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Adding the drug bevacizumab (Avastin) to the standard chemotherapy regimen for non-small cell lung cancer – 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 theme 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 presented the findings at a JAMA media briefing at the National Press Club in Washington on Tuesday, Apr. 17.
A previous trial found that adding bevacizumab to the standard two-drug treatment for non-small cell lung cancer – 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 non-small cell lung cancer. 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 non-small cell lung cancer 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.
At Dana-Farber, patients receive lung cancer treatment through the Lowe Center for Thoracic Oncology.