Independent radiologic review of OCEANS, a phase III trial of carboplatin, gemcitabine, and bevacizumab or placebo for the treatment of platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer

Objective: OCEANS is a phase III, randomized, double-blind, placebo-controlled trial of gemcitabine and carboplatin (GC) plus concurrent and continued single-agent bevacizumab (BV) or placebo (PL) in platinum-sensitive, recurrent ovarian cancer. OCEANS met its primary end point, investigator-determined progression-free survival (PFS) by RECIST, which showed a clinically meaningful and statistically significant improvement in PFS for GC+BV when compared with GC+PL (ASCO 2011 LBA5007). The PFS hazard ratio (HR) was 0.484 (95% confidence interval [CI]: 0.388–0.605; P<0.0001) with a median improvement in PFS from 8.4 mos for GC+PL to 12.4 mos for GC+BV. To determine the reliability of RECIST in assessing progression in ovarian cancer and as a sensitivity analysis for this study, an independent review committee (IRC) assessment of radiologic images and clinical data was conducted.