Mirth and Medicine: Hope or Hype?

from the German Breast Group (GBG44) randomly assigned 1,948 patients to receive neoadjuvant epirubicin and cyclophospha-mide followed by docetaxel with or without Avastin. In the Avastin group, PCR was 18.4%, compared with 14.9% in the non-Avastin arm. The other study, dubbed NSABP B-40, randomly assigned 1,206 patients to receive neoadjuvant docetaxel-based chemo-therapy with or without Avastin. Adding Avastin statistically significantly increased the rate of PCR (34.5% with Avastin vs. 28.2% without). In both studies, Avastin was associated with more side effects. PCR still needs to be validated as a surrogate endpoint for clinical outcomes. lead author of the NSABP B-40 trial, said, " At this time, the results of B-40 should not warrant any change in practice for the treatment of breast cancer. However, it does suggest that the issue of Avastin's potential to improve outcome is not settled. "aging director of the German Breast Group Research Institute—the largest cooperative group in Germany working in breast can-cer—and lead author of the GBG44 trial, said, " These trials highlight the fact that we do not know the full picture of the activity of this compound. We have to wait for long-term survival data to prove that this improvement of PCR corresponds with a lower relapse rate. " Avastin's Future " These neoadjuvant trials may also aid prospective collection of tissue and other patient specimens that could be critical to further define which subgroup might gain the most benefit in both the adju-vant and metastatic settings, " said Bryan P. Schneider, M.D., associate professor of hematology and oncology at Indiana University Melvin and Bren Simon Cancer Center. " It must be clear that Avastin did improve outcome in multiple trials in the metastatic setting. The concern outlined by FDA and others centered on the fact that the benefit is relatively marginal given the drug's toxic effects. That being said, if a subgroup that gains substantial benefit can be identified (similar to trastuzumab for those with HER2-amplified tumor), the drug may indeed be resurrected in the metastatic setting as well. " These studies have renewed interest in Avastin, and trials continue to probe its efficacy in various disease settings. An exploratory subgroup analysis of a randomized phase III RIBBON-2 trial that enrolled metastatic breast cancer patients who had progressed on first-line chemotherapy without Avastin showed that triple-negative metastatic breast cancer had longer PFS. The study also found a non– statistically significant trend toward …