Journal of Hematology Oncology Pharmacy - December 2011, VOL 1, NO 4

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The Peer-Reviewed Forum for Oncology Pharmacy Practice

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<ul><li><p>HEMATOLOGYONCOLOGYPHARMACY</p><p>JOURNAL OFVOL 1 I NO 4</p><p>DECEMBER 2011</p><p>THE PEER-REVIEWED FORUM FOR ONCOLOGY PHARMACY PRACTICETM</p><p>2011 Green Hill Healthcare Communications, LLCwww.JHOPonline.com</p><p>CLINICAL CONTROVERSIESBevacizumab in Metastatic Breast Cancer: Ready for Prime Time? CON: Katherine Mandock, PharmD, BCPS; </p><p>Scott A. Soefje, PharmD, BCOPPRO: Val R. Adams, PharmD, BCOP, FCCP</p><p>REVIEW ARTICLESCurrent Practice in the Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting in AdultsLisa K. Lohr, PharmD, BCOP, BCPS</p><p>The Evolution of Tyrosine Kinase Inhibitor Therapy: Improving Outcomes in Patients with Newly Diagnosed Chronic Myelogenous LeukemiaNatalie J. Greisl, PharmD; Christopher A. Fausel, PharmD, BCPS, BCOP</p><p>From the LiteratureConcise Reviews of Studies Relevant to Hematology Oncology Pharmacy Robert J. Ignoffo, PharmD, FASHP, FCSHP</p><p>1-Cover_Layout 1 12/19/11 1:12 PM Page 1</p></li><li><p>Find out whats new</p><p>www.XGEVA.com</p><p>2011 Amgen Inc. All rights reserved. 61187-R1-V1</p><p>Visit XGEVA.com</p><p>1-Cover_Layout 1 12/19/11 11:12 AM Page 2</p></li><li><p>3www.JHOPonline.com l Journal of Hematology Oncology Pharmacy Vol 1, No 4 l December 2011</p><p>EDITORIAL BOARD</p><p>CLINICAL CONTROVERSIESChristopher Fausel, PharmD, BCPS, BCOP Clinical DirectorOncology Pharmacy ServicesIndiana University Simon Cancer CenterIndianapolis, IN</p><p>PRACTICAL ISSUES IN PHARMACY MANAGEMENT Timothy G. Tyler, PharmD, FCSHP Director of PharmacyComprehensive Cancer CenterDesert Regional Medical CenterPalm Springs, CA</p><p>ORIGINAL RESEARCH R. Donald Harvey, PharmD, FCCP, BCPS, BCOPAssistant Professor, Hematology/Medical Oncology Department of Hematology/Medical OncologyDirector, Phase 1 UnitWinship Cancer InstituteEmory University, Atlanta, GA </p><p>REVIEW ARTICLESScott Soefje, PharmD, BCOPAssociate Director, Oncology PharmacySmilow Cancer Hospital at Yale New HavenYale New Haven HospitalNew Haven, CT</p><p>FROM THE LITERATURERobert J. Ignoffo, PharmD, FASHP, FCSHPProfessor of Pharmacy, College of PharmacyTouro UniversityCalifornia Mare Island Vallejo, CA</p><p>Patrick J. Medina, PharmD, BCOPAssociate ProfessorDepartment of PharmacyUniversity of Oklahoma College of PharmacyOklahoma City, OK </p><p>Val R. Adams, PharmD, BCOP, FCCPAssociate Professor, Pharmacy Program Director, PGY2 Specialty ResidencyHematology/OncologyUniversity of Kentucky College of PharmacyLexington, KY </p><p>SECTION EDITORS</p><p>CO-EDITORS-IN-CHIEF</p><p>Joseph Bubalo, PharmD, BCPS, BCOPAssistant Professor of MedicineOncology Clinical Specialist and Oncology LeadOHSU Hospital and ClinicsPortland, OR</p><p>Sandra Cueller, PharmD, BCOPDirectorOncology Specialty ResidencyUniversity of Illinois at Chicago Medical CenterChicago, IL</p><p>Sachin Shah, PharmD, BCOPAssociate ProfessorTexas Tech University Health Sciences CenterDallas, TX</p><p>Steve Stricker, PharmD, MS, BCOP Assistant Professor of Pharmacy PracticeSamford University McWhorter School of PharmacyBirmingham, AL </p><p>John M. Valgus, PharmD, BCOPHematology/Oncology Senior Clinical PharmacySpecialistUniversity of North Carolina Hospitals and ClinicsChapel Hill, NC</p><p>Daisy Yang, PharmD, BCOP Clinical Pharmacy SpecialistUniversity of Texas M. D. Anderson Cancer CenterHouston, TX</p><p>EDITORS-AT-LARGE</p><p>2-EditBoard_Cover 12/19/11 11:18 AM Page 3</p></li><li><p>4 l Journal of Hematology Oncology Pharmacy l www.JHOPonline.com December 2011 l Vol 1, No 4</p><p>Senior Vice President, Sales &amp; Marketing</p><p>Philip Pawelkophil@greenhillhc.com</p><p>PublisherJohn W. Hennessy</p><p>john@greenhillhc.com732.992.1886</p><p>Editorial DirectorDalia Buffery</p><p>dalia@greenhillhc.com732.992.1889</p><p>Associate EditorsBrett KaplanLara J. Lorton</p><p>Editorial AssistantJennifer Brandt732.992.1536</p><p>Directors, Client ServicesJoe Chanley</p><p>joe@greenhillhc.com732.992.1524</p><p>Jack Iannacconejack@greenhillhc.com</p><p>732.992.1537</p><p>Production ManagerStephanie Laudien</p><p>Quality Control DirectorBarbara Marino</p><p>Business ManagerBlanche Marchitto</p><p>blanche@greenhillhc.com</p><p>Editorial Contact:Telephone: 732.992.1536</p><p>Fax: 732.656.7938E-mail: JHOP@greenhillhc.com</p><p>TABLE OF CONTENTS</p><p>DECEMBER 2011 VOLUME 1, NUMBER 4</p><p>Journal of Hematology Oncology Pharmacy, ISSN applied for (print); ISSN applied for (online), is published 4 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. Journal ofHematology Oncology Pharmacy logo is a trademark of Green Hill Healthcare Com munications, LLC. No part of this publication may be reproduced or transmitted in any form or by anymeans 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.</p><p>EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DIRECTOR, Journal of Hematology Oncology Pharmacy, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ08831. E-mail: JHOP@greenhillhc.com. YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issues, $17.00. Orders will bebilled 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 inthis journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Commun i cations, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831.The ideas and opinions expressed in Journal of Hematology Oncology Pharmacy do not necessarily reflect those of the Editorial Board, the Editorial Director, or the Publisher. Publication ofan advertisement or other product mention in Journal of Hematology Oncology Pharmacy should not be construed as an endorsement of the product or the manufacturers claims. Readers areencouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the Editorial Board nor the Publisher assumes any responsibilityfor 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 lit-erature 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 contraindi-cations. 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 thebest 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. </p><p>CLINICAL CONTROVERSIES 6 Bevacizumab in Metastatic Breast Cancer: Ready for Prime Time?</p><p>CON: Katherine Mandock, PharmD, BCPS; Scott A. Soefje, PharmD, BCOPPRO: Val R. Adams, PharmD, BCOP, FCCP</p><p>REVIEW ARTICLES13 Current Practice in the Prevention and Treatment of Chemotherapy-Induced </p><p>Nausea and Vomiting in AdultsLisa K. Lohr, PharmD, BCOP, BCPS</p><p>25 The Evolution of Tyrosine Kinase Inhibitor Therapy: Improving Outcomes in Patients with Newly Diagnosed Chronic Myelogenous LeukemiaNatalie J. Greisl, PharmD; Christopher A. Fausel, PharmD, BCPS, BCOP</p><p>FROM THE LITERATURE36 Concise Reviews of Studies Relevant to Hematology Oncology Pharmacy </p><p>Robert J. Ignoffo, PharmD, FASHP, FCSHP</p><p>PUBLISHING STAFF</p><p>MISSION STATEMENTThe Journal of Hematology Oncology Pharm -acy is an independent, peer-reviewed jour-nal founded in 2011 to provide hematologyand oncology pharmacy practitioners andother healthcare professionals with high-quality peer-reviewed information rele-vant to hematologic and oncologic condi-tions to help them optimize drug therapyfor patients. </p><p>THE PEER-REVIEWED FORUM FOR ONCOLOGY PHARMACY PRACTICETM</p><p>3-TOC_Cover 12/21/11 2:15 PM Page 4</p></li><li><p>3-TOC_Cover 12/19/11 11:17 AM Page 5</p></li><li><p>CLINICAL CONTROVERSIES </p><p>6 l Journal of Hematology Oncology Pharmacy l www.JHOPonline.com December 2011 l Vol 1, No 4</p><p>Controversy has developed over the label indica-tions for bevacizumab in metastatic breast cancer(MBC). The US Food and Drug Administration(FDA) had granted accelerated approval for bevacizumabfor the treatment of MBC based on clinical trials thatdemonstrated a progression-free survival (PFS) advantage.This controversy begins when the postapproval trialsrequired with the FDA approval failed to demonstrate anoverall survival (OS) advantage in addition to the PFSadvantage. Subsequently, the Oncology Drug AdvisoryCommittee (ODAC) recommended, and ultimately theFDA issued its decision, to remove bevacizumabs currentlabeled indication for MBC.1</p><p>In this debate we take the side that supports theFDAs final decision to remove that indication. Our posi-tion is based on the arguments that reflect the regulato-ry, efficacy, safety, and economic perspectives. We willdemonstrate that this indication does not meet the stan-dard required for labeled indications, that the efficacy forthe indication does not show a clinical benefit, thatthere are serious safety concerns, and that the economicimpact is too great to justify the drugs approval.</p><p>The FDA Modernization Act of 1997 permitted theFDA to approve the marketing of drugs upon a deter-mination that the product has an effect on a clinicalendpoint or on a surrogate endpoint that is reasonablylikely to predict clinical benefit.2 This is exactly whathas happened with bevacizumab. </p><p>However, the FDAs Guidance for Industry also states,</p><p>Where an accelerated approval is based upon a surro-gate endpoint or on an effect on a clinical endpointother than survival or irreversible morbidity, postmar-keting studies are ordinarily required to verify anddescribe the drugs clinical benefit and to resolve remain-ing uncertainty as to the relation of the surrogate end-point upon which approval was based to clinical benefit,or the observed clinical benefit to ultimate outcome (57FR 58942, December 11, 1992).3 This is the focus ofthe regulatory argument. </p><p>The FDA has not recognized PFS as an end point thatwill grant approval for first-line indications in oncology.PFS has not translated to OS in any clinical trial inMBC and is, therefore, not considered a surrogate forsurvival. The burden is then on the drug manufacturer todemonstrate a clinical benefit that meets the criteria forapproval, for example, OS, improved quality of life, oranother end point that the FDA has recognized. </p><p>One other such example in oncology is gefitinib,which was approved on a surrogate end point and wasthen pulled from the market when the primary end pointwas not met. Bevacizumab has not met the requirementsfor full approval for an MBC indication; therefore, theFDAs decision was the correct one. </p><p>The results of the Eastern Cooperative OncologyGroup (ECOG) E2100 trial formed the basis for theFDAs decision to grant bevacizumab conditional accel-erated approval for the first-line treatment of patientswith MBC. The ECOG E2100 study demonstrated analmost 2-fold increase in response rate and time to pro-gression, but it failed to show OS benefit when beva-cizumab was added to weekly paclitaxel therapy.4,5</p><p>Two additional phase 3 trials were designed to validatethe results from the E2100 study, while evaluating the useof bevacizumab in combination with other approvedchemotherapy in the first-line treatment of MBC.6,7</p><p>The AVADO (Avastin and Docetaxel) trial exam-ined the combination of docetaxel and bevacizumab</p><p>Dr Mandock is PGY-2 Oncology Resident, Smilow CancerHospital at Yale New Haven, and Dr Soefje is AssociateDirector, Oncology Pharmacy Services, Smilow CancerHospital at Yale New Haven, CT, and Section Editor ofJHOP; Dr Adams is Associate Professor, Pharmacy ProgramDirector, PGY2 Specialty Residency, Hematology Oncology,University of Kentucky College of Pharmacy, Lexington, andCo-Editor-in-Chief of JHOP. </p><p>Bevacizumab in Metastatic BreastCancer: Ready for Prime Time?CON: By Katherine Mandock, PharmD, BCPS; Scott A. Soefje, PharmD, BCOP</p><p>PRO: By Val R. Adams, PharmD, BCOP, FCCP</p><p>THE CASE AGAINST APPROVAL</p><p>The goal of this section is to feature current clinical controversies by presenting both sides of the problem. Readers are invited to submit articles that present the pro and </p><p>con of a relevant problem, as featured in the present article.</p><p>4-Soefje_Cover 12/19/11 11:21 AM Page 6</p></li><li><p>Bevacizumab in Metastatic Breast Cancer</p><p>7www.JHOPonline.com l Journal of Hematology Oncology PharmacyVol 1, No 4 l December 2011</p><p>administered every 3 weeks6; RIBBON (Regimens inBevacizumab for Breast Oncology)-1 assessed cape -citabine, a taxane-based regimen (docetaxel or nab-paclitaxel) administered every 3 weeks, and an anthra-cycline-containing regimen administered alone or incombination with bevacizumab.7 </p><p>As in the case of the E2100 trial, both AVADO andRIBBON-1 failed to demonstrate a significant differencein OS rates. Both trials did demonstrate statistically sig-nificant improvements in PFS and in the response rate;however, they failed to confirm the magnitude of thePFS benefit observed in the E2100 trial (Table).Statistical significance does not always correspond toclinical significance, and the clinical impact of addingbevacizumab to a regimen is unconvincing at best, inview of the incremental improvements in PFS observedin the confirmatory trials.6,7 </p><p>The concern for the clinical benefit of bevacizumab asa first-line agent in MBC is multifactorial but hinges on 3major issues: (1) the disparity of benefit observed betweenthe E2100 trial and other phase 3 trials, (2) the suitabilityof PFS as a surrogate end point for OS, and (3) the lack ofa clearly defined patient population that is most likely tobenefit from the addition of bevacizumab to the treatmentregimen. The disparity in the magnitude of improvementin PFS between E2100 and other phase 3 studies is mostlikely reflective of the choice of chemotherapy. </p><p>The E2100 trial evaluated bevacizumab in combina-tion with once-weekly paclitaxel therapy. Preclinicalevidence suggests an antiangiogenic activity that is asso-ciated with weekly paclitaxel therapy, which, whencombined with bevacizumab, may have acted synergisti-cally to result in the greater duration of PFS observed inE2100. Therefore, the robust benefit in PFS that wasseen with E2100 was most likely derived from fraction-ating the dose of paclitaxel weekly over 3 weeks ratherthan from the addition of bevacizumab to the regimen.8 </p><p>In addition, all 3 studies used PFS as the primary effi-cacy end point.6-8 As noted earlier, PFS has not beendemonstrated as a good surrogate for OS in solid tumors,including MBC.9 </p><p>Finally, the collective randomized controlled trialshave failed to identify a patient population that wouldderive the greatest potential benefit from the addition ofbevacizumab to chemotherapy. Heavily pretreatedpatients are not likely to experience significant benefitswith the addition of...</p></li></ul>