Bevacizumab is emerging as an effective strategy as a first-line or maintenance therapy for recurrent ovarian cancer, which is difficult to treat. The purpose of this trial was to determine if adding bevacizumab to standard chemotherapy and/or secondary cytoreduction could improve survival of patients with platinum-sensitive recurrent ovarian cancer.
This analysis includes the outcomes with bevacizumab treatment; the cytoreduction portion of the study is ongoing.
The open-label, phase 3 Gynecologic Oncology Group (GOG)-0213 (ClinicalTrials.gov Identifier: NCT00565851) study randomly assigned 674 women to receive paclitaxel plus carboplatin with or without bevacizumab. The median follow-up of this analysis was 49.6 months.
Median overall survival (OS) was prolonged from 37.3 months (95% CI, 23.6-39.7 months) with chemotherapy to 42.2 months (95% CI, 37.7-46.2) with chemotherapy plus bevacizumab, though these findings were not significant (hazard ratio [HR], 0.829; 95% CI, 0.683-1.005; P = .056). An audited treatment-free interval stratification, however, adjusted the HR to 0.823 (95% CI, 0.680-0.996; P = .0447).
Progression-free survival was also prolonged, with a median of 10.4 months (95% CI, 9.7-11.0) with chemotherapy only compared with 13.8 months (95% CI, 13.0-14.7) with the addition of bevacizumab (HR, 0.628; 95% CI, 0.534-0.739; P < .0001).
Objective response, defined as complete or partial response, was higher in the bevacizumab arm (78%) compared with the chemotherapy only arm (59%; P < .0001).
The proportion of patients with at least 1 grade 3 adverse event was greater in the bevacizumab group compared with the standard chemotherapy group (96% vs 86%). The most common adverse events were hypertension, fatigue, and proteinuria.
According to the authors, the results of this study suggest that “bevacizumab added to paclitaxel and carboplatin might favourably affect overall survival in women with platinum-sensitive recurrent ovarian cancer.”
- Coleman RL, Brady MF, Herzog TJ, et al. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomized, phase 3 trail. Lancet Oncol. 2017 Apr 21. doi: 10.1016/S1470-2045(17)30279-6 [Epub ahead of print]
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