Abstract
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.
Published Version
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