Bevacizumab in the first-line treatment of metastatic breast cancer

Bevacizumab plus paclitaxel has proven efficacy as first-line therapy for metastatic breast cancer based on the results of a randomised, phase III study (E2100). it has been recently reported that the addition of bevacizumab to paclitaxel doubled the median progression-free survival from 5.9 to 11.8 months (hazard ratio [HR] = 0.60, p < 0.0001). This benefit was corroborated in an analysis submitted to health authorities globally, using the intent-to-treat population; median progression-free survival of 5.8 increased to 11.4 months (HR = 0.42, p < 0.001), and confirmed by an independent review facility (5.8 vs. 11.3 months, HR=0.48). This significant progression-free survival benefit was maintained across a number of patient subgroups, including those who had received prior adjuvant taxane chemotherapy. While there was no significant difference in overall survival, the addition of bevacizumab to paclitaxel increased the 1-year survival rate (81.2% vs. 73.4%, p = 0.01). As compared with bevacizumab use in other indications, no new safety signals were evident with the combination therapy, which was generally well tolerated. The only grade 3 and 4 toxicities that were increased by >= 5% with the addition of bevacizumab to paclitaxel were hypertension, sensory neuropathy, fatigue and neutropenia, the latter ones likely to be caused by the increased duration of paclitaxel treatment. (C) 2008 Elsevier Ltd. All rights reserved.