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Bevacizumab plus first-line chemotherapy improved outcomes in metastatic breast cancer
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2009 ASCO Annual Meeting
Adding bevacizumab to chemotherapy in the first-line setting improved PFS by 31% in patients with previously untreated metastatic breast cancer, according to data from the RIBBON-1 trial. These data are the third set of phase-3 trials to demonstrate the benefit of adding bevacizumab to first-line chemotherapy in this patient population.
“For the prespecified capecitabine and taxane/anthracycline cohorts, the addition of bevacizumab led to a statistically significant improvement in PFS by the investigator, PFS by the independent review committee and objective response rate,” Nicholas Robert, MD, of Fairfax Northern Virginia Hematology Oncology, a U.S. Oncology affiliate, chairman of the Cancer Committee of the INOVA Fairfax Hospital Cancer Center, and co-chairperson of the Breast Committee of U.S. Oncology Research Network, said during his presentation at the 2009 ASCO Annual Meeting.
The study included 1,237 patients with metastatic breast cancer. Patients were randomly assigned to bevacizumab (Avastin, Genentech) plus capecitabine (Xeloda, HLR; n=409), bevacizumab plus taxane/anthracycline (n=415), placebo plus capecitabine (n=206) or placebo plus taxane/anthracycline (n=207). The primary endpoint was PFS as assessed by the investigator; secondary endpoints included PFS as assessed by an independent review committee, objective response rate, OS, one-year survival rate and safety. Median follow-up was 15.6 months for capecitabine and 19.2 months for taxane/anthracycline.
PFS was superior in the bevacizumab arms compared with the placebo arms. Objective response rates were also superior in the bevacizumab plus capecitabine (35.4%) and bevacizumab plus taxane/anthracycline (51.3%) arms compared with placebo (23.6% and 37.9%).
Median OS was 29 months for bevacizumab plus capecitabine vs. 21.2 months for placebo (HR=0.85; 95% CI, 0.63-1.14) and 25.2 months for bevacizumab plus taxane/anthracycline vs. 23.8 months for placebo (HR=1.03; 95% CI, 0.77-1.38).
“In terms of safety, the incidence of bevacizumab-related adverse events are consistent with prior studies; there were no new bevacizumab-related safety signals in each of the chemotherapy groups,” Robert said.
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