OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

摘要: Purpose This randomized, multicenter, blinded, placebo-controlled phase III trial tested the efficacy and safety of bevacizumab (BV) with gemcitabine carboplatin (GC) compared GC in platinum-sensitive recurrent ovarian, primary peritoneal, or fallopian tube cancer (ROC). Patients Methods ROC (recurrence 6 months after front-line platinum-based therapy) measurable disease were randomly assigned to plus either BV placebo (PL) for six 10 cycles. PL, respectively, was then continued until progression. The end point progression-free survival (PFS) by RECIST; secondary points objective response rate, duration (DOR), overall survival, safety. Results Overall, 484 patients assigned. PFS arm superior that PL (hazard ratio [HR], 0.484; 95% CI, 0.388 0.605; log-rank P .0001); median 12.4 v 8.4 months, respectively. rate (78.5% 57.4%; .0001) DOR (10.4 7.4 months; HR, 0.534; 0.408 0.698) significantly improved addition BV. No new concerns noted. Grade 3 higher hypertension (17.4% 1%) proteinuria (8.5% occurred more frequently arm. rates neutropenia febrile similar both arms. Two experienced GI perforation study treatment discontinuation.