An Updated Safety Analysis Of Oceans, A Randomized, Double-Blind, Phase Iii Trial Of Gemcitabine (G) And Carboplatin (C) With Bevacizumab (Bv) Or Placebo (Pl) Followed By Bv Or Pl To Disease Progression (Pd) In Patients With Platinum-Sensitive (Plat-S) Recurrent Ovarian Cancer.

5054 Background: OCEANS met its primary end point with a statistically significant and clinically meaningful hazard ratio for progression-free survival (PFS) of 0.484. Secondary end points included objective response rate, overall survival, and safety. Eleven additional months of safety data were collected after the data cut-off date for the final PFS analysis event and updated safety analyses were performed. Methods: Eligible patients (pts) were randomized to arm A: GC (G [1000 mg/m2 days 1 and 8] and C [AUC 4, day 1], q21d for 6–10 cycles) + concurrent PL (q21d), followed by PL until PD or unacceptable toxicity; or arm B: GC + concurrent BV (15 mg/kg q21d), followed by BV until PD or unacceptable toxicity. All adverse events (AE) were recorded and graded per NCI-CTCAE v3.0. Results: The incidence of any grade AE was 100% in both arms and of SAEs was 25.3% (PL arm) and 35.6% (BV arm). The rates of proteinuria, hypertension (HTN), reversible posterior leukoencephalopathy syndrome (RPLS), thrombocytopenia ...