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From the Editor For Payers, Purchasers, & Oncology P&T Committees
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PUBLISHING STAFF
his month’s Third Annual Review Issue of The Oncology Pharmacist highlights some of the top advances in cancer care over the past year. Although a few systemic cytotoxic therapies emerged as some of last year’s winners—eribulin, sipuleucel-T, bevacizumab in ovarian cancer—most of the practicechanging studies reflect the continued shift in oncology toward Patrick Medina, greater personalization of care. PharmD, BCOP With a combined 10,000-plus Editor-in-Chief abstracts submitted for the American Society of Clinical Oncology and the American Society of Hematology annual meetings alone, we just do not have the space to address every important discovery from the past 12 months, although we managed to include several of the most noteworthy developments. Many of those not included have been discussed in previous issues and are likely to be featured in
Senior Vice President, Sales & Marketing Philip Pawelko phil@greenhillhc.com Publisher John W. Hennessy john@greenhillhc.com Associate Editor Dawn Lagrosa dawn@greenhillhc.com Quality Control Director Barbara Marino Director, Client Services Joe Chanley joe@greenhillhc.com Production Manager Stephanie Laudien Business Manager Blanche Marchitto blanche@greenhillhc.com Executive Administrator Andrea Boylston Circulation Department circulation@greenhillhc.com Editorial Contact: Telephone: 732-992-1891 Fax: 732-656-7938
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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.
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upcoming issues as investigators release updated data from ongoing studies. Also this year, the role of the oncology pharmacist has reached prominence in our community and with our patients. With this in mind, we tried to summarize key findings on new regimens, drug–drug interactions, and pharmacy process changes. As we move farther into the era of personalized care, our role also will travel into pharmacogenetic testing for optimal outcomes with the least possible toxicity. We would like to thank all the authors who contributed to this important issue. Many were directly involved in the studies presented and others are experts in the therapeutic area discussed. All share a deep understanding of the subject and a passion for improving care for patients with cancer. In addition to looking at what occurred in oncology during the past year, we also took an opportunity to look ahead at what might happen in the coming year. Please take a moment to read the article at the end of the issue reviewing investigational therapies that appear to be just over the horizon. As always, please send us your questions and comments to editorial@greenhillhc.com. ●
May 2011 I VOL 4, NO 3
Breast Cancer Genome Sequenced By sequencing, then comparing the whole genomes of tumors with those of the patient’s healthy cells in 50 women with breast cancer, researchers found more than 1700 mutations, most of which were unique to the individual. They identified 8 significantly mutated genes: PIK3CA, TP53, ATR, RUNX1, MYST3, PRSS8, ZNHIT2, and MAP3K1. Of these, PIK3CA (43%), TP53 (15.2%), and MAP3K1 (9.3%) were found to have the highest rates of incidence. The novel gene MAP3K1 was found to be disabled in estrogen receptor–positive breast cancers. This gene controls programmed cell death, meaning that by being disabled, cells that should die continue to live. ATR and MYST3 mutations also occurred in approximately 10% of breast cancers. “Cancer genomes are extraordinarily complicated. This explains our difficulty in predicting outcomes and finding new treatments,” said Matthew J. Ellis, MD, PhD, FRCP, of Washington University in St. Louis, during his presentation at the 102nd American Association for Cancer Research Annual Meeting. “To get through this experiment and find only 3 additional gene mutations at the 10% recurrence level was a bit of a shock.” If a cancer’s genome can be sequenced before treatment and mutations that are rare in breast cancer but common in other cancers are identified, drugs may already exist to treat them. Ideally, the goal is to design treatment plans by sequencing the tumor genome when the cancer is first diagnosed, according to Ellis.
SQ Bortezomib as Effective as IV Delivery in Relapsed Multiple Myeloma Using the recommended dose of 1.3 mg/m2 administered as a 3- to 5-second bolus intravenous (IV) injection on days 1, 4, 8, and 11 of 21-day cycles, patients with relapsed multiple myeloma after 1 to 3 previous lines of therapy achieved noninferior efficacy with subcutaneous (SQ) versus IV delivery of the drug when receiving up to 8 cycles. In addition, those in the SQ arm experienced improvement in their systemic safety profile. In a phase 3 randomized trial, Moreau and colleagues found an overall response rate (ORR) of 42% after 4 cycles (ORR difference –0.4%; 95% confidence interval
[CI], –14.3 to 13.5; P = .002). At 12 months, they found no significant differences in time to progression (median 10.4 months; 95% CI, 8.5-11.7 vs 9.4 months; 95% CI, 7.6-10.6; P = .387) and 1-year overall survival (72.6%; 95% CI, 63.1-80.0 vs 76.7%; 95% CI, 64.1-85.4; P = .504) with SQ versus IV administration. Noninferiority was defined as retaining 60% of the IV treatment effect. In the SQ group, adverse events grade 3 or higher included thrombocytopenia (13%), neutropenia (18%), and anemia (12%). Less peripheral neuropathy of any grade was experienced in the SQ arm compared with the IVarm (38% vs 53%; P = .044), grade 2 or worse (24% vs 41%, respectively; P = .012), and grade 3 or worse (6% vs 16%, respectively; P = .026). The researchers concluded that “subcutaneous administration is a promising alternative to intravenous administration, particularly in patients with poor venous access or at increased risk of side effects.”
PhRMA Reinforces Its Commitment to Safety, Integrity, and Availability of Drugs “PhRMA’s member companies recognize the importance of avoiding unexpected disruptions in the supply of needed medicines to patients,” said Pharmaceutical Research and Manufacturers of America (PhRMA) senior assistant general counsel Maya J. Bermingham in a May 2 statement regarding the myriad factors that contribute to drug shortages. “To achieve that goal,” Bermingham continued, “PhRMA companies are committed to maintaining good manufacturing practices and working closely with the FDA, supply chain partners, and providers when unexpected shortages occur.” PhRMA’s ongoing commitment to the safety, integrity, and market availability of the drugs they manufacture includes leading the RxResponse program, which coordinates the entire drug supply chain to ensure patients’ timely access to medicines during a natural disaster, such as its new form to expedite applications for prescription medicine assistance for those patients affected by the tornadoes and floods in the South. In addition, many PhRMA companies participate in Rx360, a consortium working to develop and to implement enhanced global quality systems and processes to help members ensure product quality and authenticity throughout their supply chains. ●
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