February 2013 Vol 6 No 1 by The Oncology Nurse

FebRuary 2013

www.TheOncologyNurse.com

Vol 6, No 1

Fourth Annual Navigation and Survivorship Conference November 14-17, 2013

see page 17

The Patient’s Voice

Cancer Center Profile

Gibbs Cancer Center, Spartanburg Regional Healthcare System

Adherence to Therapy at Home: The Personal Touch

By Alice Goodman

By MMA

spent 8 long months in a city far from my own, undergoing intense chemotherapy and then an autologous stem cell transplant. Eventually, after a longerthan-I-would-have-liked stay in the hospital and another few weeks living close to the hospital in case of emergency, I was sent back home with a bagful of medicines and instructions on how/when/with what to take them. Much discussion exists around the issue of how to get patients to adhere to their treatment regimen at home. I must admit

I worried about this, too. When I first arrived back in my city, I felt a complete disconnect from the turmoil and commotion associated with being a cancer patient at a major cancer treatment center. I did not want to be that cancer patient anymore. I wanted to go back to my life precancer—progress in my career, energy to shuttle my children to and from their activities, enough resources to actually save some money, and the freedom to eat at my favorite restaurants. Though many Continued on page 7

Genetic Counseling Sharon Bartelt, RN, MSN, OCN; Lucy Gansauer, RN, MSN, OCN; Carol Lynn Cole, RN, BSN, OCN; Kristen Beeker, RN, BSN, OCN, CBN (left to right), oncology nurses at the Gibbs Cancer Center in South Carolina.

he Gibbs Cancer Center, part of the Spartanburg (South Carolina) Regional Healthcare System, is 1 of 21 National Cancer Institute (NCI)-designated community cancer centers. Recognizing in 2007 that 85% of all cancer patients receive their care in the community, NCI set benchmarks for elevating cancer care in the community setting. The Gibbs Cancer Center and other NCI-designated community cancer centers have to meet standards on reducing healthcare disparities, enhancing community outreach for cancer screening and follow-up, collection of high-quality biospecimens, improving quality of cancer care, research, and expanding information technology, survivorship, and palliative care. Approximately 1700 cancer patients are diagnosed and treated at the Gibbs Cancer Center each year, many of them underinsured or uninsured, with low levels of literacy. Continued on page 9

Inherited Colon Cancer: Peutz-Jeghers Syndrome, Juvenile Polyposis Syndrome, and Cowden Syndrome By Cristi Radford, MS, CGC

olorectal cancer (CRC) is the third most common type of non– ‒skin cancer in both men and women. As with other cancers, the majority are sporadic, 15% are familial, and 5% to 10% are hereditary. Thus, in 25% of CRC cases a familial clustering is present, and further risk assessment and possibly genetic testing are indicated. The 2 most well-described forms of

Conference News

The Whole Patient. . . . . . . . . . . .

By Alice Goodman

Breast Cancer. . . . . . . . . . . . . . . . .

Benefit for Neoadjuvant Chemotherapy Seen in Very Young Patients With Triple-Negative and Luminal-Like Breast Cancer

tion about the experimental biology, etiology, prevention, diagnosis, and therapy of breast cancer and premalignant breast disease. Following are some of the highlights from the conference.

Continued on page 12

inside

Highlights From the San Antonio Breast Cancer Symposium he 2012 Annual Meeting of the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) offered a wealth of news to attendees from around the world. The symposium, held December 4-8, 2012, presented the latest informa-

inherited CRC are familial adenomatous polyposis (FAP) and Lynch syndrome, also known as hereditary nonpolyposis syndrome. FAP is characterized by 100s to 1000s of colonic polyps, whereas Lynch syndrome has a more diverse phenotype and is associated with at least 10 extracolonic cancers. Both have been discussed in previous articles.

Approaches to Sexual Dysfunction in Breast Cancer Survivors

Survival Benefit for ER-Negative Local Breast Cancer Recurrence

Continued on page 14

Conference News: ASH. . . . . . .

Abstracts of Interest From the 54th Annual Meeting of the American Society of Hematology Through the Eyes of an Advocate. . . . . . . . . . . . . . . . . . . . . . . .

The Pace of Medicine

The median age of patients in the VISTAâ&#x20AC; trial was 71 years (range: 48-91).

Survival never gets old VELCADE® (bortezomib) delivered >13-month overall survival advantage in combination with MP* vs MP alone for previously untreated multiple myeloma (median 56.4 vs 43.1 months [HR=0.695; 95% CI, 0.57-0.85; p<0.05]; 60.1-month median follow-up†)

Approved for subcutaneous and IV administration‡ VELCADE® (bortezomib) Indication and Important Safety Information INDICATION

VELCADE (bortezomib) is indicated for the treatment of patients with multiple myeloma.

CONTRAINDICATIONS

VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration.

WARNINGS, PRECAUTIONS, AND DRUG INTERACTIONS

Peripheral neuropathy: Manage with dose modification or discontinuation. Patients with preexisting severe neuropathy should be treated with VELCADE only after careful risk-benefit assessment. ▼ Hypotension: Use caution when treating patients taking antihypertensives, with a history of syncope, or with dehydration. ▼ Cardiac toxicity: Worsening of and development of cardiac failure have occurred. Closely monitor patients with existing heart disease or risk factors for heart disease. ▼ Pulmonary toxicity: Acute respiratory syndromes have occurred. Monitor closely for new or worsening symptoms. ▼ Posterior reversible encephalopathy syndrome: Consider MRI imaging for onset of visual or neurological symptoms; discontinue VELCADE if suspected. ▼ Gastrointestinal toxicity: Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement. ▼ Thrombocytopenia or Neutropenia: Monitor complete blood counts regularly throughout treatment. ▼

Tumor lysis syndrome: Closely monitor patients with high tumor burden. ▼ Hepatic toxicity: Monitor hepatic enzymes during treatment. ▼ Embryo-fetal risk: Women should avoid becoming pregnant while being treated with VELCADE. Advise pregnant women of potential embryo-fetal harm. ▼ Closely monitor patients receiving VELCADE in combination with strong CYP3A4 inhibitors. Avoid concomitant use of strong CYP3A4 inducers. ▼

ADVERSE REACTIONS

Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia. Please see Brief Summary for VELCADE on next page. *Melphalan+prednisone.

VISTA: a randomized, open-label, international phase 3 trial (N=682) evaluating the efficacy and safety of VELCADE administered intravenously in combination with MP vs MP in previously untreated multiple myeloma (MM). The primary endpoint was TTP. Secondary endpoints were CR, ORR, PFS, and overall survival. At a prespecified interim analysis (median follow-up 16.3 months), VELCADE+MP resulted in significantly superior results for TTP (median 20.7 months with VELCADE+MP vs 15.0 months with MP [p =0.000002]), PFS, overall survival, and ORR. Further enrollment was halted and patients receiving MP were offered VELCADE in addition. Updated analyses were performed. ‡ The reconstituted concentration for subcutaneous administration (2.5 mg/mL) is greater than the reconstituted concentration for IV administration (1 mg/mL). †

Living Proof

Noteworthy Numbers Cancer Prevention According to the World Health Organization, onethird of all cancer cases are preventable.1 When individuals choose the right health behaviors and avoid exposure to certain

environmental risk factors, prevention becomes the most long-term cost-effective approach for curtailing cancer.2 The following statistics examine policy factors and behavioral prevention strategies.

Brief Summary INDICATIONS: VELCADE® (bortezomib) for Injection is indicated for the treatment of patients with multiple myeloma. VELCADE for Injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy. CONTRAINDICATIONS: VELCADE is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. VELCADE is contraindicated for intrathecal administration. WARNINGS AND PRECAUTIONS: Peripheral Neuropathy: VELCADE treatment causes a peripheral neuropathy that is predominantly sensory; however, cases of severe sensory and motor peripheral neuropathy have been reported. Patients with pre-existing symptoms (numbness, pain, or a burning feeling in the feet or hands) and/or signs of peripheral neuropathy may experience worsening peripheral neuropathy (including ≥Grade 3) during treatment with VELCADE. Patients should be monitored for symptoms of neuropathy, such as a burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, neuropathic pain or weakness. In the Phase 3 relapsed multiple myeloma trial comparing VELCADE subcutaneous vs intravenous, the incidence of Grade ≥2 peripheral neuropathy events was 24% for subcutaneous and 39% for intravenous. Grade ≥3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 15% in the intravenous treatment group. Starting VELCADE subcutaneously may be considered for patients with pre-existing or at high risk of peripheral neuropathy. Patients experiencing new or worsening peripheral neuropathy during VELCADE therapy may require a decrease in the dose and/or a less dose-intense schedule. In the VELCADE vs dexamethasone phase 3 relapsed multiple myeloma study, improvement in or resolution of peripheral neuropathy was reported in 48% of patients with ≥Grade 2 peripheral neuropathy following dose adjustment or interruption. Improvement in or resolution of peripheral neuropathy was reported in 73% of patients who discontinued due to Grade 2 neuropathy or who had ≥Grade 3 peripheral neuropathy in the phase 2 multiple myeloma studies. The long-term outcome of peripheral neuropathy has not been studied in mantle cell lymphoma. Hypotension: The incidence of hypotension (postural, orthostatic, and hypotension NOS) was 8%. These events are observed throughout therapy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics. Cardiac Toxicity: Acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction have occurred during VELCADE therapy, including reports in patients with no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing, heart disease should be closely monitored. In the relapsed multiple myeloma study of VELCADE vs dexamethasone, the incidence of any treatment-related cardiac disorder was 8% and 5% in the VELCADE and dexamethasone groups, respectively. The incidence of adverse reactions suggestive of heart failure (acute pulmonary edema, pulmonary edema, cardiac failure, congestive cardiac failure, cardiogenic shock) was ≤1% for each individual reaction in the VELCADE group. In the dexamethasone group, the incidence was ≤1% for cardiac failure and congestive cardiac failure; there were no reported reactions of acute pulmonary edema, pulmonary edema, or cardiogenic shock. There have been isolated cases of QT-interval prolongation in clinical studies; causality has not been established. Pulmonary Toxicity: Acute Respiratory Distress Syndrome (ARDS) and acute diffuse infiltrative pulmonary disease of unknown etiology, such as pneumonitis, interstitial pneumonia, and lung infiltration have occurred in patients receiving VELCADE. Some of these events have been fatal. In a clinical trial, the first two patients given high-dose cytarabine (2 g/m2 per day) by continuous infusion with daunorubicin and VELCADE for relapsed acute myelogenous leukemia died of ARDS early in the course of therapy. There have been reports of pulmonary hypertension associated with VELCADE administration in the absence of left heart failure or significant pulmonary disease. In the event of new or worsening cardiopulmonary symptoms, consider interrupting VELCADE until a prompt, comprehensive, diagnostic evaluation is conducted. Posterior Reversible Encephalopathy Syndrome (PRES): Posterior Reversible Encephalopathy Syndrome (PRES; formerly termed Reversible Posterior Leukoencephalopathy Syndrome (RPLS)) has occurred in patients receiving VELCADE. PRES is a rare, reversible, neurological disorder, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. Brain imaging, preferably MRI (Magnetic Resonance Imaging), is used to confirm the diagnosis. In patients developing PRES, discontinue VELCADE. The safety of reinitiating VELCADE therapy in patients previously experiencing PRES is not known. Gastrointestinal Toxicity: VELCADE treatment can cause nausea, diarrhea, constipation, and vomiting, sometimes requiring use of antiemetic and antidiarrheal medications. Ileus can occur. Fluid and electrolyte replacement should be administered to prevent dehydration. Interrupt VELCADE for severe symptoms. Thrombocytopenia/Neutropenia: VELCADE is associated with thrombocytopenia and neutropenia that follow a cyclical pattern, with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle. The cyclical pattern of platelet and neutrophil decreases and recovery remained consistent over the 8 cycles of twice-weekly dosing, and there was no evidence of cumulative thrombocytopenia or neutropenia. The mean platelet count nadir measured was approximately 40% of baseline. The severity of thrombocytopenia was related to pretreatment platelet count. In the relapsed multiple myeloma study of VELCADE vs dexamethasone, the incidence of bleeding (≥Grade 3) was 2% on the VELCADE arm and <1% on the dexamethasone arm. Complete blood counts (CBC) should be monitored frequently during treatment with VELCADE. Platelet counts should be monitored prior to each dose of VELCADE. Patients experiencing thrombocytopenia may require change in the dose and schedule of VELCADE. Gastrointestinal and intracerebral hemorrhage has been reported in association with VELCADE. Transfusions may be considered. Tumor Lysis Syndrome: Tumor lysis syndrome has been reported with VELCADE therapy. Patients at risk of tumor lysis syndrome are those with high tumor burden prior to treatment. Monitor patients closely and take appropriate precautions. Hepatic Toxicity: Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic reactions include hepatitis, increases in liver enzymes, and hyperbilirubinemia. Interrupt VELCADE therapy to assess reversibility. There is limited re-challenge information in these patients.

Tobacco Use Approximately 30% of all deaths from cancer in the United States are a result of smoking,2 and about 70% of lung cancer cases can be attributed to smoking alone.1

Embryo-fetal: Pregnancy Category D. Women of reproductive potential should avoid becoming pregnant while being treated with VELCADE. Bortezomib administered to rabbits during organogenesis at a dose approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area caused post-implantation loss and a decreased number of live fetuses. ADVERSE EVENT DATA: Safety data from phase 2 and 3 studies of single-agent VELCADE 1.3 mg/m2/dose administered intravenously twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously-treated multiple myeloma (N=1008) and previously-treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma. In the integrated analysis, the most commonly reported (≥10%) adverse reactions were nausea (49%), diarrhea NOS (46%), fatigue (41%), peripheral neuropathies NEC (38%), thrombocytopenia (32%), vomiting NOS (28%), constipation (25%), pyrexia (21%), anorexia (20%), anemia NOS (18%), headache NOS (15%), neutropenia (15%), rash NOS (13%), paresthesia (13%), dizziness (excl vertigo 11%), and weakness (11%). Eleven percent (11%) of patients experienced at least 1 episode of ≥Grade 4 toxicity, most commonly thrombocytopenia (4%) and neutropenia (2%). A total of 26% of patients experienced a serious adverse reaction during the studies. The most commonly reported serious adverse reactions included diarrhea, vomiting, and pyrexia (3% each), nausea, dehydration, and thrombocytopenia (2% each), and pneumonia, dyspnea, peripheral neuropathies NEC, and herpes zoster (1% each). In the phase 3 VELCADE+melphalan and prednisone study in previously untreated multiple myeloma, the safety profile of VELCADE administered intravenously in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse reactions in this study (VELCADE+melphalan/prednisone vs melphalan/prednisone) were thrombocytopenia (48% vs 42%), neutropenia (47% vs 42%), peripheral neuropathy (46% vs 1%), nausea (39% vs 21%), diarrhea (35% vs 6%), neuralgia (34% vs <1%), anemia (32% vs 46%), leukopenia (32% vs 28%), vomiting (26% vs 12%), fatigue (25% vs 14%), lymphopenia (23% vs 15%), constipation (23% vs 4%), anorexia (19% vs 6%), asthenia (16% vs 7%), pyrexia (16% vs 6%), paresthesia (12% vs 1%), herpes zoster (11% vs 3%), rash (11% vs 2%), abdominal pain upper (10% vs 6%), and insomnia (10% vs 6%). In the phase 3 VELCADE subcutaneous vs intravenous study in relapsed multiple myeloma, safety data were similar between the two treatment groups. The most commonly reported adverse reactions in this study were peripheral neuropathy NEC (37% vs 50%), thrombocytopenia (30% vs 34%), neutropenia (23% vs 27%), neuralgia (23% vs 23%), anemia (19% vs 23%), diarrhea (19% vs 28%), leukopenia (18% vs 20%), nausea (16% vs 14%), pyrexia (12% vs 8%), vomiting (9% vs 11%), asthenia (7% vs 16%), and fatigue (7% vs 15%). The incidence of serious adverse reactions was similar for the subcutaneous treatment group (20%) and the intravenous treatment group (19%). The most commonly reported SARs were pneumonia and pyrexia (2% each) in the subcutaneous treatment group and pneumonia, diarrhea, and peripheral sensory neuropathy (3% each) in the intravenous treatment group. DRUG INTERACTIONS: Bortezomib is a substrate of cytochrome P450 enzyme 3A4, 2C19 and 1A2. Co-administration of ketoconazole, a strong CYP3A4 inhibitor, increased the exposure of bortezomib by 35% in 12 patients. Monitor patients for signs of bortezomib toxicity and consider a bortezomib dose reduction if bortezomib must be given in combination with strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir). Co-administration of omeprazole, a strong inhibitor of CYP2C19, had no effect on the exposure of bortezomib in 17 patients. Co-administration of rifampin, a strong CYP3A4 inducer, is expected to decrease the exposure of bortezomib by at least 45%. Because the drug interaction study (n=6) was not designed to exert the maximum effect of rifampin on bortezomib PK, decreases greater than 45% may occur. Efficacy may be reduced when VELCADE is used in combination with strong CYP3A4 inducers; therefore, concomitant use of strong CYP3A4 inducers is not recommended in patients receiving VELCADE. St. John’s wort (Hypericum perforatum) may decrease bortezomib exposure unpredictably and should be avoided. Co-administration of dexamethasone, a weak CYP3A4 inducer, had no effect on the exposure of bortezomib in 7 patients. Co-administration of melphalan-prednisone increased the exposure of bortezomib by 17% in 21 patients. However, this increase is unlikely to be clinically relevant. USE IN SPECIFIC POPULATIONS: Nursing Mothers: It is not known whether bortezomib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from VELCADE, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: The safety and effectiveness of VELCADE in children has not been established. Geriatric Use: No overall differences in safety or effectiveness were observed between patients ≥age 65 and younger patients receiving VELCADE; but greater sensitivity of some older individuals cannot be ruled out. Patients with Renal Impairment: The pharmacokinetics of VELCADE are not influenced by the degree of renal impairment. Therefore, dosing adjustments of VELCADE are not necessary for patients with renal insufficiency. Since dialysis may reduce VELCADE concentrations, VELCADE should be administered after the dialysis procedure. For information concerning dosing of melphalan in patients with renal impairment, see manufacturer’s prescribing information. Patients with Hepatic Impairment: The exposure of bortezomib is increased in patients with moderate and severe hepatic impairment. Starting dose should be reduced in those patients. Patients with Diabetes: During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication. Please see full Prescribing Information for VELCADE at VELCADEHCP.com.

VELCADE, MILLENNIUM and are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners. Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright © 2012, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA

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A study by the American Cancer Society Cancer Action Network revealed that enacting comprehensive smoke-free legislation in states without such laws could decrease deaths by more than 624,000 over the long term and save $1.32 billion in treatment costs over 5 years.3 Also, the United States could save $1.05 billion in treatment costs, generate close to $9 billion in new state government revenue over 5 years, and save 1.32 million deaths over the long term with the passage of a one-time $1 increase in cigarette excise taxes in all US states and the District of Columbia.3 Diet, Physical Activity, and Weight One-third of the more than 500,000 cancer deaths in the US per year can be attributed to poor diet, physical inactivity, and obesity.3 To prevent cancer, individuals should achieve and maintain a healthy weight throughout life, adopt a physically active lifestyle, consume a healthy diet, and limit consumption of alcoholic beverages.3 In 2010, the Affordable Care Act created the Prevention and Public Health Fund, a source of annual funding for prevention and public health initiatives, which provided $103 million for community-based policy and environmental change initiatives dedicated to decreasing obesity, improving nutrition, and increasing physical activity through the Community Transformation Grant program.3 Continued on page 12

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February 2013 I VOL 6, NO 1

11/8/12 1:39 PM

www.TheOncologyNurse.com

Editorial Board EDITOR-IN-CHIEF

Beth Faiman,

PhD(c), MSN, APRNBC, AOCN Cleveland Clinic Taussig Cancer Institute Cleveland, OH

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

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Catherine Bishop, DNP, NP, AOCNP Johns Hopkins Kimmel Cancer Center/Sibley Infusion Washington, DC

Deena Damsky Dell, MSN, RN-BC, AOCN, LNC

Fox Chase Cancer Center Philadelphia, PA

Wendy DiSalvo,

DNP, APRN, AOCN Genentech New London, NH

Cassandra J. Hammond, RN,

Dolores “Jeff” Nordquist, RN, MS,

Avid Education Partners, LLC Sharpsburg, MD

Mayo Clinic Rochester, MN

Northern Michigan University Independent Oncology & Palliative Care Consultant Marquette, MI

Shannon Hazen,

Melinda Oberleitner, RN,

Karla Wilson, RN,

RN, BSN, OCN Novant Health Presbyterian Cancer Center Charlotte, NC

Patricia Irouer Hughes,

Amy Ford, RN,

BSN, OCN Quintiles Dallas, TX

Sharon S. Gentry, RN, MSN, AOCN

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

www.TheOncologyNurse.com

Pharmacy John F. Aforismo,

Gary Shelton,

NP, MSN, ACNP-C University of Southern California Norris Cancer Center & Hospital Los Angeles, CA

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

Arizona Cancer Center Tucson, AZ

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

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

Jayshree Shah, NP

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

Taline Khoukaz,

City of Hope National Medical Center Duarte, CA

MS, CNS, OCN

City of Hope National Medical Center Duarte, CA

RN, MSN, BSN, OCN Piedmont Healthcare Rex, GA

MSN, RN, NP-C, OCN

Kena C. Miller, RN, MSN, FNP

Roswell Park Cancer Institute Buffalo, NY

MSN, FNP-C, CPON

DNS, APRN, CNS

John Theurer Cancer Center Hackensack University Medical Center Hackensack, NJ

Ann McNeill,

Constance Engelking, RN,

PhD, RN, AOCN

CS, FNP

MSN, CRNP

Denice Economou, RN,

MN, CNS, AOCN

Rita Wickham,

MSN, NP, ANP-BC, AOCNP

BSc Pharm, RPh, FASCP RJ Health Systems International, LLC Wethersfield, CT

Nutrition Karen Connelly, RD, CSO

NYU Clinical Cancer Center New York, NY

Somerset Medical Center Somerville, NJ

Lori Stover, RN, BSN

Patient Advocate Peg Ford

Western Pennsylvania Cancer Institute Pittsburgh, PA

Ovarian Cancer Advocacy Alliance San Diego, CA

Joseph D. Tariman, PhD,

Social Work Carolyn Messner,

APRN, BC

Northwestern University Myeloma Program Chicago, IL

Jacqueline Marie Toia, RN, MS, DNP Northwestern University Myeloma Program Chicago, IL

DSW, MSW, LCSW-R, BCD CancerCare New York, NY

Managed Care and Pharmaceutical Management Burt Zweigenhaft, BS

BioPharma Partners LLC New York, NY

Patricia Molinelli, MS, RN, APN-C, AOCNS

Somerset Medical Center Somerville, NJ

Ellen A. Neylon, MSN, FNP-BC, CCRP, OCN

Columbia University Medical Center Center for Lymphoid Malignancies New York, NY

Pamela Hallquist Viale, RN, MS,

CS, ANP, AOCN

Isabell Castellano, RN

Saratoga, CA

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

Connie Visovsky,

Jeanne Westphal, RN

RN, PhD, APRN

University of South Florida College of Nursing Tampa, FL

Meeker County Memorial Hospital Litchfield, MN

February 2013 I VOL 6, NO 1

From The Editor PUBLISHING STAFF Senior Vice President, Sales & Marketing Philip Pawelko phil@greenhillhc.com Publisher John W. Hennessy john@greenhillhc.com Director, Client Services Eric Iannaccone eric@greenhillhc.com Editorial Director Kristin Siyahian kristin@greenhillhc.com Managing Editor Kristen Olafson kristen@greenhillhc.com Quality Control Director Barbara Marino Production Manager Stephanie Laudien Business Manager Blanche Marchitto blanche@greenhillhc.com Executive Administrator Jackie Luma Circulation Department circulation@greenhillhc.com Editorial Contact: Telephone: 732.656.7935 Fax: 732.656.7938

1249 South River Road, Suite 202A Cranbury, NJ 08512 The Oncology Nurse-APN/PA®, ISSN 1944-9798 (print); ISSN 1944-9801 (online) is published 11 times a year by Green Hill Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2013 by Green Hill Health care Com munications, 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®, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. E-mail: editorial@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, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. 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.

February 2013 I VOL 6, NO 1

elcome to the first issue of The Oncology NurseAPN/PA (TON) for 2013. We’ll be publishing 11 issues this year, keeping you up-to-date about what is happening in the world of oncology research and bringing you information that helps you in your day-to-day practice. In this issue, we tell you about some of the news coming out of Beth Faiman, PhD(c), the San Antonio Breast Cancer MSN, APRN-BC, AOCN Symposium (SABCS). Our covEditor-in-Chief erage from SABCS includes the results of a study indicating that “chemo brain,” the cognitive changes identified in patients undergoing chemotherapy, is present in patients with breast cancer prior to undergoing chemotherapy and appears to be related to fatigue and anxiety. As Bernadine Cimprich, PhD, RN, stated, “These findings underscore the need for increased awareness among clinicians that cognitive problems can begin before treatment…. Early identification of women at greater risk is important, because cognitive problems can worsen over time.” We

also report on an SABCS presentation that pointed out the importance of addressing sexual issues in breast cancer survivors. As one of the presenters said, “The foremost issue is breaking the silence. If you don’t see sexual problems in your practice, you are not asking the right questions.” This issue also starts our coverage of the news from the American Society of Hematology (ASH) annual meeting. You’ll see more in next month’s issue as we cover the highlights from ASH. Be sure to read MMA’s article about how she struggled to adhere to her medication regimen at home after more than 8 months of hospital-based treatment. She writes about not wanting to be a “cancer patient” anymore and how this affected her feelings toward taking her medications. This month’s Reader Poll asks if your patients talk to you about how to adhere to their medication regimen when they return home (see page 8). Please tell us what your patients are telling you and how you respond to their concerns. As always, I encourage you to visit our website, www. TheOncologyNurse.com. Be sure to tell us what topics you want to see covered in TON. We want to hear from you, and we appreciate your feedback—positive and negative—about what you see in print and on the website. l

Recent FDA News Generic Doxorubicin Hydrochloride Liposome Approved The US Food and Drug Administration (FDA) approved doxorubicin hydrochloride liposome injection (Sun Pharma Global FZE) for the treatment of patients with ovarian cancer with disease progression after platinum-based chemotherapy and for the treatment of AIDS-related sarcoma in patients after failure of systemic chemotherapy or intolerance to that therapy. Approval for doxorubicin hydrochloride liposome injection was granted on February 4, 2013. The review of this generic application was expedited by the FDA’s Office of Generic Drugs because of the continuing drug shortage of Doxil Injection (doxorubicin hydrochloride liposome; Janssen Products, LP). Doxil is under shortage because of manufacturing issues. To meet patient needs, the FDA exercised its regulatory discretion with regard to alternative doxorubicin hydrochloride liposome products. Bevacizumab for Metastatic Colorectal Cancer Bevacizumab (Avastin; Genentech) received FDA approval on January 23, 2013, for use in combination with fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin– based chemotherapy for treating patients with metastatic colorectal cancer (mCRC) with disease that has progressed on a regimen containing first-line bevacizumab.

The FDA approval was granted based on the results of a randomized, open-label, multinational clinical trial that enrolled patients with mCRC whose disease progressed during or within 3 months of discontinuation of first-line bevacizumab-based combination chemotherapy. The 820 patients accrued for the trial were randomized to receive chemotherapy alone or chemotherapy in combination with bevacizumab. Depending on their prior treatment, patients received either fluoropyrimidine-irinotecan–based or fluoropyrimidine-oxaliplatin–based chemotherapy, with treatment cycles for both groups repeated every 2 or 3 weeks. For those patients in the chemotherapy plus bevacizumab arm, bevacizumab was administered by intravenous infusion at a dose of 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks. Patients received bevacizumab until disease progression or unacceptable toxicity. Overall survival (OS) was the primary end point, with a statistically significant improvement in OS observed in patients who received chemotherapy plus bevacizumab compared with those who received chemotherapy alone. Median OS was 11.2 months for patients in the chemotherapy plus bevacizumab arm and 9.8 months for patients in the chemotherapy-alone arm. l Sources

http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm338433.htm http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm336763.htm

Get involved: have you ever wanted to write an article for TON? We’re interested in articles about the everyday issues that affect nurses—everything from chemotherapy safe handling to supportive care for patients to challenging cases.

Contact editorial@greenhillhc.com for information. www.TheOncologyNurse.com

The Patient’s Voice

Adherence to Therapy at Home... Continued from cover

www.TheOncologyNurse.com

once told me that some doctors required only 4 months of the medication, and I preferred to be in that category regardless of what anyone said; and that particular medicine, I convinced myself, was causing all my nausea and making my recovery much more difficult. And regardless of what patients actually tell their doctors, I found out that my

reaction to being home was rather common, or, at least, not uncommon, particularly for patients like myself who live in areas with negligible access to healthcare and with healthcare professionals of dubious merit. I spoke to a woman who, once sent home from the same cancer center where I was treated, took the “I no longer want to be a cancer patient” attitude to

an extreme: she stopped taking her medicines completely after only a few weeks at home. As she told me, “Hey, if no one is watching, no one will know.” Last week I found out she was back in the hospital with another blood clot that most probably could have been avoided had she kept taking those darn injections. Continued on page 8

S:7.25”

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Investigators Study of the long-term safety and efficacy of darbepoetin alfa in anemic patients with Non-Small Cell Lung Cancer (NSCLC) receiving chemotherapy Phase 3 study with approximately 3,000 subjects at 500 study sites globally KEY ELIGIBILITY CRITERIA*

PRIMARY ENDPOINT

• Stage IV NSCLC

• Overall survival

• Receiving 1st-line myelosuppressive

SECONDARY ENDPOINTS

chemotherapy

• Progression-free survival

• Hemoglobin (Hb) ≤ 11 g/dL

• Incidence of ≥ 1 red blood cell (RBC) transfusion or Hb ≤ 8.0 g/dL

• ECOG score ≤ 1

S:9.75”

Darbepoetin alfa 500-mcg Q3W

2:1 Randomization (darbepoetin alfa:placebo)

End of Investigational Product

End of Treatment Period

Long-term Follow-up

Placebo Q3W

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Week 1

Disease progression or end of chemotherapy treatment

*Complete inclusion/exclusion criteria and additional study details can be found in the protocol. ECOG = Eastern Cooperative Oncology Group; Q3W = once every 3 weeks.

For more information, please email Cory Docken/Getty Images

friends kept in close contact with me during my treatment, during my absence their lives continued—as did mine—on parallel, but no longer interconnected, tracks: their kids kept going to the same schools, they got promotions at work, they continued to save some money, and they hung out at our favorite coffee shop. My kids and I saw our entire routine interrupted: some of them stayed in the same schools and flew back and forth to see me, others left school to be with me, we moved into a rented apartment in the hospital city while paying a mortgage in our home city, and we quickly descended to the bottom of the middle class from our once-secure financial position. Now home, I just wanted my old life back! Yet, I could not have it back. Exhausted, I found that even some of the easiest tasks seemed beyond my capabilities. Standing up for more than 5 minutes was an ordeal. Keeping the house clean was absolutely impossible. Going back to the office seemed like a pipe dream. The side effects from the chemotherapy and the stem cell transplant continued to haunt me. Nausea remained the norm, controlled only by the miracle drug prescribed to me to stop it. I tried to go out for nightly walks around the block, but after 2 days of attempts, I stopped, discouraged by my inability to make it without gasping for air, even at a pace that if it were any slower, could factually be called reverse. My first few weeks at home, rather than giving me tranquility, offered me little but treasured memories of how things were before cancer invaded our life and the bitter reality of what now was. I knew I did not want to keep living like this. That did not mean, though, that I wanted to end my life. Certainly, I had some moments of severe sadness, sitting in my bed, too tired to get up, weeping. How could this have happened? Why did it happen? What would happen from here? But those moments were few and far between. Also, admittedly, during my first couple of weeks at home, I wanted to disassociate completely from my role as cancer patient and the pain associated with my treatment. I took my “easy” medications (for me this meant the medications in pill form) rather regularly (if I was asleep I would miss a dose and not take one until I woke up). But I resisted taking my painful medication—a self-injection I was supposed to take twice a day—on more than a few occasions. Oh, certainly I had many justifications: it hurt and I did not want any more pain; I was not even supposed to have to take it, because the condition I was being treated for (a pulmonary embolism) happened 5 months ago, and though my doctor told me that I would need the medication for at least 6 months, a nurse at the hospital had

Study-20070782@amgen.com or call 1-866-965-0782. Products under investigational study have not been approved by the FDA for the use under investigation in this trial.

AOCO3X0071_Recruitment782_AdAsize_r3.indd 1

72140-R2-V1

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The Patientâ&#x20AC;&#x2122;s Voice

Adherence to Therapy at Home... Continued from page 7 I spoke to a colleague at work who, to heck (he used a different word) with unknown to me, was a cancer survivor. the whole medication thing. I didnâ&#x20AC;&#x2122;t want We got to talking about our experiences, this cancer thing haunting me for the rest and he mentioned the pros and cons of of my days, and those pills just reminded being sent home. He shared with me me of how sick I really was.â&#x20AC;? that had it not been for his wife, who So, at least in my case, what strategies every morning put his pills in one of would have been helpful to keep me those pill dispenser trays, he would never motivated to follow my medication regihave taken his medication. â&#x20AC;&#x153;It was hard men exactly, at least during those first few enough to get those giant pills down when weeks of being home (I now religiously I already did not feel well,â&#x20AC;? he shared. â&#x20AC;&#x153;If take all my medications)? I think the 11/29/12 3:31 PM Page 2 it CCC had Asize_112112_TON0210 not been for her, I would have said solution would have been rather easy: a

series of phone callsâ&#x20AC;&#x201D;maybe once a week or soâ&#x20AC;&#x201D;from the pharmacist or another member of my medical team to check up on me. You see, when I was a cancer patient receiving care at the cancer center, I went to the hospital several times a week. There, I was always asked about which medicines I was taking, when I took them, and when I took them last. Someone actually looked over that information and asked me questions to clarify

eO seri Vie nc es w olo on the gy line Nu a rse t .co m

2ND ANNUAL

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CONQUERING THE CANCER CARE CONTINUUM CONQUERING CANCER CARTHE C E CONT I

A 6-part series

The publishers of The Oncology Nurse-APN/PA, The Oncology Pharmacist, and Personalized Medicine in Oncology are proud to present our 2nd annual Conquering the Cancer Care Continuum series. Upcoming topics include:

Challenges Patients Face in Cancer Care: Implications for the Healthcare Team Lea Ann Hansen, PharmD, BCOP Associate Professor, Virginia Commonwealth University

ancer is an illness associated with substantial cancer.1 More than half are living well beyond 5 years physical, emotional, social, and financial ramafter diagnosis. Women comprise a majority of longifications for affected individuals and their term survivors due to the favorable outcomes with families. In a significant number of cases, the diagnosis breast, cervical, and uterine cancers.2 The number of of cancer is either preceded by a period people living with a history of cancer of gradual, nonspecific symptoms or is projected to grow considerably over

discovered by routine screening, and the next 20 years for 2 major reasons. individuals are then thrust into a First, the number of Americans over whirlwind of diagnostic testing, inage 65 is predicted to double between vasive procedures, and complicated the years 2000 and 2030.3 Consetreatments with very little warning or Lea Ann Han quently, as a disease primarily of older sen, Associat e ProfessoPharmD, BCOP adults, cancer will also increase. Secopportunity to assimilate their circumr, Virginia Common stances. Frequently, a multidisciplinary ond, as the effectiveness of cancer wea ersity the number of â&#x201E;˘lth Univ approach to treatment is necessary, retreatments improves, he past deca de quiring patients to engage with numerpatients cured of the disease will inthe utilizatio has seen a dram atic upsu

n of spec several ous medical teams comprising crease, andrge an in even larger ialty pha types of Medpercentage rma icare Mo ther cies Lea Ann Hansen, apeutic for all dern different specialties, often in different those for can will be living longer with modaliti as â&#x20AC;&#x153;athe disease ization Act defi cer. The BCOP PharmD, es, incl ned a spec D drug cost uding multiple part of cancer while receiving locations. Many patients have beenabout $125 billi ialty drug care may ceed â&#x20AC;&#x153;linesâ&#x20AC;? of with plan-negotia on in 201 0 rise from etc) over $40 ted prices 0 to (first-line, relatively healthy prior to the cancer lion eventbyand second-line, time. per Themonth.â&#x20AC;? 2 Oth thethere7 bilthat exend of the therapy$20 fine spec er health ialty drug deca plans may de. demand fore are not sophisticated consumerstim ofe,medical overall specialtyserBy that for oncology services is expected to ins different dedrugs are ly. In gen acco predby eral, they unthealthcare icte48% vices. Consequently, it is incumbent on for 2 of ever crease d toby 2020, while the supply of oncologists high cost, adm are inistered y 5 pha lars spentransition by injectio professionals to be able to facilitate patientsâ&#x20AC;&#x2122; increase cy dol-by only 14% based on current patterns.4or infusion, t. 1 The purp willrma n require spec ose of this to expand ial handlin into care in orderealth to minimize theirisdistress These statistics article underscore the need for a wide varietyor are used for D, BCOP lain maxiUniversity Pharm the g, en, 80%, evo monw to complex lution of ia Com cialty pha Lea Ann Hans ssor, Virgin from 17% and other support personnel torequire range the mize their clinical outcomes. of ens health professionals spermacy ation Profe regim special mon diseases that ption and Associate medic assum the on oral can itoring. In func2-4 term serv cology, how A scomm Challenges existic beyond the initial diagnosis play ation part e in theand ent d 50%. itin enabling each and every patient to reonaroun ever, the getrea system treatm tment of ancer agents would be an avera andwith most com to the agents disp nt scenario forperiod as well.istracan According to National ceive quality all of their needs disc antic cer care that addresses ussence mon the pote to oral ensed by he predomina treatment has been involved admin se, ly adher and ntia a disea spec ional that cha l mac the ben ialty phartradit (NCI), more ythan 12 million throughout individ-the sever llenges ity ofefits the continuum of the illness. Patients de- y provider of cancer has Cancer Institute apy by highl poin (SPP) are dueoftothe system from e. Studies indicate the thighe targeted of view enous chemother the newer fine quality their ability to5: United the States are ar,history nt.living with the of care based on n untru patie of theofpati agents that prove tion of intrav uals in the py are ent. ly monitored are adminis for cancer thera tered oral nnel who close ly. After adherence rates5 nce has trained perso in an The Evo a systema NonadhereHealthcare view dures took place luti tic re Green Hill outco 15% to 97%. mes Communications, LLC of the literature, When these proce infuDrugs an on of Spe cia one acad group of lty iated with worse or in a hospital d Specia been emic assoc auth office s with ogistâ&#x20AC;&#x2122; ors and the proposed oncol of Pharmac lty critical desc disease states Lea Ann the most sive education y in a number of Hansen riptors of r hossion center, exten , highe More There is drug to be 3 a specialty cian visitsPha rmD, BCO , y was possible. a lack of : increased physi tal stays, P consens patient and famil comhospi spec r ly ialty asing longe â&#x20AC;˘ us High cost on therates, drug. The ver, an incre definition (prescription Food andpitalization recently, howe not defined incre of a ased morof one or Dru worsening, and s cost mor than $600 the term. involves the use inistration one-third â&#x20AC;˘ e toDifficult diseasgeAdm per month) Initially mon situation synonym dminmedication has , the6 Approximately ous with ations and self-a delivery, l was virt tedâ&#x20AC;&#x201D; Special biotech tality. labe such as more oral medic teins prod uallcatio pies in the handling y n-rela gy prod all medi uced by reco nolotwo-t hirds uctsof, eith taneous theraLea Ann requiring er pro-to medication control istered subcu mbinant strict tem respon-Hansenmon Associ oclo rmD DNtaliza perature nal, anti tions are due ate Profess, Pha nt. The direct A tech BCO onme â&#x20AC;&#x201D; hospi bilbod P envir Res niqu ies $100 or,oma home tricted loca brid es cost of produced admin Virg s,inia nceâ&#x20AC;&#x201D;at a or tion for med but Com with acquisition and dherecell this ismo nona arthis or nwe ular of no icat distr and sibility for drug se ts alth longer theUnivally.7 Thehyion preparat ibution site purpo ng to the patien caseersi ion ty en, lion annu ptsRestric . The al conceâ&#x20AC;&#x201D; istration is shifti 200gener availLea Ann Hans P ted location 7 ibe rt network, if he previous inst BCO for medicat ticle is to descr Pharm allmD,ent their social suppo ch related totration than 20 ion adminis in this can and the resear nt time, more ries examin ence t adher cer Gre care ed the growregarding patien able. At the prese en Hill ence, risk facved for se-ent. incid TheHea lthcaare Com ed. ing importacancer treatm s are FDA appro therapi with addition, mun review esInfor oral medication er icatiRons, r (Table 1). MP the em will beless adherence to nce of oral of cance probl LLC trea (82 ent imp this that of % tme rs treatm es lica vs 78%). 4 tumo deriquent nt of can tions of for quenc examine vedlyfrom conse the first-line pati cer (MPR is a tors, and agents are used ent adh and the electronic series will subse other oral metric pres prescription ent to initia l treatment. Ac-erenceThe refi patt on its article in this and clinical a number of lastsucc e, mor erns over refractory tim records bas ess. izing adherllence e thaernNetor are icat Atmaxim for the Canc 20 tim ices ed nsive oral have relapsed pract e, on ions are and 80% prehe point for adh med the best approved s in the National Com is an arbitrar erence use cording to the Drug Adm y cut of all compoundby the -Food outco d by many and mes. tely 25% inistration admin investigato ne are work, approxima linedevelopment pipeli (FD same study rs.) The ch and treatment continue.1 A) for firstfound surv oncology resear Health Organ ival at 10 yea is likely toof cancer. Aased to be by the World othtrend so the er ora rs s the incre number ofAdherence was defined nâ&#x20AC;&#x2122;s be- 81% for those l age istered orally, comeare ity nts nsibil which a perso the who to respo nt in use adcon â&#x20AC;&#x153;exte be shift tinued as the s may notd for With this that havemedic diet, and/orrapy versus 74% relaation ization in 2003 psed or that requiretumors following a for those anticancer had discont refractory havior, taking medication, possibility that initial treaially for regimensare who inued it. No to ctly, espec tment, and abo longnadherenc has also bee ministered corre of adherence utto25% of onc olog e allyestim the n shown to reseates g. Over arch pipeline repeated dosinoral produce sub unications, LLC stantial det con Healthcare compounds 1 riment in of Comm en Hillsists . This Gre clin is

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MMA is undergoing treatment for cancer. She wishes to use her initials.

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it. I shared with them that I hated doing the self-injection, and though given sympathy, I was also encouraged to continue the injections and I did so. Once I got home, though, I felt like I was thrown to the wolves, alone, to fend for myself. I was no longer amongst a swarm of cancer patients, all waging their private battles against an evil disease yet all united by the obligation to take pills and injections. No one was asking me if I was taking my medicines or if I had any concerns about them. At home, I was â&#x20AC;&#x153;theâ&#x20AC;? cancer patientâ&#x20AC;&#x201D;different, weaker, and sicker than the rest. I was waging this battle completely alone, now, and I really did not want to be so unique. Consider it a kind of culture shock. Patients who are sent home go from being checked up on several times a week to almost complete neglect. At first, we are not used to the neglect. It feels like â&#x20AC;&#x153;Out of sight, out of mind.â&#x20AC;? Though I do not consider my case of nonadherence extreme, and I did get myself back on track rather quickly, it all could have been avoided if I had just had someone, anyone, from my team personally check up on me. So, if you want your patients to adhere to their prescribed therapy at home, pick up the phone, and give them a call to ask if they are doing so. Even in this age of high technology, you might be surprised at how incredibly important a little human contact can actually be! l

NUUM

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comes in chr ical outin addition self-adminis to onic myeloid tered subcuta and childh leukemia neous the pies for the ood acute rahome env lymphoblas leukemia. 5-8 ironment are under tic that For each of FDA review. these diso ders, prolon When can rged oral cer medicat therapy has been the ions are administered standard Lea Ann orally in the of care for Hansen, decade or home env ronment rath a PharmD mo ire. It er than in , BCOP is likely tha ative consequ the clinic of adheren t negor hospital, enc ce range from es of nonadh the rates with other 15% to 97% 2 erence at the end will be doc oral cancer of the first . For examp umented in medication year of trea le, hormonal the future s tment with apy matures treatment as their role adjuvant . The purpos (AHT) for in thercer, only 79% e of this arti early-stage the results of patients breast can cle is to disc of availab remained on a gap exceed uss le adh rese erence and arch on therapy with ing 60 day maximizing suggest best out s and 85% ceeding 180 ical practices to without a outcomes. days. By yea improve clin gap exr 5, only 27% mained wit hout 60- and and 29% re180-day gap In anothe

s, respecti r study of vely. 3 AHT, pati tion possess ents with ion ratio (M a medica PR) >80% significant Direct com had a statistic ly higher munication 10-year surv ally with all pati personal barr ival rate tha ents about iers to taki n those their ng daily the period is an rapy for a pro important longed aspect to Gre maximizing en Hill Hea adherlthcare Com munications, LLC

Reader Poll Do patients talk to you about how best to adhere to their medication regimen when at home? o Yes o No MMA discusses the many issues she confronted when she returned home with â&#x20AC;&#x153;a bagful of medicines.â&#x20AC;? Do patients talk to you about similar concerns? How do you talk to patients about the issues they may confront? Go to www.TheOncologyNurse.com to answer the question.

www.TheOncologyNurse.com

Cancer Center Profile

Gibbs Cancer Center... Continued from cover The Oncology Nurse-APN/PA spoke with Lucy Gansauer, RN, MSN, OCN, director of the NCI Community Cancer Centers Program at Spartanburg Regional Healthcare, about cancer care at the Gibbs Cancer Center and her role as an oncology nurse.

What is the approach to cancer care at your center? Lucy Gansauer (LG): We have a personalized and multidisciplinary approach to our patients. We have nurse navigators who are the point of entry to our system: 1 for prostate/GU [genitourinary] cancer; 1 for hematology/head and neck/ CNS [central nervous system] and brain cancer; 2 for breast cancer; 1 for thoracic cancer; and 1 for colorectal cancer. The nurse navigator identifies cases and connects patients to the system at the time of diagnosis. He or she helps navigate patients through the system and answers any questions. The nurse navigator identifies special needs or problems, such as the need for social support, low literacy, education, or insurance barriers—in an attempt to eliminate barriers and ensure equity of care. At our center, we focus on eliminating disparities in care due to race, ethnicity, or rural location; we provide outreach to help patients have access to quality care. Many of these patients are uninsured and unemployed, and we facilitate free screening for breast, colorectal, and prostate cancer for early detection. How does your approach improve outcomes? LG: Our approach has reduced diagnosis of breast cancer at a late stage among African Americans. Thirty-six percent of the men we screen for prostate cancer are African Americans, who have worse outcomes if not diagnosed early. We can identify men early, who often can be treated with active surveillance, and we educate those who need treatment about their choices. What are you excited about at your center? LG: We are serving a larger proportion of adolescents and young adults with cancer, and we have expanded our services for this group, including support groups, survivorship clinics for those at risk of second cancers, and onco-fertility. We are partnering with fertility specialists at the Piedmont Reproductive Endocrinology Group to encourage patients who either have not had families yet or who plan to expand their families to preserve eggs and sperm. Genetic counselors meet with patients for a free consultation in person or over the telephone and give them information about fertility services. This has

www.TheOncologyNurse.com

been a wonderful collaboration that has allowed us to apply for LiveStrong discounts and free fertility drugs.

How has the role of an oncology nurse changed over the past 5 years? LG: We have become accountable now for patients’ outcomes. This is new and difficult for some nurses to adjust to. We need to make sure that patients understand their treatments,

for rehospitalization, and we have to risk-stratify these patients and manage them proactively. Nurses are now equal partners with doctors in accountability for outcomes.

What inspired you to become an oncology nurse? LG: I always wanted to be a nurse. When my father was diagnosed with colorectal cancer, I witnessed how overwhelming the diagnosis was. He had to

“In the era of personalized medicine, I find it fascinating and rewarding to match the treatment with the patient’s specific genetic markers.” Lucy Gansauer, RN, MSN, OCN

and nurse navigators are now account- meet with a medical oncologist, surable for reducing avoidable emergen- geon, and radiation oncologist within cy department and inpatient stays. For 1 week. He ultimately needed a colosexample, patients with diabetes or past tomy. I became his de facto manager. I got 4:32 an opportunity psychological problems are at greater risk Then WCMC_2013Conf_horizontalV491212_Layout 1 9/13/12 PM Page 2 to become

an oncology nurse, and I took it. In the era of personalized medicine, I find it fascinating and rewarding to match the treatment with the patient’s specific genetic markers. There is no other nurse specialty that requires such a high level of learning and expertise.

What advice would you give to an oncology nurse just entering the field? LG: You need to ground yourself by working in an oncology unit and seeing how patients deal with cancer emotionally and physically. You need certification and an advanced degree to be an oncology nurse. An entry-level degree does not prepare you for the evolving science and clinical care. You will always be learning. What would you be if you weren’t an oncology nurse? LG: I would be a cancer researcher. I find it fascinating how research can improve patient care; for example, developing less toxic regimens or being involved in new drug development. It is amazing what we can learn about the human body and its response to cancer and to cancer treatment. l

SAVE THE DATE SECOND ANNUAL CONFERENCE

2013 WORLD CUTANEOUS MALIGNANCIES CONGRESS

July 26-28, 2013 Hyatt Regency La Jolla at Aventine 3777 La Jolla Village Drive San Diego, California Melanoma • Basal Cell Carcinoma • Cutaneous T-Cell Lymphoma Squamous Cell Carcinoma • Merkel Cell Carcinoma February 2013 I VOL 6, NO 1

The Whole Patient

Approaches to Sexual Dysfunction in Breast Cancer Survivors By Alice Goodman

“Sexual and intimacy issues are the approaches to sexual problems in breast white elephant in the room for women cancer patients at the first session to be with breast cancer,” stated Susan W. planned and moderated by a patient Rafte, of the Pink Ribbons Project, advocate (herself) at the San Antonio Houston, Texas. Rafte, an 18-year sur- Breast Cancer Symposium.1 “Intimacy is vital for the breast canvivor of metastatic breast cancer, introVBCC0112_VBMAsize_Layout 1 2/9/12 4:21 PM Page 2 duced an expert in sexuality to discuss cer survivor, and she needs compre-

hensive sexual care that involves communication with the team of health care providers who treat the patient,” stated Michael Krychman, MD, executive director of the Southern California Cancer Center for Sexual Health and Survivorship Medicine in

Visit tHe neW onLine resourCe for nurses And tHe entire MuLtipLe MyeLoMA CAre teAM

“Quality care is everyone’s business.”

“The foremost issue is breaking the silence. If you don’t see sexual problems in your practice, you are not asking the right questions.”

Beth Faiman, RN, MSN, APRN, BC, AOCN Nurse Practitioner, Multiple Myeloma Program Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Michael Krychman, MD

Value-BasedCare in Myeloma

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resourCe Center for pAyers, proViders, And tHe entire CAnCer CAre teAM

Value-Based Care in Myeloma delivers exclusive interviews and perspectives related to cost, quality, and access issues. special sections for VA-based clinicians, advanced practice nurses, and pharmacists will also focus on the unique challenges in the management of multiple myeloma.

February 2013 I VOL 6, NO 1

Newport Beach, California.2 “We do a disservice when we don’t address sexual care,” he added. “The foremost issue is breaking the silence. If you don’t see sexual problems in your practice, you are not asking the right questions. Ninety percent of breast cancer survivors have some sort of sexual complaint, either immediate or long-lasting,” he continued. Sexual issues need to be addressed in the context of patients’ ethnicity and choice of partners—whether gay or straight, he continued. Also, overall health and wellness should be addressed. Several nonpharmacologic interventions can improve sexual health. “Data support that the Mediterranean diet can improve indices of sexual health function. Body mass index [BMI] and BMI maintenance is vital for overall general health and for sexual health as well. Mindfulness has been found effective for sexual desire and arousal disorders as part of a larger treatment program. Meditation can improve response and decrease sexual distress,” Krychman said.

Vulvovaginal atrophy (VVA) is a common problem that affects sexual function in sexually active postmenopausal women and breast cancer survivors, and reducing symptoms of VVA may help sexual function, he said. Lubricants and moisturizers can be used. There is a difference between these 2 products; lubricants are used at the time of sexual intercourse and moisturizers promote long-term relief of VVA. Over-the-counter lubricants include K-Y Jelly, Astroglide, olive oil, and other types of oils. Moisturizers, such as Replens, need to be used consistently to help improve plasticity of the vaginal lining. “A woman with VVA should be prescribed vaginal dilators to increase the circumference of the vagina. They come in sets and require instruction and monitoring. We see patients every 4 weeks to increase compliance. They need constant encouragement to use

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The Whole Patient these dilators, but this helps the woman increase her sexual self-esteem,” he said. Turning to pharmacologic approaches, the use of estrogen preparations to manage VVA is controversial for breast cancer survivors, because estrogen fuels some breast cancers. Some newer versions of these preparations have less estrogen. “I tread cautiously about advising use of minimally absorbed local estrogen for breast cancer survivors,” Krychman said. “The vagina is not cement. The vaginal epithelium does have some absorption. It is important to emphasize that the effects of minimally absorbed local estrogen remain to be elucidated in breast cancer patients,” he stated.

“I tread cautiously about advising use of minimally absorbed local estrogen for breast cancer survivors.” Michael Krychman, MD

Several nonhormonal products are in development for VVA and will be suitable for breast cancer survivors if approved by the US Food and Drug Administration (FDA). These include intravaginal testosterone (no systemic increase in estradiol levels, he said) and intravaginal dehydroepiandrosterone (DHEA; suppositories given daily with no increase in systemic estradiol levels, under review at the FDA). Ospemifene (a vaginal receptor agonist, or selective estrogen receptor modulator [SERM]) just completed phase 3 clinical trials and is under review by the FDA. This is a first-inclass oral agent that targets the vaginal epithelium, Krychman said, which “may be interesting for the breast cancer population. I think it is very exciting. Oncology teams are more comfortable using SERMs than local estrogens,” he commented. In Europe, Vagitocin (intravaginal oxytocin) is in phase 2 testing for VVA, while estriol, a weak endogenous estrogen, has been used for many years. Estriol is safe for the endometrium and reverses VVA, Krychman added. However, “These 2 products are not FDA approved. Some of my colleagues are using estriol in a compounded formulation. This has not been studied in breast cancer survivors,” he stated. “The approach to the breast cancer survivor with VVA should always begin with nonpharmacologic strategies. Alternatives should be tried first. Document all discussions with patients,

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and get informed consent. Consider following estradiol levels and tailor the treatment regimen accordingly. See your patients regularly,” he advised. Potential off-label approaches to treatment of sexual dysfunction include bupropion (an antidepressant with prosexual effects) and flibanserin, a nonhormonal serotonin modulator. In studies of more than 10,000 women, flibanserin improved sexual

interest and was very well tolerated. A study by Katz and colleagues called BEGONIA is in press in the Journal of Sexual Medicine, he added. Other compounds in clinical trials include a nonhormonal vulvar soothing cream called cellular lysate cream; Femprox (alprostadil), a topical cream that improves blood flow to the clitoris and response; Lybrido (testosterone with a phosphodiesterase inhibitor);

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Lybridos (testosterone with a 5-HT1A agonist); and bremelanotide (a melanocortin receptor agonist). l References

1. Rafte SW. Navigating the obstacles and risks of survivorship. Presented at: 2012 CTRC-AACR San Antonio Breast Cancer Symposium; December 4-8, 2012; San Antonio, TX. 2. Krychman M. Emerging sexual pharmacology for the breast cancer survivor. Presented at: 2012 CTRCAACR San Antonio Breast Cancer Symposium; December 4-8, 2012; San Antonio, TX.

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February 2013 I VOL 6, NO 1

Genetic Counseling

Inherited Colon Cancer... Continued from cover Mutations in 12 genes (MLH1, MSH2, EPCAM, MSH6, PMS2, APC, MUTYH, SMAD4, BMPR1A, STK11, PTEN, and CHEK2) have consistently been shown to be associated with an actionable, elevated risk of CRC, ranging from 15% to 95%. With the exception of MUTYH, all are inherited in an autosomal dominant fashion. Other genes also have been implicated in elevated CRC risk; however, the exact risks are less defined. As each gene is associated with extracolonic cancers and colon cancer is considered a preventable cancer, pinpointing the causative gene is critical for the medical management of the individual undergoing risk assessment and his or her at-risk family members. Of the 5% to 10% of inherited CRCs, approximately 2% to 3% are due to Lynch syndrome. By solely focusing on the identification of Lynch syndrome in CRC families, at least half of the patients with other identifiable inherited risk may be missed. Therefore, when developing a genetic testing strategy for a CRC family, it is important to assess the patient for all inherited CRC syndromes. As Colon Cancer Awareness Month (March) approaches, it is a good time to review 3 syndromes that have overlapping phenotypes with both FAP and Lynch syndrome. Peutz-Jeghers Syndrome Peutz-Jeghers syndrome (PJS) is an autosomal dominant syndrome associated with mutations in the STK11 gene. The cumulative risk for CRC to age 65 years is 39%. Extracolonic risks include gastric (29%), small bowel (13%), pancreatico-biliary (32%), breast (32%54%), lung (7%-17%), and uterine cancer (95%).1-3 Women also are at risk for adenoma malignum of the cervix and for ovarian cancer, specifically sex cord

tumors with annular tubules (SCTATs) and mucinous ovarian cancer. Men sometimes develop calcifying Sertoli cell tumors of the testes. The hallmark features of the syndrome are Peutz-Jeghers (PJ) hamartomatous polyps and mucocutaneous pigmentation. The polyps can be found throughout the gastrointestinal tract but are most common in the small intestine. It is not unusual for a patient to present with chronic bleeding, anemia, and/or intussusception due to the polyps. Although PJ polyps are a hallmark feature, it is important to realize that individuals also may develop other types of polyps, including adenomas, in the

• Any number of PJ polyps detected in one individual who has a family history of PJS in a close relative • Characteristic mucocutaneous pigmentation in an individual who has a family history of PJS in a close relative • Any number of PJ polyps in an individual who also has characteristic mucocutaneous pigmentation. Juvenile Polyposis Syndrome Juvenile polyposis syndrome (JPS) is an autosomal dominant syndrome associated with mutations in the SMAD4 and BMPR1A genes. Its hallmark feature is a type of hamartomatous polyp called a

When developing a genetic testing strategy for a colorectal cancer (CRC) family, it is important to assess the patient for all inherited CRC syndromes. colon. Thus, not only do the extracolonic cancers overlap with other CRC syndromes, such as Lynch syndrome, but the polyp burden does as well. Additionally, children may have dark blue to dark brown macules around the mouth, eyes, nostrils, perianal area, buccal mucosa, and fingers. Often these macules fade and, thus, may not be obvious when assessing an adult for the syndrome. They are rarely present at birth. Variable expressivity within families is common—further challenging a diagnosis. A diagnosis of PJS is made when a mutation is found in the STK11 gene or when clinical criteria are met. A clinical diagnosis of PJS is made if any of the following are present4: • Two or more histologically confirmed PJ polyps

“juvenile” polyp. Similar to the polyp burden in PJS, the number of polyps may vary greatly between individuals, polyps may be found throughout the gastrointestinal tract, and other types of polyps may be present. Individuals have been reported with greater than 100 polyps—again overlapping with phenotypes such as FAP. The risk for CRC is estimated to be 39% to 68%.5,6 Extracolonic cancers include stomach, pancreas, and possibly small intestine cancers, which also can be found in other CRC syndromes such as Lynch syndrome. Formal risks for extracolonic cancers are not well established. Individuals with mutations in the SMAD4 gene may additionally have features of hereditary hemorrhagic tel-

Noteworthy Numbers Continued from page 4 UV Radiation It is estimated that approximately 76,250 cases of melanoma were diagnosed in 2012, with likely 9180 deaths.3 Behavioral strategies for the prevention of skin cancer include wearing ultraviolet (UV)-protective clothing, seeking shade when outdoors, applying sunscreen of SPF 15 or higher to exposed skin, and avoiding indoor tanning booths.3

In 2010, 60.4% of adults said that they usually or always protected themselves from the sun by practicing at least 1 of 3 sun-protective behaviors: • 31.0% reported usually applying SPF 15 or higher sunscreen • 19.7% reported usually wearing sun-protective clothing • 37.2% usually sought shade2

Sources 1. www.WHO.int/cancer/prevention/en/. 2. http://progressreport.cancer.gov/doc.asp?pid=1&did=2007&mid=vcol&chid=71. 3. http://www.cancer.org/search/index?QueryTe xt=033423.

February 2013 I VOL 6, NO 1

angiectasia (HHT). Therefore, patients with an SMAD4 mutation should be screened for features of HHT. HHT is associated with multiple arteriovenous malformations (AVMs), as well as nosebleeds and mucocutaneous telangiectasia. A diagnosis of JPS is made when a mutation is found in the SMAD4 or BMPR1A gene or clinical criteria are met. A clinical diagnosis of JPS is made if any of the following are present7: • More than 5 juvenile polyps of the colorectum • Multiple juvenile polyps throughout the gastrointestinal tract • Any number of juvenile polyps and a family history of juvenile polyps. Cowden Syndrome Cowden syndrome (CS) is an autosomal dominant syndrome associated with mutations in the PTEN gene. Extracolonic cancers include thyroid, breast, endometrial, colon, and renal cell carcinoma. In addition, the syndrome places individuals at an increased risk for benign tumors of the skin, thyroid, breast, and endometrium. Skin findings include trichilemmomas, papillomatous papules, and acral/plantar keratoses. Adenomatous nodules, follicular adenomas, and multinodular goiter are common, as well as benign breast disease and uterine fibroids.8 Macrocephaly also is seen. Historically, cancer risks have been estimated to be approximately 25% to 50% for breast, 5% to 10% for endometrial, and 3% to 10% for thyroid cancer,8 but recent data suggest that lifetime risks may be much higher. Cumulative lifetime risks to age 70 years were estimated at 81% for breast, 21% for thyroid, 19% for endometrium, 16% for CRC, and 15% for kidney cancer.9 Once again, these are cancers that are also found in other CRC syndromes, including Lynch syndrome. Similar to PJS and JPS, gastrointestinal polyposis is common and can occur throughout the entire tract. A recent study examining the colonic polyposis in patients with CS found that 90% had polyps and 70% had more than 50 polyps. Furthermore, the polyps were of various types and included hamartomatous, inflammatory, adenomatous, ganglioneuromatous, hyperplastic, and juvenile polyps.10 A diagnosis of CS is made when a mutation is found in the PTEN gene or when diagnostic clinical criteria are met. An individual who does not have a family member previously diagnosed with CS meets diagnostic criteria when any of the following are met11:

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Genetic Counseling • Pathognomonic mucocutaneous lesions combined with 1 of the following: • Six or more facial papules, of which 3 or more must be trichilemmomas • Cutaneous facial papules and oral mucosal papillomatosis • Oral mucosal papillomatosis and acral keratoses • Six or more palmoplantar keratoses • Two or more major criteria • One major and 3 or more minor criteria • Four or more minor criteria Pathognomonic criteria • Adult Lhermitte-Duclos disease (LDD), defined as the presence of a cerebellar dysplastic gangliocytoma • Mucocutaneous lesions • Trichilemmomas • Acral keratoses • Papillomatous lesions • Mucosal lesions Major criteria • Breast cancer • Epithelial thyroid cancer (nonmed-

References

Identifying individuals with inherited CRC risk allows for medical interventions for prevention and early detection.

ullary), especially follicular thyroid cancer • Macrocephaly (occipital frontal circumference ≥97th percentile) • Endometrial carcinoma Minor criteria • Other thyroid lesions (eg, adenoma, multinodular goiter) • Intellectual disability (IQ ≤75) • Hamartomatous intestinal polyps • Fibrocystic disease of the breast • Lipomas • Fibromas • Genitourinary tumors (especially renal cell carcinoma) • Genitourinary malformation • Uterine fibroids Take-Home Messages • As Colon Cancer Awareness

Month and Lynch Syndrome Awareness Day (March 22) approach, take a moment to review inherited CRC syndromes—up to 25% of CRC survivors in your practice may need additional risk assessment and possibly genetic testing. • Historically, inherited CRC has been divided into 2 categories: polyposis and nonpolyposis syndromes. However, as more is learned about these syndromes, it has been found that their phenotypes are diverse and often overlap. • Identifying individuals with inherited CRC risk allows for medical interventions for prevention and early detection in the patient and his or her at-risk family members. l

1. Hearle N, Schumacher V, Menko FH, et al. Frequency and spectrum of cancers in the PeutzJeghers syndrome. Clin Cancer Res. 2006;12(10):32093215. 2. Korsse SE, Harinck F, van Lier MG, et al. Pancreatic cancer risk in Peutz-Jeghers syndrome patients: a large cohort study and implications for surveillance. J Med Genet. 2013;50(1):59-64. 3. Genetics of colorectal cancer (PDQ). National Cancer Institute website. http://www.cancer.gov/can certopics/pdq/genetics/colorectal/HealthProfessional/ Page4#Reference4.392. Accessed January 10, 2013. 4. Beggs AD, Latchford AR, Vasen HF, et al. PeutzJeghers syndrome: a systematic review and recommendations for management. Gut. 2010;59(7):975-986. 5. Brosens LA, Langeveld D, van Hattem WA, et al. Juvenile polyposis syndrome. World J Gastroenterol. 2011;17(44):4839-4844. 6. Brosens LA, van Hattem A, Hylind LM, et al. Risk of colorectal cancer in juvenile polyposis. Gut. 2007;56(7):965-967. 7. Haidle JL, Howe JR. Juvenile polyposis syndrome. In: Pagan RA, Bird TD, Dolan CR, et al, eds. GeneReviews. http://www.ncbi.nlm.nih.gov/books/ NBK1116/. Accessed January 10, 2013. 8. Pilarski R. Cowden syndrome: a critical review of the clinical literature. J Genet Couns. 2009;18(1): 13-27. 9. Riegert-Johnson DL, Gleeson FC, Roberts M, et al. Cancer and Lhermitte-Duclos disease are common in Cowden syndrome patients. Hered Cancer Clin Pract. 2010;8(1):6. 10. Stanich PP, Owens VL, Sweetser S, et al. Colonic polyposis and neoplasia in Cowden syndrome. Mayo Clin Proc. 2011;86(6):489-492. 11. Eng C. PTEN hamartoma tumor syndrome (PHTS). In: Pagon RA, Bird TD, Dolan CR, et al, eds. GeneReviews. http://www.ncbi.nlm.nih.gov/books/ NBK1488/. Accessed January 22, 2013.

10th Annual

Advanced Practice Oncology Providers Symposium: Innovation through Practice March 1-2, 2013 • Hyatt Regency Mission Bay • San Diego, California Scripps Cancer Center’s Advanced Practice Oncology Providers Symposium is designed for nurse practitioners, clinical nurse specialists, physician assistants, and other experienced health care professionals dedicated to the field of hematology-oncology. This newly designed two day conference aims to update advanced practice providers on a wide variety of topics affecting practice today. The 2013 program will delve into the biology of ALK inhibitors, mutationdirected therapies in melanoma, photodynamic therapy, PTSD in the oncology environment, and nutrition and exercise for cancer patients. Our Keynote lecturer, Debbie Ford, is a #1 New York Times bestselling author who has been featured on Oprah, Larry King LIVE!, and Good Morning America. She is a renowned expert in the field of emotional education and will present The Best Year of Your Life with a unique guide for people to reach their goals, overcome their limitations and make empowering choices in their lives! f o r a d d i t i o n a l i n f o r m at i o n

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February 2013 I VOL 6, NO 1

Conference News: SABCS Continued from cover

“Chemo Brain” May Be Present Before Chemotherapy

February 2013 I VOL 6, NO 1

Healthy controls had more activation in the brain region of interest than women in the other 2 groups, while patients slated for radiation

Regardless of which group patients were in, fatigue level was correlated with performance on the memory task. At the second time point, few dif-

“We believe that ‘chemo brain’ may not be an appropriate label for cancer-related cognitive problems.” Bernadine Cimprich, PhD, RN

were found to have levels of brain activity on fMRI in between those of the other 2 groups.

ferences in brain fMRI were observed between groups, largely explained by the fact that the chemotherapy patients

had recovered much of the ability to perform working memory tasks. According to Kent Osborne, MD, Baylor College of Medicine, Houston, Texas, and moderator of the press conference at which these findings were discussed, Cimprich’s study makes sense because he has observed that the worry and stress of a breast cancer diagnosis, as well as the anticipatory anxiety before chemotherapy, can affect cognitive function. “These findings underscore the need for increased awareness among clinicians that cognitive problems can begin before treatment in women with breast cancer and the problems are related to fatigue. Early identification of women at greater risk is important, because cognitive problems can worsen over time,” Cimprich stated.

Shorter Course of Radiation Equivalent to Standard 5-Week Course for Invasive Breast Cancer A 10-year follow-up of the 2-part UK Standardisation of Breast Radiotherapy Trial (START) supports the 5-year findings, which demonstrated that a shorter course of adjuvant radiation therapy is equivalent to a 5-week course of radiation for women with invasive breast cancer. Both 5-year and 10-year follow-up confirm that patients can be safely and effectively treated with a total lower dose of radiation with fewer fractions than the historical standard of 50 Gy delivered over 5 weeks. “These results support the current NICE [National Institute for Health and Clinical Excellence] guidelines for 40 Gy in 15 fractions as the UK standard of care for all patients with invasive breast cancer,” stated J. R. Yarnold, MD, lead author, on behalf of the START investigators. Yarnold is affiliated with the Institute of Cancer Research in London. START A enrolled 2236 women with complete surgical excision of invasive breast cancer stages I through III with 1 involved lymph node and no known metastasis. Patients were randomized to 50 Gy delivered in 25 fractions over 5 weeks (control group) or 39 Gy delivered in 13 fractions over 5 weeks, or 41.6 Gy in 13 fractions delivered over 5 weeks. START B enrolled 2215 patients with the same criteria from 35 centers in the UK. Patients were randomized to receive the same control-arm treatment versus 40 Gy in 15 fractions over 3 weeks. In START A, the control arm was not superior to the other 2 arms for adverse events, and 39 Gy was associated with fewer side effects, he continued. No significant differences were observed between 50 Gy and 41.6 Gy in tumor control; local recurrence rates were comparable. START B showed a clear reduction in adverse events with 40 Gy delivered in 15 fractions versus 50 Gy in 25 fractions. The risk of adverse events was reduced by 23% using the shorter schedule, with an absolute 8% reduction in adverse events. According to physician assessment, rates of adverse events were lower in the 40-Gy arm, including breast shrinkage, induration, and edema. No difference in recurrence was observed between the 2 arms.

Subgroup analysis of both START A and B showed no difference in outcomes by age, primary surgery type, presence or absence of axillary nodes, tumor grade, use of boost radiation, and adjuvant therapy. Yarnold said, “I see no reason why 40 Gy delivered in 15 fractions should not be adopted as the standard as adjuvant therapy for all women with invasive breast cancer in other countries.” In the United States and Canada, the shorter course is generally reserved for node-negative patients, and is being used at some centers. However, 25% of the women in Yarnold’s study were node-positive. Data from randomized controlled trials would be needed to confirm use of the shorter course in node-positive patients in the United States.

Photo from SABCS 2012.

Cognitive changes identified in patients undergoing chemotherapy are common and referred to as “chemo brain.” Patients report fuzzy thinking and inability to think straight. The assumption has been that chemotherapy causes these cognitive changes, but a new study presented at SABCS suggests that cognitive changes are present in breast cancer patients prior to undergoing chemotherapy and appear to be related to fatigue and anxiety. Cognitive problems in patients with breast cancer remain unexplained, and there are no treatments. In 26 studies, 69% of patients showed some evidence of cognitive decline, said lead author Bernadine Cimprich, PhD, RN, professor emeritus at the University of Michigan School of Nursing in Ann Arbor. “We believe that ‘chemo brain’ may not be an appropriate label for cancer-related cognitive problems. Our study found that pretreatment altered neural activation and fatigue contributed to cognitive problems in women diagnosed with breast cancer before they were treated,” Cimprich stated. The study enrolled 65 women with stages 0 through IIa breast cancer and 32 healthy age-matched controls. Among those with breast cancer, 28 were scheduled for adjuvant chemotherapy and 37 for radiation alone as adjuvant therapy. Functional magnetic resonance imaging (fMRI) was utilized to assess changes in the brain while performing tasks associated with working memory before adjuvant treatment and 1 month after adjuvant therapy. In the adjuvant chemotherapy group, fMRI scans were done after surgery, 1 month before adjuvant chemotherapy, and 1 month after chemotherapy. In the radiation-alone group, scans were done after surgery, 1 month before starting radiation, and then 5 months later, roughly similar to the chemotherapy patients. Healthy controls had fMRI scans performed after a negative mammogram and again 5 months later. All participants provided self-reports of cognitive function and fatigue at the same time points, Cimprich said. The researchers focused on the left inferior frontal gyrus, a region involved in working memory tasks. The chemotherapy group reported significantly greater fatigue levels than did the other 2 groups and performed less well on the verbal memory tasks before treatment, which corresponded to reduced activity in the left inferior frontal gyrus on fMRI.

J. R. Yarnold, MD

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Conference News: SABCS

Two years of trastuzumab provide no benefit over the standard of 1 year of trastuzumab therapy for human epidermal growth factor receptor 2–positive (HER2+) breast cancer, according to an 8-year follow-up of the Herceptin Adjuvant (HERA) trial reported by Martine Piccart, MD, president of the European Society for Medical Oncology and chair of the Breast International Group, Institut Jules Bordet, Brussels, Belgium. “One year of trastuzumab should remain the standard of care,” she said. HERA was a large international trial that accrued 5102 women with HER2+ breast cancer in a little more than 3 years. Oncologists had the choice of neoadjuvant or adjuvant therapy, and patients were randomized to receive 1 or 2 years of trastuzumab following chemotherapy. For the primary end point of the trial, disease-free survival (DFS) was

significantly better for 1 year versus observation. The secondary end point was DFS after 1 year versus 2 years of trastuzumab. At 8 years, no difference in DFS was observed between the 2 arms, and both were significantly better than observation. At baseline, all patients had left ventricular ejection fraction of 55%; the cumulative incidence of cardiac end points showed no difference between the 2 arms. “Severe cardiac end points are rare,” Piccart said. Most cardiac events occurred during the first year of treatment and then the curves of both arms reached a plateau. Few women experienced cardiac events after stopping trastuzumab, she said. “We were concerned that there would be a progressively smaller effect of 1 year of treatment with trastuzumab over time. Now with 8 years of follow-up, there is no further attenuation of benefit as was seen at 1 year, and a very robust

Photo from SABCS 2012.

No Benefit for Extending Trastuzumab Another Year

Martine Piccart, MD

effect with 1 year of trastuzumab.” No difference was seen between hormone receptor–positive and hormone

receptor–negative patients. No attenuation of overall survival benefit was seen at 8 years.

Extending Adjuvant Tamoxifen to 10 Years Improves Survival

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favoring the longer treatment duration. In the second decade after diagnosis, those who took tamoxifen for 10 years had a 25% lower recurrence rate and a 29% lower breast cancer mortality rate compared with those who had only 5

Photo from SABCS 2012.

Extending tamoxifen treatment for 10 years reduced the risk of dying by 29% compared with the standard 5 years of tamoxifen for estrogen receptor–positive (ER+) breast cancer, but these benefits of longer-duration tamoxifen did not emerge until the second decade after diagnosis, according to results of the international Adjuvant Tamoxifen— Longer Against Shorter (ATLAS) study. “Five years of tamoxifen is very effective, and there is a carryover effect after stopping, with about a 30% reduction in mortality over the next 5 years. In the period 10 to 14 years after diagnosis, we found many fewer recurrences: 617 in the group receiving 10 years of tamoxifen versus 711 in patients treated with 5 years of tamoxifen. Breast cancer mortality and overall were similarly affected by longer duration of tamoxifen,” stated lead author Richard Gray, MSc, Clinical Trial Service Unit, University of Oxford, United Kingdom. He reported 331 breast cancer–related deaths in the 10-year group versus 397 in the 5-year group, and 539 versus 722 deaths from all causes, respectively. ATLAS enrolled 6846 women with ER+ breast cancer from 36 countries between 1996 and 2005. About 50% had node-positive disease, and all women had been taking tamoxifen for 5 years. Women were randomized to either continue 5 more years of tamoxifen or to receive no more tamoxifen. In the period 5 to 14 years after diagnosis, the risk of breast cancer death was 12.2% for 10-year users versus 15% for 5-year users, for an absolute gain of 2.8%

continuing tamoxifen users versus 0.2% for those who did not continue. “The reduction in breast cancer deaths far outweighs this small risk of endometrial cancer and other adverse events. Contrary to expectations, no excess risk

“The reduction in breast cancer deaths far outweighs this small risk of endometrial cancer and other adverse events.” Richard Gray, MSc

years of tamoxifen. The cumulative risk of death from endometrial cancer between 5 and 14 years after diagnosis was 0.4% for the

of endometrial cancer was observed in younger women who took 10 years of tamoxifen,” Gray said. “The absolute mortality gain with 10 years of tamoxifen

at 15 years after diagnosis is 12% or 1 in 8 balanced against 1 in 250 cases of endometrial cancer deaths,” he noted. These findings are likely to be more relevant for premenopausal women. In the United States, postmenopausal women are generally given aromatase inhibitors (AIs), whereas tamoxifen is preferred for younger women with hormone receptor– positive breast cancer. However, some postmenopausal women are intolerant of AIs and may prefer to take tamoxifen, and the results are relevant for that group, stated Peter Ravdin, MD, director of the Breast Health Clinic at the Cancer Therapy & Research Center at the University of Texas Health Science Center in San Antonio. With any patient, risks versus benefits must be discussed, and low-risk women may prefer to stay with 5 years of treatment, he noted.

Higher Doses of Fulvestrant Better Than Lower Doses A 500-mg dose of fulvestrant improved survival compared with a 250-mg dose in women with estrogen receptor–positive (ER+) metastatic breast cancer with no increase in toxicity, according to an update of the Comparison of Faslodex in Recurrent or Metastatic Breast Cancer (CONFIRM) trial. “For postmenopausal women with recurrent or progressing ER+ locally advanced or metastatic breast cancer for whom fulvestrant is appropriate, the standard of care has been 250 mg. Our results indicate that this should be modified to a 500-mg dose,” said lead author Angelo Di Leo, MD, PhD, head of the department of medical oncology at the Hospital of Prato, Istituto Toscano Tumoria, Prato, Italy. CONFIRM was a double-blind, parallel-group, multicenter, phase 3 trial that randomized 736 women from 128 centers in 17 countries to receive either 250 mg or 500 mg of fulvestrant. Women were observed until 75% of the patients died; at the time of analysis, 554 died, 63 were lost to follow-up, and 16 withdrew consent. The 500-mg dose achieved a clinically relevant 4.1-month difference in median overall survival compared with a 250-mg dose: 26.4 months and 22.3 months, respectively. The relative risk reduction in death was 19% for those taking the higher dose of fulvestrant. Serious adverse events were reported in 8.9% of the 500-mg dose group and 6.7% of those receiving the lower dose.

February 2013 I VOL 6, NO 1

Breast Cancer

Benefit for Neoadjuvant Chemotherapy Seen in Very Young Patients With Triple-Negative and Luminal-Like Breast Cancer By Alice Goodman

oung women with triple-negative and luminal-type breast cancer were more likely to respond to neoadjuvant chemotherapy than were older women with these cancers, and improved outcomes were observed for young women with luminal-A–like tumors who achieved a pathologic complete response (pCR) versus those who did not. The study suggests that neoadjuvant chemotherapy is beneficial for young women with triple-negative and luminal-type breast cancer, even

those with favorable biological features that include hormone receptor positivity (HR+) and human epidermal growth factor 2–negative (HER2–) disease. “Breast cancer is less common in women age 35 or younger, and some data suggest that these younger patients have a worse prognosis. This is not only because they tend to have more aggressive breast cancers, but because tumors that arise in younger women appear to have different biological features,” stated Sibylle Loibl, MD, PhD, associate

professor at the University of Frankfurt, Germany. The meta-analysis that Loibl and colleagues reported at the CTRC-AACR San Antonio Breast Cancer Symposium included a total of 8949 women from 8 German studies. All women had operable or locally advanced nonmetastatic breast cancer and received neoadjuvant chemotherapy. Among these women, 704 were aged 35 years or younger. pCR and disease-free survival (DFS) were compared for the younger patients (aged

Survival Benefit for ER-Negative Local Breast Cancer Recurrence

Photo from SABCS 2012.

urgery and radiation are considered the standard of care for at least 2 chemotherapy agents and treatment for 3 to for estrogen receptor–negative (ER–) breast cancer. 6 months. However, adjuvant chemotherapy may have a role in Patients were enrolled in CALOR after primary surgery treating isolated ER– breast cancer recurrences, according with clinically negative margins. After surgery for an isoto results of the Chemotherapy as Adjuvant for Locally lated local recurrence, patients were stratified according Recurrent Breast Cancer (CALOR) trial presented at the to prior chemotherapy, hormone receptor status, and CTRC-AACR San Antonio Breast Cancer Symposium recurrence location. (SABCS). Originally, investigators sought to enroll 977 patients, The study showed that adjuvant chemotherapy but accrual was very slow and only 162 patients were improved disease-free survival (DFS) and overall sur- enrolled. Baseline characteristics were well balanced for vival (OS) for patients with breast primary surgery, chemotherapy, cancer, especially those who had median time to local recurrence, site an isolated local recurrence of ER– of recurrence, and hormone receptor breast cancer after surgery. expression. Median age was 56 years, ER– recurrences are not considered and 75% were postmenopausal. sensitive to hormonal therapy, and At a median follow-up of 5 years, CALOR is the first randomized conDFS was 69% in the chemotheratrolled trial to provide some definitive py arm compared with 57% in the guidance for these patients, explained no-chemotherapy arm (P = .046), lead author Stefan Aebi, MD, head for a 31% reduction in risk of disease of the division of medical oncology progression. Five-year OS was 88% at Luzerner Kantonsspital in Lucerne, versus 76% (P = .02) in the cheSwitzerland. “Optimal treatment for motherapy arm versus the no-chethe breast cancer patient with an motherapy arm, respectively, for a isolated recurrence in the breast or 59% reduction in risk of dying. The surrounding tissue has been debatabsolute difference between groups Stefan Aebi, MD ed. Disease-free survival at 5 years was 12% for both DFS and OS. is about 50% for these patients. The data for chemotherapy were Previous attempts to study this have been unsuccessful. even more robust in ER– patients, with a 77% reduction For the first time, a global trial provides an answer to this in risk of disease progression. For patients with ER– question,” he stated. recurrences, 5-year DFS was 67% for those who received In the CALOR study, 162 patients with an isolated chemotherapy compared with 35% for those who did not; local and/or regional recurrence treated surgically were OS rates were 79% versus 69%, respectively. randomized to receive chemotherapy or no chemotherAt the time of SABCS, the difference in DFS between apy. Patients also could receive radiation therapy for arms was small in ER+ patients. Aebi said that longer folmicroscopically positive margins, hormone therapy if low-up might show a benefit in the ER+ patients. Survival the tumor was hormone receptor–positive, and anti– data according to ER status are not yet mature.—AG human epidermal growth factor 2 (anti-HER2) therapy Reference for HER2+ tumors. “Treatment was individualized for this heterogeneous group Aebi S, Gelber S, Lang I, et al. Chemotherapy prolongs survival for isolated local regional recurrence of breast cancer: The CALOR trial (Chemotherapy as of patients, and the choice of chemotherapy was at the dis- or Adjuvant for Locally Recurrent breast cancer; IBCSG 27-02, NSABP B-37, BIG cretion of the treating oncologist based on the patient’s prior 1-02). Presented at: 2012 CTRC-AACR San Antonio Breast Cancer Symposium; therapy,” Aebi explained. The protocol for the trial called December 4-8, 2012; San Antonio, TX. Abstract S3-2.

February 2013 I VOL 6, NO 1

≤35 years) versus women aged 36 to 50 years and women aged 51 years or older. A greater percentage of younger women had triple-negative breast cancer (32% for younger women, about 25% for those aged 26-50 years, and 21% for those aged 51 years and older). Compared with older women, a smaller percentage of younger women had luminal-A–type breast cancer (27% vs 21%, respectively). pCR was significantly higher in younger women compared with older women: 23.6% versus 17.5% of women in the 35- to 50-year-old age group and 13.5% of those aged 51 years and older (P <.001); this difference in pCR was confined to triple-negative and luminal-like breast cancer (HR+/HER2–). More in-depth analysis showed that this difference was restricted to women with triple-negative breast cancer: the pCR rate was 45% for younger patients versus 31% for older patients (P <.001). For all patients, regardless of subtype of breast cancer, DFS and local recurrence-free survival were significantly worse for the very young patients (aged ≤35 years) compared with middle-aged patients (aged 36-50 years; P = .031 and P = .018, respectively). No difference in DFS according to age was observed among patients who achieved pCR. However, DFS was significantly worse among women who failed to achieve pCR. Tumor biology appeared to be important in predicting pCR and survival in younger women. Age but not pCR predicted DFS in women with luminal-A– type cancer. However, the worst DFS rate was seen among those women with luminal-A–type breast cancer who were younger than age 35 years and did not achieve pCR. The most favorable DFS was observed among younger women who did achieve pCR. Loibl said the investigators were surprised to find that younger women with luminal-type cancer (HR+ and HER2–) who achieved pCR had improved survival compared with patients with nonpathologic CR. “This is not seen in other age groups, indicating that breast cancer in the young women is chemosensitive, even when it is a luminal-type breast cancer,” she stated. l Reference Loibl S, Jackisch C, Gade S, et al. Neoadjuvant chemotherapy in the very young 35 years of age or younger. Presented at: 2012 CTRC-AACR San Antonio Breast Cancer Symposium; December 4-8, 2012; San Antonio, TX.

www.TheOncologyNurse.com

Conference News: ASH

Abstracts of Interest From the 54th Annual Meeting of the American Society of Hematology By Caroline Helwick

Reference

In PACE Update, Ponatinib Benefit Confirmed Updated findings from the pivotal phase 2 Ponatinib Ph+ ALL and CML Evaluation (PACE) trial found robust activity and sustained benefit for the investigational tyrosine kinase inhibitor ponatinib in heavily pretreated patients with accelerated or blastphase chronic myeloid leukemia (CML) or Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL). Twelve-month data were presented for 179 patients who were resistant to or intolerant of dasatinib or nilotinib, or had the T315I mutation.

Rivaroxaban Comparable to Enoxaparin for Anticoagulation A pooled analysis of the EINSTEIN-DVT and EINSTEIN-PE studies showed rivaroxaban to be as effective in preventing recurrences of venous thromboembolism as enoxaparin followed by a vitamin-K antagonist, with perhaps less risk for bleeding. Subgroup analyses found the drug to be safe and effective in specific high-risk populations, such as elderly fragile patients and patients with cancer or large clots. The studies had noninferiority designs and compared oral rivaroxaban (15 mg twice daily for 3 weeks, then 20 mg once daily for up to 12 months) with enoxaparin for 5 to 10 days followed by an oral vitamin-K antagonist. Among the 8282 patients enrolled in the 2 trials, thromboembolism recurred in 2.1% receiving rivaroxaban and 2.3% receiving enoxaparin/vitamin-K antagonist; major or nonmajor clinically relevant bleeding was observed in 9.4% and 10.0%, and major bleeding in 1.0% and 1.7%, respectively. In patients with cancer, recurrence was observed in 2.6% and 4.0%, and major bleeding in 2.6% and 4.1%, respectively. Reference

Buller HR. Oral rivaroxaban for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN DVT and EINSTEIN PE studies. Presented at: 54th American Society of Hematology Annual Meeting; December 8-11, 2012; Atlanta, GA. Abstract 20.

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months was 55% for patients with accelerated-phase CML and 15% for those with blast-phase/Ph+ ALL, while overall survival was 84% and 33%, respectively.

Major hematologic response, the pri- ALL patients, 35% for the resistant mary end point, was as follows: for group and 33% for the mutated group. accelerated-phase patients, 58% for the Cytologic responses were obtained in AONNAsize SaveTheDate_20513_Layout 1 2/8/13 12:02 PM Page 1 resistant group and 50% for the muta- 52%, 67%, 40%, and 43%, respection group; for blast-phase and Ph+ tively. Progression-free survival at 12

Kantarjian HM, Kim D-W, Pinilla-Ibarz J; the PACE Study Group. Efficacy and safety of ponatinib in patients with accelerated phase or blast phase chronic myeloid leukemia (AP-CML or BP-CML) or Philadelphia chromosome–positive acute lymphoblastic leukemia (PH+ ALL): 12-month follow-up of the PACE trial. Presented at: 54th American Society of Hematology Annual Meeting; December 8-11, 2012; Atlanta, GA. Abstract 915.

SAVE DATE the

NOVEMBER 14 -17, 2013

Fourth Annual Navigation and Survivorship Conference Memphis, Tennessee • The Peabody Memphis CONFERENCE CO-CHAIRS Program Director: Lillie D. Shockney, RN, BS, MAS University Distinguished Service Associate Professor of Breast Cancer Departments of Surgery and Oncology Administrative Director, Johns Hopkins Clinical Breast Programs Administrative Director, Johns Hopkins Cancer Survivorship Programs Department of Surgery and Oncology Associate Professor, JHU School of Medicine Departments of Surgery, Oncology, and Gynecology Associate Professor, JHU School of Nursing Johns Hopkins Avon Foundation Breast Center Baltimore, Maryland

Sharon Gentry, RN, MSN, AOCN, CBCN Breast Health Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC

www.AONNonline.org AONNAsize20813

February 2013 I VOL 6, NO 1

Conference News: ASH GVHD Reduced With Vorinostat The administration of the histone deacetylase inhibitor vorinostat in There were no significant differences patients undergoing matched related in rates of infectious complications or donor reduced-intensity conditioning allogeneic hematopoietic stem incidence of relapse. cell transplants could be an effective approach to reducing graft-versushost disease (GVHD), according to 10 to 100 to standard GVHD prophyAfter treatment, patients who received the first-in-human clinical trial of 45 laxis consisting of mycophenolate vorinostat had a significantly lower inciCOEAsizeCE_fish_71112_House Ad 7/11/12 11:47 AM Page 1 patients. The drug was added on days mofetil and tacrolimus. dence of GVHD than their historical

FREE

Continuing Education

Pushing Your Limits

Registered participants will receive e-mail announcements as new educational activities become available.

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Current activities at www.COEXM.com include:

controls (22% vs 42%). They also had lower rates of grade 3 and 4 GVHD (4% vs 19%) as well as transplant-related mortality at 1 year (13% vs 19%). There were no significant differences in rates of infectious complications or incidence of relapse, indicating that vorinostat helped reduce the risk of GVHD in patients without further compromise. Reference

Choi SW, DiPersio JF, Braun TM, et al. Targeting histone deacetylases as a new strategy for graft versus host disease prevention. Presented at: 54th American Society of Hematology Annual Meeting; December 8-11, 2012; Atlanta, GA. Abstract 740.

Cryotherapy Effective for Oral Mucositis Memorial Sloan-Kettering Cancer Center (MSKCC) researchers showed that cryotherapy given at the time of high-dose melphalan reduced the incidence of severe oral mucositis and the need for pain medicine in patients with multiple myeloma who are undergoing autologous stem cell support. In 2011, MSKCC adopted the use of ice chips given for 30 minutes before, during, and after melphalan ≥140 mg/m2. The retrospective analysis from the pharmacy database sought to determine if this practice reduced the incidence of oral mucositis. Eighty-five patients who received cryotherapy were compared with 129 similar patients who did not. Investigators found that mucositis (all grades) occurred in 34% who received cryotherapy and 47% who did not (P = .08). Grade 3 and 4 mucositis occurred in 2% and 16%, respectively (P = .004), and grade 4 mucositis was not observed at all in the cryotherapy group. Cryotherapy was also associated with less use of patient-controlled analgesia (19% vs 37%; P = .01). The authors suggested that because cryotherapy is readily available, it should be offered to all patients receiving high-dose melphalan. Reference

February 2013 I VOL 6, NO 1

Rodriguez M, Adel NG, Devlin S, et al. Cryotherapy reduces mucositis in multiple myeloma patients receiving high-dose melphalan conditioning prior to autologous stem cell transplantation. Presented at: 54th American Society of Hematology Annual Meeting; December 8-11, 2012; Atlanta, GA. Abstract 4265.

COEKsize71112CE

www.TheOncologyNurse.com

Conference News: ASH Genetic Profile Predicts Mortality in African American and Asian Pediatric Patients With AML Among children with acute myeloid different races/ethnicities. Patients SNP-negative patients: 0% versus nounced among these racial/ethnic leukemia (AML), the presence of who were SNP-positive had higher 25% for African Americans and 0% groups than among whites. a specific genetic marker known as 5-year overall survival rates than versus 43% for Asians, respectiveWT1 SNP rs16754 may be associ- did those who were not (61% vs ly. These results suggest that the Reference PA, Alonzo TA, Gerbing RB, et al. WT1 sp rs16754 ated with reduced chemotherapy-re- 44%, respectively). Among African protective effect of the presence of Ho genotype predicts treatment related mortality (TRM) in lated toxicity and reduced treat- Americans and Asians, SNP-positive SNP rs16754 in reducing chemo- African-American and Asian pediatric AML patients: a from the Children’s Oncology Group. Presented at: ment-related toxic deaths if they are patients had significantly lower treat- therapy-related toxicity in pediatric report 54th American Society of Hematology Annual Meeting; African American or Asian, a phase ment-related mortality rates than did patients with AML is more pro- December 8-11, 2012; Atlanta, GA. Abstract 1385. AVBCC2013Asize13013_AVBCC 2/4/13 2:10 PM Page 1 2 Children’s Oncology Group trial suggested. The WT1 gene, a tumor suppressor that regulates cell growth, can be subject to loss-of-function mutations that lead to the development of AML. Researchers have recently discovered that a certain single nucleotide polymorphism (SNP, a naturally occurring variation in DNA)—SNP rs16754 in the WT1 gene—is correlatMay 2-5, 2013 • Westin Diplomat • Hollywood, Florida ed with improved outcomes in pediatric patients with AML. The frequency CONFERENCE CO-CHAIRS AGENDA* of this SNP varies by race/ethnicity. THURSDAY, MAY 2, 2013 The study examined how the pres8:00 am - 5:00 pm Registration ence of SNP rs16754, which was FRIDAY, MAY 3, 2013 observed in 28% overall, affected 7:00 am - 8:00 am Simultaneous Symposia/Product Theaters 8:15 am - 9:15 am Session 1: Welcome, Introductions, and Opening Remarks outcomes and treatment-related morConference Co-Chairs - Craig K. Deligdish, MD; Gary M. Owens, MD; Craig K. Deligdish, MD Burt Zweigenhaft, BS Gary M. Owens, MD Burt Zweigenhaft, BS tality in 492 young AML patients of

THIRD ANNUAL

Association for Value-Based Cancer Care Conference Influencing the Patient-Impact Factor

Hematologist/Oncologist Oncology Resource Networks

Genes Linked to AnthracyclineRelated Congestive Heart Failure In patients who have undergone hematopoietic stem cell transplants, genetic factors may influence susceptibility to congestive heart failure related to anthracyclines used prior to transplant, City of Hope researchers found. A case–control study of 77 persons with hematologic cancers identified certain genetic pathways that were present in patients who developed heart failure compared with those who did not. Patients who had variations in the MRP2, RAC2, and HFE genes had up to a 3-fold higher risk for heart failure. These genes are responsible for key proteins that regulate the metabolism of anthracyclines and defend against oxidative stress. Females with ≥2 genetic variations were at highest risk, compared with males with 1 or none of them. Reference

Armenian SH, Ding Y, Mills G III, et al. Genetic susceptibility to anthracycline-related congestive heart failure (CHF) in survivors of hematopoietic cell transplantation (HCT). Presented at: 54th American Society of Hematology Annual Meeting; December 8-11, 2012; Atlanta, GA. Abstract 589.

www.TheOncologyNurse.com

President Gary Owens Associates

President and CEO OncoMed

PROGRAM OVERVIEW

Following on the success of our Second Annual Conference, AVBCC will be coming to Hollywood, Florida, on May 2-5, 2013. We continue to be guided by the expertise of leaders in these fields providing attendees with a thorough understanding of the evolution of the value equation as it relates to cancer therapies. Our goal is to be able to assist them in implementing, improving, and sustaining their organizations and institutions, while improving access for patients and ultimately quality patient care.

LEARNING OBJECTIVES

Upon completion of this activity, the participant will be able to: • Discuss the current trends and challenges facing all stakeholders in optimizing value in cancer care delivery. • Define the barriers associated with cost, quality, and access as they relate to healthcare reform and what solutions are currently being considered. • Compare and contrast the different approaches/tools providers and payers are utilizing to manage and deliver care collaboratively. • Examine the current trends in personalized care and companion diagnostics. • Analyze the patient issues around cost, quality, and access to care.

TARGET AUDIENCE

This conference is intended for medical oncologists, practice managers/administrators, and managed care professionals. Stakeholders in a position to impact cancer patient care, such as advanced practice nurses, pharmacists, and medical directors, are also invited to join this exciting forum.

DESIGNATION OF CREDIT STATEMENTS SPONSORS

This activity is jointly sponsored by the Florida Society of Clinical Oncology, Medical Learning Institute Inc, Association for Value-Based Cancer Care, Inc., Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

COMMERCIAL SUPPORT ACKNOWLEDGMENT

Grant requests are currently being reviewed by numerous supporters. Support will be acknowledged prior to the start of the educational activities.

9:15 am - 10:15 am

REGISTERED NURSE DESIGNATION

Keynote Address

10:15 am - 10:30 am

Break

10:30 am - 11:45 am

Session 2: Trends in Treatment Decision-Making: Pathways and Stakeholder Collaborations Marcus Neubauer, MD; Michael Kolodziej, MD

12:00 pm - 1:00 pm

Exclusive Lunch Symposium/Product Theater

1:15 pm - 2:00 pm

Session 3: Cost of Cure: When, How, and How Much? John Fox, MD; John Hennessy

2:00 pm - 2:45 pm

Session 4: Where Is Oncology Care Headed in the Future? Jayson Slotnick, JD, MPH (Moderator); Barbara L. McAneny, MD

2:45 pm - 3:30 pm

Session 5: What Will the Cancer Delivery System Look Like in 2015? Ted Okon; John D. Sprandio, MD

3:30 pm - 3:45 pm

Break

3:45 pm - 4:30 pm

Session 6: Employers and Oncology Care F. Randy Vogenberg, PhD, RPh (Moderator); Bridget Eber, PharmD; Patricia Goldsmith; Darin Hinderman

4:30 pm - 5:15 pm

Session 7: Advanced Care Directives: Palliative Care, Hospice, Ethics J. Russell Hoverman, MD, PhD; Thomas Smith, MD, FACP, FASCO

5:15 pm - 5:45 pm

Summary/Wrap-Up of Day 1

6:00 pm - 8:00 pm

Cocktail Reception in the Exhibit Hall

SATURDAY, MAY 4, 2013 7:00 am - 8:00 am

Simultaneous Symposia/Product Theaters

8:15 am - 8:30 am

Opening Remarks

8:30 am - 9:15 am

Session 8: The Role of Government in the Future of Oncology Care Jayson Slotnick, JD, MPH

9:15 am - 10:00 am

Session 9: Medicaid: A Healthcare Delivery System Review Matthew Brow

10:00 am - 10:15 am

Break

10:15 am - 11:00 am

Session 10: Payer, Government, and Industry Insights: Balancing Cost and Quality Kip Piper

11:00 am - 11:45 am

Session 11: National Coalition for Cancer Survivorship: Medication Nonadherence Issues Pat McKercher; Lillie Shockney, RN, BS, MAS

PHYSICIAN CREDIT DESIGNATION

The Medical Learning Institute Inc designates this live activity for a maximum of 17.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Medical Learning Institute Inc and the Center of Excellence Media, LLC. The Medical Learning Institute Inc is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

12:00 pm - 1:00 pm

Exclusive Lunch Symposium/Product Theater

1:15 pm - 3:00 pm

Session 12: Meet the Experts Networking Roundtable Session

3:00 pm - 3:45 pm

Session 13: Personalized Medicine, Companion Diagnostics, Molecular Profiling, Genome Sequencing—The Impact on Cost, Treatment, and the Value Proposition Mark S. Boguski, MD, PhD; Gary Palmer, MD, JD, MBA, MPH

3:45 pm - 4:15 pm

Summary/Wrap-Up of Day 2

4:30 pm - 6:30 pm

Cocktail Reception in the Exhibit Hall

Medical Learning Institute Inc. Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 17.25 contact hours.

SUNDAY, MAY 5, 2013

REGISTERED PHARMACY DESIGNATION

8:15 am - 8:30 am

Opening Remarks

8:30 am - 9:15 am

Session 14: Cancer Rehabilitation: The Next Frontier in Survivorship Care Julie Silver, MD

9:15 am - 10:00 am

Session 15: Current and Future Considerations for the Oncology Practice Manager Dawn Holcombe, MBA, FACMPE, ACHE; Leonard Natelson

The Medical Learning Institute Inc is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Completion of this knowledge-based activity provides for 17.25 contact hours (1.725 CEUs) of continuing pharmacy education credit. The Universal Activity Number for this activity is (To be determined).

CONFERENCE $375.00 until March 15, 2013 REGISTRATION $425.00 after March 15, 2013 REGISTER TODAY AT

www.regonline.com/avbcc2013

7:00 am - 8:00 am

Simultaneous Symposia/Product Theaters

10:00 am - 10:15 am

Break

10:15 am - 11:00 am

Session 16: Access to Drugs—Shortages, Biosimilars Douglas Burgoyne, PharmD; James T. Kenney, Jr., RPh, MBA

11:00 am - 11:45 am

Session 17: Perspectives from Oncology Group Practices—Successes, Issues, and Challenges Thomas Marsland, MD; David Eagle, MD

11:45 am - 12:00 pm

Summary and Conclusion of Conference

*Agenda is subject to change. AVBCCAsize20413

February 2013 I VOL 6, NO 1

Reader Survey

What inspired you to enter the oncology field? The Oncology Nurse-APN/PA (TON) asked its online reading community to share their inspiration for entering the oncology field. We received many responses, which made it clear that those involved in the field are passionate and caring about the profession. Often, the responses highlighted a single person who inspired a career

The responses made it clear that those involved in the field are passionate and caring about the profession. choice and a desire to help those living with cancer. On behalf of all of us

WCMC HouseAd_A-size_11512_Layout 1 11/12/12 5:02 PM Page 1

â&#x20AC;˘ Melanoma â&#x20AC;˘ Basal Cell Carcinoma â&#x20AC;˘ Cutaneous T-Cell Lymphoma â&#x20AC;˘ Squamous Cell Carcinoma â&#x20AC;˘ Merkel Cell Carcinoma

July 26-28, 2013

Hyatt Regency La Jolla â&#x20AC;˘ San Diego, California

PROGRAM OVERVIEW

at TON, thank you for all you do to help your patients. Below, we share

CONFERENCE CO-CHAIRS

â&#x20AC;˘ Epidemiology and genetic/environmental factors â&#x20AC;˘ Molecular biology and cytogenetics related to the pathogenesis of cutaneous malignancies

The awesome patients.

â&#x20AC;˘ Risk stratification based on patient and tumor characteristics â&#x20AC;˘ Principles of cancer prevention of melanoma and basal cell carcinoma â&#x20AC;˘ Current treatment guidelines â&#x20AC;˘ Future strategies in management based on translational data from current clinical trials and basic research

LEARNING OBJECTIVES Upon completion of this activity, the participant will be able to: â&#x20AC;˘ Review the molecular biology and pathogenesis of cutaneous malignancies as they relate to the treatment of cutaneous T-cell lymphoma, basal cell carcinoma, Merkel cell tumors, and malignant melanoma â&#x20AC;˘ Compare risk stratification of patients with cutaneous malignancies, and how to tailor treatment based on patient and tumor characteristics â&#x20AC;˘ Summarize a personalized treatment strategy that incorporates current standards of care and emerging treatment options for therapy of patients with cutaneous malignancies

TARGET AUDIENCE This activity was developed for medical and surgical oncologists, dermatologists, radiation oncologists, and pathologists actively involved in the treatment of cutaneous malignancies. Advanced practice oncology or dermatololgy nurses, oncology pharmacists, and researchers interested in the molecular biology and management of cutaneous malignancies are also encouraged to participate.

DESIGNATION OF CREDIT STATEMENTS SPONSORS This activity is jointly sponsored by Medical Learning Institute Inc, Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

COMMERCIAL SUPPORT ACKNOWLEDGMENT Grant requests are currently being reviewed by numerous supporters. Support will be acknowledged prior to the start of the educational activities.

Sanjiv S. Agarwala, MD Professor of Medicine Temple University School of Medicine Chief, Oncology & Hematology St. Lukeâ&#x20AC;&#x2122;s Cancer Center Bethlehem, Pennsylvania

REGISTERED NURSE DESIGNATION Medical Learning Institute Inc Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 12.0 contact hours.

REGISTERED PHARMACY DESIGNATION The Medical Learning Institute Inc is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Completion of this knowledge-based activity provides for 12.0 contact hours (1.2 CEUs) of continuing pharmacy education credit. The Universal Activity Number for this activity is (To be determined).

CONFERENCE REGISTRATION EARLY BIRD REGISTRATION NOW OPEN! $175.00 UNTIL APRIL 30, 2013

www.CutaneousMalignancies.com

February 2013 I VOL 6, NO 1

Steven J. Oâ&#x20AC;&#x2122;Day, MD Hematology/Oncology Director of Clinical Research Director of Los Angeles Skin Cancer Institute at Beverly Hills Cancer Center Clinical Associate Professor of Medicine USC Keck School of Medicine Los Angeles, California

Professor Dr. Med. Axel Hauschild Professor, Department of Dermatology University of Kiel Kiel, Germany

AGENDA* FRIDAY, JULY 26, 2013 3:00 pm â&#x20AC;&#x201C; 7:00 pm

Registration

5:30 pm â&#x20AC;&#x201C; 7:30 pm

Welcome Reception/Exhibits

SATURDAY, JULY 27, 2013 7:00 am â&#x20AC;&#x201C; 8:00 am

Breakfast Symposium/Product Theater/Exhibits

8:00 am â&#x20AC;&#x201C; 8:15 am

BREAK

8:15 am â&#x20AC;&#x201C; 8:30 am

Welcome to the Second Annual World Cutaneous Malignancies Congress â&#x20AC;&#x201D; Setting the Stage for the Meeting - Sanjiv S. Agarwala, MD

8:30 am â&#x20AC;&#x201C; 11:45 am General Session I: A Clinicianâ&#x20AC;&#x2122;s Primer on the Molecular Biology of Cutaneous Malignancies â&#x20AC;˘ Keynote Lecture Understanding the Basic Biology and Clinical Implications of the Hedgehog Pathway â&#x20AC;˘ Keynote Lecture Pathogenesis of Merkel Cell Carcinoma: An Infectious Etiology? - Paul Nghiem, MD, PhD 12:00 pm â&#x20AC;&#x201C; 1:00 pm Lunch Symposium/Product Theater/Exhibits 1:00 pm â&#x20AC;&#x201C; 1:15 pm

BREAK

1:15 pm â&#x20AC;&#x201C; 4:30 pm

General Session II: Current Treatment Guidelines in Cutaneous Malignancies â&#x20AC;˘ Case Studies Optimal, Value-Based Therapy of Cutaneous Malignancies: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients â&#x20AC;˘ Panel Discussion Management Controversies and Accepted Guidelines for the Personalized Management of Cutaneous Malignancies â&#x20AC;˘ Keynote Lecture New Combinations in Melanoma: A Role for MEK + BRAF and Antiâ&#x20AC;&#x201C;PD-1

4:30 pm â&#x20AC;&#x201C; 6:30 pm

Meet the Experts/Networking/Exhibits

PHYSICIAN CREDIT DESIGNATION The Medical Learning Institute Inc designates this live activity for a maximum of 12.0 AMA PRA Category 1 Credits â&#x201E;˘. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Medical Learning Institute Inc and the Center of Excellence Media, LLC. The Medical Learning Institute Inc is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

About 30 years ago, when our first medical oncologist came to our community, he changed the way patients were put in control of their care. I remember when families were told of a patientâ&#x20AC;&#x2122;s diagnosis of cancer and the patient was not told. He discussed directly with the patient the diagnosis and the plan of care, and they made the decisions, not the family. About that same time, my own father was diagnosed with colon cancer, and, as we all know, when a patient is diagnosed with cancer, it affects the whole family, not just that individual. My younger sister was diagnosed with NHL. I took a leave of absence and helped her through chemo/XRT. I decided to return to school and become an RN so I could make a difference in cancer patientsâ&#x20AC;&#x2122; lives.

A 2-day congress dedicated to informing, educating, and fostering the exchange of clinically relevant information in the field of cutaneous malignancies on topics in melanoma, basal cell carcinoma, cutaneous T-cell lymphoma, squamous cell carcinoma, and Merkel cell carcinoma, including:

â&#x20AC;˘ Emerging treatment options for personalized therapy

with you excerpts from several of the responses.

I worked nights as a new grad on a medical floor and spent time with a young Mexican woman named Maria with a brain tumor, who liked me and invited me to come visit her at her home. I knew she was not going to ever go home again. I had to help her right then. I survived 2 cancers. The intellectual stimulation of being on the forefront of cancer research, and the obvious calling of God as He positioned me. While doing rotations as a nursing student through various units in the hospital, I was inspired by the relationship between not only the nurses but the nurses and the physicians. I had not witnessed this in other areas of the hospital. That, and the close bond that comes with a cancer patient, even on a professional level, is the best reward I have found.

SUNDAY, JULY 28, 2013 7:00 am â&#x20AC;&#x201C; 8:00 am

Breakfast Symposium/Product Theater/Exhibits

8:00 am â&#x20AC;&#x201C; 8:15 am

BREAK

8:15 am â&#x20AC;&#x201C; 8:30 am

Review of Saturdayâ&#x20AC;&#x2122;s Presentations and Preview of Todayâ&#x20AC;&#x2122;s Sessions

8:30 am â&#x20AC;&#x201C; 11:45 am General Session III: Review of Emerging Treatment Options for Cutaneous Malignancies General Session IV: Challenges for the Cutaneous Malignancies Clinician â&#x20AC;˘ Panel Discussion How Can the Healthcare Team Work Best Together to Deliver Value-Based Care in Cutaneous Malignancies? 12:00 pm â&#x20AC;&#x201C; 1:00 pm Lunch Symposium/Product Theater/Exhibits 1:00 pm â&#x20AC;&#x201C; 1:15 pm

BREAK

1:15 pm â&#x20AC;&#x201C; 2:45 pm

General Session V: â&#x20AC;&#x153;Hot Dataâ&#x20AC;? â&#x20AC;&#x201D; What I Learned at Recent Meetings: Focus on Cutaneous Malignancies

2:45 pm â&#x20AC;&#x201C; 3:00 pm

Closing Remarks - Steven J. Oâ&#x20AC;&#x2122;Day, MD

*Agenda is subject to change.

For complete agenda please visit www.CutaneousMalignancies.com

Want to participate in TONâ&#x20AC;&#x2122;s new poll? See page 8 for details. www.TheOncologyNurse.com

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Through the eyes of an advocate

The Pace of Medicine By Peg Ford

was astonished at the pace at which the medical world functions when I went through my health crisis facing ovarian cancer 6 years ago. It was nothing compared to what I was to learn of the strides being made by the research and scientific world! I certainly had no idea I would be caught up in such speed when I became an advocate. I was slightly aware of how fast breakthroughs can change medicine, but I truly had no appreciation of how much, and how quickly, until my efforts and commitment to be an informed advocate took hold. Here are my reflections for the last half of 2012—a short summary of some of the activities! In June 2012, a week before the US Supreme Court ruled on the Affordable Care Act, I was in Washington, DC, attending the 13th Annual Patient Congress of the Patient Advocate Foundation (PAF) as a member of the National Patient Advocate Foundation’s (NPAF) volunteer Elite President’s Council. After a full intense day of preparation, my fellow advocates and I, representing 39 states, called on Capitol Hill to visit with elected officials. We presented extremely important initiatives: Prescription Drug User Fee Act Reauthorization Drug Shortages and Breakthrough Therapies, Safeguarding the Patient Protection Provisions of Patient Protection Affordable Care Act, and Patients’ Access to Treatments Act of 2012. NPAF has been a leader in patient advocacy since 1996, focusing its activities on health policies determined to have the greatest impact on patients with chronic, debilitating, and life-threatening diseases to represent the majority of patients served by PAF, NPAF’s companion organization (www.patientadvocate.org). More than 100,000 patients in all 50 states were provided case management assistance by PAF in 2011, and more than 5 million received online assistance. Two weeks after my trip to DC, I traveled to the Dartmouth Institute for Health Policy & Clinical Practice at Dartmouth College in Hanover, New Hampshire, to participate as a patient advisor in a symposium at the Summer Institute for Informed Patient Choice entitled, “Measuring Shared Decision Making in Practice.” Sessions and breakout groups discussed issues ranging from patient decision aids to identifying measurable outcomes. I also participated in a panel review on the last day to review and provide reactions to the priorities that the breakout

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Peg Ford with Kay Dickersin, PhD, Professor and Director, Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, and Director, US Cochrane Center, at the Evidence-Based Guidelines Affecting Policy, Practice and Stakeholders conference.

groups developed over the course of the 2 prior days (http://tdi.dartmouth.edu). A month later, in August, I again traveled to the DC area for an FDA Training Workshop, as I received an official appointment as a member of the Office of Special Health Issues (OSHI) FDA Patient Representative Program. As stated on the OSHI website, “The Patient Representative is responsi-

On October 7, 2012, at the opening dinner of the Scripps Cancer Center’s 32nd Annual Oncology Nurses Symposium, I was thrilled to be the keynote speaker, addressing 268 attendees from across the country and around the world convened at the Hilton San Diego Resort in California. I spoke on the topic, “Ovarian Cancer—the Silent Killer! NOT ANYMORE!”

It was heartwarming to hear the presentations and discussions focusing on issues vital to the patient community: communication, coordination, and shared decision making to involve and empower patients to participate in their own medical choices and care. ble for providing the Food and Drug Administration (FDA) and the advisory committee the unique perspective of patients and family members directly affected by a serious or life-threatening disease.” Further information can be found at the FDA’s website www. fda.gov/ForConsumers/ByAudience/ ForPatientAdvocates.

However, I also took the opportunity to share not only the success of the Survivors Teaching Students (STS): Saving Women’s Lives program of the Ovarian Cancer National Alliance in San Diego, but also the value of our nurses, as perceived by patients. My opening remarks were “I am not a medical professional or healthcare provider

or researcher. I am a human being, patient, survivor, and advocate. I do not mean to imply the others mentioned are not human, but rather, I believe many are ‘Angels in human form.’ I hope to explain the ways in which I have arrived at this conclusion, and share about a grassroots movement happening across the country to give a voice and face to a matter of great urgency—ovarian cancer!” Cathleen Sugarman, RN, MSN, AOCNS, an oncology advanced practice nurse at Scripps Memorial Hospital in La Jolla, California, and course director, stated in her much-appreciated thank you note “You are a beacon of shining light. You inspired many nurses that evening with your enthusiasm for life and the work you have chosen as an ovarian cancer survivor.” At the end of October, I attended the American Association for Cancer Research Fifth Annual Conference in San Diego on the Science of Cancer Health Disparities in racial/ethnic minorities and the medically underserved. Much insightful information was presented, from design and strategies for clinical trials for recruitment of diverse populations, to racial-ethnic disparities in patient-provider communication, as well as overall perceptions among adult cancer survivors of the quality of follow-up care (www.aacr.org). In November, I attended the American Society of Clinical Oncology (ASCO) Quality Care Symposium, where the 200 anticipated attendees grew to more than 600 individuals attending this, the first meeting of its kind! It was heartwarming to hear the presentations and discussions focusing on issues vital to the patient community: communication, coordination, and shared decision making to involve and empower patients to participate in their own medical choices and care. The learning objectives included reviewing the evidence base in quality research, with a focus on comparative effectiveness studies and patient-centered outcomes research, as well as evaluating opportunities for further research to improve the quality of cancer care, including disparities research, communication, and decision-making research. It was a special pleasure to see that ASCO included a presentation by Michael L. Kappel on the patient perspective (http://quality2012.asco.org). I was especially delighted to attend a presentation on ASCO’s innovative new program, CancerLinQ. ASCO Continued on page 22

February 2013 I VOL 6, NO 1

Through the eyes of an advocate

The Pace of Medicine... Continued from page 21 is taking a leadership role with its plan â&#x20AC;&#x153;to create a searchable knowledge bankâ&#x20AC;&#x201D;composed of information culled from millions of medical records provided by partner physicians that will yield specific, detailed information about presenting symptoms, courses of treatment, side effects, outcomes and more.â&#x20AC;? This peer-reviewed, real-time, evidence-based healthcare technology not only will be at the fingertips of physicians and researchers, but also eventually will be a portal for patients to access! See www.conquercancer foundation.org for information about this program. The year 2012 included one more trip to the East Coast, this time to New York City in early December to attend the Evidence-Based Guidelines Affecting Policy, Practice and Stakeholders conference at the New York Academy of Medicine. Two full days focused on guidelines and involved all stakeholders, with breakout sessions covering such topics as how to develop pragmatic and trustworthy guidelines; how to close the gap between guidelines and clinical education; and how to incorporate consumers, including patients, in guideline development.

I sense that 2013 will provide ample opportunities for...more of this movement in which patients will play an increasingly active role, along with their providers, in their medical choices and care. Coupling this with facilitating presentations for the STS program, it certainly has been quite a hectic year! The Ovarian Cancer Advocacy Alliance of San Diego (OCAA), with help from our volunteer ovarian cancer survivors, completed 27 STS presentations to 672 attendees, including third-year medical students at the University of California San Diego School of Medicine, physician assistants and nurse practitioners at Kaiser Permanente, and nursing students at 10 schools of nursing in San Diego County. Oh yes, 2013 is already kicking it up a notch with our announcement of a companion program for OCAA: HEAR (H: Hope, E: Experiences, A: Awareness, R: Risks), a community

outreach program developed for civic organizations. â&#x20AC;&#x153;If Only I Knew Then, What I Know Now!â&#x20AC;? is the title of the new presentation by ovarian cancer survivors, who share their personal stories to increase individualsâ&#x20AC;&#x2122; awareness of the symptoms and risk factors

of ovarian cancer to help empower women to be aware of their bodies and help spread the word about ovarian cancer awareness throughout the general public in San Diego County. In addition, I will be attending the Gynecologic Oncology Group

86th Semi-Annual Meeting and MD Anderson Cancer Centerâ&#x20AC;&#x2122;s 15th International Symposium on AntiAngiogenic Therapy, as well as traveling to Portland, Oregon, in late January for the Summit Regional Meeting of NPAFâ&#x20AC;&#x2122;s Elite Presidentâ&#x20AC;&#x2122;s Council to

(continued) Table 1. Adverse Reactions in the Randomized Trial XTANDI N = 800 Grade 1-4 Grade 3-4 (%) (%)

XTANDIÂŽ (enzalutamide) capsules for oral use Initial U.S. Approval: 2012 BRIEF SUMMARY OF PRESCRIBING INFORMATION The following is a brief summary: please see the package insert for full prescribing information. ------------------------------ INDICATIONS AND USAGE ----------------------------XTANDI is indicated for the treatment of patients with metastatic castrationresistant prostate cancer who have previously received docetaxel. --------------------------------- CONTRAINDICATIONS ------------------------------Pregnancy XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss >VHH 8VH LQ 6SHFLÂżF 3RSXODWLRQV@. -------------------------- WARNINGS AND PRECAUTIONS ------------------------Seizure In the randomized clinical trial, 7 of 800 (0.9%) patients treated with XTANDI 160 mg once daily experienced a seizure. No seizures occurred in patients treated with placebo. Seizures occurred from 31 to 603 days after initiation of XTANDI. Patients experiencing seizure were permanently discontinued from therapy and all seizures resolved. There is no clinical trial experience re-administering XTANDI to patients who experienced seizures. The safety of XTANDI in patients with predisposing factors for seizure is not known because these patients were excluded from the trial. These exclusion criteria included a history of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, brain arteriovenous malformation or the use of concomitant medications that may lower the seizure threshold. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. --------------------------------- ADVERSE REACTIONS ------------------------------Clinical Trial 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 WR UDWHV LQ WKH FOLQLFDO WULDOV RI DQRWKHU GUXJ DQG PD\ QRW UHĂ&#x20AC;HFW WKH UDWHV REVHUYHG in practice. In the randomized clinical trial in patients with metastatic castration-resistant prostate cancer who had previously received docetaxel, patients received XTANDI 160 mg orally once daily (N = 800) or placebo (N = 399). The median duration of treatment was 8.3 months with XTANDI and 3.0 months with placebo. All patients continued androgen deprivation therapy. Patients were allowed, but not required, to take glucocorticoids. During the trial, 48% of patients on the XTANDI arm and 46% of patients on the placebo arm received glucocorticoids. All adverse events and laboratory abnormalities were graded using NCI CTCAE version 4. 7KH PRVW FRPPRQ DGYHUVH GUXJ UHDFWLRQV Â&#x2022; UHSRUWHG LQ SDWLHQWV UHFHLYLQJ XTANDI in the randomized clinical trial were asthenia/fatigue, back pain, GLDUUKHD DUWKUDOJLD KRW Ă&#x20AC;XVK SHULSKHUDO HGHPD PXVFXORVNHOHWDO SDLQ KHDGDFKH upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade 3 and higher adverse UHDFWLRQV ZHUH UHSRUWHG DPRQJ RI ;7$1', WUHDWHG SDWLHQWV DQG RI placebo-treated patients. Discontinuations due to adverse events were reported for 16% of XTANDI-treated patients and 18% of placebo-treated patients. The most common adverse reaction leading to treatment discontinuation was seizure, which occurred in 0.9% of the XTANDI-treated patients compared to none (0%) of the placebo-treated patients. Table 1 shows adverse reactions reported in the UDQGRPL]HG FOLQLFDO WULDO WKDW RFFXUUHG DW D Â&#x2022; DEVROXWH LQFUHDVH LQ IUHTXHQF\ LQ the XTANDI arm compared to the placebo arm. Table 1. Adverse Reactions in the Randomized Trial XTANDI Placebo N = 800 N = 399 Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 (%) (%) (%) (%) General Disorders 9.0 44.4 9.3 Asthenic Conditionsa Peripheral Edema 1.0 13.3 0.8 Musculoskeletal And Connective Tissue Disorders Back Pain 26.4 24.3 4.0 Arthralgia 17.3 1.8 Musculoskeletal Pain 1.3 0.3 Muscular Weakness 9.8 6.8 1.8 Musculoskeletal 2.6 0.3 0.3 0.0 Stiffness

Placebo N = 399 Grade 1-4 Grade 3-4 (%) (%)

Gastrointestinal Disorders Diarrhea 21.8 1.1 0.3 Vascular Disorders Hot Flush 20.3 0.0 10.3 0.0 Hypertension 6.4 2.1 2.8 1.3 Nervous System Disorders Headache 12.1 0.9 0.0 Dizzinessb Spinal Cord 7.4 6.6 3.8 Compression and Cauda Equina Syndrome Paresthesia 6.6 0.0 0.0 4.3 0.3 1.8 0.0 Mental Impairment Disordersc Hypoesthesia 4.0 0.3 1.8 0.0 Infections And Infestations 10.9 0.0 0.3 Upper Respiratory Tract Infectiond Lower Respiratory 2.4 4.8 1.3 Tract And Lung e Infection Psychiatric Disorders Insomnia 8.8 0.0 6.0 Anxiety 0.3 4.0 0.0 Renal And Urinary Disorders Hematuria 6.9 1.8 1.0 Pollakiuria 4.8 0.0 0.0 Injury, Poisoning And Procedural Complications Fall 4.6 0.3 1.3 0.0 Non-pathologic 4.0 1.4 0.8 0.3 Fractures Skin And Subcutaneous Tissue Disorders Pruritus 3.8 0.0 1.3 0.0 Dry Skin 0.0 1.3 0.0 Respiratory Disorders Epistaxis 3.3 0.1 1.3 0.3 a Includes asthenia and fatigue. b Includes dizziness and vertigo. c Includes amnesia, memory impairment, cognitive disorder, and disturbance in attention. d Includes nasopharyngitis, upper respiratory tract infection, sinusitis, rhinitis, pharyngitis, and laryngitis. e Includes pneumonia, lower respiratory tract infection, bronchitis, and lung infection. Laboratory Abnormalities ,Q WKH UDQGRPL]HG FOLQLFDO WULDO *UDGH QHXWURSHQLD RFFXUUHG LQ RI patients on XTANDI (1% Grade 3-4) and in 6% of patients on placebo (no Grade 3-4). The incidence of Grade 1-4 thrombocytopenia was similar in both DUPV RI SDWLHQWV RQ ;7$1', DQG RQ SODFHER H[SHULHQFHG *UDGH thrombocytopenia. Grade 1-4 elevations in ALT occurred in 10% of patients on ;7$1', *UDGH DQG RI SDWLHQWV RQ SODFHER *UDGH Grade 1-4 elevations in bilirubin occurred in 3% of patients on XTANDI and 2% of patients on placebo. Infections In the randomized clinical trial, 1.0% of patients treated with XTANDI compared to 0.3% of patients on placebo died from infections or sepsis. Infection-related serious adverse events were reported in approximately 6% of the patients on both treatment arms. Falls and Fall-related Injuries In the randomized clinical trial, falls or injuries related to falls occurred in 4.6% of patients treated with XTANDI compared to 1.3% of patients on placebo. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in patients treated with XTANDI and included non-pathologic fractures, joint injuries, and hematomas. Hallucinations In the randomized clinical trial, 1.6% of patients treated with XTANDI were reported to have Grade 1 or 2 hallucinations compared to 0.3% of patients on placebo. Of the patients with hallucinations, the majority were on opioidcontaining medications at the time of the event. Hallucinations were visual, WDFWLOH RU XQGHÂżQHG

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February 2013 I VOL 6, NO 1 B19814_2b_PI 09.17.2012

12A005-ENZ_BRS_Art.pdf

Through the eyes of an advocate participate in developing our Action Plan for legislative issues for 2013. After having attended the Salzburg Global Seminar on â&#x20AC;&#x153;The Greatest Untapped Resource in Healthcare? Informing and Involving Patients in Decisions about Their Medical Careâ&#x20AC;? in Austria in December 2010â&#x20AC;&#x201D;where 58 people from 18 countries fashioned

â&#x20AC;&#x153;The Salzburg Statement on Shared Decision Making,â&#x20AC;? calling on â&#x20AC;&#x153;patients and clinicians to work together to be co-producers of healthâ&#x20AC;?â&#x20AC;&#x201D;I have a renewed sense of hope for a paradigm shift in healthcare. I sense that 2013 will provide ample opportunities for what I consider to be the great honor of witnessing more of this movement

----------------------------------DRUG INTERACTIONS ------------------------------Drugs that Inhibit or Induce CYP2C8 &R DGPLQLVWUDWLRQ RI D VWURQJ &<3 & LQKLELWRU JHPÂżEUR]LO LQFUHDVHG the composite area under the plasma concentration-time curve (AUC) of enzalutamide plus N-desmethyl enzalutamide in healthy volunteers. Co-administration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible. If co-administration of XTANDI with a strong CYP2C8 inhibitor cannot be avoided, reduce the dose of XTANDI >VHH 'RVDJH DQG $GPLQLVWUDWLRQ DQG &OLQLFDO 3KDUPDFRORJ\ @ The effects of CYP2C8 inducers on the pharmacokinetics of enzalutamide have not been evaluated LQ YLYR. Co-administration of XTANDI with strong or moderate CYP2C8 inducers (e.g., rifampin) may alter the plasma exposure of XTANDI and should be avoided if possible. Selection of a concomitant medication with no or minimal CYP2C8 induction potential is recommended >VHH &OLQLFDO 3KDUPDFRORJ\@ Drugs that Inhibit or Induce CYP3A4 Co-administration of a strong CYP3A4 inhibitor (itraconazole) increased the composite AUC of enzalutamide plus N-desmethyl enzalutamide by 1.3 fold in healthy volunteers >VHH &OLQLFDO 3KDUPDFRORJ\ @ The effects of CYP3A4 inducers on the pharmacokinetics of enzalutamide have not been evaluated LQ YLYR. Co-administration of XTANDI with strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine) may decrease the plasma exposure of XTANDI and should be avoided if possible. Selection of a concomitant medication with no or minimal CYP3A4 induction potential is recommended. Moderate CYP3A4 inducers (e.g., ERVHQWDQ HIDYLUHQ] HWUDYLULQH PRGDÂżQLO QDIFLOOLQ DQG 6W -RKQÂśV :RUW PD\ DOVR reduce the plasma exposure of XTANDI and should be avoided if possible >VHH &OLQLFDO 3KDUPDFRORJ\ @. Effect of XTANDI on Drug Metabolizing Enzymes Enzalutamide is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. At steady state, XTANDI reduced the plasma exposure to midazolam (CYP3A4 substrate), warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate). Concomitant use of XTANDI with narrow therapeutic index drugs that are metabolized by CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin) should be avoided, as enzalutamide may decrease their exposure. If co-administration with warfarin cannot be avoided, conduct additional INR monitoring >VHH &OLQLFDO 3KDUPDFRORJ\ @. -------------------------- USE IN SPECIFIC POPULATIONS -----------------------Pregnancy- Pregnancy Category X >VHH &RQWUDLQGLFDWLRQV@ XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action. While there are no human or animal data on the use of XTANDI in pregnancy and XTANDI is not indicated for use in women, it is important to know that maternal use of an androgen receptor inhibitor could affect development of the fetus. XTANDI is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with XTANDI. Nursing Mothers XTANDI is not indicated for use in women. It is not known if enzalutamide is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from XTANDI, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness of XTANDI in pediatric patients have not been established. Geriatric Use Of 800 patients who received XTANDI in the randomized clinical trial, 71 percent ZHUH DQG RYHU ZKLOH SHUFHQW ZHUH DQG RYHU 1R RYHUDOO GLIIHUHQFHV in safety or effectiveness were observed between these patients and younger SDWLHQWV 2WKHU UHSRUWHG FOLQLFDO H[SHULHQFH KDV QRW LGHQWLÂżHG GLIIHUHQFHV LQ responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Patients with Renal Impairment A dedicated renal impairment trial for XTANDI has not been conducted. Based on the population pharmacokinetic analysis using data from clinical trials in patients with metastatic castration-resistant prostate cancer and healthy YROXQWHHUV QR VLJQLÂżFDQW GLIIHUHQFH LQ HQ]DOXWDPLGH FOHDUDQFH ZDV REVHUYHG LQ SDWLHQWV ZLWK SUH H[LVWLQJ PLOG WR PRGHUDWH UHQDO LPSDLUPHQW P/ PLQ Â&#x201D; FUHDWLQLQH FOHDUDQFH >&U&/@ Â&#x201D; P/ PLQ FRPSDUHG WR SDWLHQWV DQG YROXQWHHUV ZLWK EDVHOLQH QRUPDO UHQDO IXQFWLRQ &U&/ Â&#x2022; P/ PLQ 1R LQLWLDO GRVDJH adjustment is necessary for patients with mild to moderate renal impairment. Severe renal impairment (CrCL < 30 mL/min) and end-stage renal disease have not been assessed >VHH &OLQLFDO 3KDUPDFRORJ\@. Patients with Hepatic Impairment A dedicated hepatic impairment trial compared the composite systemic exposure of enzalutamide plus N-desmethyl enzalutamide in volunteers with baseline mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively) versus healthy controls with normal hepatic function. The composite AUC of enzalutamide plus N-desmethyl enzalutamide was similar in volunteers with mild or moderate baseline hepatic impairment compared to volunteers with normal hepatic function. No initial dosage adjustment is necessary for patients with baseline mild or moderate hepatic impairment. Baseline severe hepatic impairment (Child-Pugh Class C) has not been assessed >VHH &OLQLFDO 3KDUPDFRORJ\@

in which patients will play an increasingly active role, along with their providers, in their medical choices and care. (â&#x20AC;&#x153;The Salzburg Statement on Shared Decision Makingâ&#x20AC;? was published in the September 2011 issue of The Oncology Nurse-APN/PA. Please go to http://www.theoncologynurse.com/ to access the article.)

Happy New Year! l Peg Ford is the chair of the Ovarian Cancer Advocacy Alliance of San Diego. She can be reached by email at pegford2@hotmail.com; by phone at 619-437-8438; or by mail at PO Box 180066, Coronado, CA 92178.

-------------------------------------- OVERDOSAGE -------------------------------------In the event of an overdose, stop treatment with XTANDI and initiate general VXSSRUWLYH PHDVXUHV WDNLQJ LQWR FRQVLGHUDWLRQ WKH KDOI OLIH RI GD\V ,Q D GRVH escalation study, no seizures were reported at < 240 mg daily, whereas 3 seizures were reported, 1 each at 360 mg, 480 mg, and 600 mg daily. Patients may be at increased risk of seizures following an overdose. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of enzalutamide. Enzalutamide did not induce mutations in the bacterial reverse mutation (Ames) assay and was not genotoxic in either the LQ YLWUR mouse lymphoma thymidine kinase (Tk) gene mutation assay or the LQ YLYR mouse micronucleus assay. %DVHG RQ QRQFOLQLFDO ÂżQGLQJV LQ UHSHDW GRVH WR[LFRORJ\ VWXGLHV ZKLFK ZHUH consistent with the pharmacological activity of enzalutamide, male fertility may be impaired by treatment with XTANDI. In a 26-week study in rats, atrophy RI WKH SURVWDWH DQG VHPLQDO YHVLFOHV ZDV REVHUYHG DW Â&#x2022; PJ NJ GD\ HTXDO to the human exposure based on AUC). In 4- and 13-week studies in dogs, hypospermatogenesis and atrophy of the prostate and epididymides were observed DW Â&#x2022; PJ NJ GD\ WLPHV WKH KXPDQ H[SRVXUH EDVHG RQ $8& PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (PATIENT INFORMATION). Â&#x2021; ,QVWUXFW SDWLHQWV WR WDNH WKHLU GRVH DW WKH VDPH WLPH HDFK GD\ RQFH GDLO\ XTANDI can be taken with or without food. Each capsule should be swallowed whole. Do not chew, dissolve, or open the capsules. Â&#x2021; ,QIRUP SDWLHQWV UHFHLYLQJ D *Q5+ DQDORJ WKDW WKH\ QHHG WR PDLQWDLQ WKLV treatment during the course of treatment with XTANDI. Â&#x2021; ,QIRUP SDWLHQWV WKDW ;7$1', KDV EHHQ DVVRFLDWHG ZLWK DQ LQFUHDVHG risk of seizure. Discuss conditions that may predispose to seizures and medications that may lower the seizure threshold. Advise patients of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Â&#x2021; ,QIRUP SDWLHQWV WKDW ;7$1', PD\ FDXVH GL]]LQHVV PHQWDO LPSDLUPHQW paresthesia, hypoesthesia, and falls. Â&#x2021; ,QIRUP SDWLHQWV WKDW WKH\ VKRXOG QRW LQWHUUXSW PRGLI\ WKH GRVH RU VWRS ;7$1', ZLWKRXW ÂżUVW FRQVXOWLQJ WKHLU SK\VLFLDQ ,QIRUP SDWLHQWV WKDW if they miss a dose, then they should take it as soon as they remember. If they forget to take the dose for the whole day, then they should take their normal dose the next day. They should not take more than their prescribed dose per day. Â&#x2021; $SSULVH SDWLHQWV RI WKH FRPPRQ VLGH HIIHFWV DVVRFLDWHG ZLWK ;7$1', DVWKHQLD IDWLJXH EDFN SDLQ GLDUUKHD DUWKUDOJLD KRW Ă&#x20AC;XVK SHULSKHUDO edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. Â&#x2021; ,QIRUP SDWLHQWV WKDW ;7$1', PD\ EH KDUPIXO WR D GHYHORSLQJ IHWXV Patients should also be informed that they should use a condom if having sex with a pregnant woman. A condom and another effective method of birth control should be used if the patient is having sex with a woman of child-bearing potential. These measures are required during and for three months after treatment with XTANDI.

Manufactured by: Catalent Pharma Solutions, LLC, St. Petersburg, FL 33716 Manufactured for and Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062 Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062 0HGLYDWLRQ ,QF 6DQ )UDQFLVFR &$ Issued: August 2012 $ (1= %56 Rx Only ÂŠ 2012 Astellas Pharma US, Inc. XTANDIÂŽ is a registered trademark of Astellas Pharma Inc.

ONCOLOGY

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February 2013 I VOL 6, NO 1 12A005-ENZ_BRS_Art.pdf

NOW APPROVED for the treatment of patients with metastatic

castration-resistant prostate cancer (mCRPC) who have previouslyy received docetaxel

18.4 MONTHS MEDIAN OVERALL SURVIVAL VS 13.6 MONTHS WITH PLACEBO

AND... • 37% reduction in risk of death vs placebo

(P < 0.0001; HR = 0.63 [95% CI, 0.53, 0.75])1

• XTANDI can be taken with or without food1 • Patients were allowed, but not required, to take glucocorticoids1

—

In the clinical trial, 48% of patients in the XTANDI arm and 46% of patients in the placebo arm received glucocorticoids1

• Oral, once-daily dosing1 • The rate of grade 3 and higher adverse reactions with XTANDI was 47% vs placebo at 53%1

• Seven patients (0.9%) out of 800 treated AFFIRM: A phase 3, global, placebo-controlled, randomized study of patients with mCRPC who previously received docetaxel1

XTANDI (enzalutamide) capsules is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel.

Important Safety Information Contraindications XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant. Warnings and Precautions In the randomized clinical trial, seizure occurred in 0.9% of patients on XTANDI. No patients on the placebo arm experienced seizure. Patients experiencing a seizure were permanently discontinued from therapy. All seizures resolved. Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizure were excluded from the clinical trial. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Adverse Reactions The most common adverse drug reactions (≥ 5%) reported in patients receiving XTANDI in the randomized clinical trial

with XTANDI 160 mg once daily experienced a seizure. No seizures occurred in patients treated with placebo1

were asthenia/fatigue, back pain, diarrhea, arthralgia, hot ﬂush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Drug Interactions XTANDI is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. Administration of strong CYP2C8 inhibitors can increase the plasma exposure to XTANDI. Co-administration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible. If co-administration of XTANDI cannot be avoided, reduce the dose of XTANDI. Co-administration of XTANDI with strong or moderate CYP3A4 and CYP2C8 inducers can alter the plasma exposure of XTANDI and should be avoided if possible. Avoid CYP3A4, CYP2C9 and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring. Please see adjacent pages for Brief Summary of Full Prescribing Information.

Learn more at XtandiHCP.com Reference: 1. XTANDI [prescribing information]. Northbrook, IL: Astellas Pharma US, Inc; 2012. © 2012 Astellas Pharma US, Inc. All rights reserved. Printed in USA. 012I-076-6330 9/12 XTANDI is a registered trademark of Astellas Pharma Inc. Astellas and the ﬂying star logo are trademarks of Astellas Pharma US, Inc.