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From the Editor
A
quick look at the National Cancer Institute’s news releases finds 15 items in just 1 week. These include studies on drugs, supplements, and behaviors that can influence cancer risk; trials of new anticancer agents; and results of new regimens and dosing schedules on existing drugs. As always, The Oncology Pharmacist strives to make this information Patrick Medina, relevant to you. PharmD, BCOP In addition, there is, what seems Editor-in-Chief like, constant media coverage of controversial reports and decisions by various committees within the US government. I look forward to seeing how
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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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OcTOber 2011 I VOL 4, NO 7
they affect you, and encourage you to weigh in on our reader poll (see this month’s question, page 16). In this issue, our colleagues Joanna Schwartz and Maggie Charpentier give a pharmacist’s take on the current bevacizumab situation and how it affects the everyday practice of oncology pharmacy. Melinda Tran and Emily Mackler provide a comprehensive review of oral oncolytic dosing in patients with renal dysfunction. As pharmacists, ensuring that each patient gets the right dose is of paramount importance. With this issue, Jim Koeller continues to provide us his insights on key developments in oncology pharmacy practice. His views on the drug shortage not only provide information, but also offer pathways to possible solutions. As always, I hope this issue benefits your practice. We look forward to hearing from you. ●
Denosumab to Increase Bone Mass The US Food and Drug Administration (FDA) has approved denosumab (Prolia, Amgen) to increase bone mass in patients at high risk for fracture receiving androgen-deprivation therapy for nonmetastatic prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer. This monoclonal antibody that binds to RANKL was approved based on results of 2 randomized, double-blind, placebo-controlled trials. One trial randomized 1468 men with prostate cancer. Men aged younger than 70 years were required to have either a baseline bone mineral density (BMD) T score at the lumbar spine, total hip, or femoral neck between -1.0 and -4.0, or history of osteoporotic fracture. The other trial randomized 252 women with breast cancer. Women were required to have a baseline BMD T score at the lumbar spine, total hip, or femoral neck between -1.0 and -2.5 and to have not experienced fracture after age 25. Denosumab use resulted in changes in lumbar spine BMD of +5.6% at 24 months in men and +4.8% at 12 months in women. Those on placebo experienced changes of -1.0% and -0.7%, respectively. Common adverse reactions included arthralgia and back pain. Pain in extremities and musculoskeletal pain were also noted. Hypocalcemia (serum calcium <8.4 mg/dL) was observed only in denosumab-treated patients (2.4%) at the 1-month visit. In Vitro Diagnostic Assay for Change in ProstateSpecific Antigen Over Time The FDA has granted 510k marketing clearance to an invitro diagnostic assay (NADiA ProsVue, Iris International) for determining rate of change of serum total prostate-specific antigen over a period of time. A slope of 3 assays is indicated for use as a prognostic marker in conjunction with clinical evaluation to aid in identifying those patients at reduced risk for recurrence of prostate cancer for the 8-year period following prostatectomy. This nucleic acid detection immunoassay identifies
extremely low concentrations of proteins that have not been routinely used as a diagnostic or prognostic aid. Clearance was based on a retrospective study of 304 patients that evaluated the slope of 3 successive tests over a period of at least 10 months after prostatectomy to identify patients with no evidence of disease or clinical progression. The assay correctly identified 92.7% of stable patients and 78.0% of patients with recurrence.
Bevacizumab Label Changes The FDA issued a statement warning physicians of changes in the package insert for bevacizumab (Avastin, Genentech) regarding newly identified risks. • Increased risk for ovarian failure. New cases of ovarian failure were identified in 34% of women receiving bevacizumab in combination with chemotherapy compared with 2% of women receiving chemotherapy alone. After discontinuation of bevacizumab, recovery of ovarian function was demonstrated in 22% of these women. • Osteonecrosis of the jaw. Postmarketing, osteonecrosis of the jaw was reported in patients receiving bevacizumab but not bisphosphonates. The pathogenesis is unclear, but it is possible that the antiangiogenic properties of bevacizumab may result in bone tissue avascularization leading to ischemic changes in the microvasculature of the jaw, resulting in osteonecrosis. • Venous thromboembolic event (VTE) and bleeding in patients receiving anticoagulation therapy after first VTE event. In patients with metastatic colorectal cancer, prospective evaluation found the overall incidence of first VTE was higher with bevacizumab (13.5%) than with chemotherapy alone (9.6%). Among patients treated with anticoagulants following an initial VTE event, the overall incidence of subsequent VTEs was also higher among those treated with bevacizumab (31.5% vs 25.6%, respectively) and the overall incidence of bleeding was higher in the bevacizumab group (27.4% vs 20.9%, respectively). ●
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