Breast Cancer Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Stage IIIB, Inoperable IIIC, IV, Recurrent, and Metastatic Breast Cancer
The AVADO (NCT00333775) trial randomly assigned 736 patients to docetaxel plus either placebo or bevacizumab at 7.5 mg/kg or 15 mg/kg every 3 weeks as the initial treatment for patients with metastatic breast cancer. The combination of bevacizumab at 15 mg/kg, but not 7.5 mg/kg, with docetaxel modestly improved median PFS compared with placebo (10.1 months vs. 8.1 months) but did not improve OS (30.2 months vs. 31.9 months; P = .85).[Level of Evidence: 1iiA] Again, more toxic effects were seen in patients in the bevacizumab-containing arms with significantly higher rates of bleeding and hypertension compared with the placebo arms.
Similarly, the RIBBON 1 (NCT00262067) trial randomly assigned 1,237 patients in a 2:1 fashion to standard chemotherapy plus bevacizumab or standard chemotherapy plus placebo. Median PFS was longer for each bevacizumab-containing combination (Cape cohort: increased from 5.7 mo. to 8.6 mo.; HR, 0.69; 95% CI, 0.56-0.84; log-rank, P < .001; and Taxane/Anthracycline cohort: increased from 8.0 mo. to 9.2 mo.; HR, 0.64; 95% CI, 0.52-0.80; log-rank, P < .001).[Level of Evidence: 1iiA] However, no statistically significant differences in OS between the placebo- and bevacizumab-containing arms were observed. Toxicities associated with bevacizumab were similar to those seen in prior bevacizumab clinical trials.
The RIBBON-2 (NCT00281697) trial studied the efficacy of bevacizumab as a second-line treatment for metastatic breast cancer. This trial randomly assigned 684 patients in a 2:1 fashion to standard chemotherapy plus bevacizumab or standard chemotherapy plus placebo. Median PFS increased from 5.1 to 7.2 months for the bevacizumab-containing treatment arm (stratified HR for PFS, 0.78; 95% CI, 0.64 to 0.93; P = .0072). However, no statistically significant difference in OS was seen (16.4 months vs. 18.0 months for chemotherapy plus placebo vs. chemotherapy plus bevacizumab, respectively, P = .3741).[Level of evidence: 1iA] Toxicities associated with bevacizumab were again similar to those seen in prior clinical trials.