Surgery News - April 2008 - (Page 17)

APRIL 2008 • SURGERY NEWS ONCOLOGY 17 Bevacizumab Approved for Metastatic Breast Cancer B Y E L I Z A B E T H M E C H C AT I E Else vier Global Medical Ne ws T he Food and Drug Administration and Genentech Inc. have announced “accelerated approval” of bevacizumab in combination with paclitaxel for treating patients who have not received chemotherapy for metastatic HER2-negative breast cancer. The surprise decision came less than 3 months after an FDA advisory panel narrowly recommended against approval despite evidence that the anti-angiogenesis agent delays progression of the disease. Bevacizumab, marketed as Avastin by Genentech, is a therapeutic antibody that binds to and inhibits human vascular endothelial growth factor, a protein thought to promote angiogenesis in tumors and maintain their blood vessels. The drug was previously approved as a treatment for lung cancer and for colon and rectal cancer. In December 2007, the FDA’s Oncologic Drugs Advisory Committee voted 5-4 that the data to support a favorable riskbenefit profile for bevacizumab combined with paclitaxel (Taxol) as a first-line treatment for metastatic breast cancer were inadequate. The split vote reflected disagreement over the importance of a statistically significant improvement in progression-free survival in the E2100 trial— a multicenter, randomized study of 722 patients with previously untreated, locally recurrent, or metastatic breast cancer— which had been presented to the panel. Patients in the trial received paclitaxel weekly for 3 weeks of a 4-week cycle, either with or without bevacizumab. Median progression-free survival, the study’s primary end point, was 11.3 months among women treated with bevacizumab and paclitaxel versus 5.8 months among those treated with paclitaxel alone. Overall survival, a secondary end point, was 1.7 months longer among those on bevacizumab and paclitaxel, according to Genentech, but the benefit was not statistically significant. The study was sponsored by the National Cancer Institute and conducted by the Eastern Cooperative Oncology Group. Neuropathy, hypertension, arterial thromboembolic events, and proteinuria were among grade 3/4 adverse events that were more common in the bevacizumab arm. The increase in neuropathy could be attributed to the longer time on paclitaxel, according to Genentech. The company maintained the safety findings “were generally consistent” with previous trials that combined bevacizumab with chemotherapy and “no new safety signals” were observed. However, Dr. Jeffrey Smerage pointed out that other studies have shown “significant problems with wound healing” in patients treated with bevacizumab. A 1- to 2month delay in elective procedures after treatment with this drug has been recommended, according to Dr. Smerage, assistant professor at the University of Michigan, who commented on this report. “Obviously, emergency procedures cannot be delayed, but bevacizumab prior to a planned surgery (such as mastectomy in the breast cancer population) should be avoided,” he added. The “accelerated approval” allows the agency to approve products for life-threatening diseases based on initial positive clinical data. Genentech said the company has provided the FDA with the positive results of another phase III trial of bevacizumab, and expects the results of another phase III trial to be available late this year. A review of the data from these two trials will be needed “for the accelerated approval to be converted into a full approval,” according to the company’s statement. “We want people to have this drug available, while other studies are being conducted to clarify the relationship between tumor progression and survival,” Dr. Richard Pazdur, director of the FDA’s division of oncology drug products, said in a statement. In the E2100 trial, the drug’s impact on slowing tumor growth was “robust,” he said. “In addition to Avastin’s impact on delaying progression, the drug when combined with Taxol doubles the response rate, or tumor shrinkage, compared to patients receiving Taxol alone.” The news triggered speculation that the approval represented a shift away from the traditional standard of approving cancer drugs in the United States based on data showing a statistically significant increase in overall survival and toward acceptance of data showing progression-free survival. In the FDA statement, however, Dr. Pazdur said that the accelerated approval “should not be interpreted as a change in policy regarding cancer drug approvals.” Introducing Surgeons Diversiﬁed Investment Fund The American College of Surgeons understands the ﬁnancial challenges facing surgeons today. That is why we have committed ourselves to providing our members with investment education programs and tools, including the new Surgeons Diversiﬁed Investment Fund. This diversiﬁed mutual fund uses fundamental investing principles — asset allocation, diversiﬁcation, and rebalancing — which we believe are the necessary ingredients for a successful investment program, and which are used by the College’s endowment fund. You have dedicated your career to providing high-quality surgical care for your patients. Let Surgeons Diversiﬁed Investment Fund help you develop a healthy ﬁnancial future for yourself and your family. For more information, please stop by our booth in the ACS Program Center, or visit www.surgeonsfund.com. The Fund is subject to the same risks as the underlying exchange-traded funds (ETF) that it invests in, including interest rate risk, credit/default risk, market risk, derivatives risk, management risk, NAV risk and liquidity risk. Investing in the underlying ETFs indirectly through the Fund, an investor will incur not only a proportionate share of the expenses of the ETFs held by the Fund, but also the expenses of the Fund. An investor should consider the charges, risks, expenses and investment objective carefully before investing. For a prospectus containing this and other information, please contact your ﬁnancial advisor or the Fund at 1-800-208-6070, or download the prospectus at www.surgeonsfund.com. Read it carefully before you invest or send money. 633 N. Saint Clair St. Chicago, IL 60611 The Fund is distributed by Ultimus Fund Distributors, LLC 225 Pictoria Dr., Suite 450, Cincinnati, OH 45246 Serving the membership of the American College of Surgeons http://www.surgeonsfund.com http://www.surgeonsfund.com http://www.surgeonsfund.com

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Surgery News - April 2008 Contents Comorbidities Sway Bariatric Outcomes Database Finds Gap in Dissection For Melanoma Future Surgeon Shortage Predicted Dexterity Demo Best for Bile? Health Policy Scan Plan

Surgery News - April 2008

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