The FDA has approved bevacizumab (Avastin), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by bevacizumab alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Bevacizumab in combination with chemotherapy for platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer was granted priority review, and this recent approval is based on results from two randomized, controlled phase III studies, GOG-0213 and OCEANS.
The GOG-0213 study demonstrated that adding bevacizumab to chemotherapy showed an overall survival difference of 5 months compared to chemotherapy alone (median OS: 42.6 months vs. 37.3 months; Hazard Ratio (HR)=0.84, 95% CI: 0.69-1.01 and HR=0.82, 95% CI: 0.68-0.996, depending on stratification factor). Both the GOG-0213 and OCEANS studies demonstrated a significant improvement in progression-free survival. The GOG-0213 study showed women lived a median of 3.4 months longer without disease progression with the addition of bevacizumab to chemotherapy compared to chemotherapy alone (median PFS: 13.8 months vs. 10.4 months; HR=0.61, 95% CI: 0.51-0.72).
The OCEANS study showed bevacizumab in combination with chemotherapy significantly improved PFS compared to placebo plus chemotherapy (median PFS: 12.4 months vs. 8.4 months; HR=0.46, 95% CI: 0.37-0.58; p<0.0001). Overall survival, one of the secondary endpoints in the OCEANS study, was not significantly improved with the addition of bevacizumab to chemotherapy (HR=0.95, 95% CI: 0.77-1.17).
Adverse events in both studies were consistent with those seen in previous trials of bevacizumab across tumor types for approved indications, but also included fatigue, low white blood cell count with fever, low sodium level in the blood, pain in extremity, low platelet count, too much protein in the urine, high blood pressure, and headache.