical Center, Weiler-Einstein Division, East Campus, Bronx, New York

ytotoxic chemotherapy is one of management. Important differences the cornerstones for the treat- between taxanes and epothilones yield ment of metastatic breast cancer different treatment-specific issues that (MBC). Drug resistance remains the nurses should understand to help ensure most common cause of treatment fail- that patients receive the intended benure; in particular, resistance to anthra- efit from ixabepilone therapy. cyclines and taxanes hinIxabepilone toxicity profile ders the management of and appropriate nursing MBC.1 With increasing frequency, these agents are intervention The most common adverse being used to treat earlyevents seen with ixabepilone stage breast cancer, meanused as monotherapy or in ing that these patients combination with capecitabine have fewer effective cytoare presented in Table 1. Other toxic treatment options if important adverse events that they progress to MBC.1-3 As such, a great deal of have been associated with Una Hopkins, FNP active clinical research is ixabepilone include severe focused on developing novel cytotoxics hypersensitivity reactions (HSRs) durwith reduced susceptibility to common ing drug administration7 and, when ixabepilone is given in combination drug-resistance mechanisms. One result of research into novel with capecitabine, palmar-plantar erycytotoxics has been the development of throdysesthesia (hand-foot syndrome) a new class of drugs known as the and cardiac events.7 Side effects during ixabepilone theraepothilones. The epothilones have a similar mode of action to taxanes in py can be effectively managed with dose that they disrupt microtubule function reduction and supportive care (Table 1). within tumor cells.4 The epothilones Some common side effects associated have a different chemical structure and with ixabepilone therapy, particularly have demonstrated antitumor activity neutropenia and peripheral neuropathy, in patients who have developed resist- can be manageable with proactive interance to taxanes.5,6 Ixabepilone is the vention but can be debilitating if they first epothilone to be approved by the progress to severe events. Therefore, US Food and Drug Administration. Its nurses can improve treatment outinitial indications are7: comes, adherence, and patient quality • In combination with capecitabine of life during treatment with ixabepifor the treatment of metastatic or lone by providing information to locally advanced breast cancer in patients and their families. Patients patients after failure of an anthra- receiving ixabepilone should be educatcycline and a taxane ed as to what to expect during treat• As monotherapy for the treatment ment, and they should be alert to signs of metastatic or locally advanced and symptoms that should be reported breast cancer in patients after fail- to their healthcare team (Table 2). ure of an anthracycline, a taxane, In addition to patient education, speand capecitabine. cific nursing activities to support In the MBC setting, ixabepilone has patients receiving ixabepilone include been shown to be effective in patients monitoring laboratory values, particuirrespective of their estrogen/proges- larly liver function tests, complete terone receptor status or their human blood counts (CBCs), and platelets; epidermal growth factor receptor type 2 assessing for preexisting allergies, status.8 The recommended dose of administering premedications and monixabepilone is 40 mg/m2 infused intra- itoring for HSRs during infusions; venously over 3 hours every 3 weeks.7 administering prescribed growth factor The taxanes have well-characterized support; assessing preexisting neuside effect profiles. Because ixabepilone ropathies, and monitoring for new or and the other epothilones act in a way worsening neuropathy (Table 3). that is similar to the taxanes, ixabepilone therapy is associated with many of Pretreatment assessment Extensive clinical testing has re the same side effects that oncology nurses have come to expect during taxane vealed contraindications to ixabepitherapy (Table 1). With any new class lone therapy, as well as situations of agents, however, comes new informa- under which a lower dose of ixabepition and considerations for patient lone should be used.8-11 Even though

OctOber 2010 I VOL 3, NO 7

Table 1 Management of Toxicities and Dosing Recommendations with Ixabepilone Hematologic toxicities • Ixabepilone should not be administered to patients Leukopenia with baseline neutrophils <1500 cells/mm3 or Neutropenia platelets <100,000/mm3,a • Hematopoietic growth factors (eg, G-CSF) Febrile neutropenia • Decrease ixabepilone dose by 20% for the followinga: Anemia • Neutrophil <500 cells/mm3 for ≥7 days Thrombocytopenia • Febrile neutropenia • Platelets <25,000/mm3 or <50,000/mm3 with bleeding Nonhematologic toxicities

• For any grade 3 toxicity other than neuropathy, decrease ixabepilone dose by 20%a

Peripheral neuropathy • Early recognition important • Reversible with ixabepilone dose reduction or delay • Dose adjustments recommended as followsa: • Grade 2 lasting ≥7 days—decrease dose by 20% • Grade 3 lasting <7 days—decrease dose by 20% • Grade 3 lasting ≥7 days or disabling— discontinue Gastrointestinal symptoms

• Intensive fluid management

Diarrhea

• Antidiarrheal medications • Prophylactic antibiotics (in patients also experiencing neutropenia)

Constipation

• Increase fiber intake • Laxatives

Anorexia

• Nutritional support

Nausea/vomiting

• Antiemetics

Mucositis/stomatitis

• Soothing mouthwashes • Pain relief • Nutritional support

Myalgias and arthralgias

• Dose reduction • Transient grade 3—no change in dose • Prolonged grade 3—decrease dose by 20% • Analgesics (eg, NSAIDs) if patient has normal platelet counts

Fatigue

• Correction of known causes (eg, anemia, sleep disorders, anxiety) • Regular exercise • Antidepressants • Antianxiety medications • Attention-restoring exercises • Psychological counseling • Physical therapy

Alopecia

• Plan for hair-loss management • Cut hair short prior to treatment • Use of wig

Cardiac adverse events

• Temporary or permanent discontinuation of ixabepilone

Reference 7. G-CSF indicates granulocyte colony-stimulating factor; NSAID, nonsteroidal anti-inflammatory drug.

www.theOncologyNurse.com

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Clinical Nursing Review ixabepilone is not hepatotoxic, patients with preexisting impaired liver function who were treated with the ixabepilone/capecitabine doublet were shown to be at increased risk of toxicity and neutropenia-related death in a pivotal phase 3 trial.8 For this reason, ixabepilone plus capecitabine must not be given to patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 × the upper limits of normal (ULN) or bilirubin >1 × ULN. Liver function is also an important consideration for those receiving ixabepilone monotherapy. Hepatic function should be assessed periodically during ixabepilone therapy, with the dose adjusted as

20%.7 A new treatment cycle should begin only when the neutrophil count is ≥1500 cells/mm³ and if nonhematologic toxicities have improved to grade 1 (mild) or resolved.7 Preventing HSRs Like standard formulations of paclitaxel and docetaxel, ixabepilone is for-

mulated with polyethoxylated castor oil. To avoid HSRs to this vehicle during ixabepilone infusion, patients should be premedicated approximately 1 hour before infusion with both an H1 blocker and an H2 blocker.7 Corticosteroid premedication is not mandatory for ixabepilone; in contrast, the taxanes paclitaxel and docetaxel

exhibit greater potential for HSRs and steroid premedication is required.12-14 However, patients who have experienced an HSR in a previous ixabepilone cycle should be premedicated with corticosteroids (eg, dexamethasone 20 mg intravenously 30 minutes before infusion or orally 60 minutes before infuContinued on page 16

Hepatic function should be assessed periodically during ixabepilone therapy, with the dose adjusted as necessary.

necessary.7 Before administration of ixabepilone, the nurse should be aware of the current liver function values and check doses accordingly. The following guidelines are listed in the package insert and refer to the first course of therapy; further dose reductions in subsequent courses should be based on individual tolerance7: • AST and ALT ≤2.5 × ULN and bilirubin ≤1 × ULN—administer ixabepilone monotherapy at 40 mg/m2 (full dose) • AST and ALT ≤10 × ULN and bilirubin ≤1.5 × ULN—administer ixabepilone monotherapy at 32 mg/m2 • AST and ALT ≤10 × ULN and bilirubin >1.5 × ULN to ≤3 × ULN —administer ixabepilone monotherapy at 20 mg/m2 to 30 mg/m2 • AST or ALT >10 × ULN or bilirubin >3 × ULN—use of ixabepilone monotherapy is not recommended. The CBC and platelets should be checked before the first dose is given and periodically during therapy, because low blood cell counts may preclude the use of ixabepilone or necessitate a dose reduction. As with preexisting hepatic toxicity, patients with a baseline neutrophil count <1500 cells/mm3 or a platelet count <100,000 cells/mm3 should not be given ixabepilone.7 During therapy, if the neutrophil count is <500 cells/mm³ for ≥7 days, the patient has febrile neutropenia, or the platelet count is <25,000/mm³ (or <50,000/mm³ with bleeding), the dose of ixabepilone should be decreased by

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For more information, please visit www.istodax.com or call 1-888-423-5436

OcTOber 2010 I VOL 3, NO 7

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Clinical Nursing Review Managing Metastatic Breast Cancer... Continued from page 15 sion) in addition to the H1 and H2 blockers. If possible, extending the infusion time should also be considered in these patients. Patients with a history of a severe HSR to agents containing polyethoxylated castor oil should not be treated with ixabepilone.7,13,14 During the infusion, nurses should closely monitor patients for signs of HSR, including flushing, rash, dyspnea,

and bronchospasm. Should a severe HSR occur, the ixabepilone infusion should be stopped and aggressive supportive treatment (eg, epinephrine or corticosteroids) started immediately.7,13 Neutropenia and thrombocytopenia Nurses should assess patients for myelosuppression frequently during ixabepilone therapy.7 With grade 3/4

Table 2 Ixabepilone: Key Points for Patient and Family Education Blood will be drawn periodically for tests to evaluate: • Liver function; preexisting liver dysfunction may necessitate reducing the dose of ixabepilone monotherapy, or it may contraindicate ixabepilone combination therapy with capecitabine • Blood cell counts, to be sure they are high enough to protect against infection and bleeding. The ixabepilone solution contains alcohol and may cause drowsiness or dizziness. After the infusion, patients should refrain from driving and other activities requiring alertness until they know how they will respond to the medication. The healthcare team should be notified promptly if any of the following occur: • Fever >100.5°F or chills • Cough, hoarseness, sore throat, or lower back/side pain • Burning, painful, or difficult urination • Bleeding gums; bruising; petechiae; blood in stools, urine, or vomit • Increased fatigue, dyspnea (shortness of breath), or orthostatic hypotension (dizziness upon standing). The healthcare team should also be notified promptly if the following signs and symptoms occur: • Hives, urticaria, pruritus, rash, flushing, swelling, dyspnea, chest tightness; these may be associated with a hypersensitivity (allergic) reaction to ixabepilone; it is especially important to let the nurse know immediately if these occur during the ixabepilone infusion • Numbness and tingling in hands and feet; these symptoms are associated with peripheral neuropathy • Chest pain, difficulty breathing, palpitations, unusual weight gain; these symptoms could be associated with heart problems.

Ixabepilone and certain other medicines may affect each other, causing side effects. It is important for your healthcare team to know what other medications you are taking: • A healthcare professional should be consulted before taking any prescription, over-the-counter, herbal, or vitamin products, especially St John’s wort, during ixabepilone therapy • Patients should avoid drinking grapefruit juice during therapy; it could increase the risk of side effects from ixabepilone. To help prevent infections, patients should avoid crowds and persons with known infections. Further, no vaccinations should be recieved without the advice of a healthcare professional. Patients who are thrombocytopenic should not drink alcoholic beverages or take medication containing aspirin or NSAIDs; these agents might precipitate bleeding. Patients should also be careful to avoid falls. Patients should also use soft tooth brushes and electric razors. Women of childbearing potential should use effective contraception during ixabepilone therapy and avoid breastfeeding during ixabepilone therapy. Hair loss may occur; regrowth usually occurs 2 to 3 months after discon tinuation of therapy. Explore methods of coping with this side effect, such as prescriptions for head prostheses and referral to community-based programs such as Look Good…Feel Better (www.lookgoodfeelbetter.org), sponsored by the American Cancer Society. NSAID indicates nonsteroidal anti-inflammatory drug.

OctOber 2010 I VOL 3, NO 7

neutropenia rates of almost 70% with the ixabepilone/capecitabine doublet and around 54% with ixabepilone monotherapy,8,9 effective management of this side effect is critical for optimizing patient outcomes. Risk factors for neutropenia include older age, bone marrow involvement, immune system dysfunction, hepatic or renal impairment, and malnutrition.15,16 Patients should be assessed at baseline for these factors to determine whether they are at higher risk, and the treatment team should be informed accordingly. In patients who develop neutropenia, nurses should watch for symptoms that may increase the risk of or herald infectious complications. These symptoms may be specific to the gastrointestinal system (eg, mucositis and diarrhea), respiratory tract (eg, cough and dyspnea), urinary tract, or indwelling devices, or they may consist of more generalized flulike symptoms (eg, fever, chills, and malaise).17 It is especially important to educate patients about recognizing and managing febrile neutropenia, and they

It is especially important to educate patients about recognizing and managing febrile neutropenia.

should be strongly advised to seek medical attention immediately if they experience fever, chills, and/or rigors. In addition, patients should be educated regarding steps that can be taken to help minimize the risk of neutropenia, including continuing to eat well and avoiding behaviors and situations that could increase their exposure to infectious agents.17 Although routine administration of growth factor support is not indicated by the ixabepilone prescribing instructions,7 it may be necessary in some patients, and nurses should be aware of the appropriate use of these drugs to maximize their effectiveness. Thrombocytopenia is less common than neutropenia in patients receiving ixabepilone, although it was observed in 2% to 6% of patients during the registrational trials.7 Therefore, nurses should monitor patients for signs that could indicate this problem, including bleeding from the gums, bruising, petechiae, and blood in the stool or urine. Patients with low platelet counts should not be subjected to intramuscular injections or rectal temperature

measurements, and pressure should be applied to venipuncture sites for 5 minutes. Furthermore, enemas and suppositories should be avoided to decrease the likelihood of bleeding.18 Peripheral neuropathy Affecting as many as 50% of cancer patients, chemotherapy-induced peripheral neuropathy (CIPN) most likely results from the injury, inflammation, or degeneration of peripheral nerve fibers.19 CIPN often occurs in a stocking-and-glove distribution pattern, with symptoms originating at the tips of the fingers or toes and progressing toward the trunk. CIPN is a common serious side effect of many cytotoxic agents, and it is a major cause of chemotherapy dose reductions, treatment delays, and discontinuation during ixabepilone therapy.20,21 In fact, CIPN was the primary cause of treatment discontinuation in the ixabepilone registrational trials.8,9 CIPN during ixabepilone therapy is primarily sensory, cumulative, and reversible in most patients.21-24 Although the risk of CIPN increases with accumulating exposure to ixabepilone, approximately 75% of cases of new-onset or worsening neuropathy occur within the first three cycles.7 In clinical trials, ixabepilone-associated peripheral neuropathy resolved to baseline or grade 1 within a median of 5.4 weeks after monotherapy and 6.0 to 6.2 weeks after combination therapy with capecitabine.24 To manage CIPN in patients receiving ixabepilone, nurses need to identify preexisting conditions that may affect sensory function and, if necessary, alert the treatment team to the possibility of increased risk of developing CIPN due to preexisting peripheral neuropathy or comorbidities such as diabetes mellitus.7,21 In addition, nurses should perform regular neurologic assessments, first to establish baseline neurologic function before treatment begins and then to detect any worsening function in a timely fashion. Patients with stabilization of disease may be less forthcoming with self-reports of CIPN symptoms. A brief assessment that may help reveal symptoms of CIPN may include testing the patient’s ability to button a shirt or pick up objects.21 Initiation of a handwriting sample may also be helpful in identifying patients with CIPN. Additional signs of CIPN that should be monitored include a tingling or burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, and neuropathic pain. Antidepressants, antiseizure medications, and glutamine have demonstrated some success in treating neuropathy once it has developed.25,26 Most experts Continued on page 18

www.theOncologyNurse.com

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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

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Clinical Nursing Review Managing Metastatic Breast Cancer... Continued from page 16 agree, however, that the best strategy to minimize the impact of CIPN is early detection coupled with chemotherapy dose reductions and/or delays.25,27 Accordingly, patients experiencing new or worsening symptoms of CIPN

may require a reduction or delay in the dose of ixabepilone, as follows7: • If CIPN is grade 2 (moderate) lasting for ≥7 days or grade 3 (severe) lasting for <7 days— decrease dose by 20%

Table 3 Nursing Activities Associated with Management of Patients Receiving Ixabepilone Therapy Issue

Nursing activities

Liver function

• Assess liver function tests at baseline and periodically during therapy • Ensure that ixabepilone/capecitabine combination therapy is not administered to patients with preexisting impaired liver function above the recommended threshold • Ensure that ixabepilone monotherapy is given in reduced doses to patients with preexisting mild to moderate impairment in liver function, as recommended • Closely monitor patients with impaired liver function for neutropenia and neutropenic complications

Hypersensitivity reactions (during infusions)

• Evaluate patient for risk of allergic response • Administer premedications 1 hour prior to infusion • Closely monitor patient for signs of hypersensitivity during infusion, including flushing, rash, dyspnea, and bronchospasm • Promptly alert treatment team if signs of hypersensitivity are detected • Slow or stop infusion as appropriate, and administer supportive measures as required

Neutropenia • Evaluate patient at baseline for risk of neutropenia (also thrombocytopenia) and neutropenia-related complications (eg, older age, bone marrow involvement, immune system dysfunction, hepatic or renal impairment, malnutrition) • Inform treatment team of increased risk if so determined • Monitor CBC frequently to detect neutropenia and other cytopenias (ie, anemia, thrombocytopenia) • Administer growth factor support as prescribed • Ensure that ixabepilone dose is reduced or stopped as prescribed for neutropenia or thrombocytopenia • Strongly advise patients to seek prompt attention from the treatment team if fever and chills develop • Provide patient and family education regarding measures to reduce risk of neutropenic and/or bleeding complications Peripheral neuropathy

• Evaluate patient for preexisting conditions that may increase risk of neuropathy (eg, diabetes, preexisting neuropathy) • Inform treatment team of increased risk if so determined • Perform neurologic assessment at baseline to establish pretreatment status • Perform neurologic assessments frequently during treatment to monitor for early signs of new-onset or worsening neuropathy, including burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, and neuropathic pain • Ensure that ixabepilone dose is reduced or stopped as prescribed for neuropathy • Educate patients with neuropathy about safety (eg, when dealing with hot objects), fall prevention, and skin care

CBC indicates complete blood count.

OctOber 2010 I VOL 3, NO 7

• If CIPN is grade 3 lasting ≥7 days or is disabling—discontinue treatment. Several groups are investigating the ability of neurologic tests to detect early neuropathic changes in patients treated with ixabepilone.21,23 The availability of such tests could theoretically help to prevent the development of severe CIPN, which would be especially valuable in patients with earlier stage disease who might receive ixabepilone in the future. Ixabepilone administration At many clinics and private practices, nurses are directly involved in preparing and administering chemotherapy, and therefore, they need to become familiar with the procedures unique to ixabepilone administration. Timing is critical, because a number of ixabepilone administration steps are time-limited. To minimize risk of dermal exposure when handling ixabepilone vials, nurses should wear impervious gloves during unpacking and inspection, transport within a facility, dose preparation, and administration.7 Summary Because ixabepilone has reduced susceptibility to multiple mechanisms of resistance to taxanes and anthracyclines and has proved efficacious in drug-resistant MBC, it provides a much-needed treatment option for patients in whom many other therapies have failed. Oncology nurses should be familiar with the unique aspects of providing ixabepilone therapy, that is, the toxicity profile of which is similar to yet distinct from that associated with taxane therapy. Nurses play a key role in maximizing the clinical benefit of ixabepilone therapy and encouraging adherence, so that patients may achieve optimal outcomes. Acknowledgments The author takes full responsibility for the content of this publication and confirms that it reflects her viewpoint and medical expertise. She also wishes to acknowledge StemScientific, funded by Bristol-Myers Squibb, for providing writing and editing support. Neither Bristol-Myers Squibb nor StemScientific influenced the content of the manuscript, nor did the author receive financial compensation for authoring the manuscript. ● References 1. Valero V, Hortobagyi GN. Are anthracycline-taxane regimens the new standard of care in the treatment of metastatic breast cancer? J Clin Oncol. 2003;21:959-962. 2. O’Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. Oncologist. 2005; 10(suppl 3):20-29. 3. Bernard-Marty C, Cardoso F, Piccart MJ. Facts and controversies in systemic treatment of metastatic breast

cancer. Oncologist. 2004;9:617-632. 4. Goodin S, Kane MP, Rubin EH. Epothilones: mechanism of action and biologic activity. J Clin Oncol. 2004;22:2015-2025. 5. Lee FY, Borzilleri R, Fairchild CR, et al. BMS247550: a novel epothilone analog with a mode of action similar to paclitaxel but possessing superior antitumor efficacy. Clin Cancer Res. 2001;7:1429-1437. 6. Lee FY, Smykla R, Johnston K, et al. Preclinical efficacy spectrum and pharmacokinetics of ixabepilone. Cancer Chemother Pharmacol. 2009;63:201-212. 7. Ixempra (ixabepilone) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2009. 8. Thomas ES, Gomez HL, Li RK, et al. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol. 2007;25:5210-5217. 9. Perez EA, Lerzo G, Pivot X, et al. Efficacy and safety of ixabepilone (BMS-247550) in a phase II study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2007;25:3407-3414. 10. Thomas E, Tabernero J, Fornier M, et al. Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in patients with taxane-resistant metastatic breast cancer. J Clin Oncol. 2007;25:3399-3406. 11. Low JA, Wedam SB, Lee JJ, et al. Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, in metastatic and locally advanced breast cancer. J Clin Oncol. 2005;23:2726-2734. 12. Markman M. Management of toxicities associated with the administration of taxanes. Expert Opin Drug Saf. 2003;2:141-146. 13. Myers JS. Hypersensitivity reaction to paclitaxel: nursing interventions. Clin J Oncol Nurs. 2000;4:161-163. 14. Lenz HJ. Management and preparedness for infusion and hypersensitivity reactions. Oncologist. 2007;12:601-609. 15. Scott S. Identification of cancer patients at high risk of febrile neutropenia. Am J Health Syst Pharm. 2002;59(15 suppl 4):S16-S19. 16. Alexandre J, Gross-Goupil M, Falissard B, et al. Evaluation of the nutritional and inflammatory status in cancer patients for the risk assessment of severe haematological toxicity following chemotherapy. Ann Oncol. 2003;14:36-41. 17. Marrs JA. Care of patients with neutropenia. Clin J Oncol Nurs. 2006;10:164-166. 18. Camp-Sorrell D. Myelosuppression. In: Itano JK, Taoka KN, eds. Core Curriculum for Oncology Nursing. 4th ed. Philadelphia, PA: WB Saunders; 2005:259-274. 19. Wilkes G. Peripheral neuropathy related to chemotherapy. Semin Oncol Nurs. 2007;23:162-173. 20. Quasthoff S, Hartung HP. Chemotherapy-induced peripheral neuropathy. J Neurol. 2002;249:9-17. 21. Lee JJ, Swain SM. Peripheral neuropathy induced by microtubule-stabilizing agents. J Clin Oncol. 2006;24:1633-1642. 22. Cortes J, Baselga J. Targeting the microtubules in breast cancer beyond taxanes: the epothilones. Oncologist. 2007;12:271-280. 23. Goel S, Goldberg GL, Kuo DYS, et al. Novel neurosensory testing in cancer patients treated with the epothilone B analog, ixabepilone. Ann Oncol. 2008; 19:2048-2052. 24. Perez EA, Pivot X, Vrdoljak E, et al. A prospective characterization of the resolution of ixabepilone induced peripheral neuropathy: data from a large registrational program in patients with metastatic breast cancer. Cancer Res. 2009;69(suppl):Abstract 6140. 25. Makino H. Treatment and care of neurotoxicity from taxane anticancer agents. Breast Cancer. 2004; 11:100-104. 26. Eisenberg E, River Y, Shifrin A, Krivoy N. Antiepileptic drugs in the treatment of neuropathic pain. Drugs. 2007;67:1265-1289. 27. Lee JJ, Low JA, Croarkin E, et al. Changes in neurologic function tests may predict neurotoxicity caused by ixabepilone. J Clin Oncol. 2006;24:2084-2091.

Erratum: In the article in the August issue on cabazitaxel for prostate cancer, the dosage was incorrectly stated as “three times weekly.” It should read “every 3 weeks,” as indicated in the package insert.

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Cancer Center Profile Reducing Disparities in Cancer Care... Continued from cover include access to cancer screening, treatment, and research. The staff at MSTI hopes to reduce disparities in care for their patients with help from their new contract as a member of the NCCCP. Making it a reality MSTI has “plans to beef up programs that are partly already in place but need greater funding, whether that is getting early screening with mammography at a greater intensity or getting more education within the communities,” said Paul G. Montgomery, MD, FACP, a medical oncologist. “There has been some education, there needs to be more. There has been some mobile mammography units going to rural areas, there needs to be more.” Funding from the NCCCP contract should help MSTI provide these additional services and “allow us to make an impact.” The action plans start by analyzing data on their patients. These data show where MSTI needs to focus, including geographic areas and ethnic populations. Then, areas with disparities are targeted for what is needed. Montgomery gave this example: Geographic areas where patients disproportionately present in the later stages of cancers can be targeted for patient education, hopefully leading to improved early diagnosis and screening.

of the Treasure Valley, which is home to a large Hispanic and rural population. A third breast care navigator will be hired for additional western Idaho locations. “These rural navigators will be situated in those areas and begin to develop community resources and community outreach to occur directly in their communities,” said Winschell. A second mobile mammography coach also is in the works. The current coach is booked every day, except when it is down for service, according to Winschell. “In fact, they have traveled up to Grangeville, which is 220 miles north. And we will be traveling into Oregon, which will be new for us.” Disparities meet supportive care Psychosocial and survivorship resources are expected to expand into all five sites as well, which will help MSTI embrace another of the NCCCP pillars—“Enhance cancer survivorship and palliative care services.” In addition, “we have the opportunity to provide supportive oncology clinics to meet the advanced disease population,” said Alicia Rosales, LMSW, an oncology social worker. A supportive care oncology clinic was opened in May in the Boise location. “It is not in replacement of the patients’ visits to their primary oncol-

Members of St. Luke’s Mountain States Tumor Institute, from left: Dan Zuckerman, MD; Alicia Rosales, LMSW; Jill Winschell, RN; and Paul G. Montgomery, MD, FACP.

To help get information and services out to people, MSTI plans to expand its services beyond the Boise clinic, where most of the specialized clinics are currently housed. With the high-risk breast cancer clinic, for example, all patients must travel to Boise. But, the plan is to expand into the Twin Falls area, which is about 130 miles away, and at a future date, perhaps into the Fruitland area, according to Jill Winschell, RN, a breast cancer nurse navigator. Navigation services will expand beyond the new clinic. MSTI is currently looking to fill several positions for new navigators, starting with a navigator for the Twin Falls area and one for the Fruitland area in the western end

OctOber 2010 I VOL 3, NO 7

ogist, but something that is linked in parallel,” said Dan Zuckerman, MD, medical director for the supportive care and survivorship clinics. With this clinic, patients who require help from multiple supportive disciplines now have a place to go. The clinic offers dietitians, social workers, and physical therapists. There are plans to increase psychiatric services by hiring someone with a specific interest in psycho-oncology. Although dedicated psychosocial oncology personnel can be difficult to staff in rural areas, Zuckerman is hoping to use funding from the NCCCP for this purpose. This funding may also allow a supportive oncology clinic to open in each of

St. Luke’s Mobile Mammography Service brings mammography to the rural areas of southwestern Idaho.

the five sites. Rosales envisions a halfday clinic of survivorship and a halfday clinic of advanced disease patients, staffed by a multidisciplinary team. The clinics would offer a dietitian, a social worker, a psychiatrist, a pharmacist, a nurse practitioner, and referrals to financial counselors and physical therapists. The rural location of its patients affects survivorship services as well. With patients in remote areas, survivorship services means “making sure that patients have the information, the resources, and the tools they need to empower themselves to lead healthy lives. We have to take into account that all of them may not have the opportunity to participate in exercise classes. We have to give them the information about how they can do it on their own in their own geographic setting,” said Rosales. Patient education is a similar challenge. In the Hispanic community, many believe that cancer cannot be cured. “It is even harder when these groups of workers are spread over a large area, to be able to reach out and have them understand that cancer can be cured. A great deal of time and effort will be needed to communicate that early diagnosis is important,” said Montgomery. “We are hoping that we can do more community outreach and interaction with the people in those communities to deal with a lot of those disparities and get the rural and Hispanic population into the healthcare system in a timely manner,” echoed Winschell. MSTI employs both Hispanic and Spanish-speaking oncologists and nurses to help with these efforts. Clinical trials and biospecimen research NCCCP sites are also tasked to

“increase participation in clinical trials,” and “participate in biospecimen research initiatives to support personalized medicine.” Using funding from the contract, MSTI will be able to start a phase 1 clinical trial program within the next 2 years, “which will be a huge thing because there is no place in Idaho or in our surrounding area that offers phase 1 trials,” said Zuckerman. At current, MSTI accrues only to phase 3 trials, usually from one of the cooperative groups— Southwest Oncology Group, Radiation Therapy Oncology Group, National Surgical Adjuvant Breast and Bowel Project, Eastern Cooperative Oncology Group, and Cancer and Leukemia Group B—as well as to a limited number of industry-sponsored and investigatorinitiated phase 2 trials. Biospecimen processing is already under way. In conjunction with Boise Veterans Affairs Medical Center and Boise State University, MSTI has broken ground on the building where biospecimens will be stored. “I think one of the things nationally is the NCI [National Cancer Institute] is trying to standardize how biospecimens are stored and to enable researchers from anywhere in the country to access these biospecimens,” said Zuckerman. Meeting the challenge “The challenge is not only to deliver best standards of care, but also to implement that across our multiple sites. Many of our patients cannot come into our main center in Boise, so our goal and our responsibility is to provide care in their own communities,” explained Zuckerman. Along with fellow NCCCP site Billings Clinic Cancer Center in Billings, Montana, MSTI hopes to meet the NCI’s challenge of providing the best evidence-based care to all Americans. ●

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TON_October 2010_v6_TON 10/15/10 3:01 PM Page 21

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%NKPKECNN[ 2TQXGP 2TQVGEVKQP

TON_October 2010_v6_TON 10/15/10 3:01 PM Page 22

ONCOLOGY DRUG CODES

Medications Used for the Treatment of Breast Cancer Breast cancer forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare. The following sections will assist healthcare professionals and payers by providing appropriate coding, billing, and reimbursement information associated with the management of breast cancer. The following sections include: • Associated ICD-9-CM codes used for the classification of breast cancer • Drugs that have been FDA-approved in the treatment of breast cancer • Drugs that are compendia listed for off-label use for breast 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

anastrozole (Arimidex)

J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0170: anastrozole, oral, 1 mg

anastrozole (Arimidex) bacillus Calmette-Guerin (Tice BCG, TheraCys) bevacizumab (Avastin) capecitabine (Xeloda) capecitabine (Xeloda) carboplatin (Paraplatin) cisplatin (Platinol AQ) cisplatin (Platinol AQ) cyclophosphamide (Cytoxan) cyclophosphamide (Cytoxan)

Associated ICD-9-CM Codes Used for Breast Cancer 174 Malignant neoplasm of female breast Includes: breast (female) connective tissue soft parts Paget’s disease of: breast nipple Use additional code to identify estrogen receptor status (V86.0, V86.1) Excludes: skin of breast (172.5, 173.5) 174.0 Nipple and areola 174.1 Central portion 174.2 Upper-inner quadrant 174.3 Lower-inner quadrant 174.4 Upper-outer quadrant 174.5 Lower-outer quadrant 174.6 Axillary tail 174.8 Other specified sites of female breast Ectopic sites

This information was supplied by:

FDAapproved for breast cancer

OctOber 2010 I VOL 3, NO 7

175 Malignant neoplasm of male breast Use additional code to identify estrogen receptor status (V86.0, V86.1) Excludes: skin of breast (172.5, 173.5) 175.0 Nipple and areola 175.9 Other and unspecified sites of male breast Ectopic breast tissue, male

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

Compendia listed off-label use for breast cancera

✓

Current code price (AWP-based pricing), effective 10/1/10 NDC level pricing $13.48

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10

CPT ® administration codes

$169.10

NDC level pricing S0170: not payable by Medicare $114.93

96413, 96415

✓

$68.50

$58.44

96413, 96415

✓

$8.52

$6.85

N/A

✓

$28.41

$22.58

N/A

✓

$48.55

$3.70

96409, 96413, 96415

✓

$4.33

$1.50

96409, 96413, 96415

✓

$21.66

$7.49

96409, 96413, 96415

✓

$2.09

$0.83

✓

$10.57

$5.96

✓

J9031: bCG (intravesical) per installation J9035: injection, bevacizumab, 10 mg J8520: capecitabine, oral, 150 mg J8521: capecitabine, oral, 500 mg J9045: injection, carboplatin, 50 mg J9060: cisplatin, powder or solution, per 10 mg J9062: cisplatin, 50 mg J8530: cyclophosphamide, oral, 25 mg J9070: cyclophosphamide, 100 mg (all 100-mg NDCs inactive: 500-mg NDCs used to calculate code price)

174.9

Inner breast Lower breast Malignant neoplasm of contiguous or overlapping sites of breast whose point of origin cannot be determined Midline of breast Outer breast Upper breast Breast (female), unspecified

N/A

N/A 96409, 96413, 96415

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TON_October 2010_v6_TON 10/15/10 3:01 PM Page 23

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

generic (Brand) name cyclophosphamide (Cytoxan)

cyclophosphamide (Cytoxan) cyclophosphamide (Cytoxan) cyclophosphamide (Cytoxan) daunorubicin citrate liposome (DaunoXome) docetaxel (Taxotere) doxorubicin (Adriamycin) doxourubicin HCl liposome (Doxil) epirubicin (Ellence) estradiol (Estrace) etoposide (Vepesid) exemestane (Aromasin) exemestane (Aromasin)

HCPCS code: code description J9080: cyclophosphamide, 200 mg (all 100-mg NDCs inactive: 500-mg NDCs used to calculate code price) J9090: cyclophosphamide, 500 mg J9091: cyclophosphamide, 1 gram J9092: cyclophosphamide, 2 gram J9151: injection, daunorubicin citrate, liposomal formulation, 10 mg J9171: injection, docetaxel, 1 mg J9000: injection, doxorubicin hydrochloride, 10 mg J9001: injection, doxorubicin hydrochloride, all lipid formulations, 10 mg J9178: injection, epirubicin HCl, 2 mg J8499b: prescription drug, oral, non-chemotherapeutic, not otherwise specified J8560: etoposide, oral, 50 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0156: exemestane, 25 mg

fluorouracil (Adrucil) fluoxymesterone (Androxy)

J9190: injection fluorouracil, 500 mg J8499b: prescription drug, oral, non-chemotherapeutic, not otherwise specified fulvestrant J9395: injection, fulvestrant, (Faslodex) 25 mg gemcitabine J9201: injection, (Gemzar) gemcitabine hydrochloride, 200 mg goserelin acetate J9202: goserelin acetate (Zoladex 3.6 mg ONLY) implant, per 3.6 mg hydroxyurea J8999b: prescription drug, (Hydrea) oral, chemotherapeutic, not otherwise specified hydroxyurea S0176: hydroxyurea, oral, (Hydrea) 500 mg ifosfamide (Ifex)

J9208: injection, ifosfamide, 1 gram

✓

Current code price (AWP-based pricing), effective 10/1/10 $21.15

✓

$52.87

$29.79

96409, 96413, 96415

✓

$95.21

$59.59

96409, 96413, 96415

✓

$171.35

$119.18

96409, 96413, 96415

$68.00

$57.66

96413

✓

$24.29

$18.01

96413

✓

$13.20

$3.04

96409

$613.03

$486.80

96413

✓

$5.38

$1.80

✓

NDC level pricing $57.33

NDC level pricing $28.48

✓

NDC level pricing $13.50

✓

$3.37

NDC level pricing S0156: not payable by Medicare $1.74

✓

NDC level pricing $97.29

NDC level pricing $83.02

96402

✓

$177.83

$148.35

96413

✓

$451.19

$194.29

96372, 96402

FDAapproved for breast cancer

Compendia listed off-label use for breast cancera

✓

✓ ✓

✓

NDC level pricing $1.28

✓

$56.40

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10 $11.92

CPT ® administration codes 96409, 96413, 96415

96409, 96413 N/A

N/A N/A

N/A

96409 N/A

NDC level pricing S0176: not payable by Medicare $34.15

N/A

96413, 96415

Continued on page 24 www.TheOncologyNurse.com

OcTOber 2010 I VOL 3, NO 7

TON_October 2010_v6_TON 10/15/10 3:01 PM Page 24

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems Continued from page 23

generic (Brand) name

HCPCS code: code description

irinotecan (Camptosar) ixabepilone (Ixempra) lapatinib ditosylate (Tykerb)

J9206: injection, irinotecan, 20 mg J9207: injection, ixabepilone, 1 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified J0640: injection, leucovorin calcium, per 50 mg J9217: leuprolide acetate (for depot suspension), 7.5 mg J9218: leuprolide acetate, per 1 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0178: lomustine, oral, 10 mg

letrozole (Femara) leucovorin calcium (Wellcovorin) leuprolide (Eligard, Lupron Depot) leuprolide (Lupron) lomustine (CeeNu) lomustine (CeeNu)

medroxyprogesterone J1051: injection, (Depo-Provera) medroxyprogesterone acetate, 50 mg megestrol J8999b: prescription drug, (Megace) oral, chemotherapeutic, not otherwise specified megestrol S0179: megestrol acetate, (Megace) oral 20 mg melphalan (Alkeran) melphalan (Alkeran) methotrexate sodium methotrexate sodium methotrexate sodium mitomycin (Mutamycin) mitomycin (Mutamycin) mitomycin (Mutamycin) mitoxantrone (Novantrone) oxaliplatin (Eloxatin)

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10

CPT ® administration codes

$31.48

$6.12

96413, 96415

✓

$73.76

$63.74

96413, 96415

✓

NDC level pricing NDC level pricing $3.60

NDC level pricing NDC level pricing $1.05

✓

$493.20

$208.22

96402

✓

$27.52

$4.79

96402

✓

$9.67

NDC level pricing S0178: not payable by Medicare $8.12

N/A

✓

NDC level pricing $10.59

✓

NDC level pricing $0.66

FDAapproved for breast cancer

J8600: melphalan, oral, 2 mg J9245: injection, melphalan hydrochloride, 50 mg J8610: methotrexate, oral, 2.5 mg J9250: methotrexate sodium, 5 mg J9260: methotrexate sodium, 50 mg J9280: mitomycin, 5 mg J9290: mitomycin, 20mg J9291: mitomycin, 40 mg J9293: injection, mitoxantrone hydrochloride, per 5 mg J9263: injection, oxaliplatin, 0.5 mg

Compendia listed off-label use for breast cancera

✓

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

NDC level pricing S0179: not payable by Medicare $4.80

N/A

96372, 96374, 96409

N/A

96402

N/A

✓

$5.68

✓

$1,922.50

$1,401.83

✓

$3.61

$0.12

✓

$0.29

$0.19

✓

$2.86

$1.89

✓

$67.20

$20.77

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

✓

$218.40

$83.07

96409

✓

$300.00

$166.15

96409

✓

$106.50

$40.83

96409, 96413

✓

$8.25

$4.71

96413, 96415

N/A 96409, 96413 N/A

Continued on page 26

OctOber 2010 I VOL 3, NO 7

www.theOncologyNurse.com

TON_October 2010_v6_TON 10/15/10 3:01 PM Page 25

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

TON_October 2010_v6_TON 10/15/10 3:01 PM Page 26

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems Continued from page 24

generic (Brand) name

HCPCS code: code description

paclitaxel (Taxol) paclitaxel protein-bound particles (Abraxane) pemetrexed (Alimta) prednisone

J9265: injection, paclitaxel, 30 mg J9264: injection, paclitaxel protein-bound particles, 1 mg J9305: injection, pemetrexed, 10 mg J7506: prednisone, oral, per 5 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0187: tamoxifen citrate, oral, 10 mg

tamoxifen (Nolvadex) tamoxifen (Nolvadex) testolactone (Teslac) thiotepa (Thiotepa) toremifene citrate (Fareston) trastuzumab (Herceptin) triptorelin (Trelstar Depot, Trelstar LA) topotecan (Hycamtin) topotecan (Hycamtin) vinBLAStine vinCRIStine (Vincasar) vinCRIStine (Vincasar) vinCRIStine (Vincasar) vinorelbine (Navelbine)

J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified J9340: injection, thiotepa, 15 mg J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified J9355: injection, trastuzumab, 10 mg J3315: injection, triptorelin pamoate, 3.75 mg J8705: topotecan, oral, 0.25 mg J9350: injection topotecan, 4 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

FDAapproved for breast cancer

Compendia listed off-label use for breast cancera

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

Medicare allowable (ASP + 6%), effective 10/1/10-12/31/10

CPT ® administration codes

✓

$15.54

$7.45

96413, 96415

✓

$11.20

$9.38

96413

✓

$61.65

$51.44

96409

✓

$0.04

N/A

NDC level pricing $1.89

N/A

NDC level pricing $138.00

NDC level pricing S0187: not payable by Medicare NDC level pricing $114.09

NDC level pricing $78.26

NDC level pricing $68.28

96413, 96415

✓

$870.00

$181.93

96372, 96402

✓

$89.73

$77.10

N/A

✓

$1,306.10

$1,090.84

96413

$3.18

$1.64

96409

✓

$5.83

$3.98

96409

✓

$11.66

$7.96

96409

✓

$29.15

$19.90

96409

✓

$42.60

$11.05

96409

✓

N/A

51720, 96409 N/A

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 Nolvadex) 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 (CPT © copyright 2010 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Volumes 1 and 2, 2010 • The Drug Reimbursement Coding and Pricing Guide by RJ Health Systems International, LLC, Volume 7, Number 4, 4th Quarter 2010 • FDA-approved indication (from the product’s prescribing information) • National Cancer Institute® • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Wethersfield, Connecticut • CMS (Centers for Medicare & Medicaid Services), Medicare Allowable 4th Quarter 2010 (effective dates 10/1/10-12/31/10). Prices listed herein are effective as of October 1, 2010.

OctOber 2010 I VOL 3, NO 7

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Who Will Be the ONE? The Oncology Nurse Excellence Award Winner The Oncology Nurse-APN/PA is pleased to announce the inaugural Nurse Excellence Award. The award will recognize an oncology nurse nominated by his/her peers for an outstanding contribution to oncology nursing practice, patient care, research, or education in 2010. The four leading nominees will be profiled in the February issue of The Oncology Nurse-APN/PA. Readers will have an opportunity to vote for the winner online at www.TheOncologyNurse.com/award or by visiting The Oncology Nurse-APN/PA booth at the 2011 ONS Congress. The winner will be announced in the June issue of The Oncology Nurse-APN/PA .

Nomination forms are available at

www.TheOncologyNurse.com/award

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Lung Cancer

In Metastatic NSCLC, Early Palliative Care Improves Survival as Well as QOL By Caroline Helwick

CHICAGO—Early initiation of palliative care (PC) in the management of metastatic non–small-cell lung cancer (NSCLC) led to a longer survival time and better quality of life (QOL) than standard treatment, in a randomized phase 3 trial. The study compared QOL and clinical outcomes for early PC versus standard oncology care in 150 patients with newly diagnosed metastatic NSCLC. “We found that compared with standard oncology care, integrated palliative care led to improvements in quality of life, lower rates of depression, less aggressive care at the end of life, greater documentation of resuscitation preferences, and, in addition, higher survival rates,” said Jennifer S. Temel, MD, of Massachusetts General Hospital, Boston, during her presentation at the annual meetting of the American Society of Clinical Oncology. Patients were randomly assigned to receive early PC integrated with standard oncology care (n = 77), which included PC visits at least monthly from the time of enrollment, or standard care (n = 74), which included meeting with PC providers only when requested by the patient, family, or oncologist. PC was delivered according to established guidelines for symptom management, decision making, and assistance with coping. There were no differences among the

arms in patient demographics, baseline measures of QOL, or psychological distress, and no difference between the number of chemotherapy lines they received during the study period. Although the design was randomized, the study was not assessed in blinded fashion. QOL was determined by measures of symptoms and psychological distress. The FACT-Lung instrument assessed lung cancer–specific symptoms (Lung Cancer Symptom Index) and functional/physical well-being (Trial Outcome Index), whereas psychological distress was measured by the Hospital Anxiety and Depression Scale (HADS) and the Patient Health Questionnaire (PHQ)-9. Change in FACT-Lung Trial Outcome Index was the primary end point. The 12-week QOL assessment was completed by 78% in the PC group (13% had died) and by 64% in the standard care group (23% had died). At 12 weeks, 100% of the PC group had experienced a PC visit (by definition), which included four or more visits for 65% of patients. In the standard care group, 4% of the patients had two visits and 9% had one visit; no patient in this arm had more than two PC visits. Early PC superior in multiple outcomes “At 12 weeks, patients assigned to early PC experienced better QOL, as

measured by the FACT-Lung and Trial Outcome Index,” Temel reported. The effect of early PC on psychological distress was also highly favorable, as these patients experienced lower rates of depression according to both the HADS (15.8% vs 38.3%; P = .01) and the PHQ-9 (3.5% vs 17%; P = .02).

“At 12 weeks, patients assigned to early PC experienced better QOL, as measured by the FACT-Lung and Trial Outcome Index.” —Jennifer S. Temel, MD

Interestingly, fewer patients randomized to PC received aggressive care at the end of life (33.3% vs 53.6%; P = .05), but despite this they lived significantly longer than the standard care arm (11.6 months vs 8.0 months; P = .02), Temel reported. Aggressive care was defined as no use of hospice, use of hospice for 3 days or less, or chemotherapy administered within 14 days of death. Patients in the

standard care arm averaged 4 days of hospice care, compared with 11 days for those in PC arm. Patients treated in the PC arm were also more likely to have documented their resuscitation preferences (53% vs 28%; P = .05). Temel suggested that the improvement in QOL and decreased rates of depression may be related to better symptom management and patients’ acceptance of their illness. Prolonged survival may be related to earlier recognition and management of medical issues, improved QOL and mood, the administration of less chemotherapy at the end of life and longer hospice admission. The paper’s discussant, Raffit Hassan, MD, of the National Cancer Institute, lauded the investigators. “This is the first randomized study of early palliative care in newly diagnosed patients with advanced NSCLC,” he noted. “It shows that palliative care and active cancer therapy can go hand in hand, and that initiation of early palliative care at diagnosis improves QOL, psychological well-being, end-of-life care, and even overall survival.” He said future research should have overall survival as the primary end point, and should include more diverse populations and more patients with poor performance status in order to better define PC benefits in this subset. ●

HEMATOLOGIC CANCERS

New “Tip Sheets” Help NHL Patients Communicate with the Oncology Team By Caroline Helwick

research-based educational program aimed at enhancing communication between nonHodgkin lymphoma patients and their healthcare providers has just been launched and is available for healthcare providers. Framing Life With Lymphoma was developed by the Cancer Support Community, which unites The Wellness Community and Gilda’s Club Worldwide, and was supported by a grant from Cephalon. “Non-Hodgkin lymphoma is the seventh most common cancer, yet the majority of people who are diagnosed have very little information on the disease and how it may impact their

OctOber 2010 I VOL 3, NO 7

lives,” said David Henry, MD, clinical professor of medicine at Pennsylvania Hospital and the physician advisor for Framing Life With Lymphoma. The program contains simple tip sheets outlining ways to approach each conversation the patient is likely to encounter from diagnosis through treatment. The information was created through input from an expert steering committee and a national survey of 150 hematologists/oncologists and 133 patients with indolent lymphoma. The survey found that 96% of physicians and 86% of patients felt their communication could be made more efficient with informational aids. The survey also revealed that about two in

five patients do not ask all their intended questions during visits, usually because they don’t remember. “This survey shows that it is critical that patients have resources to help them understand their condition and treatment options. This helps them communicate more effectively with their physicians,” Henry said. “In addition to providing information, physicians need to work with their patients to create a team-based approach to treatment,” he added. “Working as a team creates an environment where informed patients are more comfortable addressing their concerns and questions, and this can have a positive impact on their overall

treatment experience.” Kim Thiboldeaux, president and CEO of the Cancer Support Community, also applauded the program.“We hope Framing Life With Lymphoma will become an important resource for the lymphoma community,” she said. “A clear majority of patients and physicians reported that discussion materials would improve their conversations. That is what this program aims to do.” The patient tip sheets for newly diagnosed patients and those undergoing treatment, along with the survey results and other program information, can be downloaded at www.Framing LifeWithLymphoma.org. ●

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Hematologic Cancers

More Cycles of Decitabine Equals Better MDS Outcomes By Caroline Helwick

CHICAGO—Patients with myelodysplastic syndromes (MDS) treated with hypomethylating agents (HMAs), especially decitabine, are more likely to achieve hematologic responses when treated with a greater number of cycles, investigators from Georgia Cancer Specialists in Marietta reported at the 2010 annual meeting of the American Society of Clinical Oncology. “The likelihood of improvement in anemia, thrombocytopenia, and neutropenia is associated with the number of cycles. For every extra cycle, the chance of improvement increases,” said Rodolfo Bordoni, MD. Responses increased by 15% to 19% with each additional cycle beyond the first. Although clinical trials of HMAs have demonstrated a range of clinical benefits, concern exists about the applicability of trial results in the community practice setting where patients may differ in terms of demographics, risk level, comorbidities, and treatment regimen, Bordoni noted. “We therefore examined hematologic outcomes in MDS among patients treated with the HMAs azacitidine and decitabine in a large community hematology/oncology practice,” he said. This was a retrospective observational study of patients through electronic medical record data for 2006-2009. The population included 1070 patients with intermediate- or high-grade MDS, 137 (13%) of whom received azacitidine (n = 53) or decitabine (n = 84). The groups were well-balanced except that decitabine recipients were somewhat sicker, he noted. The Charlson comorbidity index was ≥1 in the month preindex for 40/53 on azacitidine and 66/84 on decitabine. Mean Charlson index was 1.2 for the azacitidine group and 1.7 for the decitabine group. Mean number of cycles was five for azacitidine and four for decitabine. Response increased per cycle The total number of cycles significantly predicted hemoglobin level (odds ratio [OR], 1.19; P = .029), platelet count (OR, 1.15; P = .031), and absolute neutrophil count (ANC) (OR, 1.16; P = .047), Bordoni reported. This improvement, however, was largely driven by decitabine, which was associated with a 58% improvement in hemoglobin response per additional cycle (P = .0035). There was also a trend toward a greater likelihood of hemoglobin ≥11 g/dL for decitabine over azacitidine (OR, 2.70; P = .085) after controlling for the number of cycles given. Although decitabine-

treated patients were also more likely to have a platelet response, the difference was not statistically significant after controlling for the number of cycles. The drugs were equally likely to pro-

P = .007), he added. The findings suggest that “we should not give up on slow responders,” Bordoni said. “Continuing on treatment is the key to hematologic response.” ●

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

Act before febrile neutropenia strikes Potential consequences of febrile neutropenia may be serious and can impact patient care First- and every-cycle Neulasta® achieved: ■ 94% reduction in febrile neutropenia (17% placebo vs 1% Neulasta®; P < 0.001).1,2 ■ 93% reduction in febrile neutropenia– related hospitalization (14% placebo vs 1% Neulasta®; P < 0.001).1,2 ■ 80% reduction in febrile neutropenia– related IV anti-infective use (10% placebo vs 2% Neulasta®; P < 0.001).1,2 Neulasta® (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Neulasta® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information Do not administer Neulasta® to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Splenic rupture, including fatal cases, can occur following the administration of Neulasta®. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta®. Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta®. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta® for ARDS. Discontinue Neulasta® in patients with ARDS. Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta®. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta® in patients with serious allergic reactions. Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta®. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim. The granulocyte colony-stimulating factor (G-CSF) receptor, through which pegfilgrastim and filgrastim act, has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded. Bone pain and pain in extremity occurred at a higher incidence in Neulasta®-treated patients as compared with placebo-treated patients. Please see brief summary of Neulasta® Prescribing Information on the adjacent page. *Regimens associated with 17% risk of febrile neutropenia. References: 1. Vogel C, et al. J Clin Oncol. 2005;23:1178-1184. 2. Neulasta® (pegfilgrastim) Prescribing Information. Thousand Oaks, Calif: Amgen. © 2010 Amgen. All rights reserved.

MC49047-A-1

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duce an ANC response. The use of growth factors during treatment was negatively associated with ANC response (OR, 0.96; P = .046) as well as hemoglobin response (OR, 0.85;

04-10

www.neulasta.com

OcTOber 2010 I VOL 3, NO 7

TON_October 2010_v6_TON 10/15/10 3:01 PM Page 30

International News Reports from the European Society of Cardiology Congress and the Joint Annual Meeting of the International Continence Society and International Urogynecological Association By Jill Stein

Western Lifestyle Responsible for UK Breast Cancer Surge LONDON—A Western lifestyle charBRIEF SUMMARY OF PRESCRIBING INFORMATION Neulasta® (pegfilgrastim) injection, for subcutaneous use INDICATIONS AND USAGE Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. CONTRAINDICATIONS Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. WARNINGS AND PRECAUTIONS Splenic Rupture Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta. Acute Respiratory Distress Syndrome Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta, for ARDS. Discontinue Neulasta in patients with ARDS. Serious Allergic Reactions Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta in patients with serious allergic reactions. Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Use in Patients With Sickle Cell Disorders Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim. Potential for Tumor Growth Stimulatory Effects on Malignant Cells The granulocyte-colony stimulating factor (G-CSF) receptor through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded. ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the Brief Summary: s 3PLENIC 2UPTURE ;3EE Warnings and Precautions] s !CUTE 2ESPIRATORY $ISTRESS 3YNDROME ;3EE Warnings and Precautions] s 3ERIOUS !LLERGIC 2EACTIONS ;3EE Warnings and Precautions] s 5SE IN 0ATIENTS WITH 3ICKLE #ELL $ISORDERS ;3EE Warnings and Precautions] s 0OTENTIAL FOR 4UMOR 'ROWTH 3TIMULATORY %FFECTS ON -ALIGNANT #ELLS ;3EE Warnings and Precautions] The most common adverse reactions occurring in r 5% of patients and with a between-group difference of r 5% higher in the pegfilgrastim arm in placebo controlled clinical trials are bone pain and pain in extremity. 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 with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Neulasta clinical trials safety data are based upon 932 patients receiving Neulasta in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and lymphoma (n = 56) received Neulasta after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles. The following adverse reaction data in Table 1 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer

OctOber 2010 I VOL 3, NO 7

acterized by an excess of food and alcohol and a lack of exercise may explain increasing breast cancer rates in the receiving docetaxel 100 mg/m2 every 21 days. (Study 3). A total of 928 patients were randomized to receive either 6 mg Neulasta (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and <1% Asian, Native American or other. Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients. Table 1. Adverse Reactions With ≥ 5% Higher Incidence in Neulasta Patients Compared to Placebo in Study 3 System Organ Class Preferred Term

Placebo (N = 461)

Neulasta 6 mg SC on Day 2 (N = 467)

Musculoskeletal and connective tissue disorders Bone pain

26%

31%

Pain in extremity

Leukocytosis In clinical studies, leukocytosis (WBC counts > 100 x 109/L) was observed in less than 1% of 932 patients with nonmyeloid malignancies receiving Neulasta. No complications attributable to leukocytosis were reported in clinical studies. Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment. None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Neulasta with the incidence of antibodies to other products may be misleading. Postmarketing Experience The following adverse reactions have been identified during post approval use of Neulasta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) reported frequency of the reaction, or (3) strength of causal relationship to Neulasta. Gastro-intestinal disorders: 3PLENIC RUPTURE ;SEE Warnings and Precautions] Blood and lymphatic system disorder: Sickle cell crisis ;SEE Warnings and Precautions] Respiratory, thoracic, and mediastinal disorder: ARDS ;SEE Warnings and Precautions] General disorders and administration site conditions: Injection site reactions Skin and subcutaneous tissue disorders: Allergic reactions/ hypersensitivity, including anaphylaxis, skin rash, and urticaria, Sweet’s syndrome, generalized erythema and FLUSHING ;SEE Warnings and Precautions] DRUG INTERACTIONS No formal drug interaction studies between Neulasta and other drugs have been performed. Increased hematopoietic activity of the bone marrow in response to growth factor therapy may result in transiently positive bone-imaging changes. Consider these findings when interpreting boneimaging results. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Pegfilgrastim was embryotoxic and increased pregnancy loss in pregnant rabbits that received cumulative doses approximately 4 times the recommended human dose (based on body surface area). Signs of maternal toxicity occurred at these doses. Neulasta should be used during

United Kingdom, new data suggest. Findings from the World Cancer Research Fund (WCRF) show that the pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. In animal reproduction studies, when pregnant rabbits received pegfilgrastim at cumulative doses approximately 4 times the recommended human dose (based on body surface area), increased embryolethality and spontaneous abortions occurred. Signs of maternal toxicity (reductions in body weight gain/food consumption) and decreased fetal weights occurred at maternal doses approximately equivalent to the recommended human dose (based on body surface area). There were no structural anomalies observed in rabbit offspring at any dose tested. No evidence of reproductive/ developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). Women who become pregnant during Neulasta treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll. Nursing Mothers It is not known whether pegfilgrastim is secreted in human milk. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. Caution should be exercised when administered to a nursing woman. Pediatric Use Safety and effectiveness of Neulasta in pediatric patients have not been established. The adverse reaction profile and pharmacokinetics of pegfilgrastim were studied in 37 pediatric patients with sarcoma. The mean (± standard DEVIATION ;3$= SYSTEMIC EXPOSURE !5#0-inf) of pegfilgrastim after subcutaneous administration at 100 mcg/kg was 22.0 (± 13.1) mcg·hr/mL in the 6 to 11 years age group (n = 10), 29.3 (± 23.2) mcg·hr/mL in the 12 to 21 years age group (n = 13), and 47.9 (± 22.5) mcg·hr/mL in the youngest age group (0 to 5 years, n = 11). The terminal elimination half-lives of the corresponding age groups were 20.2 (± 11.3) hours, 21.2 (± 16.0) hours, and 30.1 (± 38.2) hours, respectively. The most common adverse reaction was bone pain. Geriatric Use Of the 932 patients with cancer who received Neulasta in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients. Renal Impairment In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim. Therefore, pegfilgrastim dose adjustment in patients with renal dysfunction is not necessary.

breast cancer rate in the United Kingdom is more than four times higher than in eastern Africa, which has the lowest breast cancer rate worldwide. The organization recently reported that 87.9 women per 100,000 in the United Kingdom were diagnosed with breast cancer in 2008 versus only 19.3 women per 100,000 women in eastern Africa, which includes Kenya and Tanzania. Cancer experts have suggested that the growing gap in breast cancer rates between rich and poor countries may be partly a function of better surveillance and diagnosis in wealthier countries. They also emphasize, however, that lifestyle is an important contributor. In fact, it is estimated that 40% of breast cancer cases in the United Kingdom, or more than 18,000 cases per year, could be avoided if women adopted a healthier lifestyle involving a better diet, more exercise, and less alcohol. Women in eastern Africa consume less alcohol than UK women and are less likely to be obese. They are also more likely to breastfeed, and breastfeeding has been associated with a lower rate of breast cancer. Rachel Thompson, MD, with the WCRF, said that breast cancer is not the only cancer for which lifestyle may be a contributor. In fact, roughly a third of the most common cancers in the United Kingdom could be prevented by lifestyle changes, she noted.

No Evidence that Statins Cause Cancer

DOSAGE AND ADMINISTRATION The recommended dosage of Neulasta is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle in adults. Do not administer Neulasta between 14 days before and 24 hours after administration of cytotoxic chemotherapy. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Neulasta if discoloration or particulates are observed. NOTE: The needle cover on the single-use prefilled syringe contains dry natural rubber (latex); persons with latex allergies should not administer this product.

STOCKHOLM—Statins do not increase the risk of cancer, according to the results of a large meta-analysis released at the European Society of Cardiology Congress 2010. Researchers from the University of Oxford, United Kingdom, and the University of Sydney, Australia, said in a news release that their results will “reassure the millions of people worldwide who are taking statins to lower cholesterol levels and clarify earlier research that had raised concerns of a causal link.” The data are from the Cholesterol Treatment Trialists’ Collaboration, which reviewed data from 170,000 patients enrolled in 26 trials. Overall, 10,000 patients developed cancer and more than 3500 died of cancer. “Statin therapy had no adverse effect on cancer at any site or in any group of individuals, irrespective of their cholesterol levels,” said principal

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

Neulasta® (pegfilgrastim) Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 © 2010 Amgen Inc. All rights reserved. www.neulasta.com 1-800-77-AMGEN (1-800-772-6436) v 11.0

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International News investigator Jonathan Emberson, MD, of the University of Oxford. â&#x20AC;&#x153;There was also no association of cancer with statin dose or duration.â&#x20AC;? The study was funded by the UK Medical Research Council, the British Heart Foundation, and the National Health and Medical Research Council (Australia).

were reported at the joint annual meeting of the International Continence Society and International Urogynecological Association. Of 764 men who completed a questionnaire roughly 6 weeks after radical prostate surgery, 93% had urinary incontinence. At 12 months, 76% remained incontinent. Results also

revealed that 80% of men had persistent erectile dysfunction at 12 months. Neither the route of operation (abdominal, perineal, or laparoscopic) nor the nerve-sparing technique (one nerve bundle spared, both nerve bundles spared, neither spared, or unknown sparing) was associated with long-term persistent urinary inconti-

nence. Erectile dysfunction was most likely to occur when nerve sparing was not possible. Principal investigator Suzanne Hagen, MD, of Glasgow Caledonian University, urged clinicians to provide men scheduled for prostate cancer surgery with a clear-cut assessment of outcomes they can expect afterward. â&#x2014;?

Overactive Bladder without Hematuria May Be Cancer Symptom TORONTOâ&#x20AC;&#x201D;Overactive bladder (OAB) symptoms without hematuria may be a presenting symptom of bladder cancer, researchers reported at the joint annual meeting of the International Continence Society and International Urogynecological Association. Most patients with bladder cancer present with hematuria. Jeffrey Weiss, MD, of State University of New York Downstate College of Medicine in Brooklyn, and colleagues searched a database for the years 1998 through 2008 to identify patients without hematuria who underwent cystoscopy as part of an evaluation for refractory OAB. Overall, 1420 patients underwent cystoscopy, and eight were found to have bladder cancer. The mean duration of OAB symptoms was 3.3 years. In all cases, the initial biopsy in patients with bladder cancer demonstrated low-grade Ta transitional carcinoma that, in most cases, resembled a typical papillary transitional cell tumor on cystoscopy. At a mean follow-up of 5.2 years, four (50%) patients had experienced one or two recurrences and two had disease progressionâ&#x20AC;&#x201D;in one case to carcinoma in situ and in the other case to high-grade T3 disease. The study also found that bladder cancer was 10 times more common in women with OAB than men with OAB despite the fact that it is two to three times more common in men than in women in the general population. Because OAB symptoms without hematuria may be an initial symptom of bladder cancer, patients with OAB symptoms even without hematuria should be advised to undergo cystoscopy to rule out underlying bladder cancer, the authors said.

Â&#x201D;Â&#x2039;Â&#x2DC;Â&#x192;Â?Â&#x2039;Â&#x201E; Â&#x2013;Â&#x2014;Â&#x2020;Â&#x203A; Â&#x2039;Â? Â&#x192;Â&#x2013;Â&#x2039;Â&#x2021;Â?Â&#x2013;Â&#x2022; Â&#x192;Â&#x2013; Â&#x2039;Â&#x2022;Â?

Â&#x17D;Â&#x2039;Â?Â&#x2039;Â&#x2026;Â&#x192;Â&#x17D; Â&#x2021;Â&#x2022;Â&#x2021;Â&#x192;Â&#x201D;Â&#x2026;Â&#x160; Â&#x2013;Â&#x2014;Â&#x2020;Â&#x2039;Â&#x2021;Â&#x2022;ÇŁ Now Enrolling Subjects with

Advanced Hepatocellular Carcinoma CA182-033 BRISK-FL: A Randomized, Double-blind Phase III Study of Brivanib versus Sorafenib as First-line Treatment in Patients with Advanced HCC

CA182-034 BRISK-PS: A Randomized, Double-blind Phase III Study of Brivanib plus Best Supportive Care versus Placebo plus BSC in Patients with HCC Who Have Failed or are Intolerant to Sorafenib

Key Inclusion Criteria:

Urinary Incontinence and Erectile Dysfunction after Prostate Cancer Surgery Common and Enduring

Men and women, at least 18 years of age

Brain metastasis or evidence of leptomeningeal disease

Histologic or cytologic confirmed diagnosis of advanced HCC

Previous or concurrent cancer that is distinct from HCC

Not eligible for surgery and loco-regional therapy

History of active cardiac disease

At least 1 measurable lesion

No prior use of any systemic anti-cancer chemotherapy for HCC (except sorafenib for CA182-034 ONLY)

For more information, please go to 105678 07/10

TORONTOâ&#x20AC;&#x201D;New data show that urinary incontinence and erectile dysfunction frequently occur after radical prostatectomy for prostate cancer and persist in more than 75% of men at follow-up 1 year after surgery. The new findings, based on a survey by Scottish and Canadian researchers,

www.clinicaltrials.gov and search under NCT-00858871 and NCT-00825955.

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Key Exclusion Criteria:

NOPQ

OcTOber 2010 I VOL 3, NO 7

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

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

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

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

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Estimated Survival of Lower-risk MDS Patients by Risk Category1

‡

Assigned Score 0-2 3-4 ≥5

Cumulative Proportion Alive

1.0

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

43 212 173

80 27 14

65 33 7

0.8 0.6 0.4 0.2 0 0

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

This study indicated that it is possible to identify those lower-risk MDS patients with a poor prognosis (those in Risk Categories 2 and 3) who may benefit from early therapeutic intervention. The proposed prognostic tool based on the IPSS classification of this specific patient type may have a significant impact on1: • MDS treatment approaches • When to treat lower-risk MDS • Clinical trial development

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

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

07/10

CELG10172T

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Genetics

Identifying Newly Diagnosed Individuals with Breast Cancer at Risk for Hereditary Breast Cancer By Cristi Radford, MS, CGC Sarasota Memorial Health Care System, Sarasota, Florida

ultiple professional sion: one before definitive and societal guidesurgery and one after lumplines emphasize the ectomy and before radiaimportance of genetic countion therapy. In addition, seling and testing for indineither referral was interviduals at risk for hereditnal. To increase the number ary breast cancer.1,2 For a of women offered genetic woman newly diagnosed counseling and testing with breast cancer, informabefore definitive surgery, tion gained from genetic SMHCS implemented a Cristi Radford, counseling and testing can quality-im provement initiaMS, CGC directly impact her surgical tive. Identification focused management and treatment plan. Of on women at risk for HBOC. The the syndromes known to have an ele- genetic counselor met with breast vated risk of breast cancer, hereditary health (BH) clinicians, four oncology breast and ovarian cancer (HBOC) is certified nurses, to determine the prethe most common. HBOC is associated ferred medium for a risk assessment tool. with mutations in the BRCA1 and A flow sheet, modeled off Medicare criBRCA2 genes. Women with a BRCA teria for BRCA1/2 testing, was designed mutation have up to a 65% chance of to capture women with personal and developing a new primary breast can- family histories suggestive of HBOC. cer3 and often choose mastectomy with BH clinicians used the tool during contralateral risk-reducing mastectomy intakes for all individuals presenting for over breast-conservation surgery.4,5 Ac- biopsy, and information was recorded. cording to the American Society of For individuals returning to the BH Breast Surgeons, in ideal circumstances center with positive results, a BH clinipatients who are at significant risk for cian introduced genetics. Fact sheets for harboring a BRCA mutation may interested clients were faxed to the undergo testing before definitive sur- genetic counselor for an appointment. gery.6 However, for a woman and her Between January 1, 2009, and Dehealthcare team to use genetic informa- cember 31, 2009, 99.6% (229/230) of tion, a woman has to be identified as at newly diagnosed individuals seen at the risk and undergo appropriate services in BH center were screened for features of a timely manner. One method for iden- HBOC. Approximately one fourth tifying women at risk for BRCA muta- (53/229) were identified as being at risk tions is an inexpensive, one-page flow for BRCA mutations. This is consistent chart. with data obtained at major academic A chart review of patients seen medical centers.7 BH clinicians were between May 1, 2007, and December involved in positive biopsy disclosure 31, 2008, at Sarasota Memorial Health for 23 (43.4%) at-risk individuals. Of Care System’s (SMHCS) Genetic Ed- the 19 (82.6%) individuals referred for ucation Program revealed only two genetic counseling, the genetic counindividuals were referred for genetic selor spoke with and offered services to counseling at the time of surgical deci- 15 individuals: seven proceeded with

genetic counseling before definitive surgery, one after treatment was complete, three were uninsured and could not afford the cost, and four were not interested. Regarding the at-risk individuals who did not receive positive results from BH clinicians, as of July 1, 2010, 23% (7/30) had been referred for genetic counseling. However, none were referred before definitive surgery. A chart review is planned to determine if any at-risk individuals underwent inoffice genetic testing.

biopsy results from BH clinicians. In addition, as of July 1, 2010, only 17 of 53 at-risk individuals had undergone a genetic counseling consult at SMHCS. Identifying individuals at risk for hereditary breast cancer requires a multidisciplinary team approach. The mechanism used depends on the needs and resources of the institution. To ensure all at-risk individuals are offered genetic services, hospitals need to evaluate their current method of identification and consider collaboration with local genetic professionals and/or companies providing phone genetic counseling. ●

By creating a flow chart and providing minimal training to BH clinicians, SMHCS was able to increase the number of women speaking to a genetic counselor before definitive surgery from one to 15.

References

By creating a flow chart and providing minimal training to BH clinicians, SMHCS was able to increase the number of women speaking to a genetic counselor before definitive surgery from one to 15. Although this is greater than a 1000% increase, it is less than ideal. The National Comprehensive Cancer Network guidelines clearly state “a genetic counselor or medical geneticist should be involved early in counseling patients who potentially meet criteria for an inherited syndrome.”8 The process failed to account for the 30 at-risk individuals who would not receive positive

1. Lu K, Kauff N, Powell B, et al; for American College of Obstetricians and Gynecologists; ACOG Committee on Practice Bulletins—Gynecology; ACOG Committee on Genetics; and Society of Gynecologic Oncologists. ACOG practice bulletin No. 103: hereditary breast and ovarian cancer syndrome. Obstet Gynecol. 2009;113: 957-966. 2. Khatcheressian JL, Wolff AC, Smith TJ, et al; for the American Society of Clinical Oncology. American Society of Clinical Oncology 2006 update of the breast cancer follow-up and management guidelines in the adjuvant setting. J Clin Oncol. 2006;24:5091-5097. 3. Antoniou A, Pharoah PDP, Narod S, et al. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2 mutations detected in case series unselected for family history: a combined analysis of 22 studies. Am J Hum Genet. 2003;72:1117-1130. 4. Stolier AJ, Fuhrman GM, Mauterer L, et al. Initial experience with surgical treatment planning in the newly diagnosed breast cancer patient at high risk for BRCA-1 or BRCA-2 mutation. Breast J. 2004;10:475-480. 5. Schwartz MD, Lerman C, Brogan B, et al. Impact of BRCA1/BRCA2 counseling and testing on newly diagnosed breast cancer patients. J Clin Oncol. 2004;22: 1823-1829. 6. American Society of Breast Surgeons Official Statement. BRCA genetic testing for patients with and without breast cancer. June 12, 2006. www.breastsur geons.org/statements/PDF_Statements/BRCA_Testing. pdf. Accessed July 1, 2010. 7. Shannon KM, Lubratovich ML, Finkelstein DM, et al. Model-based predictions of BRCA1/2 mutation status in breast carcinoma patients treated at an academic medical center. Cancer. 2002;94:305-313. 8. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Genetic/Familial High-Risk Assessment: Breast and Ovarian. V.1.2010. www.nccn.org/ professionals/physician_gls/PDF/genetics_screening.pdf. Accessed July 1, 2010.

Genetic Profiling Changing Clinical Practice in Some Areas of Oncology By John Schieszer

CHICAGO—Gene-expression profiling, combined with a novel chemoradiation regimen, may predict pathologic complete response in patients with esophageal cancer, according to new data presented at the 46th annual meeting of the American Society of Clinical Oncology. New studies presented at this meeting highlighted several new “genetic fingerprinting” techniques that may improve and guide chemotherapy

OctOber 2010 I VOL 3, NO 7

in specific cancer populations. Researchers looked at pathologic complete response rate and toxicity in a phase 2 trial involving 36 patients with stage II to IVa esophageal cancer, 29 (81%) of whom had undergone surgery in the course of their treatment. The treatment consisted of three 85-mg/m2 doses of oxaliplatin over the course of a month, a 625-mg/m2 twice-daily dose of oral capecitabine, and radiation thera-

py, followed by surgery 4 to 6 weeks later. Two cycles of oxaliplatin and capecitabine were given postoperatively. Gene-expression profiling (using microarrays by Agilent Technology) was conducted on primary tumor tissue. The researchers have found that eight of the 29 patients who had their esophagus removed following the oxaliplatin regimen had no cancer in the surgical specimen (a 28% pathologic com-

plete response rate). “Another clear result is that this regimen is very welltolerated by patients without significant side effects,” said study investigator Nikhil Khushalani, MD, who is an assistant professor of medicine at Roswell Park Cancer Institute. “There appear to be several gene pathways that are enriched when studying different subgroups, the pathologic complete response Continued on page 46

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SARCOMA: THE ONLY THING PROGRESSING IS THE DISEASE THE 5 - Y EAR SURV IVAL RATE IS 17 % F OR PATIENTS WITH METASTATIC SO F T TISSU E SA RC OMA , Y ET SIG NIF ICAN T THE RA PEU TIC ADVANCEM ENTS ARE L A GGIN G.1

NEW TREATMENTS ARE URGENTLY NEEDED.

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

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Nursing Practice

Split Scheduling for Chemotherapy Increases Efficiency, Reduces Costs By Karen Rosenberg

ith community to be sitting in the chair. For cancer centers facexample, say a patient has ing rising costs an 8:00 AM appointment but first the nurse has to get and declining revenues, a blood count, the results of finding more efficient ways the blood count have to be to run a practice is critical. interpreted, and the nurse In this interview, Cathy has to get a doctor’s order Maxwell, RN, OCN, direcbefore the infusion can tor of clinical operations at begin. So if you have that Advanced Medical Spe patient scheduled in the cialties in Miami, Florida, Cathy Maxwell, chemo chair at 8:00 AM, discusses how community RN, OCN your schedule is already set cancer centers can make the most efficient use of chemotherapy up incorrectly. One of the best ways to nurses by efficient scheduling and how use your nurses’ time efficiently is what this not only increases nurse and patient we call a “split schedule.” This means that the patient comes in the day before satisfaction but also reduces costs. the infusion for their blood count, for What efficiencies can be gained their office visit with the doctor, and for with proper scheduling in an infusion assessment of their readiness for the treatment; then he or she gets treatcenter? Because chemotherapy nurses are usu- ment the next day. Many people think their patients ally among the higher paid employees, it is important to use them efficiently. You won’t accept split scheduling, but we do don’t want to have them doing tasks and this in the three sites that I’m responsiduties that do not require a registered ble for and it is very successful. In this nurse (RN), and you want to schedule day and age when you have to control them in a way that you’re not wasting your inventory of drugs, this is the best them as resources. That all translates way to predict what you’re going to into dollars. There are different ways to need for the next day, which is especialstaff an infusion suite to make optimal ly important when you’re talking about expensive drugs. We used to carry use of nurses’ time. The scheduling of the treatments is $800,000 to $1 million worth of drugs crucial because you want to make sure in our mixing room every day for three that your schedule reflects what is actu- locations. We are now at $400,000 with ally going to happen as much as you the split schedule, and our goal is to get possibly can predict. I’ve found that in even lower than that. many cases, the schedule is already set How would you achieve that? up to fail before the first patient walks My goal by the end of the year is to in the door because it doesn’t reflect what time the patient is actually going get the doctors’ orders 48 hours ahead of

Nurses and patients interact in the chemotherapy infusion suite at Advanced Medical Specialties.

OctOber 2010 I VOL 3, NO 7

Tips for Scheduling Chemotherapy Infusions • Develop and follow guidelines for scheduling • Consider time needed for intravenous access and premedication • Allow extra time for new patients • Schedule in 15-minute slots (ie, 2-hour treatment = 8 slots) • Stagger the infusion schedules (ie, recliner 1 at 8:15; recliner 2 at 8:30; …) • Assign four to five recliners per nurse, and arrange them close together in pods • Make necessary adjustments to the nurses’ assignments the day before treatment to adjust to the census • Have enough chairs and enough time to handle patients • Limit the number of exceptions to the scheduling guidelines

time, because we would be able to tighten up our inventory even more. In most places around the country, you have until about 6:00 PM to place your orders for delivery by 10:00 AM the next morning. If you have that ability, you don’t have to house expensive drugs; you can order them as you need them. If you have same-day scheduling, you don’t know for sure whether the patient is going to get their chemotherapy until after the office visit. Meanwhile, the patient has an appointment in the chemotherapy infusion suite and the nurses are waiting for the patient. If there is a delay in receiving the patient or the treatment is canceled, it wastes resources and costs the practice money. When the doctor orders a change in treatment, in our practice we need 5 business days to run it through our financial department to make sure the patient’s out-of-pocket costs haven’t changed, that it’s not an off-label regimen, and that we don’t need prior approval from the insurance company. What changes have you seen in your practice as a result of the implementation of split scheduling? With the split schedule, patients’ treatment begins as soon as they arrive at the infusion suite so you can stay on schedule and staff the suite for what you truly need, not what you think you might need. This way, you can use your nurses more efficiently, not waste resources, and free up chair space. Another thing that we noticed when we started split scheduling was that overtime was practically eliminated. In centers where the nurses are paid hourly salaries, eliminating overtime can result in huge savings. Keeping on schedule increases both

nurse satisfaction and patient satisfaction. Studies of patient satisfaction showed that patients most dislike waiting. So even though with split scheduling patients have to come in for two visits, their actual time in the office is less. They’re not wasting time waiting. They go in, see the doctor, and go home. Then when they come back for their treatment, they get in on time, know how long it’s going to take, and go home. They’re much happier because of that. We had an independent group do a patient satisfaction survey a few months after we started split scheduling in a new satellite office. This satellite office was opened in an effort to decompress our original office of 15 doctors. We split the schedule at that time because all of the chemotherapy was prepared at the remote site and we needed to be certain the patients were going to get their prescribed doses and drugs. We interviewed those patients who had experienced both same-day scheduling and split scheduling. We found that patient satisfaction was higher for the split schedule than the old schedule, and patients believed the wait time was better at the new office. That made it easier when we decided to start split scheduling in a larger practice. We basically told the patients that we had no choice, because with split scheduling we found we could lower inventory, cut costs, and reduce overtime. Did you meet with any resistance from patients when you introduced split scheduling? We distributed a letter in our waiting room about 2 months before starting that explained the reasons for the Continued on page 38

www.theOncologyNurse.com

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ALOXI provides powerful CINV prevention that canâ&#x20AC;&#x2122;t be ignored. ÂŽ

Help support your patientsâ&#x20AC;&#x2122; chemotherapy treatment goals s Powerful CINV prevention in the first 24 hours and up to 5 days following moderately emetogenic chemotherapy1,2 s Lasts long against nausea following moderately emetogenic chemotherapy s Powerful acute CINV prevention following highly emetogenic chemotherapy 4 s %ISAI OFFERS A VARIETY OF SUPPORT PROGRAMS AND RESOURCES

Indication ALOXIÂŽ (palonosetron HCl) injection 0.25 mg is indicated in adults 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 s !,/8) IS CONTRAINDICATED IN PATIENTS KNOWN TO HAVE HYPERSENSITIVITY TO THE DRUG OR ANY of its components s -OST COMMONLY REPORTED ADVERSE REACTIONS IN CHEMOTHERAPY INDUCED NAUSEA AND VOMITING include headache (9%) and constipation (5%) Please see the brief summary of the Full Prescribing Information on the adjacent page. References: 1. Gralla R, Lichinitser M, Van der Vegt S, et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol. 2003;14:1570-1577. 2. Eisenberg P, Figueroa-Vadillo J, Zamora R, et al. Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist: results of a phase III, single-dose trial versus dolasetron. Cancer. 2003;98:2473-2482. 3. Data on file. Eisai Inc., Woodcliff Lake, NJ. 4. Aapro MS, Grunberg SM, Manikhas GM, et al. A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Ann Oncol. 2006;17:1441-1449.

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ALOXIÂŽ IS A REGISTERED TRADEMARK OF (ELSINN (EALTHCARE 3! 3WITZERLAND USED UNDER LICENSE $ISTRIBUTED AND MARKETED BY %ISAI )NC ÂĽ %ISAI )NC !LL RIGHTS RESERVED 0RINTED IN 53! !,/ "

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Nursing Practice Split Scheduling for Chemotherapy... Continued from page 36 change, but we still had a lot of angry patients and family members at first. I had to do a lot of damage control. I called every patient or caregiver who requested to speak to someone and explained to them that we were doing this to stay in business. When we were honest with them and explained why we

ALOXIÂŽ (palonosetron HCl) injection BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE Chemotherapy-Induced Nausea and Vomiting ALOXI is indicated for: L =23@/B3:G 3;3B=53<71 1/<13@ 163;=B63@/>G K >@3D3<B7=< =4 /1CB3 /<2 23:/G32 </CA3/ /<2 D=;7B7<5 /AA=17/B32 E7B6 7<7B7/: /<2 @3>3/B 1=C@A3A L 756:G 3;3B=53<71 1/<13@ 163;=B63@/>G K >@3D3<B7=< =4 /1CB3 </CA3/ /<2 D=;7B7<5 /AA=17/B32 E7B6 7<7B7/: /<2 @3>3/B 1=C@A3A DOSAGE AND ADMINISTRATION Recommended Dosing Chemotherapy-Induced Nausea and Vomiting =A/53 4=@ 2C:BA / A7<5:3 ;5 ) 2=A3 /2;7<7AB3@32 =D3@ A31=<2A =A7<5 A6=C:2 =11C@ />>@=F7;/B3:G ;7<CB3A 034=@3 B63 AB/@B =4 163;=B63@/>G Instructions for I.V. Administration "+ 7A AC>>:732 @3/2G 4=@ 7<B@/D3<=CA 7<831B7=< "+ A6=C:2 <=B 03 ;7F32 E7B6 =B63@ 2@C5A :CA6 B63 7<4CA7=< :7<3 E7B6 <=@;/: A/:7<3 034=@3 /<2 /4B3@ /2;7<7AB@/B7=< =4 "+ #/@3<B3@/: 2@C5 >@=2C1BA A6=C:2 03 7<A>31B32 D7AC/::G 4=@ >/@B71C:/B3 ;/BB3@ /<2 27A1=:=@/B7=< 034=@3 /2;7<7AB@/B7=< E63<3D3@ A=:CB7=< /<2 1=<B/7<3@ >3@;7B CONTRAINDICATIONS "+ 7A 1=<B@/7<271/B32 7< >/B73<BA 9<=E< B= 6/D3 6G>3@A3<A7B7D7BG B= B63 2@C5 =@ /<G =4 7BA 1=;>=<3<BA [see Adverse Reactions (6) 7< 4C:: >@3A1@707<5 7<4=@;/B7=< ] WARNINGS AND PRECAUTIONS Hypersensitivity G>3@A3<A7B7D7BG @3/1B7=<A ;/G =11C@ 7< >/B73<BA E6= 6/D3 3F6707B32 6G>3@A3<A7B7D7BG B= =B63@ '

@313>B=@ /<B/5=<7ABA ADVERSE REACTIONS 31/CA3 1:7<71/: B@7/:A /@3 1=<2C1B32 C<23@ E723:G D/@G7<5 1=<27B7=<A /2D3@A3 @3/1B7=< @/B3A =0A3@D32 7< B63 1:7<71/: B@7/:A =4 / 2@C5 1/<<=B 03 27@31B:G 1=;>/@32 B= @/B3A 7< B63 1:7<71/: B@7/:A =4 /<=B63@ 2@C5 /<2 ;/G <=B @3J 31B B63 @/B3A @3>=@B32 7< >@/1B713 < 1:7<71/: B@7/:A 4=@ B63 >@3D3<B7=< =4 </CA3/ /<2 D=;7B7<5 7<2C132 0G ;=23@/B3:G =@ 6756:G 3;3B=53<71 163;=B63@/>G

/2C:B >/B73<BA @3137D32 >/:=<=A3B@=< 2D3@A3 @3/1B7=<A E3@3 A7;7:/@ 7< 4@3?C3<1G /<2 A3D3@7BG E7B6 "+ /<2 =<2/<A3B@=< =@ 2=:/A3B@=< =::=E7<5 7A / :7AB7<5 =4 /:: /2D3@A3 @3/1B7=<A @3>=@B32 0G â&#x2030;Ľ =4 >/B73<BA 7< B63A3 B@7/:A '/0:3 Table 1: Adverse Reactions from ChemotherapyInduced Nausea and Vomiting Studies â&#x2030;Ľ 2% in any Treatment Group ALOXI Ondansetron Dolasetron Event 0.25 mg 32 mg I.V. 100 mg I.V. (N=410) (N=194) (N=633) 3/2/163

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OctOber 2010 I VOL 3, NO 7

did it, they were extremely understanding and cooperated. Anyone thinking of starting split scheduling has to realize itâ&#x20AC;&#x2122;s going to be rough at first, but after you get through that period, itâ&#x20AC;&#x2122;s a piece of cake. In addition, within the next month, we saw the change in inventory and change in

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overtime, so you get instant financial gratification from making that change. What are some other ways practices can increase efficiency? To run efficiently, you have to schedule your nursing staff so that you have the bulk of your nurses there at the

Pediatric Use &/43BG /<2 34431B7D3<3AA 7< >/B73<BA 03:=E B63 /53 =4

G3/@A 6/D3 <=B 033< 3AB/0:7A632 Geriatric Use #=>C:/B7=< >6/@;/1=97<3B71A /</:GA7A 272 <=B @3D3/: /<G 27443@3<13A 7< >/:=<=A3B@=< >6/@;/1=97<3B71A 03BE33< 1/<13@ >/B73<BA â&#x2030;Ľ G3/@A =4 /53 /<2 G=C<53@ >/B73<BA B= G3/@A "4 B63

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ALOXIÂŽ 7A / @357AB3@32 B@/23;/@9 =4 3:A7<< 3/:B61/@3 & &E7BH3@:/<2 CA32 C<23@ :713<A3 7AB@70CB32 /<2 ;/@93B32 0G 7A/7 <1 *==21:744 /93 ! O 7A/7 <1 :: @756BA @3A3@D32 #@7<B32 7< (&

busier times. I recommend having flexible nursing schedules with staggered starting times and a per diem pool of nurses to help you cover vacations and other time off. Cancer treatments today are much more complicated than they used to be, and it takes more interactions from the nurse to take care of the patient. A

I recommend having flexible nursing schedules with staggered starting times.

nurse who works 10 hours probably shouldnâ&#x20AC;&#x2122;t take care of more than 10 or 11 patients who are getting chemotherapy. In our practice, we separate patients who are coming in for shots and blood counts and other nonâ&#x20AC;&#x201C;infusion-related services from those who are getting infusions. Theyâ&#x20AC;&#x2122;re seen in the rapid treatment area where a nurse looks at their blood count and a medical assistant gives the injections. That way the nurses who are in the infusion suite are doing infusions. In most cases, you donâ&#x20AC;&#x2122;t need an RN to give an injection. But you do need an RN (in some states an LPN) to give chemotherapy. Our challenge every day is to keep everybody safe and happy. As things change in our field, we have to be flexible, we have to change. We have to stay efficient, save money, but at the same time we have a huge service to deliver. â&#x2014;?

Recent FDA Approval FDA Approves Docetaxel Injection One-Vial Formulation The US Food and Drug Administration (FDA) has approved a new one-vial formulation of docetaxel injection concentrate (Taxotere, sanofi-aventis). This new formulation eliminates the initial dilution step, as well as the second vial containing the diluent. With the one-vial formulation, the pharmaceutical ingredients and the 1hour intravenous infusion administration remain unchanged. Docetaxel is approved for use in treating patients at specific stages of metastatic and adjuvant breast cancer, metastatic androgen-independent prostate cancer, advanced nonâ&#x20AC;&#x201C;small-cell lung cancer, ad vanced gastric adenocarcinoma, and locally advanced squamous cell carcinoma of the head and neck.

www.theOncologyNurse.com

TON_October 2010_v6_TON 10/15/10 3:01 PM Page 39

A Friday Satellite Symposium preceding the 52nd ASH Annual Meeting

Challenging Cases in Multiple Myeloma A Dialogue Between Community and Academic Clinicians to Improve Patient Care and Outcomes December 3, 2010 Rosen Centre Hotel Ballrooms A & B, Orlando, Florida

PROGRAM AGENDA

This continuing medical education symposium will serve as a forum for discussion of current questions and concerns regarding the treatment and management of patients through the multiple myeloma (MM) life cycle. A panel of domestic and international myeloma experts will be joined by representatives from community cancer care facilities and private oncology practices. By thoroughly engaging participants with interactive cases and physician point-counterpoint-style discussions, this symposium will provide evidence-based treatment and management recommendations and address new treatment regimens and management strategies based on recent clinical trials and emerging data. In addition to considering differences in domestic and international care, barriers and/or limitations faced by community cancer centers and private-practice oncologists will be debated.

12:30 -

1:00 PM

Registration and Lunch Service

1:00 -

1:10 PM

Welcome and Introduction Sundar Jagannath, MD - Chair

CASE PRESENTATIONS Each case will be presented by an expert faculty member and discussed by the international and community panel. 1:10 – 1:40 PM

Case 1: Difficult diagnosis G. David Roodman, MD, PhD

1:40 – 2:10 PM

Case 2: Newly diagnosed, stem cell transplant eligible patient Sundar Jagannath, MD

2:10 – 2:40 PM

Case 3: First-line therapy in a non-SCT eligible patient Stefan Knop, MD

2:40 – 3:10 PM

Case 4: Multiple risk factors Jonathan L. Kaufman, MD

3:10 – 3:40 PM

Case 5: Treatment of MM across the life cycle Noopur Raje, MD

3:40 -

3:50 PM

Question & Answer Session

3:50 -

4:00 PM

Closing Remarks Sundar Jagannath, MD

LEARNING OBJECTIVES At the end of this activity participants will be able to: • Apply early management strategies that consider new diagnostic and staging criteria for SMM, MGUS, and MM and new imaging studies in order to improve prognosis for your patients. • Evaluate novel therapeutic regimens as induction therapy for your patients considering an SCT in order to provide the most rapid response and allow the largest amount of stem cell collection, while maintaining safety and tolerance. • Integrate novel agent-based regimens that provide optimal outcomes and a survival benefit into your management strategy for patients ineligible for SCT after appraising emerging data from clinical trials. • Identify patient- and disease-associated factors that impact choice of therapeutic agent and formulate management strategies using a risk-adapted approach to treatment of MM. • Construct optimal treatment regimens based on novel combinations and make informed treatment decisions in order to improve the long-term outlook for myeloma patients across the life cycle of the disease.

TARGET AUDIENCE This activity has been developed for hematologists and medical oncologists, as well as nurses, pharmacists, and other allied health professionals who are interested in meeting the challenges faced when treating patients with multiple myeloma in academic and community settings.

ACCREDITATION INFORMATION Physician Accreditation The University of Cincinnati designates this activity for a maximum of 3 AMA PRA Category 1 Credits ™. The University of Cincinnati is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Physicians should only claim credit commensurate with the extent of their participation in the activity. Registered Nurse Designation Medical Learning Institute, Inc. (MLI) Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 3.0 contact hours. Registered Pharmacy Designation Medical Learning Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Completion of this activity provides for 3.0 contact hours (0.3 CEUs) of continuing education credit. The universal activity number for this activity is 0468-9999-10-058-L01-P.

FACULTY CHAIR: Sundar Jagannath, MD Professor, Hematology and Medical Oncology Mount Sinai School of Medicine’s Tisch Cancer Institute Director of the Multiple Myeloma Program, The Mount Sinai Medical Center New York, NY Leon Dragon, MD, FACP Medical Director Kellogg Cancer Center Northshore University HealthSystem Highland Park, IL Charles M. Farber, MD, PhD Section Chief of Hematology and Oncology Department of Medicine Carol G. Simon Cancer Center, Morristown, NJ Shoba Kankipati, MD Associate Physician EPIC Care East Bay Partners in Cancer Care San Francisco Bay Area, CA Jonathan L. Kaufman, MD Assistant Professor Blood and Marrow Transplantation Department of Hematology and Medical Oncology Emory University School of Medicine Member, Winship Cancer Institute Emory University, Atlanta, GA

ACKNOWLEDGMENT This activity is supported by an educational grant from Millennium Pharmaceuticals, Inc.

This activity is jointly sponsored by the University of Cincinnati, Medical Learning Institute, Inc., a nonprofit medical accreditation company, and Center of Excellence Media, LLC.

Stefan Knop, MD University Hospital Würzburg Würzburg, Germany Noopur Raje, MD Associate Professor of Medicine Harvard Medical School Director, Center for Multiple Myeloma Massachusetts General Hospital Boston, MA G. David Roodman, MD, PhD Professor of Medicine Vice Chair for Research Department of Medicine Director, Myeloma Program Director, Bone Biology Center University of Pittsburgh Medical Center Pittsburgh, PA Ari Umutyan, MD Redwood Regional Medical Group Hematology and Medical Oncology Napa, CA

TON_October 2010_v6_TON 10/15/10 3:01 PM Page 40

CONTINUING EDUCATION PROGRAM CNE002 • RELEASE DATE: OCTOBER 15, 2010 • EXPIRATION DATE: OCTOBER 15, 2011 ESTIMATED TIME TO COMPLETE: 1.0 HOUR

Bar Coding: An Effective Strategy for Preventing Medication Errors By Eric G. Poon, MD, MPH Director of Clinical Informatics, Brigham and Women’s Hospital; Assistant Professor of Medicine, Harvard Medical School, Boston STATEMENT OF NEED

Medication safety is an ongoing challenge, and medication errors can lead to patient harm. Serious medication errors can occur during physician ordering, nurse administration, transcription, and pharmacy dispensing. Bar code technology has been shown to prevent errors in dispensing drugs from the pharmacy and verifying a patient’s identity and the medication to be administered at the bedside. Strategies to help reduce preventable adverse drug events through the use of bar code technology are increasingly being implemented in healthcare systems, requiring nurses to be up to date on the technology to ensure that medication administration is for the right patient, the right route, the right dose, the right time, and the right medication. TARGET AUDIENCE

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

After completing this activity, the reader should be able to: • Explain how bar code verification technology combined with an electronic medication administration record can help reduce medication errors • Describe technologic solutions to administration-stage and medication transcription–stage errors • Discuss the importance of using the technology properly to ensure that bar code technology is effective in reducing medication errors

edication safety is an ongoing challenge for hospitals, healthcare providers, and healthcare delivery systems. Medication errors in hospitals are common1,2 and can lead to patient harm. A study by Leape and colleagues found that serious medication errors occurred most often in physician ordering (39%) and nurse administration (38%). The remaining 23% occurred during transcription (12%) and pharmacy dispensing (11%).3 Strategies are needed to reduce preventable adverse drug events (ADEs), and the implementation of healthcare information technology (HIT) has been touted as a promising strategy for preventing medication errors. Comput erized physician order entry (CPOE) has been shown to decrease serious medication errors by 55%.4 Bar code technology, which is widely adopted in industries outside of healthcare because of its ease

OctOber 2010 I VOL 3, NO 7

of use and reliability, has been shown to prevent errors in dispensing drugs from the pharmacy.5 At the bedside, the use of bar code technology to verify a patient’s identity and the medication to be administered has been shown to be an effective strategy for preventing medication errors, and its use has been increasing. The US Department of Veterans Affairs, for example, pioneered the way by instituting a national bar coding program in 1999 in its hospital system.6,7 Bar code medication verification at the bedside is usually implemented in conjunction with an electronic medication administration record (eMAR). This combination of technologies allows nurses to automatically document the administration of drugs by scanning their bar codes6 to ensure the correct medication is administered in the correct dose at the correct time to the correct patient. Because the eMAR imports drug orders electronically from the physician’s order entry or the pharmacy system, its implementation may reduce transcription errors.6 Bar code plus eMAR technology is not without its drawbacks. One study found that although medication management improved, the system studied was difficult to implement.8 Furthermore, other studies have highlighted certain unintended consequences of eMAR implementation, such as hospital staff relying too heavily on the technology, bypassing some of the hospital’s safety processes, or overriding the system’s alerts, thus increasing the risk for new errors.9,10 Study examines efficacy and safety of bar code technology in hospital setting Given the uncertainties with bar code plus eMAR technology, my colleagues and I at Brigham and Women’s Hospital evaluated its implementation in 35 adult medical, surgical, and intensive care units in our 735-bed tertiary academic medical center to assess its effects on administration and transcription errors, as well as associated potential ADEs.6 During the 9-month study, we compared 6723 medication administrations on patient units before the bar code plus eMAR technology was introduced with 7318 medication administrations after

the technology was introduced. We also reviewed order transcriptions in both time frames.6 Results Of the 1272 nontiming errors observed, 776 occurred in medication administration on units without the bar code plus eMAR system (an 11.5% error rate) compared with 495 such errors on units that used it (a 6.8% error rate), corresponding to a 41.4% relative reduction in errors (P <.001). The rate of potential ADEs (associated with nontiming errors) fell from 3.1% without the use of the bar code plus eMAR system to 1.6% with its use, representing a 50.8% relative reduction (P <.001). A 27.3% (P <.001) reduction was seen in the rate of timing errors in medication administration, but the rate of potential ADEs associated with timing errors did not differ significantly.6 Transcription errors also were reduced with the bar code plus eMAR system. Of the 3082 transcription orders reviewed, 1799 orders were on units CONTINUING NURSING EDUCATION ACCREDITATION AND CONTACT HOURS STATEMENT

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

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

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

without the technology. We found 110 transcription errors, of which 53 were potential ADEs, corresponding to 6.1 transcription errors and 2.9 potential ADEs per 100 medication orders transcribed. In the 1282 medication orders reviewed on units with the bar code plus eMAR system, transcription errors were completely eliminated.6 Clinical implications of bar code technology This study demonstrates that bar code plus eMAR technology can be an important intervention to improve medication safety. Because the study hospital administers approximately 5.9 million doses of medications per year, use of the bar code plus eMAR is expected to prevent approximately 95,000 potential ADEs at the point of medication administration every year in this medical center. The electronic order-entry system processed about 1.69 million medication orders during the study period. As a result, the system is also expected to prevent approximately Disclosures are as follows: • Joanne Abbotoy, BSN, RN, has nothing to disclose. • Eileen Koutnik-Fotopoulos has nothing to disclose. • Dawn Lagrosa has nothing to disclose. • Eric G. Poon, MD, MPH, has nothing to disclose. • Karen Rosenberg has nothing to disclose. The staff of Science Care have nothing to disclose. DISCLAIMER

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

Joanne Abbotoy, BSN, RN Nurse Administrator Roswell Park Cancer Institute Elm & Carlton Streets Buffalo, NY 14263 Eric G. Poon, MD, MPH Director of Clinical Informatics Brigham and Women’s Hospital Assistant Professor of Medicine Harvard Medical School 75 Francis Street Boston, MA 02115

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www.TheOncologyNurse.com 50,000 potential ADEs related to transcription errors.6 Whereas nurses and pharmacists often intercept errors made by physicians during the medication-ordering stage, errors made during the administration stage and, to a lesser extent, during the medication transcription stage often go undetected.3 This finding underscores the need for highly reliable strategies, such as bar code technology, to act as an additional safety component in medication administration and order transcription.6 Pharmacists’ role in dispensing medications is crucial in hospitals. The close integration of order-entry, pharmacy, and medication administration systems ensures that nurses administer medications only after pharmacists have reviewed the orders, providing patients with the added benefit of the pharmacists’ clinical knowledge.6 Preventing transcription errors is also vital. Factoring in the high number of doses administered and orders transcribed in acute care hospitals, implementation of a bar code plus eMAR system could significantly improve medication safety.6 The results of this study were similar to Bates and colleagues’ findings on CPOE, which reduced serious medication errors at the ordering stage by more

than 50%.4 Decision support embedded within CPOE systems is more likely to prevent errors that result from poor judgment, lack of knowledge, or incomplete clinical information when choosing a therapeutic plan. In contrast, a bar code plus eMAR system is more likely to prevent errors associated with memory lapses or mental slips in executing a therapeutic plan.6 My colleagues and I have suggested that these two technologies could play complementary roles in improving medication safety in acute care. More research is needed to determine which of these two technologies should be implemented first, if an organization has to make that choice.6 In the current study, the rate of medication administration errors fell significantly, but not all the errors were eliminated. We offer two possible reasons. Patient safety technology is effective if it is used as intended. Whereas the study hospital expended substantial resources in the training of end users, 20% of the drugs administered on units with the bar code plus eMAR technology were administered without the bar code scanning step during the study period. In addition, the study hospital used an early version of the software; several important improvements have been made since this study was conducted. In

light of these issues, we recommend that deployment of HIT should be envisioned not as a single event in time but rather as an ongoing process that requires modifications and improvements.6 Multiple limitations of this study, however, warrant consideration. The study findings reflect the experience of one hospital that already has fully implemented CPOE for physicians and bar code verification for pharmacy staff. Hospitals considering implementation of a bar code plus eMAR technology without CPOE, pharmacy bar code verification, or both may observe a different outcome on the effect on administration errors. The study also examined potential ADEs, not actual ADEs. Furthermore, the study hospital worked closely with users and clinical leaders who were willing to support a significant change in workflow to improve the overall medication process.6 Healthcare organizations interested in using a bar code plus eMAR technology should take into account these factors and find strategies to implement the technology in the most cost-effective way.6 Bar code plus eMAR technology, in my opinion, improves medication safety by reducing administration and transcription errors, providing support for

its inclusion as a 2013 criterion for meaningful use of HIT under the American Recovery and Reinvestment Act of 2009. ● References 1. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324:370-376. 2. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA. 1995;274:29-34. 3. Leape LL, Bates DW, Cullen CJ, et al. Systems analysis of adverse drug events. ADE Prevention Study Group. JAMA. 1995;274:35-43. 4. Bates DW, Leape LL, Cullen DJ, et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA. 1998;280:1311-1316. 5. Poon EG, Cina JL, Churchill W, et al. Medication dispensing errors and potential adverse drug events before and after implementing bar code technology in the pharmacy. Ann Intern Med. 2006;145:426-434. 6. Poon EG, Keohane CA, Yoon CS, et al. Effect of barcode technology on the safety of medication administration. N Engl J Med. 2010;362:1698-1707. 7. Wright AA, Katz IT. Bar coding for patient safety. N Engl J Med. 2005;353:329-331. 8. Puckett F. Medication-management component of a point-of-care information system. Am J Health Syst Pharm. 1995;52:1305-1309. 9. McDonald CJ. Computerization can create safety hazards: a bar-coding near miss. Ann Intern Med. 2006; 144:510-516. 10. Koppel R, Wetterneck T, Telles JL, Karsh BT. Workarounds to barcode medication administration systems: their occurrences, causes, and threats to patient safety. J Am Med Inform Assoc. 2008;15:408-423.

Eileen Koutnik-Fotopoulos contributed to the preparation of this article.

COMMENTARY

Simply Implementing a Bar Coding System Is Not Enough: A Nurse’s Perspective By Joanne Abbotoy, BSN, RN Nurse Administrator, Roswell Park Cancer Institute, Buffalo, New York

edication safety is a complex issue that needs to be addressed from multiple points throughout the patient care continuum. The errors associated with handwritten orders, transcription practices, prescribing, dispensing, and administering medication can be reduced when a bar coding system is implemented. This is especially true with the implementation of electronic health records (EHRs) and computerized physician order-entry systems. For a bar coding system to be successful, staff education and onsite support during implementation are of critical importance. Education of frontline users should include use of the system, problem resolution, “warning” message management, and accurate error reporting. The possibility of developing system “workarounds” is a realistic yet flawed manner of addressing problems that arise, making it very important to teach nurses why these workarounds should

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not be used. The bar code plus electronic medication administration record (eMAR) system discussed is based on the “Five Rights” of medication administration: (1) right patient, (2) right route, (3) right dose, (4) right time, and (5) right medication. Workarounds bypass the safety features built into the bar code plus eMAR system, which help ensure these “rights.” For many reasons, it can be difficult and time-consuming to implement and operationalize a bar code system. Therefore, it is important to set realistic goals and to manage the expectations for nurses who will be end users as well as to elicit their buy-in early in the process. One of the best ways to ensure buy-in is to include the end user in the decision-making process before implementation. At Roswell Park Cancer Institute, staff nurses were included in policy revision, workflow redesign, scanner selection, and trials of new computer carts.

Nursing time for medication administration may be increased during the time that nurses are learning to use the bar code plus eMAR system. Nurses need to understand that the system is designed to increase patient safety, not to decrease nursing time for administering medications. In addition, processes and structures may need to change. • Policies and procedures may need to be updated. • Workflow must be reviewed and may need to be changed. • Hardware needs must be evaluated and addressed. • Work groups and committees may need to be created or changed. It is important that the information technology department be involved in the planning from the start. In this manner, the EHR system can be evaluated to assess the impact of adding a bar code program. After a bar code system is implemented for medication administra-

tion, its use will need to be monitored to ensure that it continues to function properly. As noted by Koppel and colleagues, this can be accomplished by direct observation, user interviews, review of override data, and proactive process change. Repeated examination, evaluation, and correction are necessary on an ongoing basis.1 The literature supports the implementation of bar code systems for medication administration to promote the safe administration of medications. The implementation of such systems should not be done hurriedly or without preparation and evaluation. Bar code technology should not be seen as a quick fix but rather as a tool to be used and reevaluated as the dynamic nature of technology evolves. ● Reference 1. Koppel R, Wetterneck T, Telles JL, Karsh BT. Workarounds to barcode medication administration systems: their occurrences, causes, and threats to patient safety. J Am Med Inform Assoc. 2008;15:408-423.

OcTOber 2010 I VOL 3, NO 7

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Supportive Care

Palonosetron Demonstrates Benefits over Other 5-HT3 Receptor Antagonists in Lung Cancer Patients By Caroline Helwick

CHICAGO—Among patients with lung cancer on highly emetogenic chemotherapy, those receiving palonosetron throughout all cycles of chemotherapy had a 31% lower risk of chemotherapy-induced nausea and vomiting (CINV) associated with an emergency department or hospital visit, than patients receiving other 5-

hydroxytryptamine type 3 (5-HT3) receptor antagonists (RAs). The study was presented by Hind T. Hatoum, PhD, of the Center of Pharmacoeconomic Research at the University of Illinois at Chicago during the 46th annual meeting of the American Society of Clinical Oncology. The study compared the risk of serious

CINV among 1692 lung cancer patients initiated on cisplatin-based chemotherapy who were started and maintained on a 5-HT3–based prophylactic strategy, including palonosetron, dolasetron, granisetron, or ondansetron. Patients were identified from claims data (PharMetrics) between 2005 and 2008 and stratified into one of two groups:

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OctOber 2010 I VOL 3, NO 7

palonosetron throughout all cycles of chemotherapy (n = 390) and any other 5-HT3–based regimen (n = 1302). CINV events were identified from emergency department and hospital claims with codes of nausea, vomiting, and/or dehydration. The two groups were compared for the risk of CINV, controlling for age, sex, comorbidity, and chemotherapy treatment days. The two treatment groups had comparable comorbidities, with no significant differences in the Charlson Comorbidity Index. The most widely represented chemotherapy regimens were cisplatin/etoposide (25%), cisplatin alone (7%) and cisplatin/docetaxel/etoposide (6%). In what Hatoum called a “realworld practice,” the average patient receiving palonosetron had significantly fewer claims of both 5-HT3 RAs and all antiemetics, as compared with patients receiving all other 5-HT3 RAs: 6.4 versus 12.4 for other 5-HT3 RA claims (P <.0001), and 8.5 versus 14.7 in all antiemetic claims (P <.0001). This represents 42% fewer antiemetic claims and 58% fewer 5-HT3 RA claims for palonosetron compared with patients who received other agents, Hatoum noted. With palonosetron, fewer patients experienced CINV events leading to emergency department or hospital visits: 16.4% versus 22.6% (P <.01) in the unadjusted analysis, which remained a significant 31% reduction (P <.05) in the adjusted analysis. Palonosetron-treated patients also had, on average, significantly fewer cisplatin treatment days: 4.9 versus 5.7 days (P <.0001). “We cannot ascertain with 100% certainty what this means, but we suspect these patients were able to have the dose pushed higher because they had less nausea and vomiting. They did not have to delay treatment; and therefore, there were fewer treatment days,” Hatoum suggested. In addition, 51.0% of patients used palonosetron without combining it with the neurokinin-1 (NK1) antagonist aprepitant and/or dexamethasone, compared with 45.6% of the alternate group. Palonosetron, in contrast to other 5-HT3 RAs, differentially inhibits “crosstalk” between NK1 receptors and 5-HT3 signaling pathways, and exhibits prolonged inhibition of receptor function, Hatoum explained, suggesting that “it may have properties such that you don’t need the NK1 antagonist.” ●

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Nursing Education and Training

Doctor of Nursing Practice: An Oncology Nurse Practitioner’s Journey By Catherine S. Bishop, DNP Hematology-Oncology Associates of Fredericksburg, Virginia

he Doctor of Nursing Practice (DNP) degree has been designated by the American Association of Colleges of Nursing (AACN) as the graduate degree for advanced practice nurses (APNs). Currently, obtaining this degree remains an option; pursuit of a doctoral degree in nursing is a personal and professional decision made by some APNs. The trend toward doctoral preparation appears to be gaining momentum, however, and after the year 2015 it may be difficult to find a nurse practitioner program that awards a Master of Science in Nursing (MSN). The DNP degree is a practice-focused doctorate that has gained enthusiastic support from the nursing community. Currently, 127 universities nationwide are accepting students into DNP programs, and another 100 programs are in the planning stages. The curriculum is built on the DNP Essentials developed by AACN (www.aacn.nche.edu).

My nursing journey I completed my undergraduate nursing degree in 1992 at Marymount University, Arlington, Virginia. Soon after graduation I took a PRN (per diem) position at George Washington University

Medical Center, Washington, DC, in the outpatient clinics. I rotated through various clinics reporting to the Department of Medicine. This experience was great for a new graduate as it allowed me to decide which specialty was the best fit. One afternoon in April of 1994, I took a phone call from the nurse manager in the cancer center asking if there was anyone who would be interested in doing some per diem work. It took me about 15 seconds to say, “I would be interested.” I was healing from my own mother’s death from a brain tumor. I believed that working with cancer patients would help me continue to heal and allow me to provide great service to those with the disease. The oncology nurses I worked with were wonderful mentors. They were generous with their time and always willing to share their knowledge. I learned quickly and soon took a full-time position with an oncologist. He guided and inspired me to be the best I could be. I constantly thought of continuing my education. I wanted to offer more to cancer patients than I was able to in that position. In 2004, I began an MSN and Family Nurse Practitioner (FNP) pro-

Residency Programs for Nurses Surging in Popularity By John Schieszer

SEATTLE—New doctors have received on-the-job training in residency programs for decades. Now, a growing number of new nurses are doing the exact same thing. Nurse residency programs are now rising in popularity and that, in part, is due to hospitals trying to stave off a huge projected nursing shortage over the next 10 to 15 years. Nurse residency programs were first introduced in the United States approximately 15 years ago, and programs were established in Illinois and Texas. Until now, however, the idea really did not take off. This summer, a comprehensive cancer care center was the first to implement a nurse residency program, and other cancer centers may soon be joining the trend. Because of an aging workforce, it is expected that there will be a significant nursing shortage over the next

OctOber 2010 I VOL 3, NO 7

two decades. So, some hospitals around the country are establishing special nursing residency programs as a means of retaining new graduates. Nationally, the average turnover rate of first-year nurses is reported to be approximately 27%. One study showed that 35% to 60% of new graduates change employers within the first year of employment (Beecroft P, et al. Nurs Econ. 2007; 21:13-18, 39). “At 6 months, the nurses get hit hard, and many places lose nurses. Some nurses leave the profession as well as the hospital. So, we wanted to find out how we could better support nurses during this time,” said Martha Kershaw, RN, MS, OCN, who is the nursing staff development instructor at Roswell Park Cancer Institute, Buffalo, New York. Roswell Park Cancer Institute is one Continued on page 48

Table AACN’s Doctor of Nursing Practice Essentials • Scientific underpinnings for practice • Organizational and systems leadership for quality improvement and systems thinking • Clinical scholarship and analytical methods for evidence-based practice • Information systems/technology and patient care technology for the improvement and transformation of healthcare • Healthcare policy for advocacy in healthcare • Interprofessional collaboration for improving patient and population health outcomes • Clinical prevention and population health for improving the nation’s health • Advanced Nursing Practice Source: www.aacn.nche.edu/DNP/pdf/Essentials.pdf.

gram. In our comprehensive examinations, I argued in favor of the DNP degree in a debate. I had done a fair amount of reading regarding this new degree and felt strongly in favor of it. AACN had published their position statement, and I had read it thoroughly. I knew from that point that obtaining the DNP was my next goal. Although my MSN/FNP education was excellent, I felt a need and desire for more education to fulfill my intellectual appetite for knowledge that would enhance my clinical skills as an APN. The DNP focus was on practice and the application of evidence directly to the bedside. This appealed to me. I would earn this degree. I graduated with my MSN/FNP degree from Marymount University in May 2007 and immediately was hired by a solo oncologist in a private practice. In a solo practice, I faced challenges such as explaining the role of an NP to patients, who were often resistant to seeing a new provider. With the full support of my collaborating physician, great humility, and perseverance over the next year, the oncology patients accepted me as a full provider. Soon I was seeing a full load of patients and learning how to perform bone marrow biopsies. Life as an oncology NP was good. Nonetheless, I could still hear that little voice calling out to me to move forward with my doctoral degree. I began researching universities offering the DNP. In December that year, I was accepted into Chatham University, Pittsburgh, Pennsylvania. I would be part of the second cohort to graduate. There were 22 other APNs in my cohort—several NPs, numerous nurse anesthetists, and one chief nursing officer. The program curriculum was rigorous and chal-

lenging. My capstone project was a research study looking at cancer patients’ perceptions of the oncology NP’s role in cancer management. The new knowledge gained from my doctoral work provided me with clinical leadership skills as well as an increased awareness of evidence-based practice, which allowed me to bring research results directly to patients at bedside. In May 2009, I walked down the aisle at Chatham University and was announced to the faculty and student body as Dr Catherine Bishop. I knew I had earned the title through my uncompromising work. I am now proud to meet new patients and introduce myself as Dr Bishop, the oncology NP. Implications for APNs The DNP is the highest degree that can be earned by APNs. It has been said that this practice-focused doctorate puts nursing on the same level as many other healthcare fields, such as pharmacy, medicine, and physical therapy. It is important to remember, however, that the DNP is a degree, not a role. I continue to function within my scope of practice as a doctorally prepared NP. I am better equipped to manage the complexities of my patient population because of the breadth of knowledge gained within my doctoral program. The degree has led to professional opportunities that may not have presented themselves otherwise. My collaborating physicians are proud of my achievements and my commitment to furthering my education. My patients believe that earning this degree shows the commitment I have made to them to provide excellent, quality care. They feel rewarded by my work and are happy to call me Dr Bishop. ●

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CONTINUING EDUCATION CREDITS

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Breast Cancer

Targeted Intraoperative Radiotherapy May Be as Good as Whole Breast Radiotherapy at Reducing Breast Cancer Recurrence By John Schieszer

CHICAGO—Targeted intraoperative radiotherapy (TIR) for breast cancer, in which radiotherapy is confined to the area of the breast where the tumor has been removed, has been found to be as good as whole breast radiotherapy at reducing breast cancer recurrence. Most important, the new data presented at the 46th annual meeting of the American Society of Clinical Oncology showed TIR can be carried out in just one hospital visit. The researchers say TIR for breast cancer could mean much more than convenient care for patients, as well as reduced waiting lists and substantial savings for the healthcare systems. Oncologist Michael Baum, MB, ChB, FRCS, ChM, MD(hc), professor emeritus of surgery at the University College London and chairman of the TARGITA trial, said the nurses will be the key people on this major shift in the use of radiotherapy for breast cancer. “The oncology nurse has a pretty tough job,” said Baum, who helped set up the first oncology nurse training program in England. “They have to explain to the women the benefits and the harms of treatments. I think the oncology nurse will have to get up to speed very quickly. This trial has already attracted worldwide interest.” After breast-conserving surgery, 90% of local recurrences occur very close to the removed tumor (index quadrant)

despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the site of tumor removal (tumor bed) during surgery could be adequate for selected patients. In TARGIT-A, the researchers compared TIR with the conventional policy of whole breast external beam radiotherapy (EBRT). The prospective, randomized trial included women aged 45 years and older with invasive ductal breast carcinoma undergoing breast-conserving surgery.

cations and major toxicities were similar in the two groups. For major toxicity, the rates were 3.3% in the TIR group versus 3.9% in the EBRT group. “The side effects have been looked at very carefully,” said Baum in an interview with The Oncology Nurse. “The toxicity levels are good in both arms. However, there is significantly more grade 3 radiation toxicity in the external beam compared with the intraoperative.” The investigators, however, found

that the intraoperative approach produced a greater incidence of seroma requiring aspiration. The incidence rate was 2.1% for the TIR group compared with 0.8% in the EBRT group. The trial used the INTRABEAM radiotherapy system, a mobile radiotherapy platform with a miniature, electronic, high-dose rate (HDR), lowenergy x-ray source. The use of lowenergy x-ray radiation eliminates the

need for a specialized treatment room, in contrast to other high-energy radiation sources (linear accelerators and HDR/HDR brachytherapy systems) that require specially designed rooms. This system is set up to be used in the operating room at the time of surgery. The intrabeam radiation is applied for 20 to 30 minutes, exposing the affected tissue in the tumor bed from inside the tumor cavity. Baum said that this study was set up to demonstrate that 25 minutes in the operating room is equivalent to 6 weeks of postoperative radiotherapy. He said that these study results will now change how women with this type of breast cancer (early invasive breast cancer suitable for breast-conserving surgery) receive their therapy. Once they are aware of this option, he thinks the demand will then be great. “I think personally the women will vote with their feet,” he told The Oncology Nurse. Besides the obvious benefits of completing all the necessary radiotherapy in a single session at the time of surgery, TIR almost completely avoids irradiation of the intrathoracic structures such as the heart, lung, and esophagus. Baum said he hoped these trial results influence a paradigm shift from conventional radiation ap proaches to single-dose treatment for eligible patients. ●

six (55%) had recurrence. Gene microarrays were used to identify differentially expressed genes for trastuzumab (responsive vs resistant). The investigators found that the differentially expressed genes for recurrence or nonrecurrence were distinct between the group treated with trastuzumab and the group that was not treated with the drug. The researchers hope that differential expression of key genes identified in this study may offer insights into trastuzumab resistance among breast cancer patients. It is hoped that this type of technology fingerprinting can lead to new potential biomarkers for diagnosis, prognosis, and treatment. “The group that was treated with trastuzumab and developed recurrence had a genetic makeup different from

those who were not treated and developed recurrence,” said study investigator Thaer Khoury, MD, who is an assistant professor of pathology and laboratory medicine at Roswell Park Cancer Institute. “The idea from the beginning was to know why these patients who are treated with trastuzumab develop recurrence and why the others did not. There is definitely something going on, and we’re starting to understand these mechanisms.” Khoury, who presented the study findings at the meeting, said they should be of particular interest to clinicians working in this area of cancer. The message about treatment and how it should be guided is now changing, as molecular markers are complementing clinical markers. ●

“There is significantly more grade 3 radiation toxicity in the external beam compared with the intraoperative.” —Michael Baum, MB, ChB, FRCS, ChM, MD(hc)

In this trial, 2232 women were included. The median age was 63 years and 83% of the women were less than age 70. The median tumor size was 12 mm and 17% were lymph-node positive. After 4 years of follow-up, there were six local recurrences in the intraoperative radiotherapy group and five in the EBRT group. This translated to very similar recurrence rates in both groups. The frequency of any compli-

GENETICS

Genetic Profiling Changing... Continued from page 34 group versus the nonpathologic complete response group.” The study continues to accrue patients, and Khushalani expects to have mature survival data by fall 2010. “I believe this is an efficacious regimen, and it’s definitely well-tolerated,” he said. “We hope that the exploratory geneexpression profiling results will translate into clinically meaningful hypotheses that can be validated in a large, preferably multicenter study.” Genetic profiling to identify trastuzumab resistance in breast cancer patients Other researchers at Roswell Park Cancer Institute are hoping to determine whether genetic profiling may effectively identify which breast cancer

OctOber 2010 I VOL 3, NO 7

patients are most likely to respond to the drug trastuzumab. Trastuzumab interferes with a protein, known as the human epidermal growth factor receptor type 2 (HER2), which is linked to breast cancer. However, a high number of breast cancer patients (approximately 50%) don’t respond to the drug and experience recurrence. Currently, there is great interest in research that might elicit factors that drive responses. Over the past 2 years, researchers looked at 41 breast carcinoma cases in which amplified HER2 levels were seen and for which fresh frozen tissue was available. Of these patients, 12 were treated with trastuzumab and three (25%) experienced recurrence. Among the 11 patients not treated with the drug,

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Residency Programs for Nurses Surging in Popularity Continued from page 44

Pasta fagioli

ollowing a diet high in fruits, vegetables, and whole grains can reduce your risk of colorectal cancer. Limit your intake of red meat to less than 18 ounces per week and avoid processed meats. Replace animal protein once or twice a week with a plant-based meal using legumes or tofu. Try to consume at least 35 g of fiber per day. Look for highfiber cereals and breads to help meet this goal. This month’s recipe is packed with high-fiber ingredients and immune-boosting nutrients. Enjoy this recipe of pasta fagioli as a main dish for a quick and easy, nutritious weeknight dinner.

Ingredients ⅛ cup olive oil 4 garlic cloves, chopped 1 small white onion, chopped 2 tablespoons basil, chiffonade 1 15-oz can white beans 1 15-oz can plum tomatoes ½ lb whole wheat ditalini ½ teaspoon oregano Salt and pepper to taste Grated Parmesan cheese to taste

Directions • Cook pasta and set aside • In a medium saucepan, heat olive oil • Add onion and sauté for 5 minutes • Add garlic, basil, and oregano and cook for 1 more minute • Add white beans and plum tomatoes • Cook for about 15 minutes • Add salt and pepper to taste • Mix in pasta • Finish with grated Parmesan cheese Serves 4

Nutritional Information Each serving provides: 380 calories, 9 g total fat, 0 mg cholesterol, 150 mg sodium, 63 g carbohydrate, 17 g dietary fiber, 16 g protein Recipe courtesy of Peter Pascale, CCC Executive Chef, Somerville, New Jersey.

OctOber 2010 I VOL 3, NO 7

of four healthcare centers collaborating on the first nurse residency program (Western New York Nurse Residency Program) in the Buffalo, New York, area. The program was kicked off on July 29, 2010, with a program on skills reinforcement. Sixteeen new nurses working at Roswell Park Cancer Institute were among 96 nurses signed up for the residency program from the four Buffalo area healthcare centers. In many respects, a nursing residency program can be especially beneficial for new oncology nurses. It can help address many problems that new nurses are faced with and thus allow them to better focus on oncology treatments. “With oncology nurses, the treatments change every day, and the things that our nurses have to know in addition to what a regular new graduate has to know are amazing. So we are able to focus on the oncology aspects of nursing that they need to know. The residency program helps with the basic nursing skills as well as the basic assessment skills and also help them become a member of the team on their floor,” said Kershaw in an interview with The Oncology Nurse. The residency program focuses on how to be a member of the hospital team and be active in the hospital as well as the nursing profession. The nursing residency program in the Buffalo area is based on one in Wisconsin, which was started several years ago and has been highly successful. In the program, each new graduate nurse is hired into a “home” unit where that nurse will be based. Each nurse is then connected with a mentor, whose role is not to evaluate the new graduate, but to offer psychosocial and professional support throughout the first year of employment. Valerie Smith, who is 29 years old, just finished nursing school last May. Eight weeks later, Smith started her nursing residency program. “I think it is a good program. It is nice to be able to learn about things that you are not really confident about,” Smith said in an interview with The Oncology Nurse. “This kind of program lets you know that everyone has the same fears. It really helps to talk to other nurses about how their first year is going.” In the Western New York Nurse Residency Program, all new graduate nurses have the opportunity to participate in approximately 6 hours of interactive professional education sessions each month. The sessions are offered off-unit and allow new graduates to review their knowledge and skills in an

Martha Kershaw, RN, MS, OCN, nursing staff development instructor at Roswell Park Cancer Institute, left, with new graduate nurse Valerie Smith, RN

encouraging and productive learning environment. The goals of the program are to help nurses develop clinical competence and to help expand their critical-thinking skills. Studies suggest that new nurses often feel that they have grasped the requirements of their job and how to be an effective member of a nursing team. However, many new nurses may need assistance in managing competing priorities on their unit, unexpected and abrupt changes in

patients’ conditions, and other teamwork challenges. “New nurses need support the first year,” Kershaw said. “They have a preceptor, an experienced nurse who teaches them their role as a nurse and evaluates them to make sure they are competent to be on the floor. Our program provides education events each month, and the mentors help nurses when they have a bad day or help answer the questions they are too embarrassed to ask.” ●

CARTOON

“I had a good week at the clinic. Not one malpractice suit.”

www.theOncologyNurse.com

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Meetings

NOVEMBER 2010

9-13

NEW YORK, NY Chemotherapy Foundation Symposium www.chemotherapyfoundationsympo sium.org

11-13 ORLANDO, FL Oncology Nursing Society’s Advanced Practice Nursing Conference www.ons.org

12-14

ORLANDO, FL Oncology Nursing Society’s 11th Annual Institutes of Learning www.ons.org

DECEMBER 2010

4-7 ORLANDO, FL American Society of Hematology Annual Meeting www.hematology.org

8-12 SAN ANTONIO, TX San Antonio Breast Cancer Symposium www.sabcs.org

JANUARY 2011

20-22 SAN FRANCISCO, CA Gastrointestinal Cancers Symposium www.gicasymposium.com

FEBRUARY 2011

17-19

ORLANDO, FL Genitourinary Cancers Symposium www.gucasymposium.org

www.TheOncologyNurse.com

FEBRUARY 2011

MARCH 2011

10-12

2-5 SAN ANTONIO, TX

9-13 HOLLYWOOD, FL

LOS ANGELES, CA National Conference on Cancer Nursing Research www.ons.org

Society of Surgical Oncology Annual Cancer Symposium www.surgonc.org

National Comprehensive Cancer Network 16th Annual Conference: Clinical Practice Guidelines & Quality Cancer Care www.nccn.org

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

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

OcTOber 2010 I VOL 3, NO 7

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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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May 2010