(ChemotherapyAdvisor) – Gemcitabine/carboplatin plus bevacizumab followed by bevacizumab until disease progression significantly improved progression-free survival (PFS) vs. gemcitabine/carboplatin plus placebo in patients with platinum-sensitive recurrent ovarian, primary peritoneal, or fallopian tube cancer (ROC), according to results of a Phase 3 study in the Journal of Clinical Oncology online April 23.
“To our knowledge, OCEANS is the first positive, randomized, Phase 3 trial evaluating the addition of a biologic therapy to a standard platinum doublet in ROC,” the investigators wrote.
The multicenter trial randomly assigned 484 patients to gemcitabine/carboplatin plus either bevacizumab or placebo for 6 to 10 cycles. Bevacizumab or placebo, respectively, was then continued until disease progression.
Median PFS was 12.4 months in the bevacizumab arm vs. 8.4 months in the placebo arm (HR 0.484; log-rank P<0.0001). The objective response rate was 78.5% in the bevacizumab arm vs. 57.4% in the placebo arm (P<0.0001), and duration of response was also longer, 10.4 months vs. 7.4 months (HR 0.534), respectively.
“No new safety concerns were noted,” they stated. Patients in the bevacizumab arm experienced grade 3 or higher hypertension, 17.4%, and proteinuria, 8.5%, more frequently than those in the placebo arm (<1% for both). Rates of neutropenia and febrile neutropenia were similar in both arms. Following study treatment discontinuation, 2 patients in the bevacizumab arm experienced gastrointestinal perforation.
The investigators noted that overall survival data from the trial “are not yet mature and the percentage of patients receiving subsequent therapy with chemotherapy and with bevacizumab or other antiangiogenic therapy is being observed for subsequent analysis.”