Earlier, the Oncologic Drugs Advisory Committee (ODAC) had voted unanimously in favor of withdrawal, citing toxicity and noting that confirmatory trials had not repeated the magnitude of benefit in the E2100 trial (J. Clin. Oncol. 2009;27:4966-72) on which accelerated approval had been based.
Dr. Robert W. Carlson
The National Comprehensive Cancer Network (NCCN) has stood by its endorsement of bevacizumab in combination with paclitaxel, however. "The data observed in the [E2100 trial] really had not changed from its approval previously, and we thought that if the data were compelling 2 years ago, why isn’t it compelling enough today?" explained Dr. Robert W. Carlson of Stanford (Calif.) University, chair of the NCCN’s breast cancer panel, after the FDA moved to revoke the indication.
Genentech, the U.S. drugmaker owned by Roche, expressed disappointment with the final FDA decision, and vowed to continue seeking biomarkers that would identify which breast cancer patients can benefit from bevacizumab.
This fall, investigators presented results of the Roche-sponsored TURANDOT trial at the annual meeting of the European Society for Medical Oncology in Vienna. They reported that paclitaxel appeared to be a better partner than capecitabine (Xeloda) for bevacizumab in patients with metastatic breast cancer, but overall survival was not significantly different between the two combinations, and results echoed outcomes in earlier trials.
Quality-of-life results from the TURANDOT trial will be presented in a poster session in San Antonio (Poster session, P5-17-03). Among the other scheduled bevacizumab presentations are:
• Final results of the single-arm, phase II AVANTHER trial from Spain. Investigators combined bevacizumab and trastuzumab (Herceptin) with weekly paclitaxel as a neoadjuvant treatment in HER2-positive breast cancer. Treatment was followed by surgery and adjuvant therapy (Poster session 1, P1-14-10).
• First toxicity results from the Eastern Cooperative Oncology Group E5103 trial. This randomized phase III study compared doxorubicin, cyclophosphamide, and paclitaxel with and without bevacizumab in patients with lymph node–positive or high-risk, lymph node–negative breast cancer (Poster session 5, P5-17-01).