Avastin bevacizumab: Phase III data

Researchers at the National Surgical Adjuvant Breast and Bowel Project and colleagues reported data from the North American Phase III NSABP-B-40 trial in 1,206 patients with operable HER2-negative breast cancer showing that the addition of Avastin to neoadjuvant chemotherapy (docetaxel plus doxorubicin and cyclophosphamide alone or in combination with capecitabine or gemcitabine) significantly increased the proportion of patients achieving a pCR, the primary endpoint, vs. chemotherapy alone (34.5% vs. 28.2%, p=0.02). However, the addition of capecitabine or gemcitabine to the docetaxel chemotherapy regimen did not significantly increase the proportion of patients achieving a pCR vs. the docetaxel regimen alone (29.7% and 31.8%, respectively, vs. 32.7%, p=0.69). Additionally, a subgroup analysis showed that Avastin plus chemotherapy significantly increased pCR rate in hormone-receptor-positive patients vs. chemotherapy alone (23.2% vs. 15.1%, p=0.007), but non-significantly increased the endpoint in hormone-receptor-negative patients (51.5% vs. 47.1%, p=0.34). The National Cancer Institute (NCI) sponsored the trial. Data were published in the New England Journal of Medicine. ...