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Final data show no survival benefit from combination therapy
Source: (cancerfacts.com)
Monday, December 21, 2009
Third of four summaries of studies presented at the San Antonio Breast Cancer conference Dec. 9-13
SAN ANTONIO – Dec. 21, 2009 – Results of the AVADO study showed that adding the anti-blood vessel drug, bevacizumab, to chemotherapy (docetaxel) significantly improved progression-free survival for patients with metastatic breast cancer.
"The AVADO study confirms that the use of bevacizumab in combination with a taxane, in this case docetaxel, increases the chance of reducing tumor burden and prolongs the time for which disease is controlled," said Dr. David W. Miles, consultant medical oncologist, Mount Vernon Hospital, Northwood, Middlesex, United Kingdom. "The greater ability to control metastatic breast cancer, particularly in patients with immediately life-threatening disease, is reflected in the significant improvement in one-year survival."
Miles presented final overall survival results from the AVADO trial, which included 736 patients in 24 countries at 106 sites, here at the CTRC-AACR San Antonio Breast Cancer Symposium.
In this large, controlled comparison trial, researchers randomly assigned patients with HER2-negative, locally recurrent or metastatic breast cancer, and no central nervous system metastases, to treatment with the combination therapy at two dose levels versus docetaxel alone. Bevacizumab is a monoclonal antibody that blocks the ability of tumors to grow the blood vessels needed for tumor growth.
In the study, one group of 241 patients received docetaxel plus placebo, another 248 patients received docetaxel plus low-dose bevacizumab, while the third group of 247 patients received or docetaxel plus a higher dose of bevacizumab. The researchers administered docetaxel once every three weeks for up to nine cycles. They administered bevacizumab or placebo once every three weeks until the cancer resumed progression or the patient could not tolerate the side effects.
The primary endpoint was progression-free survival, or the amount of time the cancer stopped growing secondary endpoints included overall survival, time to treatment failure, overall response rate, duration of response and safety.
Primary analysis results after 10 months of follow-up showed that adding bevacizumab to docetaxel significantly improved progression-free survival without affecting toxicity.
"Bevacizumab does not exacerbate the toxicity of chemotherapy but increases its effect in terms of response rate and progression-free survival," Miles said. "We must make efforts to identify those most likely to benefit based on conventional characteristics or molecular markers, though the latter remain somewhat elusive."
Final overall survival results showed that despite the improved response and progression-free survival results, there was no difference in median survival, Miles said.
SOURCE: adapted from press materials provided by the American Association for Cancer Research
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