Abstract
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 and epistaxis were higher in the BV arm. More pts in the BV arm (20.6%) than in the PL arm (4.7%) experienced an AE that led to discontinuation of study drug, in the BV arm most commonly due to HTN (4%), proteinuria (2.8%), epistaxis (1.2%), thrombocytopenia (1.6%) and RPLS (0.8%). Median number of BV cycles in pts with G ≥3 proteinuria was 22.5 and the AE resolved in 91.7% of pts. Among the pts with G ≥3 HTN, the median number of BV cycles was 16.5 and the AE resolved in 72.7% of pts. Conclusions: The overall safety profile was similar to that seen at the time of the final PFS analysis. Higher incidences of proteinuria and HTN were possibly related to longer BV treatment duration and resolved in the majority of pts. [Table: see text]
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