September 2011, Vol4 No6 by The Oncology Pharmacist

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SEPTEMBER 2011

www.TheOncologyPharmacist.com

VOL 4, NO 6

THE WHOLE PATIENT

CANCER CENTER PROFILE

Children’s Memorial Center for Cancer and Blood Diseases Oncology Pharmacists Dedicated to Treating Children and Their Families By Dawn Lagrosa

Cancer and the Workplace By Carolyn Messner, DSW, MSW, LCSW-R, BCD Director of Education and Training, CancerCare, New York, New York Tatiana Vera Prep for Prep—Prep 9, Freshman, Barnard College, New York, New York

ignificant progress in the treatment of cancer, coupled with early detection, has led to meaningful improvement in survival and quality of life. Novel symptom and pain-control interventions have made it possible for more patients with cancer to continue to work while receiving chemotherapy and radia-

tion therapy, as well as biologic, hormonal, and targeted agents. In addition, the trend of delivering cancer treatments in the outpatient setting, as opposed to inpatient hospital stays, has reduced time away from work during treatments. For many, personalized medicine and oral Continued on page 21

PHARMACOECONOMICS

The pharmacy oncology team at Children’s Memorial Hospital’s Hematology/Oncology/BMT Division (left to right): Susan Berg, RPh; Tara Mongkolpradit, PharmD; Sophia Parhas, PharmD, MBA; Yoomi Lee, PharmD; Jamie Sovcik, PharmD; Myra Delaney, CPhT.

fter the Great Chicago Fire in 1871, Chicago became one of the fastest growing cities in the world. But in this time of prosperity and growth, the prognosis for children born in the city was grim. A child had only a 50% chance of surviving to the age of 5 years, and those who survived were likely to be exposed to a host of diseases. In 1882, Julia Foster Porter took bold steps to transform the future of children’s health in Chicago by renovating a modest home and establishing Chicago’s first—and still its only—hospital dedicated exclusively to caring for children. From these modest roots Julia’s cottage eventually would become Children’s Memorial Hospital.

Continued on page 11

New Resource Available to Help Assess Value of DrugBased Oncology Therapies By John Schieszer

ncology pharmacists have a new tool for helping them better treat their patients. The Association of Community Cancer Centers (ACCC) has released a new publication, “The Practical Cancer Pharmacy,” designed to help hospital cancer pharmacy and financial teams move past the short-term orientation of considering only cost when deciding which drugs to purchase. “Pharmacists and other providers need

to really understand the value that these products have for their patients, which may be different than the assessment of them on a national level or from the payer’s perspective,” George Silberman, a consultant who worked with the advisory board of the ACCC to write the workbook, told The Oncology Pharmacist. “The acquisition price may not reflect the cost to the institution. For example, an oral Continued on page 26

CONFERENCE NEWS

Get Ready for the New Era of “Genomic Chaos” in Cancer Care ASCO President Urges Preparation for Incorporating Genetic Technology into Daily Care

INSIDE Complimentary Ce

...........

Update on Multiple Myeloma: Treatment Trends and Strategies for Value-Based Care

reader survey results

...

What Inspired Our Readers to Become Hematology/Oncology Pharmacists

By Wayne Kuznar

CHICAGO—A new era of cancer care, in which genomic advances alter the landscape of cancer care and clinical research, is emerging. As “genomic chaos” rules this landscape, the healthcare system must be prepared to incorporate genetic technology into cancer care and clinical trial design must adapt

as well, said George W. Sledge Jr, MD, American Society of Clinical Oncology (ASCO) president and professor of oncology, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis. Targeted therapies marked a true

ConferenCe news

............

American Society of Clinical Oncology fundraising for the Cause . . . . . . . . . . . . . . . . . . . .

Play for P.I.N.K.: Making a Difference

Continued on page 8

Answered!

Your FAQs... Q:

Ne Featuw re

What are some treatment options for elderly patients with chronic lymphocytic leukemia?

Page 24

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ONE FOR ALL A S T H E C O M P L E X I T Y O F H E ALT H C AR E E VO LVE S , HOS PIR A D OC E TAX E L I N J E C T I O N DE L I V E R S O N E SO L U TIO N F O R A L L .

FOR PHARMACISTS—160 MG MULTIPLE-DOSE VIALS ADD DOSING FLEXIBILITY

FOR CLINICIANS—UNIQUE ONCO-TAIN ™ VIALS REINFORCE SAFETY 1

With 3 dosing options, including a 160 mg multiple-dose vial, Hospira Docetaxel Injection requires no dilution prior to adding to the infusion solution. This reduces the number of handling steps, which can promote safety and add to workflow efficiency.

Because docetaxel is a hazardous antineoplastic agent, Hospira utilizes Onco-Tain vials to reinforce safety from transportation to administration.

FOR ADMINISTRATORS—MULTIPLE-DOSE VIALS LEAD TO LESS WASTE

As a generic equivalent to Taxotere®, Hospira Docetaxel Injection offers a lower-cost alternative for patients with non-small cell lung cancer, breast cancer and hormone refractory prostate cancer.

FOR YOUR INSTITUTION—OUR SINGLE-VIAL SYSTEM LEADS TO COST SAVINGS

160 mg and 80 mg multiple-dose vials help to reduce waste and to streamline workflow due to less handling of vials, resulting in significant time savings and minimizing the need for ancillary compounding disposables.

160 mg

80 mg

20 mg

160 mg/16 mL multiple-dose vial

80 mg/8 mL multiple-dose vial

20 mg/2 mL single-dose vial

10 mg/mL

For reimbursement support, contact the Hospira Reimbursement Support Line at 1-800-340-8667. Contact your representative today to learn more or to place an order at e.hospira.com.

Please refer to boxed warning and see Brief Prescribing Information on back page. Taxotere is a registered trademark of Aventis Pharma SA. Reference: 1. Data on file. Hospira, Inc. Hospira, Inc., 275 North Field Drive, Lake Forest, IL 60045

P11-3401-Sep., 11

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News Notes

BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Docetaxel Injection safely and eﬀectively. See full prescribing information for Docetaxel.

Docetaxel Injection For intravenous infusion only. Initial U.S. Approval: 1996

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION See full prescribing information for complete boxed warning • Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m2 (5.1) • Should not be given if bilirubin > ULN, or if AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle (8.6) • Should not be given if neutrophil counts are < 1500 cells/mm3. Obtain frequent blood counts to monitor for neutropenia (4) • Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of Docetaxel Injection and administration of appropriate therapy (5.4) • Contraindicated if history of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80 (4) • Severe ﬂuid retention may occur despite dexamethasone (5.5)

CONTRAINDICATIONS • Hypersensitivity to docetaxel or polysorbate 80 (4) • Neutrophil counts of <1500 cells/mm3 (4) WARNINGS AND PRECAUTIONS • Acute myeloid leukemia: In patients who received docetaxel doxorubicin and cyclophosphamide, monitor for delayed myelodysplasia or myeloid leukemia (5.6) • Cutaneous reactions: Reactions including erythema of the extremities with edema followed by desquamation may occur. Severe skin toxicity may require dose adjustment (5.7) • Neurologic reactions: Reactions including. paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent. (5.8) • Asthenia: Severe asthenia may occur and may require treatment discontinuation. (5.9) • Pregnancy: Fetal harm can occur when administered to a pregnant woman. Women of childbearing potential should be advised not to become pregnant when receiving Docetaxel Injection (5.10, 8.1) ADVERSE REACTIONS Most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, myalgia (6) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

BRCA1 Mutation May Determine Response to Neoadjuvant Systemic Chemotherapy After neoadjuvant systemic chemotherapy, more BRCA1 carriers achieve a pathologic complete response (pCR) than BRCA2 carriers and than noncarriers, according to a study published online in the Journal of Clinical Oncology (ArunB, et al. September 6, 2011). In addition, the association between gene mutation status and pCR remained, regardless of baseline clinical and tumoral predictive factors or choice of chemotherapy. No statistical difference was found in overall survival rates, however. In this study of 317 women with breast cancer identified through a prospectively maintained single-institution database, researchers searched for significant factors predictive of a pCR as well as evaluated the association between BRCA status and pCR, after adjusting for age, tumor stage, estrogen-receptor (ER) status, nuclear grade, and inclusion of trastuzumab in the chemotherapy regimen. Data analysis found BRCA1 mutation status, ER negativity, and concurrent trastuzumab use to be independent, significant predictors of a pCR. In addition, BRCA1 carriers who achieved a pCR had longer recurrence-free and overall survival at 5 years.

Concurrent Chemoradiation Prolongs Survival Over Sequential Therapies For patients with non–small-cell lung cancer (NSCLC), concurrent delivery of once-daily chemotherapy and thoracic radiotherapy produced significantly higher 5-year survival in a phase 3 trial (Curran WJ Jr, et al. J Natl Cancer Inst. September 8, 2011. Epub ahead of print). Researchers randomized 610 patients with inoperable stage II or III NSCLC to 1 of 2 concurrent regimens (chemotherapy with once-daily or twice-daily radiotherapy) or to sequential treatment with these therapies. With a medium follow-up of 11 years, they found median survival times to be 14.6 months for sequential therapy, 17.0 months for once-daily concurrent therapy, and 15.6 months for twice-daily concurrent therapy. In addition, the 5-year survival rate was statistically significantly higher for patients treated with the concurrent once-daily therapy at 16%, compared with 10% for sequential treatment and 13% for twice-daily concurrent therapy. The rate of grade 3 to 5 nonhematologic adverse effects was higher with the once-daily concurrent therapy.

Extending Pediatric Treatments to Adults with ALL With the high survival rate of children with acute lymphoblastic leukemia (ALL), there is interest in extending pediatric regimens to adult populations with the disease. Choosing the right therapy for the right patient, however, remains challenging, according to Daniel J. DeAngelo, MD, at the National Comprehensive Cancer Network (NCCN) 6th Annual Congress: Hematologic Malignancies. Age and cytogenetic abnormalities (Philadelphia chromosome status) should guide treatment decisions, he stated. Clinical trials have indicated that a pediatric treatment regimen is more effective than an adult treatment regimen used in young adults of the same age, but, as DeAngelo noted, deciphering at what age older adolescents/young adults should be considered adults continues to allude experts. “Future research needs to continue to target more specific age ranges in this often broad categorization of adolescent and young adults,” stated DeAngelo in an NCCN press release.

Lapatinib Monotherapy Fails to Reduce Disease-Free Survival Lapatinib as adjuvant monotherapy in early HER2-positive breast cancer produced poorer outcomes than trastuzumab in a head-to-head trial, according to the trial’s sponsor. “Consequent to this finding, patients assigned to the lapatinib alone arm of the trial will discontinue lapatinib and discuss treatment options with their study physician,” according to a statement released by GlaxoSmithKline. The 3 other arms of the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO) trial will continue uninterrupted. These arms include trastuzumab monotherapy, lapatinib followed by trastuzumab, and trastuzumab followed by lapatinib. The trial’s redefined goal will be to “test for superiority between the combination arms and trastuzumab alone with respect to disease-free survival,” the statement noted.

Two Doses of HPV Vaccine?

Manufactured by: Hospira Australia Pty., Ltd., Mulgrave, Australia Manufactured by: Zydus Hospira Oncology Private Ltd., Gujarat, India Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA GUJ DRUGS/G/28/1267

Two doses, possibly even 1 dose, of the HPV16/18 vaccine may provide protection equal to the standard 3-dose schedule against persistent HPV16/18 infections, according to an analysis of data taken from women who missed 1 or more prescribed doses in a vaccine trial (Kreimer AR, et al. J Natl Cancer Inst. September 9, 2011. Epub ahead of print). At 4 years postvaccination, vaccine efficacy (prevention of incident HPV16 and HPV18 infections that persist for at least 1 year) was found to be 80.9% for 3 doses, 84.1% for 2 doses, and 100% for 1 dose. The investigators cautioned against generalizing their results because of how the study was conducted. Their study involved the bivalent HPV16/18 vaccine, and their results may not apply to other vaccine formulations. In addition, this study was conducted with women in Costa Rica, and other populations may have more comorbidities, such as endemic parasitic infections. ●

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SePTember 2011 I VOL 4, NO 6

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Editorial Board EDITOR-INCHIEF Patrick Medina, PharmD, BCOP Oklahoma University College of Pharmacy Tulsa, OK

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

Jim Koeller, MS University of Texas at Austin San Antonio, TX

Timothy G. Tyler, PharmD, FCSHP Desert Regional Medical Center Palm Springs, CA

Christopher Fausel, PharmD

Christopher J. Lowe, PharmD

John M. Valgus, PharmD, BCOP

Indiana University Simon Cancer Center Indianapolis, IN

Indiana University Hospital Indianapolis, IN

University of North Carolina Hospitals and Clinics Chapel Hill, NC

David Baribeault, RPh, BCOP

Rebecca S. Finley, PharmD, MS

Emily Mackler, PharmD, BCOP

Boston Medical Center Boston, MA

Jefferson School of Pharmacy Philadelphia, PA

University of Michigan Health System & College of Pharmacy Ann Arbor, MI

Gary C. Yee, PharmD, FCCP, BCOP

Betty M. Chan, PharmD, BCOP

David C. Gammon, BSPh

USC/Norris Cancer Hospital Los Angeles, CA

OncologyPharmacist.net Warwick, RI

Laura Boehnke Michaud, PharmD, BCOP, FASHP

Steven L. Dâ&#x20AC;&#x2122;Amato, RPh, BCOP

Lew Iacovelli, BS, PharmD, BCOP, CPP

LeAnn Best Norris, PharmD, BCPS, BCOP

Maine Center for Cancer Medicine Scarborough, ME

Moses H. Cone Health System Greensboro, NC

South Carolina College of Pharmacy Columbia, SC

John F. Aforismo, BSc Pharm, RPh, FASCP RJ Health Systems International, LLC Wethersfield, CT

The University of Texas M. D. Anderson Cancer Center Houston, TX

University of Nebraska College of Pharmacy Omaha, NE

Burt Zweigenhaft, BS BioPharma Partners LLC New York, NY

Marlo Blazer, RPh, PharmD James Cancer Hospital & Solove Research Institute Columbus, OH

Heidi D. Gunderson, PharmD, BCOP Mayo Clinic Cancer Center Rochester, MN

Anjana Elefante, PharmD, BSc, BSc Pharm, RPh

Dwight Kloth, PharmD, FCCP, BCOP

Steve Stricker, PharmD, MS, BCOP

Roswell Park Cancer Institute Buffalo, NY

Fox Chase Cancer Center Philadelphia, PA

Samford University McWhorter School of Pharmacy Birmingham, AL

September 2011 I VOL 4, NO 6

Kamakshi V. Rao, PharmD, BCOP University of North Carolina Hospitals and Clinics Chapel Hill, NC

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BUILDING

pillars of knowledge

IN SUPPORTIVE CARE CINV LOG ON TODAY TO PARTICIPATE

www.coexm.com/ace07 Release Date: July 11, 2011 Expiration Date: July 10, 2012

TARGET AUDIENCE The educational series is intended for nurses, pharmacists, and others with clinical, research, and management interests in CINV treatment

EDUCATIONAL OBJECTIVES On completion of this activity, participants should be able to: â&#x20AC;˘ Describe recent advances in the treatment of cancer patients with chemotherapy-induced nausea and vomiting (CINV) â&#x20AC;˘ Outline key barriers and challenges that impact the supportive care of patients with CINV â&#x20AC;˘ Examine strategies for achieving optimal control of CINV, based on recent evidence-based data and updated clinical practice guidelines

ACCREDITATION STATEMENTS Creative Educational Concepts, Inc. (CEC) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This knowledge-based activity has been assigned ACPE # 0245-0000-11019-H01-P and will award 1.0 contact hour (0.10 CEUs) of continuing pharmacy education credit. CEC complies with the Criteria for Quality for continuing education programming.

FACULTY Regina Cunningham, PhD, RN, AOCN Senior Director, Oncology The Tisch Cancer Institute Mount Sinai Medical Center New York, NY

Shawna Kraft, PharmD, BCOP Clinical Pharmacist/Oncology Adjunct Clinical Assistant Professor Department of Pharmacy Services College of Pharmacy University of Michigan Ann Arbor, MI

For further information and to participate, please go to: www.coexm.com/ace07

NURSING Creative Educational Concepts, Inc. (CEC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Centerâ&#x20AC;&#x2122;s Commission on Accreditation. CEC provides this activity for 1.0 contact hour. Learners are advised that accredited status does not imply endorsement by the provider or ANCC of any commercial products displayed in conjunction with an activity. Your statement of credit will be issued immediately upon successful completion of the posttest and evaluation form.

This activity is supported by an educational grant from Eisai, Inc. $!)

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From the Editor

recently read how the simple act of explaining briefly the “uncertainties about the benefit of drugs approved based on surrogate outcomes and the safety of new prescription drugs improved choices.” With the number of approved drugs skyrocketing and direct-to-consumer advertising, the researchers sought to identify the public’s current understanding of US Food and Drug AdPatrick Medina, ministration (FDA) approvals (Arch PharmD, BCOP Intern Med. 2011;171:1463-1468). Editor-in-Chief Their Internet-based randomized trial surveyed 2944 consumers. What they found suggests we have our work cut out for us as patient-care pharmacists. Woloshin and Schwartz reported that: • 39% of the participants agreed that the “FDA only approves prescription drugs that are extremely effective” • 25% thought that “only extremely effective drugs can be advertised to consumers” • 25% believed the “FDA only approves drugs that do not have serious side effects” • 17% agreed that “drugs that have serious side effects cannot be advertised to consumers.” To help, the trial also evaluated the effect of brief explana-

PUBLISHING STAFF Senior Vice President, Sales & Marketing Philip Pawelko phil@greenhillhc.com Publisher John W. Hennessy john@greenhillhc.com Editorial Director Kristin Siyahian kristin@greenhillhc.com Managing Editor Kristen Olafson kristen@greenhillhc.com Associate Editor Dawn Lagrosa dawn@greenhillhc.com Quality Control Director Barbara Marino Directors, Client Services Joe Chanley joe@greenhillhc.com Jack Iannaccone jack@greenhillhc.com Production Manager Stephanie Laudien Business Manager Blanche Marchitto blanche@greenhillhc.com Executive Administrator Andrea Boylston

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The Oncology Pharmacist®, ISSN 1944-9607 (print); ISSN 1944-9593 (online) is published 8 times a year by Green Hill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2011 by Green Hill Healthcare Communications LLC. All rights reserved. The Oncology Pharmacist® 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 Pharmacist®, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. 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, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. The ideas and opinions expressed in The Oncology Pharmacist® 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 Pharmacist® 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. BPA Worldwide membership applied for April 2011.

SePTember 2011 I VOL 4, NO 6

tions on consumer choices. Testing both nondirective and directive explanations, they found each method can help patients make better choices. As pharmacists, these findings should invigorate us to initiate drug discussions with our patients. Working in healthcare every day, we can lose sight of how the average patient comprehends the drug information they receive. Each patient cannot be expected to know and understand the details of complex drug studies or to interpret the statistical data in the prescribing information. It is hard enough for professionals to keep up. In fact, just below this letter are 4 FDA approvals in oncology alone—all from the past month. This is why, as always, The Oncology Pharmacist aims to provide you information you can use in your practice. This issue’s discussions on new drugs in the pipeline and managing the cost of care for your institution and your patients zero in on the specifics, while our coverage of ASCO President George Sledge’s presentation on oncology care in the genomic era sets the stage for oncology in general. This issue also offers you new ways to participate in our community. Visit our website and answer this month’s readers’ survey or submit a question for our new column—Your FAQs... Answered!, a column devoted to providing you the information you requested. We look forward to hearing from you. ●

Brentuximab for HL and ALCL The US Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris; Seattle Genetics) to treat Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL). With brentuximab, an antibody-drug conjugate, the antibody directs the drug to the target CD30. The agent is to be used in patients with HL whose disease has progressed after autologous stem-cell transplant or, for those who cannot receive a transplant, after 2 lines of chemotherapy. Brentuximab also may be used in patients with ALCL whose disease has progressed after 1 line of chemotherapy. Approval was based on 1 clinical trial involving patients with HL. In the single-arm study, patients were treated solely with brentuximab. Of the study’s 102 patients, 73% achieved either a complete or partial response to the treatment. On average, these patients responded to the therapy for 6.7 months. Effectiveness in ALCL also was evaluated in 1 single-arm study. Of 58 patients receiving brentuximab for ALCL, 86% experienced either a complete or partial response and responded, on average, for 12.6 months. The most common side effects reported include neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and thrombocytopenia. Pregnant women should be aware that brentuximab could cause harm to their unborn baby. Approval was granted under the FDA’s accelerated approval program. As such, the manufacturer is required to submit additional clinical information after approval to confirm the drug’s clinical benefit. Crizotinib and Companion Diagnostic for ALK-Positive NSCLC The FDA has approved crizotinib (Xalkori; Pfizer) to treat patients with locally advanced or metastatic non–small-cell lung cancer (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. Crizotinib has been approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular). Crizotinib blocks protein kinases, including the protein produced by abnormal ALK. This oral agent is designed to be

taken twice daily as a single-agent treatment. Approval was based on 2 multicenter, single-arm studies enrolling a total of 255 patients with late-stage ALKpositive NSCLC. In one study, the objective response rate (ORR) was 50%, with a median response duration of 42 weeks. In the other, the ORR was 61%, with a median response duration of 48 weeks. The Vysis ALK Break Apart FISH Probe Kit was approved on data from one of the studies. The most common side effects reported with crizotinib include vision disorders, nausea, diarrhea, vomiting, edema, and constipation. Vision disorders included visual impairment, flashes of light, blurred vision, floaters, double vision, sensitivity to light, and visual field defects. Crizotinib use was associated with pneumonitis; patients with treatment-related pneumonitis should permanently stop treatment. In addition, the drug should not be used in pregnant women. Crizotinib also was approved under the FDA’s accelerated approval program.

HE4 Test to Assess Risk of Ovarian Malignancy The FDA has issued 510(k) clearance to market HE4 Test in an algorithm (ROMA [HE4 EIA + ARCHITECT CA 125 II]; Fujirebio Diagnostics), which aids in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. This Risk of Ovarian Malignancy Algorithm test uses the results from CA 125 and HE4 blood tests to identify patients presenting with adnexal mass as high or low likelihood for finding malignancy on surgery. Approval was based on data from a study of 462 patients, which showed that, when used in conjunction with the methods a physician would normally use to assess likelihood of ovarian cancer in a combined pre- and postmenopausal patient population, ROMA had a sensitivity of 88.4%, a specificity of 67.2%, and a negative predictive value of 96.2%. The ROMA test is indicated for women who are older than 18 years, have an ovarian pelvic mass for which surgery is planned, and have not yet been referred to an oncologist. The test must be interpreted in conjunction with an independent clinical and radiological assessment, according to the manufacturer. ●

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Newsletter Series

YOUR QUESTIONS ANSWERED

Editor in Chief

Sagar Lonial, MD

Stephanie A. Gregory, MD

Associate Professor of Hematology and Oncology Emory University School of Medicine

The Elodia Kehm Chair of Hematology Professor of Medicine Director, Section of Hematology Rush University Medical Center/Rush University

Topics include: â&#x20AC;˘ Newly Diagnosed Patients â&#x20AC;˘ Maintenance Therapy â&#x20AC;˘ Transplant-Eligible Patients â&#x20AC;˘ Retreatment â&#x20AC;˘ Transplant-Ineligible Patients â&#x20AC;˘ Cytogenetics â&#x20AC;˘ Side-Effect Management â&#x20AC;˘ Bone Health

Topics include: â&#x20AC;˘ Hodgkin Lymphoma â&#x20AC;˘ Follicular Lymphoma â&#x20AC;˘ Mantle Cell Lymphoma â&#x20AC;˘ Waldenstromâ&#x20AC;&#x2122;s Macroglobulinemia â&#x20AC;˘ Diffuse Large B-Cell Lymphoma â&#x20AC;˘ T-Cell Lymphoma

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

This activity is supported by educational grant from Cephalon Oncology, Millennium Pharmaceuticals, Inc., and Seattle Genetics, Inc.

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

Accreditation This activity has been approved for 1.0 AMA PRA Category 1 Creditâ&#x201E;˘ (a total of 14.0 credit hours will be issued for completion of all activities). Nursing and Pharmacy credit hours will also be provided. For complete learning objectives and accreditation information, please refer to each activity. This activity is jointly sponsored by Global Education Group and Medical Learning Institute, Inc. Coordination for this activity provided by Center of Excellence Media, LLC.

For information about the physician accreditation of this activity, please contact Global at 303-395-1782 or inquire@globaleducationgroup.com. COEKsize40611MM

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Conference News Get Ready for the New Era... Continued from cover breakthrough in cancer treatment. DNA sequencing technology represents the next frontier, and the technology is becoming less expensive and more powerful at an alarming rate: companies already are marketing a person’s genome delivered on a USB drive, although the price is still substantial, Sledge said.

care. Soon, the demand for care will exceed the number of providers, providing yet another challenge. Add in the rising cost of cancer care and the decline in the number of physicians willing to conduct clinical investigaGeorge W. tions, and cancer care in the Sledge Jr, MD coming years looks particularly daunting. The first complete sequencing of Preparing for the Coming human cancer genomes was published Challenges only 3 years ago. “Today, as a result of “What happens when the next 10 efforts such as the National Institute of patients you see require 8 different com- Health’s Cancer Genome Atlas Project binations based on their tumor genomes? and the International Cancer Genome Our current system is not designed to Consortium, several thousands of canhandle genomic chaos,” Sledge said. cers covering 20 major tumor types are Although the data will help inform being sequenced,” he said. “Such largephysicians about a given patient’s tumor scale sequencing will rapidly change our biology, at the same time cancer man- understanding of cancer biology, it will agement will become “very, very compli- identify new targets in previously hard cated…we will actually be able to mea- to treat diseases, and it will explain the sure the degree and kind of mutations in causes of drug resistance. Within the an individual’s tumor.” next few years, perhaps by the end of In the not-too-distant future, patients this decade, we will likely see the beginwould walk into physicians’ offices with ning of population-based deep sequenca memory stick “loaded with gigabytes ing of patients’ tumor genomes.” of personal genomic data.” Although the rate of cancer deaths “Stupid” versus “Smart” Mutations has decreased partly as a result of better The promise of the genomic era was application of diagnostics, new systemic revealed in a recent article (Welch JS, treatments, and a decline in tobacco et al. JAMA. 2011;305:1577-1584), in use, a rising tide of cancer in an aging which deep sequencing of a patient’s population will challenge that trend, he leukemic cells was used to select a said. A rapid increase in therapeutic retinoic acid inhibitor therapy. “We can look forward to a future in options will push demand for cancer

which the unraveling of the secrets of the genetic code is commonplace, expected, and routinely drives care,” said Sledge. “But this case, as wonderful as it is as a harbinger of our collective future, is not the whole story. Not every story will end this happily.” The problem is that cancers are segregating into “stupid cancers” and “smart cancers.” “Stupid cancers have a single dominant mutation and a small mutational load,” he said. “Tar geting that dominant driver is regularly effective, and resistance is rare, often occurs late, and can frequently be reversed via other attacks on the same pathway. Smart tumors have multiple simultaneous drivers, carry a large mutational load, and require the targeting of multiple drivers. Resistance is common in smart cancers and occurs early into treatment.” Mutation rates can vary between cancers by >1000-fold. Several hematologic and childhood tumor types have <1 mutation for every 1000 bases, whereas melanoma, head and neck, colorectal, lung, and squamous-cell cancers have a median close to 10 mutations per 1000 DNA bases and can reach 100. Chronic myelogenous leukemia is an example of a stupid cancer, with an easy target that is treated effectively by imatinib. And non–small-cell lung cancer (NSCLC) caused by cigarette smoking is an example of a smart cancer. In one

Exemestane Effective for Primary Prevention of Breast Cancer Risk for First Invasive Breast Cancer Reduced by 65%

September 2011 I VOL 4, NO 6

for prevention of breast cancer, study provides a rationale only about 4% of eligible women for wider implementation actually take the drug, explained of preventive use of exlead author Paul Goss, MD, emestane,” Goss stated. director of breast cancer research, Between 2004 and 2010, Harvard Medical School and the study enrolled 4560 Massachusetts General Hospital postmenopausal women in Boston. Tamoxifen carries seriolder than age 37 (median Paul Goss, MD ous, but relatively rare, risks of age, 62 years) with at least venous thromboembolism and 1 risk factor for breast canendometrial cancer. Unlike tamoxifen, cer (age 60 or older, Gail score >1.66%, exemestane is not approved for preven- prior atypical ductal hyperplasia, and tion of breast cancer. The drug is about atypical lobular hyperplasia). At baseto go off-patent, and it is not clear line, median Gail score was 2.3% and whether Pfizer will try to file for the pre- average body mass index was 28 kg/m2. About half of participants were older vention indication. “It is extraordinary that we can reduce than 50 years, 40% had a Gail score the incidence of breast cancer by 65%. >1.66%, and 11% had prior intraepitheThat is a massive benefit. In our opinion, lial neoplasia. During the 3-year follow-up, 11 cases exemestane represents a new option for consideration for breast cancer preven- of breast cancer were diagnosed in the tion in postmenopausal women who exemestane arm compared with 32 in meet the criteria of the MAP.3 trial. This the placebo arm. The benefit of exemesPhoto by © GMG/Todd Buchanan 2011.

CHICAGO—Exemestane appears to be a good alternative to tamoxifen for prevention of breast cancer in postmenopausal women, according to results of the randomized, placebo-controlled MAP.3 trial. Exemestane reduced the risk of a first invasive breast cancer by 65% in healthy postmenopausal women with risk factors for breast cancer, and also reduced the risk of known breast cancer precursor lesions, including ductal carcinoma in situ, lobular carcinoma in situ, atypical ductal hyperplasia, and atypical lobular hyperplasia, which would suggest further reductions in invasive cancers as time goes by. Exemestane did not increase the incidence of serious side effects, including osteoporosis and clinical fracture, cardiovascular events, and second malignancies, or treatmentrelated deaths, compared with placebo. Although tamoxifen is approved by the US Food and Drug Administration

study, investigators determined that a patient’s tumor had 1 mutation for every 3 cigarettes smoked (Bang Y, et al. J Clin Oncol. 2010;28[18S]:Abstract 3). Agents such as crizotinib work preferentially in NSCLC in nonsmokers, who have a lower mutational load. Health Information Technology Key With many gene mutations occurring at frequencies <5%, cancers can be considered as a “whole series of orphan diseases,” each requiring a different treatment. There will be no magic bullet for these tumors. Investigating treatments for cancers with multiple drivers (kinases) is an enormous task. With 2 drivers that would require 2 tyrosine kinase inhibitors to treat, for example, 154 patients would have to be screened to find 1 relevant patient. “Who in their right mind would screen 154 patients to enter 1 into a clinical trial? And forget 3-drug combinations of novel agents,” said Sledge. In this new era, ASCO must be committed to advance into the field of health information technology (HIT), a concept known as the “rapid learning system.” “HIT will be central to the rapid learning system in the genomic era. Doctors will need real-time access to clinical data from all practice settings. This, in turn, will require interoperable databases using common terminology,” Sledge concluded. ●

tane was in the reduction of estrogen receptor–positive tumors (7 in the exemestane arm vs 27 in the placebo arm) and in HER2-negative tumors (10 vs 26, respectively). The superiority of exemestane to placebo was evident across all risk groups, including Gail score, age, body mass index, prior lobular carcinoma in situ, and prior ductal carcinoma in situ. Side effects that were increased with exemestane included hot flashes, fatigue, insomnia, gastrointestinal effects, and arthritis. Hot flashes occurred in 40% of women treated with exemestane and 32% of those in the placebo group. The incidence of bone fracture, osteoporosis, cardiovascular events, and other malignancies was similar in both arms. “The elephant in the kitchen [in women at risk for breast cancer] is prophylactic mastectomy. Exemestane is now another treatment option for these women,” said Andrew Seidman, MD, of the Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center in New York City. Seidman chaired the press conference where these data were presented. ●

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Conference News

Novel Cancer Therapies in the Pipeline Promising Agents for NSCLC, Ovarian Cancer, Supportive Care By Caroline Helwick

CHICAGO—The cancer drug pipeline is bursting with promising new therapies for a variety of tumors. Of the many investigational drugs presented, this article highlights some of the most promising agents now in phase 2 or 3 clinical trials. Cabozantinib This oral inhibitor of MET kinase and the vascular endothelial growth factor (VEGF) receptor produced high rates of disease control in several solid tumor types, and fully or partially eliminated bone metastases in a randomized phase 2 study. Disease control rates (demonstrated by response rate and stable disease) were 76% in liver cancer, 71% in prostate cancer, 58% in ovarian cancer, 45% in melanoma, 45% in breast cancer, and 40% in non–small-cell lung cancer (NSCLC). Complete or partial resolution of bone metastases on bone scans was seen in 80% of patients. Several phase 3 trials are being planned.

Iniparib This poly ADP ribose polymerase (PARP) inhibitor, being studied for the treatment of ovarian cancer, showed promise in a phase 2 trial of 41 platinumsensitive patients in the setting of first recurrence. The overall response rate was 65%, and median progression-free survival (PFS) was 9.5 months. In a separate phase 2 study in the second line, the response rate was 25%, and 81% of patients derived clinical benefit. Ganetespib Another agent investigated for NSCLC, treatment with the heat shock protein 90 inhibitor ganetespib was associated with a disease control rate of 54%. The drug was evaluated for single-agent activity in a phase 2 study of 76 patients with advanced disease, many of whom carried tumor mutations. A phase 2b/3 trial has been initiated for ganetespib in combination with docetaxel. Semuloparin This experimental anticoagulant (an

ultra-low-molecular-weight heparin) reduced the risk of thromboembolic events by 64% in patients undergoing chemotherapy. In the phase 3 Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy (SAVEONCO) study of 3212 patients, mostly with metastatic disease, 20 (1.2%) patients who received semuloparin and 55 (3.4%) who received placebo experienced a thromboembolic event (P <.001), with similar rates of bleeding. Semuloparin is administered 20 mg daily subcutaneously. Based on the results of this trial, its manufacturer, sanofi oncology, will soon submit regulatory filing for semuloparin. Ruxolitinib A Janus kinase inhibitor, ruxolitinib reduced spleen size in 2 separate phase 3 studies in the treatment of 3 forms of myelofibrosis. The manufacturer, Incyte, filed for marketing approval in June 2011.

Most End-of-Life Costs for Patients with Cancer Are Not Drug Related Healthcare Services and Inpatient Hospitalization Top Cost Increases By Wayne Kuznar

CHICAGO—Most end-of-life costs accrued by patients with cancer are related to health services rather than the use of drugs, according to an analysis of claims from a large health plan (UnitedHealth). “The bottom line is that most of the costs were not related to drugs but to healthcare services plus the inpatient hospitalizations,” said April Teitelbaum, MD, coinvestigator and a practicing oncologist and Senior Medical Director, Life Sciences, Hematology/

Oncology, Innovus, Eden Prairie, Minnesota. For this analysis, end-of-life healthcare costs were examined for 28,530 patients with cancer who died while enrolled in the plan. The most frequent type of malignancy was lung cancer (18% of the cohort). The total cancer-related monthly costs increased as the period before death shortened (Table), from a mean of $7835 during the sixth month before

death to more than $25,000 in the last month of life. Total cancer-related costs over the last 6 months of life were $74,212: $30,254 for outpatient services; $40,702 for acute inpatient hospitalization; and $3256 for hospice. “We only looked at the last 6 months because there’s a misconception that there are a lot of needless drug costs spent in futility. In reality, those costs are minimal compared to the inpatient hos-

Table Mean Costs, by Month, During the Last 6 Months of Life Period before death, months 6

Mean total cost, $

Mean inpatient cost, $

Mean hospice cost, $

Mean outpatient service cost, $

7835

1785

3849

Mean outpatient chemotherapy cost, $ 2172

9229

3269

3751

2149

10,051

4087

3762

2107

10,364

4646

173

3692

1852

11,471

6356

435

3242

1437

25,260

2059

2464

1632

606

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Telatinib Two thirds of patients with advanced gastric or gastroesophageal junction cancer responded to a combination of telatinib (a small-molecule inhibitor of VEGF receptors 2 and 3), capecitabine, and cisplatin as first-line therapy in an open-label study of 39 patients. Cixutumumab This monoclonal antibody that targets the insulin-like growth factor 1 receptor demonstrated in a phase 2 clinical trial that 57% of 113 patients with adipocytic sarcoma experienced stable disease when they received this new therapy. Axitinib This selective VEGF receptor 1, 2, and 3 inhibitor extended PFS more than sorafenib as second-line therapy for metastatic renal-cell carcinoma. The median PFS was 6.7 months with axitinib versus 4.7 months with sorafenib. ●

pitalizations,” said Teitelbaum. “Ultimately, cancer-related services cost much much more than any of the drug services could possibly ever cost,” she said. Of the outpatient cancer-related costs: • $10,323 was spent on chemotherapy (including biologic and hormonal therapy) and related care (ie, use of erythropoiesis-stimulating agents, granulocyte macrophage colony-stimulating factor) • $3710 was for radiation therapy • $10,123 was for outpatient services • $4040 was for office visits. The $10,323 spent for chemotherapy and related medications accounted for only 13.9% of the total costs over the last 6 months of life. The use of services such as inpatient hospitalization and hospice care increased noticeably while the use of chemotherapy declined over time, especially during the last 1 to 3 months of life. “One of the key points is that there needs to be better communication between the physicians, ancillary staff, and the patients and their families in regard to what their wishes are,” said Teitelbaum. “A lot of patients are hesitant to say that they’re not interested in any more care because they’re afraid of abandonment. The term ‘hospice’ has a negative connotation.” ●

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Conference News

Patients Want to Discuss Cost of Cancer Care, Oncologists Often Avoid It But Out-of-Pocket Share Should Not Affect Clinical Decisions By Wayne Kuznar

CHICAGO—Patients are more willing than their oncologists to discuss the cost of cancer care, according to a recent survey of patients with cancer. Discussion of cost has been promoted as a way to decrease spending on cancer care, and although oncologists recognize the importance of cost discussions, many are uncomfortable and ill-equipped to initiate them, according to Erin W. Hofstatter, MD, assistant professor of medicine in medical oncology, Yale Cancer Center, New Haven, Connecticut, who presented the survey results. In previous surveys, only 36% of oncologists reported feel-

“I’m not really sure that patients understand the value they’re getting for their money.” —Erin W. Hofstatter, MD

ing comfortable discussing cost with their patients. “I’m not sure that fellows in general receive much training about how to talk to patients about the topic. As a result of that, oncologists even 10 to 20 years in practice aren’t used to

talking about it,” said Hofstatter. She and colleagues surveyed 256 patients from an academic ambulatory clinic in Massachusetts. Approximately two thirds (63%) were female, and 87% were white; 65% had private or employer-based insurance coverage,

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and 24% had Medicare with supplemental coverage. A total of 59% of the patients indicated that they would like their doctor to discuss out-of-pocket (OOP) costs related to recommended cancer tests and treatments, and 78% said that they were comfortable talking about the cost of cancer care with their doctor. The respondents were divided when they were asked if they would prefer to discuss the cost of cancer care with someone other than their doctor: 30% indicated a preference or strong preference, 44% indicated no preference, and 23% said that they would not prefer such an option. More than two thirds (68%) indicated that they agreed or strongly agreed with the statement, “I prefer to know about the out-of-pocket costs for my treatment before I am treated,” whereas 36% either disagreed or strongly disagreed, and 45% neither agreed nor disagreed. Despite the substantial cost burden, most patients did not want cost considered in medical decision-making, said Andrea J. Bullock, MD, lead investigator and gastrointestinal malignancies specialist, Beth Israel Deaconess Medical Center, Boston. Only 33% of respondents indicated that they wanted their doctor to consider OOP costs when making a medical decision, and 24% said that they considered their own OOP costs when making a decision about their cancer treatment. If patients aren’t receiving cost information from their oncologists, where do they go for such information? “I think it’s variable,” said Bullock. “It depends on the size of the practice and if they have other resources…care managers, case managers, financial assistants available. I suspect that in a lot of practices there aren’t resources.” Hofstatter noted, “To translate the research, it’s telling us that oncologists need to have better training in how to talk about it, and what their resources are. This study did suggest that there is a role for a third party to talk about finances with patients…to address oncologists’ discomfort.” The survey stemmed from cost-ofcare guidelines published by the American Society of Clinical Oncology, which suggested that a potential method to curb costs is to raise the issue with patients, indicated Hofstatter. “To be honest, a lot of doctors and a lot of patients don’t have any idea how much money they’re spending,” she said. “I’m not really sure that patients understand the value they’re getting for their money. It’s difficult because if you start talking about value, that leads to a discussion about prognosis, which can be very difficult.” ●

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Cancer Center Profile Children’s Memorial Center... Continued from cover Today, Children’s Memorial is guided by the belief that all children need to grow up in a protective and nurturing environment in which each child is given the opportunity to reach his or her potential. Part of the Multidisciplinary Team To serve this special population of cancer patients, an elite team of pharmacists specialize in not only pediatrics but also oncology. Staffing 2 satellite oncology pharmacies—1 inpatient, 1 outpatient— pharmacists fill all chemotherapy orders. Within this team, each oncology pharmacist works both the inpatient and the outpatient satellites, going on rounds when he or she works inpatient. “A multidisciplinary round team, with a pharmacist, a physician, a nurse practitioner, and a nutrition discharge planner discusses the patient as a whole,” says Sophia Parhas, PharmD, MBA, pharmacy manager of Children’s Memorial Hospital’s Hematology/Oncology/BMT Division. “The team depends on us for dosing, looking at levels, trying to figure out if we need to adjust anything renally. There is a combination of things we are involved in with inpatients.” These specially trained pharmacists are able to catch dosing errors and provide recommendations to optimize therapy, says Parhas. Teamwork extends beyond just dosing. “Our satellite is located right by the outpatient clinic, and the physicians feel really comfortable coming to us, as do the nurse practitioners, if they want to discuss something or they need to bounce ideas off of us. We work as a very good multidisciplinary team, and they always think of us as part of the team,” Parhas says. Direct patient care also spreads into education. For example, “Many of our

bone marrow transplant kids go home with a lot of medications, prophylaxis, etc. If this is their first time going home, our pharmacist will meet with the patient after he or she obtains the drugs from the outpatient pharmacy and will go over everything. We make a takehome sheet for them with morning, afternoon, and night. We type in their medications, we go over it with them, and we make sure they can verbalize it back to us—that they understand what we are talking about,” Parhas shares. Depending on the patient’s age, this can mean educating the parents or both the patient and the parents. “If we have teenagers, we will make both of them verbalize back to us, because we want the parents to be aware. If the patient is a young child, we educate the parents, because they are the ones who will be administering the medications at home.” Parhas, for one, appreciates playing a big role in patient care. “It is really nice to see, in the outpatient area, a patient who is having his or her last chemotherapy treatment and the nurses are having a little party. It is nice seeing the good side, [patients] completing their protocols and coming off treatment.” Two Specialties in One When working with pediatric patients, pharmacists also must use pediatric dosing. “We dose a little bit different than for adults. We have to dose everything per the weight of the patient and then we have to take it one step further. Sometimes when our patients are smaller, you have to figure out, based on protocols, whether you are going to dose them based on meter squared [body surface area] or kilo weight [body weight],” explains Parhas. In addition, the pharmacy uses a

Margaret Tobin, stem cell transplant nurse, holds patient Matthew Furinbondo, while Sophia Parhas, PharmD, MBA, pharmacy manager, goes over his treatment with his mother.

triple-check system. This entails the physician entering or writing the order, another licensed independent practitioner performing a second doublecheck, and the pharmacist performing the triple-check. This system helps catch any issues upfront. And if not, when the chemotherapy goes to the nursing staff for administration, they perform 2 independent double-checks, says Parhas. Working the oncology pharmacy requires extensive training, which is provided by the hospital. “We start off with the main services, basically training the pharmacists on pediatrics or, if they come to us from a pediatric hospital, it is a little bit easier. After teaching the pharmacists the basic pediatric concepts, they branch out,” says Parhas. Regardless of their background, all newcomers must meet rigid standards. “We wouldn’t put someone in

oncology who hadn’t demonstrated specific competencies,” she states. Looking to the Future Children’s Memorial will soon take on a new name at a new location, The Ann & Robert H. Lurie Children’s Hospital of Chicago. The new facility will be in the heart of downtown Chicago on the medical campus of Northwestern University’s Feinberg School of Medicine. Scheduled to open in June 2012, the new building will be a 23-story, state-of-theart children’s hospital. Moreover, the oncology pharmacy will expand with the move. Parhas is excited about the planned clean rooms—one negative pressure, the other positive pressure. And although they will be keeping up with the <USP>-797 standards, Parhas is most excited to continue to “work as a team.” ●

Children’s Memorial Hospital Timeline 1896 Julia’s cottage

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2010 - Landscape architect Mikyoung Kim confers with members of the hospital’s Kids Advisory Board. The design of the new Crown Sky Garden will implement many of the Board’s ideas.

2011 - The new facility, Ann & Robert H. Lurie Children’s Hospital of Chicago, which completed shell construction and is on schedule to open in June 2012. SePTember 2011 I VOL 4, NO 6

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Fundraising for the Cause

Play for P.I.N.K.: Making a Difference

olf balls may be small, but if struck by one, you would know that they have tremendous impact. So it was in the beginning of the Play for P.I.N.K. (PFP) organization when a small group of women proved to make a huge impact on funding for breast cancer research. Driven by the elements of the PINK acronym (Prevention, Immediate diagnosis, New technology, Knowledge), PFP is a grassroots fundraising organization using lifestyle and sporting events to raise funds for breast cancer research. An impressive 100% of all proceeds are donated to the group’s partner, the Breast Cancer Research Foundation, to fund top researchers.

This year’s theme was Support Our Heroes in honor of the women of Forsgate who are survivors or currently undergoing breast cancer therapy.

PFP began in New Jersey in 1990 when a small group of women, shocked and saddened by the news of their friend’s diagnosis of breast cancer, decided to do something to help their friend, themselves, and anyone touched by breast cancer. One of the founders suggested a golf tournament; she had experience in coordinating golf tournaments, so this seemed a perfect fit for a fundraiser. Indeed, it was. In 1996, because of increased interest in PFP events and the desire of the founders to reach more people, the organization decided to reach out to individual country clubs throughout the tristate area of New Jersey, New York, and Connecticut in hope of inspiring each club to host its own event. In the first year of this expansion, PFP held golf tournaments at 6 clubs in New Jersey and raised an impressive $77,000 for breast cancer research. Since then, participation has grown to more than 220 clubs in more than 24 states across the United States. Each year, an estimated 20,000 women, men, and children have participated in and enjoyed this fundraiser. Although PFP originated as a golf tournament, their fundraising efforts have expanded to include other creative events—tennis tournaments, equestrian events, card games, knitting circles, and even spa days.

September 2011 I VOL 4, NO 6

The Play for P.I.N.K. golfers take to the links at Forsgate Country Club to raise money for breast cancer research, this year raising an estimated $37,000 for the Breast Cancer Research Foundation.

One of the charity’s most notable achievements is their significant 2010 contribution to the Breast Cancer Research Foundation in the amount of $3,250,000, bringing PFP’s total contribution to more than $22 million. TOP as Event Sponsor The publishers of The Oncology Pharmacist were proud to support PFP through hole sponsorship at the Annual Forsgate Country Club Golfathon Event. (PFP

“sells” hole flags for a donation.) On June 22 of this year, a total of 42 golfers turned out to support the cause, raising an estimated $37,000. Forsgate County Club remains among the top contributors to the PFP organization and is an excellent example of a grassroots effort supporting the cause of breast cancer research. The club graciously donates the use of the golf course, cart fees, and the support of their staff. Each year, they adopt a theme for their

event—this year’s theme was Support Our Heroes in honor of the women of Forsgate who are survivors or currently undergoing breast cancer therapy. As literal and figurative signs of support, the club displayed posters where members, Golfathon participants, and staff could write the names of their loved ones living with cancer. Forsgate Event coordinator Ernie McCarren was kind enough to speak to us about her involvement in this extraordinary event (Sidebar). ●

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Fundraising for the Cause Play for P.I.N.K.’s Annual Forsgate Country Club Golfathon An interview with Event Coordinator Ernie McCarren Thanks for taking the time to speak to us, Ernie. Can you tell us what motivated you to organize a P.I.N.K. event? Ernie McCarren (EM): As a breast cancer survivor and as director of business development for MAMM, a magazine for women with breast cancer, I became keenly aware of the critical need for funding to support research to bring new and better therapies to market faster. By partnering with Play for P.I.N.K., we know that 100% of the funds that we raise will go directly to the Breast Cancer Research Foundation (BCRF).

Do you have a personal connection to the cause? EM: I guess initially, the cause was particularly meaningful to me because of my own personal experience with the disease. But it has become more about joining in the fight to eradicate breast cancer so that future generations will not have to

experience this disease. The fact that finding a cure is within our grasp—possibly within our lifetime—is what compels so many of us to continue in the fight. Thanks again, Ernie. The Oncology Pharmacist wishes you continued success with this program!

Ernie McCarren

CEU’s for PHARMACISTS Y ONCOLOGY MEETING HARMACISTS A AV VAI AILABLE ILABLE AT AT FOUR DA DAY M The The Greenspan Meeting XXIX XX IX

What kind of support do you get from Play for P.I.N.K.? EM: The single, most important contribution would have to be the generosity of Bloomberg, who underwrites all of the program expenses, which allows us to turn over all of our proceeds to BCRF. And overall, the organization is very supportive, hosting an annual statewide planning meeting and supplying event materials, prizes, and gifts (donated by Bloomberg, Estee Lauder, and Wilson).

CHEMOTHERAPY FOUNDA FOUNDATION TION SYMPOSIUM ATION INNOV VATIVE T CANCER THERAPY FOR TOMORROW ® INNOVATIVE

How do you go about fundraising? What kind of event do you hold? EM: I believe we are the only club to use a golfathon format where participants solicit sponsors to pledge monetary support on a per-hole basis. The women then push the limits of their endurance to play as many holes as they can, with some reaching 36, 45, 70+ holes! In addition, we sell sponsorships for hole flags and signs and run other simultaneous activities like raffles and putting contests.

Wednesday-Friday y-Friday y, November Novembe 9-11

No November vember 8-12, 2011, New New York York City Tues uesday sday y, November 8

ADV DV VANCES IN ONCOLOGY PEDIA ATRIC T INNOV VATIVE CANCER THERAPY FOR TOMORROW Practical Applications For The Medical Oncologist New Agents, Clinical Trials and Emerging Therapies Saturday y, November 12

NEW PERSPECTIVES IN ONCOLOGY PRACTICE Empowering the Clinical Care T Team eam Therapeutic Advances, Multidisciplinary Issues, Oncologic Emergencies, New T echnologies, Oral Medications, Technologies, Medication Cost Issues, Symptom Management, Medication Safety November 8-12 (inclusive) Tuesday or Saturday only

$150 $50

Complimentarry Breakffasts asts, Lunches, Dinners

Pharmacists will be eligible for CEU’s for the Tuesday-Friday sessions, November 8-11 plus additional contact hours for the Saturday session on November 12 provided by the New York State Council of Health-System Pharmacists (NYSCHP) an approved provider of continuing pharmaceutical education by the Accreditation Council for Pharmaceutical Education (ACPE). Total number of contact hours available to pharmacists will be 34.5. Cer tification of Attendance will be provided to all professionals.

Register on line at www.chemotherapyfoundationsymposium.org www.chemotherapyfoundationsymposium.org Contact: jaclyn.silverman@mssm.edu, (212) 866-2813

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SePTember 2011 I VOL 4, NO 6

TOP_September 2011_v4_TOP 9/19/11 1:39 PM Page 14

CONTINUING EDUCATION PROGRAM P11009 • RELEASE DATE: MARCH 4, 2011 • EXPIRATION DATE: MARCH 4, 2012 ESTIMATED TIME TO COMPLETE: 1.0 HOUR • COMPLETE THE POSTTEST AT WWW.THEONCOLOGYPHARMACIST.COM

Update on Multiple Myeloma: Treatment Trends and Strategies for Value-Based Care TARGET AUDIENCE This activity was developed for physicians, pharmacists, and other healthcare professionals practicing in a managed care environment. LEARNING OBJECTIVES After completing this activity, the reader should be able to: • Explain the impact of key data presented at ASH 2010 on payers and providers in the treatment and management of multiple myeloma (MM) • Identify patient/disease-associated factors, as well as economic factors that may impact the choice of therapeutic agent, and formulate a management strategy using a risk-adapted approach to the treatment of MM • Construct informed treatment decisions for the purpose of improving the long-term outlook for patients with MM across the life-cycle of the disease • Discuss the future of MM treatment and the potential clinical, business, and regulatory changes that will affect the cost-value benefit design

• Linda Ritter, PhD, has nothing to disclose.

SPONSOR

PhARmACIST DESIGNATION

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

Medical Learning Institute, Inc., is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Completion of this activity provides for 1.0 contact hour (0.1 CEU) of continuing education credit. The universal activity number for this activity is 0468-9999-11-004H01-P.

University of Cincinnati, the associates of Medical Learning Institute, Inc., the accredited provider for this activity, and Center of Excellence Media, LLC, do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this CME/CE activity for any amount during the past 12 months.

fACULTy DISCLOSURES

DISCLAImER

Before the activity, all faculty will disclose the existence of any financial interest and/or relationship(s) they might have with the manufacturer(s) of any commercial product(s) to be discussed during their presentation(s): honoraria, expenses, grants, consulting roles, speaker’s bureau membership, stock ownership, or other special relationships. Presenters will inform participants of any off-label discussions.

The information provided in this CME/CE activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

INSTRUCTIONS fOR CREDIT

1. Read the article in its entirety 2. Log on to www.TheOncologyPharmacist.com 3. Select “Continuing Education” 4. Click on this article’s title from the list shown 5. Select “Click here to complete the posttest and obtain a CE certificate online” 6. Complete and submit the CE posttest and CE Activity Evaluation 7. Print your Statement of Completion For questions regarding the accreditation of this activity, please contact Medical Learning Institute, Inc., at 609-333-1693 or cgusack@ mlicme.org.

• John Fox, MD, and James T. Kenney, RPh, MBA, have nothing to disclose.

COmmERCIAL SUPPORT ACkNOwLEDGmENT This activity is supported by an educational grant from Millennium Pharmaceuticals, Inc.

Perspectives on Multiple Myeloma: Treatment Trends and Strategies for Value-Based Care By Linda Ritter, PhD

ith the advent of biologically targeted therapies, oncology costs have escalated. Payer involvement in oncology drug management has become an important aspect toward effective cost-containment in cancer care. Reimbursement and coverage models are emerging to grapple with the massive financial burden involving oncology treatment. Collaboration among payers and providers is key to improving clinical outcomes while controlling costs. Alignment of clinical and economic goals is essential for oncology care to achieve the progress made possible by the impressive advancements in therapy design, and to provide patients with value-based treatment that balances cost, quality, and access. Physicians often make clinical decisions based on evidence that has emerged from major clinical trials and has been released at major conferences before publication. This often occurs before new treatment strategies have been incorporated into guidelines. Becoming familiar with new and emerging data can assist payers in developing value-based strategies toward the goal of improving patient management. At the American Society of Hematology (ASH) annual meet-

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ing in Orlando, Florida, December 47, 2010, key data from a number of ongoing clinical trials were released, including many presentations on new advances in the management of patients with multiple myeloma (MM). This article highlights key findings released at the meeting that can affect the management of patients with MM. Addressing all ASH 2010 attendees, Ezekiel J. Emanuel, then-special advisor for health policy in the Office of Management and Budget of the White House, delivered a general session focused on the current state of US healthcare, titled, “Health Care Reform—A Physician’s Perspective from Inside the White House.”1 He emphasized that healthcare delivery and outcomes remain inferior in the United States compared with other developed countries, even though the United States spends far more on research and treatment. He further advised that the passage of the Patient Protection and Affordable Care Act will not place a cost burden on Americans, calling on providers to “focus on patients,” emphasizing that the new healthcare reform will make “their care better.”1

The Significance of Clinical End Points in Multiple Myeloma At ASH 2010, evidence from many clinical trials in the autologous stemcell transplant (ASCT) setting have established that achievement of complete response (CR) or at least very good partial response (VGPR) is significantly associated with prolonged progression-free survival (PFS) and higher overall survival (OS) in patients with MM.2,3 Francesca Gay and colleagues presented findings that highlight a significant association between the achievement of CR and long-term outcomes in the nontransplant setting.4 Their retrospective analysis of 1175 elderly patients with MM confirmed the importance of achieving CR, regardless of age, International Staging System (ISS) stage, or treatment (Table 1).4 Kastritis and colleagues presented data indicating that salvage treatments may not be effective in patients who fail to respond to therapy or whose disease progresses early after first-line treatment, including that with novel agents.5 In their multivariate analysis of 115 patients aged >65 years who were treated upfront with novel agent-based regimens, “PFS <12 months was the most significant adverse prognostic factor

associated with a 12.7-fold increase in the risk for death,”5 the researchers said. Patients who relapsed or progressed within the first 12 months had a median survival of 18 months compared with 53 months for patients who relapsed after at least 12 months from treatment initiation (P <.001). The researchers recommended that patients who fail to respond or who progress early should be encouraged to enter a clinical trial with investigational agents or with combination agents. Novel Regimens and the Use of Maintenance Therapy Newly Diagnosed Patients— ASCT-Eligible Bortezomib/thalidomide/dexamethasone (VTD). In the phase 3 randomized trial, the Spanish Myeloma Group PETHEMA/GEM compared VTD with thalidomide/dexamethasone (TD) and combination chemotherapy (vincristine/carmustine/cyclophosphamide/ melphalan/prednisone, vincristine/carmustine/doxorubicin/dexamethasone) plus bortezomib (VBMCP/ VBAD/B) in patients aged ≤65 years with newly diagnosed symptomatic MM, followed by ASCT with melphalan 200 mg (MEL-200).6 Primary end points includ-

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ed response rate after induction and after ASCT, and time to progression (Table 2).6 Treatment with VTD provided a significantly higher rate of immunofixation electrophoresis–negative CR compared with TD and VBMCP/ VBAD/B (35% vs 14% and 22%; P = .0001 and P = .01, respectively). Patients with high-risk cytogenetics also responded better to VTD. The CR rate for these patients was significantly greater with VTD compared with TD (35% vs 0%; P = .002) and with VBMCP/VBAD/B (35% vs 22%; P = .02). The CR rates in patients with chromosomal deletion (del)17p were 58% versus 0% versus 0%, respectively (P = .03 and P = .02). Significantly fewer patients receiving VTD had disease progression during induction compared with those receiving TD (7% vs 23%; P = .001). On an intention-to-treat (ITT) basis, the post-ASCT CR rate was higher in the VTD arm compared with the TD and VBMCP/ VBAD/B arms (46% vs 24% vs 38%, respectively).6 The incidence of thrombotic events did not differ significantly among the 3 arms (2%, 6%, and 5%, respectively). The frequency of grade ≥3 peripheral neuropathy (PN) was 12% with VTD compared with 1% in the TD and the VBMCP/VBAD/B arms (P = .0002). Treatment was discontinued because of toxicity in 9 patients with VTD, 4 with TD, and 3 with VBMCP/VBAD/B.6 Cavo and colleagues prospectively compared VTD with TD as induction therapy before, and consolidation after, double ASCT in patients with newly diagnosed MM in a phase 3 trial.7,8 Patients were randomized to VTD (n = 236) or TD (n = 238), and were analyzed on an ITT basis for response rate, PFS, and OS (Table 3).7 The CR/nearCR (nCR) rate was significantly higher for patients receiving VTD compared with those receiving TD after all treatment phases, including induction therapy (31% vs 11%; P <.0001), double ASCT (55% vs 41%; P = .0024), and consolidation therapy (62% vs 45%; P = .0002). Median time to best CR or nCR was significantly shorter for patients receiving VTD (9 months) compared with 14 months for patients receiving TD (P <.0001).7 After a median follow-up of 36 months, time to progression and PFS were both significantly prolonged with VTD treatment. The estimated 3-year probability of disease progression or relapse was 29% in the VTD group versus 39% in the TD group (P = .0061). Median PFS was not yet reached in the VTD arm compared with 42 months of PFS in the TD arm. The estimated 3year rate of PFS was 68% in the VTD group and 56% in the TD group (P = .0057). Multivariate analysis revealed that the most important and independ-

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ent variables that correlated with PFS were low beta 2-microglobulin concentration, absence of chromosomal translocation (t[4;14]) with or without del(17p), receiving VTD, and ≥CR/nCR. No difference was reported between the 2 groups in stem-cell mobilization. The estimated 3-year rate of OS was 86% in the VTD group and 84% in the TD group, a nonsignificant difference.7,8 During the induction phase, the most common grade 3 and 4 adverse events were PN and skin rash, which occurred in a higher proportion of patients receiving VTD than TD. Resolution of grade 3 and 4 PN or improvement by at least 1 grade was recorded in 18 of 23 patients receiving VTD within a median of 26 days from onset, and in 3 of 5 patients receiving TD on days 39, 48, and 67 from onset.7,8 Bortezomib/lenalidomide/dexamethasone (VRD) followed by VRD consolidation and lenalidomide maintenance. In an open-label phase 2 study, newly diagnosed patients aged <65 years received induction with VRD followed by stem-cell collection, MEL-200, and ASCT. Two months after hematologic recovery, patients could receive 2 consolidation cycles of VRD, followed by 1 year of maintenance with lenalidomide.9 The primary end point was the best response achieved 1 month after consolidation. In the ITT population (n = 32), the overall response rate after induction was 97%; after ASCT, 94%; and after consolidation, 94% (Table 4).9 The most common grade 1 and 2 toxicities were sensory PN, neuropathic pain, gastrointestinal (GI) symptoms (including diarrhea and constipation), fatigue, and erythrodermia. No grade 3 or 4 PN was reported. Only 1 patient was unable to undergo ASCT because of stem-cell mobilization difficulties.9 Bortezomib-based induction followed by bortezomib maintenance. The HOVON-65/GMMG-HD4 trial evaluated the efficacy of bortezomib during induction and maintenance on PFS in ASCT-eligible patients with newly diagnosed MM (N = 744).10 Patients were randomized to bortezomib/doxorubicin/ dexamethasone (PAD) followed by ASCT and bortezomib maintenance, or to the standard vincristine/doxorubicin/dexamethasone (VAD) regimen followed by ASCT and thalidomide maintenance. Approximately 90% of patients in each arm were able to complete induction therapy. A total of 56% and 64% of patients in each arm initiated maintenance therapy, and 28% and 19% completed 2 years of maintenance therapy, respectively. In an ITT analysis, response rates during all stages of therapy were significantly superior with PAD/ bortezomib compared with VAD/ thalidomide (Table 5).10 The VGPR or better response rates were 42% and 15% (P <.001) after

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induction therapy, and 61% and 36% (P <.001) after high-dose therapy, respectively. Overall, 76% and 55% of patients were able TheOncologyPharmacist.com to achieve VGPR or better on protocol, respectively (P = .001).10 Survival outcomes were significantly prolonged with PAD/bortezomib compared with VAD/thalidomide. At a median follow-up of 40 months, median PFS for patients receiving the bortezomib-based regimen was 36 months patients receiving VAD/thalidomide compared with 27 months for those (15% grades 3/4). For those receiving receiving standard therapy. The PAD/bortezomib, the rate of PN PAD/bortezomib regimen decreased the was 23% (9% grades 3/4). Fewer patients risk of disease progression at 3 years by receiving PAD/bortezomib discontinued 21% compared with VAD/thalidomide treatment because of toxicity than did (P = .01). With ASCT patients cen- those receiving VAD/thalidomide (9% vs sored, PAD/bortezomib decreased the 31%, respectively).10 Lenalidomide maintenance therapy risk of progression by 25% (P = .001). The bortezomib-based regimen was also following ASCT. CALGB 100104 was a associated with significant improvement randomized phase 3 trial evaluating the in OS, with a 27% lower risk of mortal- ability of maintenance lenalidomide to ity compared with standard therapy (P = prolong time to progression after a sin.02). Survival benefit was observed in gle ASCT in patients with MM.11 patients with cytogenetic abnormalities, Patients were eligible to participate if they had stable disease ≥2 months after including t(4;14) and del(17p). During the 2 years of maintenance a single ASCT, and were randomized to therapy, PN was observed in 41% of receive 5-mg to 25-mg lenalidomide or

Table 1 Association of CR with Prolonged Survival in Nontransplant Setting Variable

VGPR

Age-group, yr

All

>75

All

>75

All

>75

3-year PFS, %

3-year OS, %

CR indicates complete response; OS, overall survival; PFS, progression-free survival; PR, partial response; VGPR, very good partial response. Source: Reference 4.

Table 2 Comparing VTD, TD, and VBMCP/VBAD/B Induction VTD

VBMCP/ VBAD/B

Postinduction CR (IFE–), %

Post-ASCT CR, %

Not reached

Median PFS, mo

ASCT indicates autologous stem-cell transplant; CR, complete response; IFE, immunofixation electrophoresis; PFS, progression-free survival; TD, thalidomide/dexamethasone; VBMCP/VBAD/B, vincristine/carmustine/cyclophosphamide/melphalan/prednisone and vincristine/carmustine/doxorubicin/dexamethasone plus bortezomib; VTD, bortezomib/thalidomide/dexamethasone. Source: Reference 6.

Table 3 VTD versus TD Induction before, and VTD Consolidation after, Double ASCT VTD (n = 236)

TD (n = 238)

Postinduction, %

Post-ASCT ⳯ 2, %

Postconsolidation, %

Not reached

CR/nCR

Median PFS, mo 3-year PFS, %

ASCT indicates autologous stem-cell transplant; CR, complete response; nCR, near-complete response; PFS, progression-free survival; TD, thalidomide/dexamethasone; VTD, bortezomib/thalidomide/dexamethasone. Source: Reference 7.

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CONTINUING EDUCATION Table 4 Response Rate: VRD/ASCT/VRD Consolidation/Lenalidomide Maintenance After induction, % (n = 31)

After ASCT, % (n = 30)

After consolidation, % (n = 18)

sCR

VGPR

ORR

Response

ASCT indicates autologous stem-cell transplant; CR, complete response; ORR, overall response rate; PR, partial response; sCR, stringent complete response; VGPR, very good partial response; VRD, bortezomib/lenalidomide/ dexamethasone. Source: Reference 9.

Table 5 Response Rate: VAD/Thalidomide Maintenance versus PAD/Bortezomib Maintenance Response

VAD/thalidomide

PAD/bortezomib

Postinduction, %

Post–high-dose therapy, %

On protocol, %

Postinduction, %

Post–high-dose therapy, %

On protocol, %

Median PFS, mo

CR/nCR

VGPR or better

CR indicates complete response; nCR, near-complete response; PAD, bortezomib/doxorubicin/dexamethasone; PFS, progression-free survival; VAD, vincristine/doxorubicin/dexamethasone; VGPR, very good partial response. Source: Reference 10.

Table 6 Response Rate: MPR-R versus MP Response

MPR-R

ORR, %

CR, %

VGPR or better, %

Median time to response, mo

Median PFS, mo

2-year PFS, %

CR indicates complete response; MP, melphalan/prednisone; MPR, melphalan/prednisone/lenalidomide; MPR-R, MPR plus lenalidomide maintenance; ORR, overall response rate; PFS, progression-free survival; VGPR, very good partial response. Source: Reference 13.

placebo daily until disease progression (N = 460). All patients were required to receive some form of anticoagulation therapy, including aspirin, warfarin, or heparin compounds.11 At a median follow-up of 17.5 months from randomization, significantly fewer patients receiving lenalidomide maintenance therapy had a progression event compared with those receiving placebo (19.9% vs 41.5%, respectively; P <.0001). Median time to progression was 42.3 months for patients receiving lenalidomide compared with 21.8 months for patients receiving placebo. The effect on sur-

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vival is not available, because 78.2% of patients who were receiving placebo at unblinding (December 2009) crossed over to receive lenalidomide. An increased frequency of grade 3/4/5 adverse events occurred in patients receiving lenalidomide compared with those receiving placebo, including thrombocytopenia, neutropenia, and infections. More patients receiving lenalidomide discontinued the study because of adverse events (12% vs 1%, respectively).11 IFM 2005-02 was a prospective, randomized phase 3 trial that also evaluated lenalidomide maintenance therapy after

ASCT.12 Patients aged <65 years with nonprogressive disease after a first-line ASCT (performed within the past 6 months) were randomized to receive consolidation with lenalidomide followed by maintenance with either placebo or lenalidomide until relapse. After first interim analysis in December 2009, the data and safety monitoring board recommended to unblind the trial because of a significant PFS benefit seen with lenalidomide compared with placebo. With the current follow-up, the median postrandomization PFS was 42 months for patients receiving lenalidomide maintenance compared with 24 months for those receiving placebo; the 4-year postdiagnosis PFS rates were 60% and 33%, respectively. In a multivariate analysis, improved PFS was related to the achievement of VGPR or better after consolidation and to maintenance with lenalidomide. Maintenance treatment with lenalidomide was well tolerated.12

Newly Diagnosed Patients— ASCT-Ineligible Melphalan/prednisone/lenalidomide (MPR) followed by lenalidomide maintenance (MPR-R). MM-015 is a prospective, randomized phase 3 trial evaluating the efficacy and safety of MPR-R in transplant-ineligible patients.13 Comparator arms in this study are fixed-duration regimens of melphalan and prednisone (MP) or MPR. The 459 patients enrolled in this study (aged ≥65 years) were stratified by age and ISS stage. Data from a preplanned interim analysis at 70% of events were presented.13 Median follow-up at this analysis was 21 months. Treatment with MPR-R resulted in significantly higher overall response, CR, and VGPR rates than did treatment with MP (Table 6).13 Responses were also more rapid in patients receiving MPR-R compared with MP. MPR-R reduced the risk of disease progression by 58%, providing a median PFS of 31 months compared with 14 months with MPR and 13 months with MP. The 2-year PFS rate with MPR-R was 55% compared with 16% for MP. Maintenance lenalidomide (ie, MPR-R regimen) provided a 69% reduced risk of progression compared with placebo (ie, MPR regimen). No significant difference in OS was observed among the 3 treatment arms. MPR-R had a manageable safety profile, with minimal cumulative toxicities. Discontinuation rates because of adverse events for patients treated with MPR-R and MP were 20% and 8%, respectively. Grade 3/4 hematologic toxicities occurred more frequently in patients receiving MPR-R compared with those receiving MP. Maintenance lenalidomide was as well tolerated as placebo, with few grade 3/4 adverse events.13

First-line bortezomib-based regimens followed by bortezomib maintenance. The UPFRONT study is a US community-based, randomized phase 3b trial comparing the safety and efficacy of 3 bortezomib-based regimens followed by bortezomib maintenance in newly diagnosed patients with MM who are ineligible for ASCT.14 Patients were randomized to bortezomib/dexamethasone, VTD, or bortezomib/melphalan/ prednisone (VMP). All patients have received bortezomib maintenance. All patients have received prophylaxis therapy for herpes zoster reactivation; patients receiving VTD are also receiving aspirin, full-dose warfarin, or lowmolecular-weight heparin, unless contraindicated. The primary end point in this study is PFS.14 In an ITT analysis at a median followup of 13.4 months (N = 502), median PFS did not differ significantly among the 3 arms. Results for the first 300 patients who were able to complete the entire 49 weeks of therapy (8 induction plus 5 maintenance cycles) were presented at ASH 2010. High response rates were observed across the 3 bortezomibbased regimens (Table 7).14 The most common grade 3/4 toxicities reported during induction cycles included fatigue, neutropenia, diarrhea, pneumonia, and PN; except for PN, these were considered to most likely result from dexamethasone and melphalan, because toxicity decreased during the maintenance cycles with bortezomib. The incidence of PN did not increase substantially during maintenance therapy.

Patients with Relapsed/Refractory Disease: Subcutaneous Bortezomib. MMY-3021 was a prospective, randomized (2:1) phase 3 trial designed to evaluate the efficacy and safety of subcutaneous bortezomib compared with intravenous (IV) bortezomib in patients with relapsed MM (N = 220).15 The primary end point of this trial was overall response after 4 cycles of bortezomib. Secondary end points included pharmacokinetics and pharmacodynamics, and safety and tolerability. Subcutaneous bortezomib was noninferior to IV bortezomib (Table 8).15 Responses were rapid and sustained with both formulations. Median time to first response was 1.4 months for both formulations; median durations of response were 9.7 months for subcutaneous and 8.8 months for IV bortezomib, respectively. No differences were found in time to progression or OS between treatment arms.15 Pharmacokinetic and pharmacodynamic measurements demonstrated that bortezomib exposure and proteasome inhibition were equivalent for both formulations. Most important, overall grade 3/4 adverse events were significantly lower in patients receiving subcu-

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taneous bortezomib, as were PN and white blood cell toxicity.15 The Cost and Cost-Effectiveness of Myeloma Treatment

Cost of Nonadherence to the International Uniform Response Criteria (IURC). The International Myeloma Working Group proposed guidelines in July 2006 defining an IURC for patients with MM. These criteria define the tests necessary to evaluate patients depending on the magnitude of the response, and incorporate the serum-free light chain assay. A retrospective analysis of patients who underwent ASCT within the South Texas Veterans Health Care System revealed that only 16% of patients with MM underwent post-ASCT evaluations that adhered to the IURC guidelines.16 In addition, laboratory tests not included in the IURC are frequently obtained, even though they do not provide additional clinical information and increase the cost of care for patients with MM. Once-Weekly Bortezomib.Two studies presented at ASH 2010 reported on the safety and efficacy of once-weekly bortezomib.17,18 In an ongoing phase 2 study, bortezomib is being administered once weekly at 1.6 mg/m2 in combination with dexamethasone in newly diagnosed patients with MM who are not eligible for ASCT, in participating Veterans Affairs hospitals nationwide.17 Preliminary results suggest that this once-weekly bortezomib regimen is effective and tolerable, with reduced toxicity, even in an older patient population with significant comorbidities.17 The second report concerned the amendment of bortezomib, melphalan, prednisone, and thalidomide followed by maintenance treatment with bortezomib-thalidomide (VMPT-VT) versus VMP trial protocol.18 VMPT-VT and VMP induction schedules were changed to nine 5-week cycles and the bortezomib schedule was modified to 1.3 mg/m2 once weekly. Patients were rerandomized to receive either the amended once-weekly schedule or to remain using the original protocol. In a pooled ITT analysis based on administration schedule, efficacy data did not appear to be affected by the bortezomib schedule. Overall response rates were 85% with once-weekly and 86% with twice-weekly bortezomib, including 30% and 35% CR rates, respectively. Three-year PFS was 50% and 47%, and 3-year OS was 88% and 89%, respectively. Similar efficacy equivalency was seen when the analysis was restricted to patients receiving VMP.18 In both studies, adverse events were significantly reduced with the onceweekly schedule. In the randomized trial,

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the incidence of nonhematologic grade 3/4 adverse events was 35% for patients receiving the once-weekly schedule compared with 51% for those using the original protocol (P = .003). Grade 3/4 GI, systemic, and dermatologic events were also less frequent in patients receiving once-weekly bortezomib. Most notable was the significant reduction in the overall incidence of grade 3/4 PN in patients receiving once-weekly bortezomib (8% vs 28%; P <.001).18

Cost-Effectiveness of VMP Compared with MPR-R. As discussed, the MM015 trial showed that MPR was associated with superior PFS compared with MP, but only when lenalidomide was continued as maintenance therapy (MPR-R) through disease progression. MPR without lenalidomide maintenance was not superior to MP in terms of PFS. To assess the value of MPR-R, investigators indirectly estimated this regimen’s incremental cost-effectiveness for patients with MM who are ineligible for ASCT.19 Seven periods of treatment response were considered, including stable disease/minimal response, partial response, CR, treatment-free interval/maintenance treatment, progressive disease, second-line treatment, and death. Costs included per-protocol drug and medical expenses, treatment-related adverse events, second-line treatments, and resource utilization during the treatment-free interval and progressive disease; all costs were adjusted to 2010 US dollars. Health outcomes were expressed in life-years and quality-adjusted lifeyears. Incremental cost-effectiveness ratios were calculated over a lifetime horizon (20 years). The cost-effectiveness analysis showed a cost-savings for patients receiving VMP compared with MPR-R, and improved health outcomes (Table 9).19 Based on this analysis, the estimated OS was 4.187 years with VMP and 3.409 years with MPR-R. At 21 months of follow-up, MPR-R has not shown OS benefit.19 The Cost of Hematologic Testing Raibagkar and colleagues discussed the results of an investigation into the changes in neutrophil and platelet counts in patients treated with bortezomib, and the need for hematologic testing typically required before each bortezomib infusion.20 “This prerequisite substantially increases the time patients need to be in the clinic, putting both patients as well as healthcare providers at potentially increased inconvenience,” Raibagkar said. They analyzed data from relapsed patients enrolled in the phase 3 APEX study. Their analysis suggested that the change in complete blood counts (CBCs) with bortezomib treatment as monotherapy is predictable and

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that CBCs done on day 1 of cycle 2 and beyond were able to predict the chance of thrombocytopenia TheOncologyPharmacist.com and neutropenia on days 4, 8, and 11. These authors suggested that patients with a platelet count >100 ⳯ 109/L and absolute neutrophil count >1.5 ⳯ 109/L on day 1 of cycle 2 and beyond may not require rechecking of CBCs on days 4, 8, and 11. “Reducing the number of CBCs needed during of advances in treatments and manageeach cycle may improve patient compli- ment strategies that can improve outance and save time both for patients and comes for patients with cancer, especialhealthcare providers, as well as improve ly in terms of response to therapy, long-term outcomes, and quality of life. resource utilization,” Raibagkar said. The data presented here that emerged at Summary the ASH 2010 meeting may affect manThe healthcare environment today agement strategies for patients with necessitates that payers be acutely aware MM. As providers implement new treatTable 7 Comparing Response Rates with 3 Regimens, Followed by Bortezomib Maintenance VD (n = 100), %

VTD (n = 100), %

VMP (n = 100), %

CR/nCR

VGPR or better

ORR

CR/nCR

VGPR or better

ORR

Response Postinduction

Postmaintenance

CR indicates complete response; nCR, near-complete response; ORR, overall response rate; VD, bortezomib/ dexamethasone; VGPR, very good partial response; VMP, bortezomib/melphalan/prednisone; VTD, bortezomib/thalidomide/dexamethasone. Source: Reference 14.

Table 8 Subcutaneous Noninferior to Intravenous Bortezomib Subcutaneous (n = 145), %

Intravenous (n = 75), %

CR/nCR

VGPR or better

ORR

CR/nCR

VGPR or better

ORR

Response After 4 cycles

After 8 cycles

CR indicates complete response; nCR, near-complete response; ORR, overall response rate; VGPR, very good partial response. Source: Reference 15.

Table 9 Cost-Effectiveness of VMP Compared with MPR-R over a Lifetime Outcome

VMP

MPR-R

VMP–MPR-R

119,102

248,358

–135,688

LY, N

4.187

3.409

0.778

QALY, N

2.994

2.427

0.567

Cost, $

LY indicates life-year; MPR-R, melphalan/prednisone/lenalidomide induction followed by lenalidomide maintenance; QALY, quality-adjusted life-year; VMP, bortezomib/melphalan/prednisone. Source: Reference 19.

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CONTINUING EDUCATION ment strategies based on these data, payers must weigh all aspects of care, balancing outcomes with cost-effectiveness and resource utilization, and design value-based cancer care that will best meet these goals of improving clinical outcomes while controlling costs. ● References Note: All abstracts in this reference list were presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010. These were all published in Blood. 2011 Jan 12. Epub ahead of print. 1. Emanuel EJ, Broxmeyer HE, Foá R. Health care reform—a physician’s perspective from inside the White House. ASH/EHA Policy Forum. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010. 2. Chanan-Khan AA, Giralt S. Importance of achieving a complete response in multiple myeloma, and the impact of novel agents. J Clin Oncol. 2010;28:2612-2624. 3. Harousseau JL, Avet-Loiseau H, Attal M, et al. Achievement of at least very good partial response is a simple and robust prognostic factor in patients with multiple myeloma treated with high-dose therapy: long-term analysis of the IFM 99-02 and 99-04 trials. J Clin Oncol. 2009;27:5720-5726.

4. Gay F, Larocca A, Wijermans PW, et al. Achievement of complete response is a strong prognostic factor in elderly newly diagnosed myeloma: retrospective analysis of 1175 patients. December 2010. Abstract 1949. 5. Kastritis E, Roussou M, Gavriatopoulou M, et al. Short progression free survival predicts for poor overall survival in older patients with multiple myeloma treated upfront with novel agent-based therapy. December 2010. Abstract 3035. 6. Rosiñol L, Cibeira MT, Mateos MV, et al. A phase III PETHEMA/GEM study of induction therapy prior autologous stem cell transplantation (ASCT) in multiple myeloma: superiority of VTD (bortezomib/thalidomide/dexamethasone) over TD and VBMCP/VBAD plus bortezomib. December 2010. Abstract 307. 7. Cavo M, Perrone G, Buttignol S, et al. Bortezomibthalidomide-dexamethasone compared with thalidomidedexamethasone as induction and consolidation therapy before and after double autologous transplantation in newly diagnosed multiple myeloma: results from a randomized phase 3 study. December 2010. Abstract 42. 8. Cavo M, Tacchetti P, Patriarca F, et al. Bortezomib with thalidomide plus dexamethasone compared with thalidomide plus dexamethasone as induction therapy before, and consolidation therapy after, double autologous stem-cell transplantation in newly diagnosed multiple myeloma: a randomised phase 3 study. Lancet. 2010;376:2075-2085. 9. Roussel M, Avet-Loiseau H, Moreau P, et al. Frontline therapy with bortezomib, lenalidomide, and dexamethasone (VRD) induction followed by autologous stem cell transplantation, VRD consolidation and lenalidomide mainte-

nance in newly diagnosed multiple myeloma patients: primary results of the IFM 2008 phase II study. December 2010. Abstract 624. 10. Sonneveld P, Schmidt-Wolf I, van der Holt B, et al. HOVON-65/GMMG-HD4 randomized phase III trial comparing bortezomib, doxorubicin, dexamethasone (PAD) vs VAD followed by high-dose melphalan (HDM) and maintenance with bortezomib or thalidomide in patients with newly diagnosed multiple myeloma (MM). December 2010. Abstract 40. 11. McCarthy PL, Owzar K, Anderson KC, et al. Phase III intergroup study of lenalidomide versus placebo maintenance therapy following single autologous hematopoietic stem cell transplantation (AHSCT) for multiple myeloma: CALGB 100104. December 2010. Abstract 37. 12. Attal M, cances Lauwers V, Marit G, et al. Maintenance treatment with lenalidomide after transplantation for MYELOMA: final analysis of the IFM 2005-02. December 2010. Abstract 310. 13. Palumbo A, Delforge M, Catalano J, et al. A phase 3 study evaluating the efficacy and safety of lenalidomide combined with melphalan and prednisone in patients ≥65 years with newly diagnosed multiple myeloma (NDMM): continuous use of lenalidomide vs fixed-duration regimens. December 2010. Abstract 622. 14. Niesvizky R, Flinn IW, Rifkin RM, et al. Phase 3b UPFRONT study: safety and efficacy of weekly bortezomib maintenance therapy after bortezomib-based induction regimens in elderly, newly diagnosed multiple myeloma patients. December 2010. Abstract 619.

15. Moreau P, Pylypenko HV, Grosicki S, et al. A phase 3 prospective randomized international study (MMY-3021) comparing subcutaneous and intravenous administration of bortezomib in patients with relapsed multiple myeloma. December 2010. Abstract 312. 16. Utz K, Neumon B, Frye BL, et al. Have clinicians adopted the International Uniform Response Criteria (IURC) for multiple myeloma (MM)? Adherence to the IURC for posttransplant evaluations in patients with multiple myeloma. December 2010. Abstract 84. 17. Munshi NC, Lee S, Kambhampati S, et al. Interim results of an ongoing clinical study suggests efficacy and improved toxicity profile with once a week bortezomib with dexamethasone in newly diagnosed multiple myeloma patients with older age and co-morbidities. December 2010. Abstract 3061. 18. Bringhen S, Larocca A, Rossi D, et al. Efficacy and safety of once weekly bortezomib in multiple myeloma patients. December 2010. Abstract 3029. 19. Wang S-T, Huang H, Ba-Mancini A, et al. The costeffectiveness of bortezomib plus melphalan and prednisone versus lenalidomide plus melphalan and prednisone with continuous lenalidomide maintenance treatment for the initial treatment of multiple myeloma in the United States. December 2010. Abstract 2563. 20. Raibagkar PS, Richardson PG, Sonneveld P, et al. Hematological testing is not required with every dose of bortezomib in patients with adequate blood counts at the start of each cycle. December 2010. Abstract 1963.

Advances in the Management of Multiple Myeloma: Implications for Payers By James T. Kenney, RPh, MBA Pharmacy Operations Manager, Harvard Pilgrim Health Care, Wellesley, Massachusetts

ecent changes in the therapeutic options for the treatment of multiple myeloma (MM) raise the concept of cancer as a chronic disease. This requires that payers and providers work effectively together to balance the clinical needs of the physician and patient with the financial concerns of the health plan. A value-based treatment approach to cancer care focuses on cost, quality, and access as a logical methodology to address the need to improve the chances for optimal clinical outcomes that are cost-effective. Newer agents approved by the US Food and Drug Administration (FDA) for cancer therapy are increasingly targeted therapies with efficacy advancements and improved safety and tolerability that may also lead to specific quality-of-life (QOL) improvements. Historically, the Pharmacy & Therapeutics (P&T) Committee was not focused on QOL as a significant differentiating factor in the drug review process. Because of the toxicities of many cancer therapies, the benefits of QOL improvements may lead to a more favorable review by the P&T Committee. Recent FDA drug ap provals include patient-reported outcomes as an additional consideration in assessing the value of pharmaceutical products. This information provides P&T Committees with additional data to consider during their drug review process. Advances in diagnostic options for

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the assessment of MM have led to earlier treatment and an improved prognosis for patients. For example, the ability to accurately identify patients with smoldering MM or monoclonal gammopathy of undetermined significance is important, because these patients are not candidates for therapy. The cost of treating patients who are not likely to respond to therapy includes the obvious wasted spending on the drug, and more important, the cost of managing the side effects of any medications. In addition, any delay in the selection and administration of the best treatment may shorten the clinical window of benefit for the patient with cancer. The future role of genetics to aid in product selection is unknown; however, it is likely to be an important factor in the selection of a particular treatment option. Health plans seek the proper balance of drug and nondrug treatments in MM, which include autologous stem-cell transplant (ASCT), induction, and chemotherapy. The role of diagnostics is an integral part of this process, including costly positronemission tomography scans or magnetic resonance imaging to screen for appropriate patients. The challenge of managing a patient with MM includes the proper selection of patients who will benefit from ASCT, and combining this treatment with the timing and selection of appropriate chemotherapy for the best chance for a successful outcome.

Newer agents, including lenalidomide and bortezomib, offer particular promise for patients with MM. These agents deliver improved efficacy, as well as better safety and tolerability profiles, than many of the traditional chemotherapeutic agents. Recently published clinical information may suggest that off-label use of these therapies will yield valuable clinical benefits. These data have to be processed and managed by health plans to allow for reasonable access to treatments that provide real clinical benefits to patients. The risk– benefit evaluation of these new treatment approaches is typically left to the treating oncologist as opposed to the plan trying to actively direct care to specific agents. Plans have to acknowledge the clinical improvements of newer agents and allow for reasonable access to providers. Recent data presented at the American Society of Hematology (ASH) 2010 meeting demonstrated high response rates in bortezomib-treated patients,1-3 and maintenance therapy with lenalidomide was effective and well tolerated.4,5 Patients responded equally to intravenous and subcutaneous administration of bortezomib; however, the grade 3/4 adverse events were significantly lower in the subcutaneous-treated population.6 Plans may choose to influence the route of administration with benefit design to reduce potential complications and to encourage the best dosing interval, which was demonstrated to be once

weekly in the recent data presented at ASH. Payer management strategies must account for new therapeutic options and treatment strategies to provide improved outcomes while balancing the need to control costs. ● References 1. Rosiñol L, Cibeira MT, Mateos MV, et al. A phase III PETHEMA/GEM study of induction therapy prior autologous stem cell transplantation (ASCT) in multiple myeloma: superiority of VTD (bortezomib/thalidomide/dexamethasone) over TD and VBMCP/ VBAD plus bortezomib. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010. 2. Cavo M, Perrone G, Buttignol S, et al. Bortezomibthalidomide-dexamethasone compared with thalidomidedexamethasone as induction and consolidation therapy before and after double autologous transplantation in newly diagnosed multiple myeloma: results from a randomized phase 3 study. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010. 3. Bringhen S, Larocca A, Rossi D, et al. Efficacy and safety of once weekly bortezomib in multiple myeloma patients. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 47, 2010. 4. Roussel M, Avet-Loiseau H, Moreau P, et al. Frontline therapy with bortezomib, lenalidomide, and dexamethasone (VRD) induction followed by autologous stem cell transplantation, VRD consolidation and lenalidomide maintenance in newly diagnosed multiple myeloma patients: primary results of the IFM 2008 phase II study. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010. 5. McCarthy PL, Owzar K, Anderson KC, et al. Phase III intergroup study of lenalidomide versus placebo maintenance therapy following single autologous hematopoietic stem cell transplantation (AHSCT) for multiple myeloma: CALGB 100104. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010. 6. Moreau P, Pylypenko HV, Grosicki S, et al. A phase 3 prospective randomized international study (MMY-3021) comparing subcutaneous and intravenous administration of bortezomib in patients with relapsed multiple myeloma. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010.

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The Novel Chemotherapies Dilemma: Can Society Afford to Support Improved Progression-Free Survival Without Overall Survival Benefit?

To Receive cRediT, compleTe The posTTesT aT TheOncologyPharmacist.com

By John Fox, MD Associate Vice President, Medical Affairs, Priority Health, Grand Rapids, Michigan

n 1968, Science magazine published an article by Garrett Hardin titled “The Tragedy of the Commons.”1 In that article, Hardin highlights what would happen if any shepherd, acting in his own self-interest, added more sheep to the commons than was sustainable. Ultimately, individuals acting in their own self-interest would lead to the ruin of the commons and the death of all sheep. Applying a 2011 analogy: there is a healthcare bull on the loose on the same commons that supports our prized sheep—our schools, roads, parks, libraries, museums, arts, sports, and environment. If we cannot contain the bull, if we cannot contain the self-interested healthcare system, the sheep on the commons will have to be sacrificed. Clearly the cost trajectory for novel chemotherapeutics is steeply increasing and threatens the commons. With molecules targeted at smaller and smaller niches, the expected costs of these therapies will approach those of orphan drugs. The unwillingness of most payers to intervene in the chemotherapeutic decision process is likely to continue, with 2 exceptions. First, if comparative effectiveness trials demonstrate superior efficacy, this clinical evidence and presumably guidelines, such as those of the National Comprehensive Cancer Network (NCCN), could be used to require one therapy over another. Second, if molecular markers—genomic, proteomic, or metabolomic—predict response or nonresponse, payers would be justified in limiting access. In fact, many payers already use KRAS and EGFR mutations in prior authorization. For patients with multiple myeloma (MM) there are no biomarkers available for nontransplant candidates, yet several cytogenetic prognostic factors are available. Partial response and relapse, or disease progression within 12 months of initial treatment, are both associated with poor response to salvage therapy, as discussed in the main article.2,3 For example, Gay and colleagues demonstrated that nontransplant candidates with progression-free survival (PFS) <12 months had a median survival of 18 months compared with 53 months for those who relapsed within >12 months after response.2 In transplant candidates, the Spanish

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Reliance on surrogate outcomes measures ultimately deprives everyone—patients, society, physicians, and payers—of critical information that could be used comparatively to decide how to use limited resources.

Myeloma Group demonstrated that patients with high-risk cytogenetics and chromosome deletion (del[17p]) who received the bortezomib/thalidomide/ dexamethasone regimen had higher complete remission rates than similar patients receiving the thalidomide/dexamethasone regimen or conventional chemotherapy followed by bortezomib.4 Conversely, patients with the chromosome del(p13) benefited less from thalidomide maintenance after autologous stem-cell transplant (ASCT) than those without.4 It is unlikely that payers could legitimately use prognostic factors to deny coverage; however, especially in the maintenance setting with high-cost regimens, guidelinebased alternatives could be promoted through prior authorization processes. The NCCN MM guidelines list 4 of 9 category 1 (which reflects uniform consensus among NCCN participants) therapies for induction in transplant candidates and 3 of 10 in nontransplant candidates.5 Some payers have adopted NCCN categorization coverage methodology, allowing coverage of category 2b regimens only if no category 1 or 2a options exist or if these are contraindicated. Given the number of category 1 regimens available, it would seem reasonable to cover only category 2a if no category 1 regimens were clinically appropriate. Dr Ritter’s article highlights other studies that evaluate novel agents, including thalidomide, lenalidomide, and bortezomib. A number of these trials demonstrated improved PFS, without differences in overall survival (OS),6 whereas others have demonstrated improvements in OS when adding these agents. Although one could reasonably argue that improving PFS and avoiding chemotherapy would improve quality of life, the inconsistency in improving OS begs this question—Can society and the US healthcare system

afford improved PFS without an OS benefit? This question demands a formal cost-effectiveness analysis to help us answer whether society wants to tackle the healthcare bull raging on the societal commons. Efforts to increase OS have led to multiple studies evaluating maintenance therapy. Previous research has demonstrated that thalidomide maintenance therapy status post-ASCT improved OS in 3 studies, but not in a fourth. In a new trial discussed in Dr Ritter’s article, patients in the HOVON-65/GMMG-HD4 trial received 2 years of thalidomide or bortezomib post-ASCT (which is already a category 1 recommendation); and OS was improved by 27% in the bortezomib

Given the number of category 1 regimens available, it would seem reasonable to cover only category 2a if no category 1 regimens were clinically appropriate.

group compared with thalidomide (P = .02).7 As discussed, the CALGB 100104 and IFM 2005-02 trials compared lenalidomide and placebo maintenance in the post-ASCT setting.8,9 Compared with placebo, lenalidomide yielded 58% and 47% reductions, respectively, in disease progression.8,9 These findings led to the unblinding of both trials, a move that precludes an estimate of the OS benefit and a designation of category 2a for lenalidomide maintenance. Early termination of studies is worrisome: systematic reviews have shown

that this results in an overestimate of treatment effects.10,11 Miller and Joffe argue that using “clinical equipoise”— what’s best for this patient in this trial—as a rationale for early termination precludes a clear understanding of risks, benefits, and costs.12 The recent meta-analysis concluding that bevacizumab in combinate with chemotherapy or biologic therapy, compared with chemotherapy alone, was associated with increased treatment-related mortality,13 highlights the importance of drawing premature conclusions. Furthermore, reliance on surrogate outcomes measures ultimately deprives everyone—patients, society, physicians, and payers—of critical information that could be used comparatively to decide how to use limited resources. Bortezomib was approved by the US Food and Drug Administration for relapsed, refractory MM based on phase 2 trial data only (NCCN category 1).14 For example, why should lenalidomide be used in the maintenance setting when both thalidomide and bortezomib have hard OS data? With tandem ASCT commanding $200,000 and more, and bortezomib and lenalidomide upwards of $80,000 annually, the first year’s worth of therapy with either product is in excess of $300,000 for noncurative care. The role of maintenance therapy in cancer treatment is rapidly evolving and is poised to add billions of dollars to healthcare costs. Is it adequate to accept response rates or PFS rates, or should clear evidence of significant OS be expected? The addition of 2 years of maintenance therapy with novel agents that cost $80,000 annually again begs for comparative and cost-effectiveness analyses. However, until national consensus emerges on controlling the healthcare bull and rationalizing the cost of care, payers will likely cover these therapies. Certainly all stakeholders, especially patients, welcome studies that demonstrate that once-weekly bortezomib appears to be as effective as twice weekly, because dosing reductions improve the patient’s experience, maintain OS, while reducing grade 3/4 peripheral neuropathy and costs. Similarly, further studies, such as MMY-3021,15 which showed that subcutaneous bortezomib in relapsed MM provided comparable

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CONTINUING EDUCATION time to progression and OS compared with intravenous bortezomib, would be welcomed by all stakeholders as a result of better patient experience and presumably lower costs. Finally, we still have a conundrum about what to do for patients with poor prognosis. The NCCN recommends that patients who fail to respond or who progress early should be encouraged to enter a clinical trial with investigational agents or combinations of agents. What we continue to ignore, however, is the increasing evidence that palliative care treatment options, with or without active therapy, can improve the patient experience and health outcomes. Engaging patients in a discussion of their goals, preferences, and priorities so that treatment can be tailored accordingly is the bedrock of patient-centered

care but is clearly embedded in the NCCN’s and the American Society of Clinical Oncology’s guidelines. Moreover, most payers are actively engaged in advance care planning and palliative care initiatives, and even require advance care planning before entering into clinical trials or distal-line therapy. Keeping the bull in check and our societal commons healthy requires that the health profession asks regularly about patient preferences and tailors treatments to meet them. ● References 1. Hardin G. The tragedy of the commons. Science. 1968;162:1243-1248. 2. Gay F, Larocca A, Wijermans PW, et al. Achievement of complete response is a strong prognostic factor in elderly newly diagnosed myeloma: retrospective analysis of 1175 patients. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010. 3. Kastritis E, Roussou M, Gavriatopoulou M, et al. Short progression free survival predicts for poor overall survival in

older patients with multiple myeloma treated upfront with novel agent-based therapy. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010. 4. Harousseau JL, Avet-Loiseau H, Attal M, et al. Achievement of at least very good partial response is a simple and robust prognostic factor in patients with multiple myeloma treated with high-dose therapy: long-term analysis of the IFM 99-02 and 99-04 trials. J Clin Oncol. 2009;27:5720-5726. 5. NCCN multiple myeloma guidelines. www.nccn.org/pro fessionals/physician_gls/f_guidelines.asp. Accessed February 13, 2011. 6. Cavo M, Perrone G, Buttignol S, et al. Bortezomibthalidomide-dexamethasone compared with thalidomidedexamethasone as induction and consolidation therapy before and after double autologous transplantation in newly diagnosed multiple myeloma: results from a randomized phase 3 study. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010. 7. Sonneveld P, Schmidt-Wolf I, van der Holt B, et al. HOVON-65/GMMG-HD4 randomized phase III trial comparing bortezomib, doxorubicin, dexamethasone (PAD) vs VAD followed by high-dose melphalan (HDM) and maintenance with bortezomib or thalidomide in patients with newly diagnosed multiple myeloma (MM). Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010. 8. McCarthy PL, Owzar K, Anderson KC, et al. Phase III intergroup study of lenalidomide versus placebo mainte-

nance therapy following single autologous hematopoietic stem cell transplantation (AHSCT) for multiple myeloma: CALGB 100104. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 47, 2010. 9. Attal M, cances Lauwers V, Marit G, et al. Maintenance treatment with lenalidomide after transplantation for MYELOMA: final analysis of the IFM 2005-02. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010. 10. Bassler D, Briel M, Montori VM, et al. Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA. 2010;303:1180-1187. 11. Montori VM, Devereaux PJ, Adhikari NK, et al. Randomized trials stopped early for benefit: a systematic review. JAMA. 2005;294:2203-2209. 12. Miller FG, Joffe S. Equipoise and the dilemma of randomized clinical trials. N Engl J Med. 2011;364:476-480. 13. Ranpura V, Hapani S, Wu S. Treatment-related mortality with bevacizumab in cancer patients: a meta-analysis. JAMA. 2011;305:487-494. 14. Richardson PG, Barlogie B, Berenson J, et al. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med. 2003;348:2609-2617. 15. Moreau P, Pylypenko HV, Grosicki S, et al. A phase 3 prospective randomized international study (MMY-3021) comparing subcutaneous and intravenous administration of bortezomib in patients with relapsed multiple myeloma. Presented at the 52nd American Society of Hematology Annual Meeting; Orlando, FL; December 4-7, 2010.

Reader Survey

What inspired you to become a hematology/oncology pharmacist? T

he Oncology Pharmacist recently asked its online reading community to share their inspiration for becoming a hematology/oncology pharmacist. The response was overwhelming. It is abundantly clear that those involved in the field are passionate, caring, and extremely optimistic. Repeatedly responses highlighted a single person who inspired a career choice and a desire to help those living with cancer. Below, we share with you excerpts from several responses. To view more responses, please visit us at www.TheOncologyPharmacist.com.

I was diagnosed with CLL [chronic lymphocytic leukemia] and received chemotherapy in 2005. I began working as a hematology/oncology pharmacist 1 month after finishing chemotherapy. Euless P. Sacramento, California Two reasons: the personal experience of my father undergoing 8 lines of treatment for CLL [chronic lymphocytic leukemia], and the fact there is always something new. Isabel C. Vallejo, California

September 2011 I VOL 4, NO 6

I greatly enjoy working with the patients at an oncology practice complete with its own infusion room. Tom H. Providence, Rhode Island I survived Hodgkin lymphoma 11 years ago and wanted to help others survive their cancers. Kerry P. Birmingham, Alabama My cousin was struggling with latestage ovarian cancer as I was finishing pharmacy school. Simultaneously, paclitaxel was getting US Food and Drug Administration approval. Zahra S. Las Cruces, New Mexico Our most sincere gratitude to all who participated in this survey.

Want to Participate in Next Month’s Survey? See page 10 for details www.TheOncologyPharmacist.com

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The Whole Patient Cancer and the Workplace Continued from cover agents for the treatment of cancer have normalized further the cancer treatment experience. Today’s cancer care paradigm has led to new challenges regarding cancer and the workplace. Despite a number of laws protecting the rights of employees with cancer and their caregivers in the workplace, numerous obstacles confront anyone continuing to work during treatments or reentering the workplace after active cancer treatments. Many myths about cancer abound in our society, and also in the workplace. Employers, supervisors, and coworkers may assume that patients with cancer will not be able to perform job responsibilities after cancer as they did before the cancer diagnosis. They also may perceive these individuals or their caregivers as a poor risk for promotion. Any or all of these attitudes may lead to subtle or blatant workplace discrimination. In spite of the progress in the treatment of cancer, it is important to note that, for some, return to work may not be a feasible option. They might not be able to sustain a workday combined with their commute.1 The Meaning of Work “[Work] is about a search, too, for daily meaning as well as daily bread, for recognition as well as cash....” —Studs Terkel Working: People Talk About What They Do All Day and How They Feel About How They Do It

There are a number of reasons to continue or return to work: independence, identity, economic necessity, health insurance, social support, sense of purpose, satisfaction from work, and productivity. Many cancer patients and survivors appreciate the distraction work offers from thinking about cancer. Most adults spend more than half of their waking hours in the workplace. Returning to work during or after cancer treatments restores an important sense of self apart from the disease— something that may have been lost while not working. Continuing to work may be emotionally, socially, and cognitively helpful to patients during and after treatment. When a person living with cancer returns to work, deciding to tell an employer about his or her condition is a personal decision. Some workplace legal protections, however, require disclosure to human resources or one’s supervisor to benefit from these laws. Thanks to new laws put into place in the past few decades, this information remains confidential.

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Key Legal Protections The Americans with Disabilities Act (ADA). Enacted in 1990 by Congress, the ADA took effect in 1992. This national mandate eliminates discrimination against individuals with disabilities. Organizations with 15 or more employees must comply with ADA guidelines. Patients with cancer are protected under the ADA if the following criteria are met2:

Knowing that they have the backing of the EEOC can provide strength to patients with cancer who are either reentering the workforce or who are in the workforce.

• Classified as a “disabled person” under ADA • Qualified for the job • Able to perform the essential functions of the job • The employer has provided a reasonable accommodation; and this accommodation will not cause “undue hardship” to the employer • The patient does not pose a direct threat to his or her own or others’ health or safety. The most frequent workplace accommodation required by patients with cancer is flexibility in their work hours. They may need to leave early or come in late because of scheduled radiation or chemotherapy appointments. If flextime is required, it is critical the patient request a workplace accommodation by disclosing to his or her supervisor or human resources personnel the cancer diagnosis, so the flextime comes under the protection of the ADA.2 If no reason is given for a request of flextime, the employer could document time and leave problems, which could jeopardize job security. The ADA protects people living with cancer and cancer survivors when they apply for a job. The ADA prohibits an employer from asking any questions regarding health history or current medical status during job interviews or any time before an offer is made. Patients living with cancer, as well as survivors, are not required to share their health history with prospective employers. After a position is offered, however, if the company requires all employees to undergo a physical examination or drug testing, then it is prudent for the patient

with cancer to provide full disclosure to the medical personnel conducting the examination.2 The Family and Medical Leave Act (FMLA). Enacted in 1993, the FMLA enables both patients with cancer and their family members to take an unpaid leave for health challenges that make them unable to perform their job functions. A person may take up to 12 weeks of unpaid leave within 1 year. The employer is required to continue health benefits during FMLA leave. The FMLA applies to organizations with 50 or more employees, and the employee must have worked with his or her employer for at least 1 year, in which he or she has worked for 1250 hours (about 25 hours per week).3 The 12-week leave does not have to be taken all at once. Intermittent FMLA allows the employee to take time in blocks, such as several hours a day or 1 hour at a time. The FMLA also allows the employee to use accrued paid annual leave or accrued sick leave during family or medical leave. It is important to realize that the employer is not required to reinstate an employee who takes more than 12 weeks’ leave in a year. In addition, to be defined as “family members,” the employee must be either a

parent (including parents of young and/or adult children), a child (including adult children), or a spouse. The employer may request a medical certification by a doctor or other healthcare provider.3 The Equal Employment Opportunity Commission (EEOC). This federal agency was created to address the needs of citizens who have been discriminated against in the workplace. An employee who feels that there is subtle or blatant discrimination in the workplace should contact the EEOC directly before retaining a lawyer. This underused public resource is the federal enforcer of the ADA and FMLA. The EEOC will investigate any allegations against an employer or perceived discrimination or inappropriate behavior and policies. EEOC staff is helpful for people currently working, as well as for those seeking employment, who have questions about the job interview process and preoffer phase of work reentry. A charge must be filed with the EEOC within 180 days of the discrimination. The EEOC is invaluable in assisting with workplace complaints. Knowing that they have the backing of the EEOC can provide strength to patients with cancer who are either reentering the workforce or who are in the workforce.4

Table Tips for Returning to Work 1. Ask about follow-up care. If necessary, make sure you have a plan with your doctor, nurse, and/or social worker about any concerns regarding physical, emotional, or practical issues you may have. It is critically important that the medical team knows exactly what each patient’s job entails. This information helps in scheduling doctor visits and their impact on time out of the office, work projects, or work flow. 2. Set up an interview with the human resource department and/or manager to discuss your needs. It is always helpful to have a simple note from your treating oncologist to document any accommodations required. This can include flexible work schedule and necessary accommodations. Human resources and/or your manager can set up a plan to reasonably accommodate your requests. 3. Once back to work, move at your own pace. It is essential for your physical and emotional well-being that you do not try to place too many tasks on your plate. Scheduling periodic 10- to 15-minute breaks can help ease stress and the process of returning to work. Along with this, you must remember to… 4. Diminish as many unnecessary stresses as possible. With this, it is important to be able to say “no” to tasks that are not imperative. This is so you do not become overburdened. Stress can be eased in a multitude of other ways too, from eating a well-balanced diet to going out for a walk. 5. Most importantly, stay true to yourself. If you are naturally open, feel free to tell your coworkers how you are doing and, if you need their help, let them know what they can do to help. If you are more private, just tell everyone that you are glad to be back at work, appreciate their asking, and thank them for their interest. This approach will help protect your privacy during this time. Source: Cancer and Careers. Your mindset. www.cancerandcareers.org/en/at-work/Your-Mindset. Accessed August 29, 2011.

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The Whole Patient The Health Insurance Portability and Accountability Act (HIPAA) of 1996. HIPAA ensures privacy of patient medical information. It protects medical diagnoses and/or treatment by limiting those who have access to the patient’s health records and by requiring the patient’s consent to share such information. It also protects the rights of people when they are part of group health plans and gives the option of bringing the patient’s health insurance to another job in the future.5

his or her cancer or disease risk and/or family history of disease cannot be a reason for an employer to not hire.6

The Genetic Information Nondiscrimination Act (GINA) of 2008. This act prohibits discrimination based on genetic information, with respect to employment opportunities and health insurance companies. Therefore, if a patient is looking for new employment,

Psychosocial Aspects of Returning to the Workplace Cancer not only takes a toll on patients’ and survivors’ physical well-being, but also impacts their psychosocial outlook. Sadness, anxiety, fear, uncertainty, shame, and other emotional concerns

Young adult survivors need opportunities to learn about the laws that protect them against discrimination as well as their rights for workplace accommodations due to cancer, its treatment, or long-term side effects.

Selected Resources for Cancer Patients and Survivors in the Workplace American Cancer Society www.cancer.org 800.227.2345 Americans with Disabilities Act www.ada.gov 800.514.0301 Cancer and Careers www.cancerandcareers.org CancerCare www.cancercare.org 800.813.HOPE (4673) Equal Employment Opportunity Commission www.eeoc.gov 800.669.4000 I’m Too Young for This Cancer Foundation www.i2y.org or www.stupidcancer.com 877.735.4673 Intercultural Cancer Council www.iccnetwork.org 713.798.4614 LIVESTRONG www.livestrong.org 866.673.7205 National Cancer Institute www.cancer.gov 800.4.CANCER (22.6237) National Coalition for Cancer Survivorship www.canceradvocacy.org 888.650.9127 Planet Cancer www.planetcancer.org

September 2011 I VOL 4, NO 6

may arise. Psychosocial support and guidance in coping is critically important at this time.7 In surveying 421 cancer experts, Greenfield and colleagues found that many correlated the receipt of information on cancer’s late effects as a potential barrier for follow-up doctor visits. Many also believed that such information potentially could increase patient anxiety.8 In addition, Carlson and colleagues assessed 3095 representative cancer patients over 4 weeks with the Brief Symptom Inventory-18, a common psychosocial problem checklist, and their awareness and use of psychosocial support services. They found that almost half of all patients who were distraught did not seek professional psychosocial support, nor did they intend to do so in the future.9 Informed and evidencebased practice, however, recommends that patients should be encouraged to seek psychosocial support during and after cancer treatments.7

The interdisciplinary healthcare team should work hard to identify those in need of support and to develop and implement outreach programs and services to meet their needs. The interdisciplinary healthcare team, therefore, should work hard to identify those in need of support and to develop and implement outreach programs and services to meet their needs.10 To help in this effort, Manicom described psychosocial challenges facing patients and their families along each step of the cancer journey.11 Whereas many clinicians are aware that, on diagnosis, many patients confront their mortality and experience overwhelming emotions, they may need to be reminded that psychosocial challenges also are present at other stages of the continuum. For example, on ending treatment, patients may need to cope with a withdrawal of support from family and friends and adjust to a “new normal” that requires managing possible ongoing physical limitations. In addition, on terminal illness, patients will

need to face the disappointment of stopping active treatment and moving to supportive care as well as plan for those who will be left behind.11 Young Adults with Cancer and the Workplace Young adults have unique priorities and psychosocial concerns related to their age and life-cycle developmental challenges. They experience particular lifecycle issues as they deal with the sequelae of cancer.12 Young adults may be entering the workforce for the first time as well as trying to figure out and plan the future direction of their career and life choices. Their specific psychosocial challenges focus on establishing independence, dating and romantic relationships, discovering the impact of cancer treatments on fertility and body image, seeking to establish their personal identity, choosing a career, deciding whether to continue school, and obtaining health insurance.12 More than one-third of cancer survivors are young adults.7 Yet, peer support may not be at its peak for young adults, who may be more focused on enhancing their education, starting a career, or handling the psychosocial challenges previously identified. These developmental challenges may cause young adult cancer patients to experience significant isolation from peers as well as biological changes from their cancer and its treatments.12 Clinical trial data often are based on older cancer patients; therefore, treatment side effects and the impact of treatments on loss of muscle mass or changes in metabolic rate may impact young adults differently and require further study (A. Eckhard, oral communication, 2011). Fortunately, in the United States and in developed countries globally, there is increased interest in the needs of young adult cancer patients and survivors. There is a proliferation of support groups for young adults as well as specialized cancer centers conducting research focused on young adults and cancer. In spite of this progress, the unique issues young adults confront may leave them with more difficulties when pursuing employment because of their lack of experience and knowledge of their legal protections and/or their many psychosocial concerns. These may put young adults at a competitive disadvantage in the labor market, especially if cancer has caused a noticeable physical disability or a perceived difference in the self-image of a young adult.7 Young adult survivors need opportunities to learn about the laws that protect them against discrimination as well as their rights for workplace accommodations due to cancer, its treatment, or long-term side effects. If a young adult is undergoing treatment

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The Whole Patient and wants to continue working for financial or other reasons, legal protections exist to protect his or her job as long as he or she is able to perform the essential functions of the job. There is no “right” way to cope with cancer. Every individual is different and responds to psychosocial life crises in his or her own way. There are increasing numbers of young adults living with cancer, and survivors are using psychosocial and practical support services to cope with their cancer experience and journey. To help, Cancer and Careers, an organization that helps empower and educate people with cancer to thrive in their workplace, has devised tips for cancer patients and survivors looking to return to work (Table, page 21). Financial Resources Unfortunately, many young adults do not have health insurance. In addition, their cancer may be diagnosed at a later stage because of their age. If not able to work, there are resources for financial assistance. They should start looking for this financial aid with the Social Security Administration. Supplemental Security Income (SSI) is what most young adults will receive if they have not worked enough quarters to qualify for Social Security.13 Older adults may apply for retirement benefits from their workplace, private insurance, or investments. Those who have worked ade-

quate quarters can apply for Social Security Disability benefits. The SSI application process includes an interview. If a patient is rejected, he or she must make sure to appeal. During treatment, money is a concern, so any aid can be beneficial. Once determined eligible for SSI, the patient will be enrolled automatically for Medicaid, which will pay for medical expenses. Patients also should apply for food stamps from the US Department of Agriculture.

Once determined eligible for SSI, the patient will be enrolled automatically for Medicaid, which will pay for medical expenses. Patients also should apply for food stamps from the USDA.

The Patient Protection and Affordable Care Act (ACA) of 2010. This recent law helps patients with the struggles of health insurance companies denying coverage for any reason. These reasons may include health status and/or gender, which can cause rates to skyrocket. This

act also requires most people to have health insurance by 2014.5 The Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1986. This act provides the continuation of group health coverage that might otherwise be terminated. It offers the right to temporary continuation of health coverage for 18 months after an individual has left the company and lets the patient continue seeing his or her doctors, because the healthcare plan has remained unchanged.5 Help for Young Adults Young adults with cancer should never feel as if they are alone. There are a variety of specific resources available for them and more aid is being created every day (Sidebar). When reentering the workforce or if entering it for the first time, young adults should be aware of their rights. They should familiarize themselves with the laws that protect them, the psychosocial effects they may feel before, during, and after treatment, and the many ways to cope that would be beneficial for them. With supportive guidance and a dedicated healthcare team, the cancer journey becomes more manageable. ● References 1. Fleischman SB. Learn to Live Through Cancer: What You Need to Know and Do. New York, NY: Demos Health Publishing; 2011.

2. American Cancer Society. Americans with Disabilities Act: information for people facing cancer. December 7, 2010. www.cancer.org/Treatment/FindingandPayingfor Treatment/UnderstandingFinancialandLegalMatters/ame ricans-with-disabilities-act. Accessed August 30, 2011. 3. American Cancer Society. Family and Medical Leave Act (FMLA). May 19, 2010. www.cancer.org/Treat ment/FindingandPayingforTreatment/UnderstandingFin ancialandLegalMatters/family-and-medical-leave-act. Accessed August 30, 2011. 4. The US Equal Employment Opportunity Commission. Questions and answers about cancer in the workplace and the Americans with Disabilities Act. January 19, 2011. www.eeoc.gov/facts/cancer.html. Accessed August 30, 2011. 5. Cancer and Careers. New insurance legislation (HIPAA, COBRA, GINA, PPACA). www.cancerand careers.org/en/at-work/Legal-and-Financial/NewInsurance-Legislation-HIPAA-COBRA-GINAPPACA. Accessed August 29, 2011. 6. Sheppard Mullin Labor & Employment Law Blog. The Genetic Information Nondiscrimination Act of 2008: civil rights or science fiction? May 22, 2008. www.laboremploymentlawblog.com/discrimination-thegenetic-information-nondiscrimination-act-of-2008civil-rights-or-science-fiction.html. Accessed August 29, 2011. 7. Adler NE, Page AEK, eds. Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs. Washington, DC: National Academies Press; 2008. 8. Greenfield DM, Absolom K, Eiser C, et al. Follow-up care for cancer survivors: the views of clinicians. Br J Cancer. 2009;101:568-574. 9. Carlson LE, Angen M, Cullum J, et al. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004;90:2297-2304. 10. Holland JC, Breitbart WS, Jacobsen PB, et al, eds. Psycho-Oncology. 2nd ed. New York, NY: Oxford University Press; 2010. 11. Manicom C. Psychosocial cancer care: there is more to cancer than medical management. African Journals Online. 2010;28:58-63. 12. Odo R, Potter C. Understanding the needs of young adult cancer survivors: a clinical perspective. Oncology (Williston Park). 2009;23(11 suppl nurse ed):23-27, 33. 13. Social Security Administration. Understanding Supplemental Security Income: SSI eligibility requirements. 2011 Edition. www.ssa.gov/ssi/text-eligibilityussi.htm. Accessed August 30, 2011.

Noteworthy Numbers

AYA Oncology By the Numbers

ach year, a significant number of adolescents and young adults (AYAs), aged 15 to 39 years, are faced with a cancer diagnosis. And yet, there has been a lack in progress when it comes to treating this age-group. To better understand the facts and figures associated with these patients, let’s take a closer look at AYA oncology by the numbers.

Over the past 30 years, cancer incidence in young adults has increased more than any other age-group… However, survival rates among AYAs have not improved at the same rate as other age-groups. Each year 70,000 AYAs aged 15 to 39 years are diagnosed with cancer. This is equivalent to 1 diagnosis every 8 minutes. The incidence of specific www.TheOncologyPharmacist.com

cancer types varies dramatically across the AYA age continuum. For example, leukemias, lymphomas, and germ-cell tumors (cancers that begin in cells that give rise to sperm or eggs, such as testicular cancer) are the most common cancer types in younger AYAs… However, by ages 25 through 39, these cancers decline in frequency, whereas other cancers—cervical, colorectal,

and particularly breast— comprise a growing share of cancers in older AYAs. Among AYA women, cancer is the most common disease-related cause of death. For AYA men, cancer is the second most common disease-related cause of death. (Heart disease is the most common.) Among AYAs, only unintentional injury, suicide, and

homicide claim more lives than cancer. There are more than 350,000 long-term childhood cancer survivors in the United States under the age of 40. One AYA loses his or her fight with cancer approximately every hour. Among the US college student population, 1 in 100 is a cancer survivor. Sources: National Cancer Institute; The I’m Too Young For This! Cancer Foundation.

SePTember 2011 I VOL 4, NO 6

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Answered!

Your FAQs... Q:

What are some treatment options for elderly patients with chronic lymphocytic leukemia?

darabine-based regimens. Dose-reduced regimens, therefore, were developed to ameChronic lymphocytic leukemia (CLL) is a neoplastic disease charliorate treatment toxicity while maintaining efficacy. Several small studies have acterized by the accumulation of monoclonal lymphocytes in reported decent response rates and modest toxicity of either low-dose fludarabine blood, bone marrow, and lymphoid tissue.1 It is the most common form of leukemia in adults worldwide, with prevalence increasing monotherapy or low-dose fludarabine/cyclophosphamide combination. Foon and with age. The median age at diagnosis of CLL is 70 years.2 CLL colleagues evaluated a regimen with decreased doses of fludarabine/cyclophosis diagnosed by the presence of at least phamide, dubbed FCR-Lite, in untreated CLL patients. Results 5000/µL monoclonal B lymphocytes (positive for CD5, showed a 79% CR, with a 95% ORR and a reduction in grade Older patients CD19, CD20, and CD23) by peripheral flow cytometry of 3/4 neutropenia (13%) compared with 52% in the full-dose the blood. Patients typically are followed with a watch-and- (18 of 64 patients >70 FCR regimen. The median age, however, was 58 years, which wait approach until indications for treatment are met. does not represent the median age for patients with CLL. Of Decisions regarding treatment selection are based on sever- years) tolerated PCR 7 patients >70 years, 4 achieved a CR and completed 6 cycles ity of CLL in addition to patient characteristics, including as well as younger of FCR-Lite (full course of treatment); 3 achieved partial comorbidities.3 remission, but none completed 6 cycles of therapy. In addipatients and were Results of German CLL Study Group-8 and the internation, 1 patient aged 69 years also did not complete 6 cycles, tional Study of Relapsed Chronic Lymphocytic Leukemia suggesting that FCR-Lite is better tolerated in a younger just as likely to (REACH) showed that combination therapy with fludarapatient population.9 complete 6 cycles of Pentostatin/cyclophosphamide/rituximab (PCR) also has bine/cyclophosphamide/rituximab (FCR) improves the been studied in older patients with CLL. Shanafelt and coloverall response rate (ORR) and complete remission (CR) therapy and to leagues found that older patients (18 of 64 patients >70 rate, as well as prolongs progression-free survival (PFS) and achieve complete years) tolerated PCR as well as younger patients and were overall survival (OS) when used in the first line.4,5 FCR, therefore, currently is accepted as the gold standard in or partial remission just as likely to complete 6 cycles of therapy and to achieve physically fit patients. Further analysis of the data, howevcomplete or partial remission without excess grade 3/4 toxiwithout excess er, showed that the FCR regimen provided no benefit in city.10 More data are needed, however, to answer the ques6 the 10% of patients who were 70 years of age or older. grade 3/4 toxicity. tion of whether pentostatin is less toxic than fludarabine in There is no clearly superior first-line therapy for elderly elderly/comorbid patients. patients with CLL, and despite the fact that two-thirds of Bendamustine is a chemotherapy agent that combines the the patients diagnosed with CLL are aged older than 65 years, few studies have properties of an alkylating agent and a purine analog. In a study of treatment-naïve explored the efficacy and toxicities of therapies in this population. Clinicians patients with CLL, bendamustine was shown to be more efficacious than chloramoften have concern about offering elderly patients chemotherapy because of their bucil, with a CR rate of 31% and PFS of 21.6 months.11 However, the median age of these patients was 64 years and the number of elderly patients enrolled was small, increased comorbidity and higher rates of treatment-related toxicities. making it difficult to determine if it is appropriate for this population. First-Line Treatment Options for Elderly/Comorbid Patients Danese and colleagues recently published an observational study of patients Current recommendations by the National Comprehensive Cancer Network (NCCN) for frail patients or those with significant comorbidity (unable to tolerate purine analogs, ie, fludarabine) include chlorambucil with/without prednisone, single-agent rituximab, and pulse steroids.3 Chlorambucil was first used for the treatment of CLL in the 1950s and remains the standard treatment for frail elderly patients. Of the several possible dosing schedules for chlorambucil, the most optimal regimen has not yet been identified. For patients aged 70 years or older, NCCN Guidelines currently recommend 8 different regimens: chlorambucil, with/without prednisone; bendamustine/rituximab; Taussig Cancer Institute cyclophosphamide/prednisone, with/without rituximab; alemtuzumab/rituximab/flu3 darabine, with/without rituximab; and cladribine. None are specified as preferred. Cleveland Clinic Foundation German CLL Study Group-5, which focused on the elderly, randomized 193 patients Cleveland, Ohio aged 65 years or older to receive therapy with fludarabine or chlorambucil. Results demonstrated higher response rates with fludarabine, but these did not translate to prolonged PFS or OS. Hillmen and colleagues compared alemtuzumab and chlorambucil as initial therapy for CLL. Results showed a higher response rate with alemDo you have a question you’d like answered? tuzumab (83% vs 55%).7 However, in a subgroup analysis of 105 patients aged 65 8 E-mail us at editorial@greenhillhc.com years or older, median PFS did not increase, remaining at 12.5 months. Myelotoxicity and infection are potential complications of treatment with flu-

This Month’s FAQ

Answered by:

James Karol, MS, PA-C

SePTember 2011 I VOL 4, NO 6

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Answered!

Your FAQs... aged 66 years or older with CLL who were registered in the Surveillance, Epidemiology and End Results program. Of 6433 patients, 2040 received infused therapy: 16% received rituximab monotherapy, 14% rituximab plus chemotherapy, and 70% chemotherapy alone. Rituximab plus chemotherapy was associated with a 25% lower risk of overall mortality compared with chemotherapy alone.6 These results suggest that initial treatment with rituximab was associated with improved survival in a heterogeneous group of older CLL patients. Future Directions Results of a recent phase 2 study to evaluate the therapeutic potential of lenalidomide in elderly patients for initial treatment were recently published.8 Len alidomide, an immunomodulatory agent that activates the T and natural killer cells, downregulates several critical prosurvival cytokines, and affects antibodydependent cell-mediated cytotoxicity. ORR was 65%, with a 2-year OS rate of 88%, which compares favorably with studies involving chlorambucil, fludarabine, or alemtuzumab monotherapy. Neutropenia was the most common side effect, occurring in 34% of cycles. Grade 1 and 2 tumor flare reactions were common; no severe reactions were noted. Study investigators noted that tumor flare was associated with a higher likelihood of response, as suggested by other published findings in patients with CLL. Additional phase 2 clinical trials are ongoing to evaluate combination immunomodulating agents and rituximab in untreated patients with CLL. Conclusion Optimal treatment of elderly patients with CLL has not been clearly defined. Patients aged 70 years or older have been underrepresented in past clinical trials, making the selection of treatment regimens complex compared with selection for younger patients. Multiple chemotherapy regimens exist for elderly patients with good performance stat us and without comorbidities. Chlorambucil is the current standard treatment for elderly frail patients. Supportive therapy is always an option for severely comorbid patients. Promising new agents, such as lenalidomide with or without monoclonal antibody therapy, are being studied. Ongoing clinical trials enrolling patients older than 70 years hopefully will improve survival and quality of life in this population in the future. â&#x2014;? References 1. Amrein PC. Chronic lymphocytic leukemia. In: Chabner BA, Lynch TJ Jr, Longo DL, eds. Harrisonâ&#x20AC;&#x2122;s Manual of Oncology. New York, NY: McGraw-Hill; 2008:263-274.

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2. Rai KR, Keating MJ. Initial treatment of chronic lymphocytic leukemia. June 13, 2011. www.uptodate.com/ contents/initial-treatment-of-chronic-lymphocyticleukemia. Accessed August 26, 2011. 3. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Non-Hodgkinâ&#x20AC;&#x2122;s Lymphomas. Version 4.2011. www.nccn.org/professionals/physi cian_gls/pdf/nhl.pdf. Accessed August 26, 2011. 4. Hallek M, Fingerle-Rowson G, Fink AM, et al. Firstline treatment with fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) improves overall survival (OS) in previously untreated patients (pts) with advanced chronic lymphocytic leukemia (CLL): results of a randomized phase III trial on behalf of an international group of investigators and the German CLL Study

Group. Blood (ASH Annual Meeting Abstracts). 2009; 114:Abstract 535. 5. Robak T, Dmoszynska A, Solal-CĂŠligny P, et al. Rituximab plus fludarabine and cyclophosphamide prolongs progression-free survival compared with fludarabine and cyclophosphamide alone in previously treated chronic lymphocytic leukemia. J Clin Oncol. 2010;28:1756-1765. 6. Danese MD, Griffiths RI, Gleeson M, et al. An observational study of outcomes after initial infused therapy in Medicare patients diagnosed with chronic lymphocytic leukemia. Blood. 2011;117:3505-3513. 7. Hillmen P, Skotnicki AB, Robak T, et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol. 2007;25:5616-5623.

Whatâ&#x20AC;&#x2122;s Hot in

8. Badoux XC, Keating MJ, Wen S, et al. Lenalidomide as initial therapy of elderly patients with chronic lymphocytic leukemia. Blood. July 1, 2011. Epub ahead of print. 9. Foon KA, Boyladzis M, Land SR, et al. Chemoimmunotherapy with low-dose fludarabine and cyclophosphamide and high dose rituximab in previously untreated patients with chronic lymphocytic leukemia. J Clin Oncol. 2009;27:498-503. 10. Shanafelt TD, Lin T, Geyer SM, et al. Pentostatin, cyclophosphamide, and rituximab regimen in older patients with chronic lymphocytic leukemia. Cancer. 2007;109:2291-2298. 11. Knauf WU, Lissichkov T, Aldaoud A, et al. Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia. J Clin Oncol. 2009;27:4378-4384.

SEPTEMBER 2011

JOURNAL OF

VOL 1 I NO 3

HEMATOLOGY ONCOLOGY PHARMACY TM

THE PEER-REVIEWED FORUM FOR ONCOLOGY PHARMACY PRACTICE

EDITORIAL Brother, Can You Spare Some Chemotherapy? No End in Sight for Drug Shortages

Timothy G. Tyler, PharmD, FCSHP ORIGINAL RESEARCH Ifosfamide Neurotoxicity in Pediatric Patients: A Multi-Institutional Case Series Report

Amy Lee, MD; David W. Henry, MS, BCOP, FASHP; John Szechung Ng, PharmD; Kerry Parsons, PharmD, BCOP; Betsy Bickert Poon, PharmD, FCCP; Jeff Schwartz, MD; Tara Smith, PharmD; Chatchawin Assanasen, MD Carboplatin Dosing in Overweight and Obese Patients: A Single-Center Experience

Ginah Nightingale, PharmD, BCOP; James A. Trovato, PharmD, MBA, BCOP, FASHP; Myounghee Lee, PhD, PharmD; Jennifer Thompson, PharmD, BCOP COMMENTARY Dosing Chemotherapy in Obese Patients: No Clear Answers, Yet

Scott Soefje, PharmD, BCOP

From the Literature Concise Reviews from the Literature Relevant to Hematology Oncology Pharmacy

Robert J. Ignoffo, PharmD, FASHP, FCSHP

This Month September 2011

ÂŠ2011 Green Hill Healthcare Communications, LLC www.JHOPonline.com

â&#x20AC;˘ Brother, Can You Spare Some Chemotherapy? No End in Sight for Drug Shortages Timothy G. Tyler, PharmD, FCSHP

â&#x20AC;˘ Ifosfamide Neurotoxicity in Pediatric Patients: A Multi-Institutional Case Series Report Amy Lee, MD; David W. Henry, MS, BCOP, FASHP; John Szechung Ng, PharmD; Kerry Parsons, PharmD, BCOP; Betsy Bickert Poon, PharmD, FCCP; Jeff Schwartz, MD; Tara Smith, PharmD; Chatchawin Assanasen, MD

â&#x20AC;˘ Carboplatin Dosing in Overweight and Obese Patients: A Single-Center Experience Ginah Nightingale, PharmD, BCOP; James A. Trovato, PharmD, MBA, BCOP, FASHP; Myounghee Lee, PhD, PharmD; Jennifer Thompson, PharmD, BCOP

â&#x20AC;˘ Dosing Chemotherapy in Obese Patients: No Clear Answers, Yet Scott Soefje, PharmD, BCOP

Subscribe Today to Receive the Next Issue www.JHOPonline.com

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Pharmacoeconomics New Resource Available to Help... Continued from cover product would require fewer resources than an IV product. Those resources need to be factored in.” The workbook is accompanied by 3 webinars, which will cover a practical approach to pharmacoeconomics. We now have more anticancer options than ever before. ACCC’s goal is to help hospital cancer programs accurately assess the true value associated with these drug-based therapies. “As hospitals continue to face increasing pressures to provide the highest quality care for the lowest possible cost, understanding the true value of the health services they provide to patients is critical for their continued viability,” said ACCC president Thomas L. Whittaker, MD. With healthcare reform and increased cost-consciousness, oncology pharmacists are faced with continued pressures to adhere to budgetary restrictions and keep down the costs of drugbased therapy. Whereas some pharmacists may approach this task with the required level of sophistication, some may translate the requirement to keep costs down into an overly simplistic rule of selecting drugs with the lowest purchase price. An emphasis solely on purchase price

ignores the reality that there are numerous other “costs” associated with drug use, including dosing, treatment side effects, and costs needed to support the use of a drug. Consequently, providers who rely entirely on drugs that initially cost less often may spend considerably more because of the additional staff, space, and supportive resources that these drugs can require. Timothy Tyler, who is director of pharmacy services at the Desert Regional Medical Center in Palm Springs,

California, helped develop the workbook. He said this type of tool may be highly beneficial in preserving the most appropriate treatments for each individual patient. “One of the biggest concerns facing pharmacists today is the drug shortage. It is impacting everyone in the pharmacy,” Tyler said in an interview with The Oncology Pharmacist. “In the current scenario with drug shortages, it helps to look at things through an economic viewpoint and offer analyses.” “The Practical Cancer Pharmacy” begins with an overview of pharmacoeconomics. Using the principle that the best way to learn is to do, the workbook includes an exercise in which readers will conduct a pharmacoeconomic analysis. The text, presented in nontechnical terms, makes the subject matter more accessible to those with little familiarity with formal methods for health technology assessment. Readers gain sufficient grounding in the discipline so that they can both understand pharmacoeconomic studies done by others and contribute to pharmacoeconomic analyses undertaken at their institutions. The workbook explores the 7 major steps involved in estimating the cost-utility of one oncology drug compared with another:

1. What type of pharmacoeconomic analysis is best? 2. How should the analysis be designed? 3. Who is the client for results? 4. How should the relevant factors be measured? 5. Where do you get the data? 6. How do you build the model and interpret results? 7. How should you present the findings to decision makers? Although no oncology drugs are mentioned by name, through a series of assignments the workbook helps the reader build a decision-analytic model to estimate the relative cost-utility of 2 hypothetical drugs indicated for recurrent, metastatic breast cancer patients. The discussion centers on measures of costs, outcomes, and patient preferences. In addition, the reader learns how to compute the cost-effectiveness ratios of 2 hypothetical antiemetics. ● The publication and archived webinars are available through ACCC’s Center for Provider Education and ACCC’s Oncology Pharmacy Education Network (OPEN). They can be accessed at www.accc-cancer.org/openweb.

BEST PRACTICES

Hospital Uniforms Often Contain Dangerous Bacteria By John Schieszer

ore than 60% of hospital staff uniforms are colonized with potentially pathogenic bacteria, according to a new study (Am J Infect Control. 2011;39:555-559). The findings suggest that physicians and nurses may be transferring pathogens that could cause clinically relevant infection. Interestingly, the findings may have significant implications for oncology pharmacists. The investigators found antibiotic-resistant bacteria isolated from samples from 14% of nurses’ uniforms and 6% of physicians’ uniforms. “With the pharmacists, we rely on them for their clinical expertise, and they are at the center of advising physicians on guiding antibiotic use. We draw on pharmacy quite a bit,” said Russell Olmsted, MPH, who is president of the Association for Professionals in Infection Control and Epidemiology. “Pharmacists are the key partners in this one area in particular.” He said pharmacists now more than ever play a pivotal role in safe medication practices, antibiotic stewardship, and safe injection practices. All of these tasks are pivotal in preventing nosocomial infections. In recent years, studies have shown that physicians’ white coats

September 2011 I VOL 4, NO 6

and ties, medical students’ coats, and nurses’ uniforms have been colonized with pathogenic organisms and could be potential sources of cross-infection. It is believed that the greatest amount of contamination may occur in areas of greatest hand contact, such as pockets and cuffs, allowing recontamination of already washed hands. In the current study, researchers at the Shaare Zedek Medical Center in Jerusalem, Israel, collected swab samples from 3 areas of the uniforms of 75 registered nurses (RNs) and 60 medical doctors (MDs) by pressing standard blood agar plates at the abdominal zone, sleeves’ ends, and pockets. The researchers found that more than half of all the cultures taken (65% of the RN uniforms and 60% of the MD uniforms) harbored pathogens. Of those, 21 cultures from RN uniforms and 6 cultures from MD uniforms contained multidrug-resistant pathogens, including 8 cultures that grew methicillin-resistant Staphylococcus aureus. Although the uniforms themselves may not pose a direct risk of disease transmission, these results indicate a prevalence of antibiotic-resistant strains in close proximity to hospital-

ized patients. The study was conducted at a 550bed, university-affiliated hospital. It is unknown how widely applicable these findings are to community hospitals and cancer centers in the United States. The study did not include pharmacists. However, Olmsted said pharmacists are probably at a significantly lower risk of transferring pathogenic bacteria. “Theoretically, they have lower risk of harboring these microorganisms. But some do a lot of patient care and provide immunizations. It is a concern for them,” said Olmsted in an interview with The Oncology Pharmacist. He said any clothing that is worn by humans will become contaminated with microorganisms. The cornerstone of infection prevention remains the use of good hand hygiene to prevent the movement of microbes from surfaces to patients. “We need more champions, and pharmacists can be champions by promoting good hygiene practices among their colleagues and other healthcare workers,” said Olmsted. He noted that pharmacists are strong supporters of immunizations against vaccine-preventable diseases. Influenza-vaccinat-

ed patients, for example, have a much lower risk of developing bacterial complications. “If you immunize them, they have a lower risk of developing healthcare-associated infections,” he noted. According to the World Health Organization, the risk of healthcareassociated infection (HAI) in some developing countries is as much as 20 times higher than in developed countries. Even in hospitals in developed countries such as the United States, HAIs occur too often, can be deadly, and are expensive to treat. A previous study conducted at a burn unit demonstrated the possibility of transferring S aureus from nurses’ gowns to patients and bed sheets. In this current study, researchers say the high prevalence of contaminated uniforms may be related to inadequate compliance with hand hygiene. However, that still needs to be further studied. Overall, the researchers isolated potentially pathogenic bacteria from 63% of sampled uniforms. They found no significant differences between nurses and physicians or between staff from medical departments and surgical departments. ●

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