Incorporation of bevacizumab in the primary treatment of ovarian cancer
New England Journal of Medicine, 01/03/2012
Clinical Article
Burger RA et al. – The use of bevacizumab during and up to 10 months after carboplatin and paclitaxel chemotherapy prolongs the median progression–free survival by about 4 months in patients with advanced epithelial ovarian cancer.
Methods- Double–blind, placebo–controlled, phase 3 trial, we randomly assigned eligible patients with newly diagnosed stage III (incompletely resectable) or stage IV epithelial ovarian cancer who had undergone debulking surgery to receive one of three treatments
- All 3 included chemotherapy consisting of intravenous paclitaxel at a dose of 175 mg per square meter of body–surface area, plus carboplatin at an area under the curve of 6, for cycles 1 through 6, plus a study treatment for cycles 2 through 22, each cycle of 3 weeks' duration
- Control treatment was chemotherapy with placebo added in cycles 2 through 22; bevacizumab–initiation treatment was chemotherapy with bevacizumab (15 mg per kilogram of body weight) added in cycles 2 through 6 and placebo added in cycles 7 through 22
- Bevacizumab–throughout treatment was chemotherapy with bevacizumab added in cycles 2 through 22
- Primary end point was PFS
- 1873 women were enrolled
- Median PFS was 10.3 months in the control group, 11.2 in the bevacizumab–initiation group, and 14.1 in the bevacizumab–throughout group
- Relative to control treatment, HR for progression or death was 0.908 (95% CI, 0.795 to 1.040; P=0.16) with bevacizumab initiation and 0.717 (95% CI, 0.625 to 0.824; P<0.001) with bevacizumab throughout
- At the time of analysis, 76.3% of patients were alive, with no significant differences in overall survival among 3 groups
- Rate of hypertension requiring medical therapy was higher in bevacizumab–initiation group (16.5%) and the bevacizumab–throughout group (22.9%) than in control group (7.2%)
- Gastrointestinal–wall disruption requiring medical intervention occurred in 1.2%, 2.8%, and 2.6% of patients in the control group, the bevacizumab–initiation group, and the bevacizumab–throughout group
