BOSTON--Adding the drug bevacizumab (Avastin) to the standard chemotherapy regimen for non-small cell lung cancer (NSCLC) - an approach approved by the FDA in 2006 - did not lead to significantly increase survival rates for patients over the age of 65 enrolled in Medicare, a new study by Dana-Farber Cancer Institute researchers has found.
The study is being published in the April 18 Journal of the American Medical Association, a these issue on comparative effectiveness research.
"Effectiveness research examines the impact of treatments when they are used in day-to-day practice in ordinary circumstances," says the study's senior author, Deborah Schrag, MD, MPH, of Dana-Farber. "First, we found that bevacizumab was not universally adopted after its FDA approval. Second, the addition of bevacizumab did not provide any substantial survival advantage when added to standard chemotherapy."
Schrag will present the findings at a JAMA media briefing at the National Press Club in Washington on Tuesday, Apr. 17, 9:15 am. A separate video commentary is available on request.
A previous trial found that adding bevacizumab to the standard two-drug treatment for NSCLC - the chemotherapy agents carboplatin and paclitaxel - improved survival in many patients with advanced cases of the disease, but not those aged 65 years or older, the study authors write. In the new study, Schrag and her colleagues measured survival rates in patients who received bevacizumab-carboplatin-paclitaxel therapy and in two groups of patients who received carboplatin-paclitaxel therapy - one group receiving it in 2006-2007, the other in 2002-2005.
They found that the median overall survival was 9.7 months for patients receiving the three-drug combination compared with 8.9 months for the 2006-2007 standard-therapy group, and 8.0 months for the 2002-2005 standard-therapy group. The probability of surviving for one year was 39.6 percent for those who received the three drugs vs. 40.1 percent for the 2006-2007 standard-therapy group, and 35.6 percent for the 2002-2005 standard-therapy group. Controlling for factors that can skew the results, the authors did not find a significant difference in overall survival between patients treated with bevacizumab and those treated only with standard chemotherapy.
Based on these results, the authors recommend that bevacizumab should not automatically be administered together with carboplatin-paclitaxel for older patients with NSCLC. They continue that clinicians should exercise caution in making treatment recommendations and use bevacizumab judiciously for their patients.
The authors also advise that for cancers like NSCLC that tend to arise in elderly patients, clinical trials of potential new therapies should include an adequate number of older patients and ensure that data for these patients is analyzed.
The lead author of the study is Junya Zhu, MS, MA, of Dana-Farber. Co-authors are Dhruv Sharma, PhD, Stacy Gray, MD, Aileen Chen MD, and Jane Weeks, MD, MS, of Dana-Farber.
Funding for the study was provided by the Agency for Healthcare Research and Quality and the National Cancer Institute.
Dana-Farber Cancer Institute is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute. It provides adult care with Brigham and Women's Hospital as Dana-Farber/Brigham and Women's Cancer Center, and it provides pediatric care with Children's Hospital Boston as Dana-Farber/Children's Hospital Cancer Center. Dana-Farber is the top-ranked cancer center in New England, according to U.S. News & World Report, and one of the largest recipients among independent hospitals of National Cancer Institute and National Institutes of Health grant funding. Follow Dana-Farber on Twtter: @dana-farber or Facebook: facebook.com/danafarbercancerinstitute.