PD07-08: The Effect on Surgical Complications of Bevacizumab Added to Neoadjuvant Chemotherapy: NSABP Protocol B-40.

The NSABP trial B-40 was designed to determine whether adding capecitabine or gemcitabine to docetaxel followed by AC would increase the pathologic complete response (pCR) rates in patients with operable HER2−negative breast cancer and to determine whether the addition of bevacizumab to three docetaxel-based regimens followed by AC would increase pCR rates. Secondary endpoints include the percentage of surgical complications after mastectomy, lumpectomy, and axillary staging procedures in the patients who received chemotherapy versus those who received chemotherapy and bevacizumab. Methods: Women with HER2−negative operable breast cancer received one of the following docetaxel-based regimens with or without bevacizumab (15mg/kg) every 3 weeks for four cycles: docetaxel 100 mg/m 2 IV; docetaxel 75 mg/m 2 and capecitabine 825 mg/m 2 po BID days 1–14; and docetaxel 75 mg/m 2 day 1 and gemcitabine 1000 mg/m 2 IV days 1 and 8. These regimens were followed by preoperative standard AC on day 1 every 21 days for four cycles with or without bevacizumab 15 mg/kg given with the initial 2 cycles of AC. Treatment groups randomized to receive bevacizumab resumed postoperative bevacizumab 15 mg/kg IV every 3 weeks for an additional 10 doses. Assessment of surgical complications was performed from the date of surgery through 24 months following study entry. Results: Planned analysis for surgical complications will be conducted in October 2011 and will be presented along with breast reconstruction data. Funded by NCI PHS grants U10-CA-37377, U10-CA-69974, U10-CA-12027, U10-CA-69651, and U10-CA-52667, with additional support from F. Hoffmann La-Roche, Ltd., Genentech, USA, and Eli Lilly and Company. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr PD07-08.