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Gynecol Oncol. 2015 Oct;139(1):10-6. doi: 10.1016/j.ygyno.2015.08.004. Epub 2015 Aug 10.

Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer.

Author information

1
Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: aghajanc@mskcc.org.
2
University of Washington School of Medicine, Seattle, WA, USA.
3
Novant Health Forsyth Cancer Center, Winston-Salem, NC, USA.
4
Genentech, Inc., South San Francisco, CA, USA.
5
NYU School of Medicine, New York, NY, USA.

Abstract

OBJECTIVE:

OCEANS is a randomized, placebo (PL)-controlled, phase 3 trial evaluating the efficacy and safety of bevacizumab combined with gemcitabine+carboplatin (GC) for patients with platinum-sensitive recurrent ovarian cancer (ROC). The study met its primary endpoint, demonstrating improved progression-free survival with GC+bevacizumab compared with GC+PL. Herein, we describe results of final overall survival (OS) and updated safety.

METHODS:

Patients with recurrent platinum-sensitive ROC (recurring ≥6months after first-line platinum-based therapy) and measurable disease at baseline were randomized to receive GC+bevacizumab or GC+PL for 6-10cycles; PL or bevacizumab was then continued until disease progression. In this updated analysis, a Cox proportional hazards model was used to compare OS between the 2 treatment arms.

RESULTS:

At the data cutoff date (July 19, 2013), 353 patients (72.9%) had died. Median follow-up for OS was 58.2months in the experimental arm and 56.4months in the control arm. Consistent with interim analyses, median OS was comparable between arms (GC+bevacizumab: 33.6months; GC+PL: 32.9months; hazard ratio=0.95; log-rank p=0.65), and was consistent across all examined patient subgroups. The frequency and severity of adverse events were consistent with previous analyses; no new safety concerns were identified.

CONCLUSIONS:

Results from final OS analysis of the phase 3 OCEANS study showed no significant difference in OS for patients treated with GC+bevacizumab compared with GC+PL.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00434642.

KEYWORDS:

Bevacizumab; OCEANS; Ovarian cancer; Overall survival; Safety

PMID:
26271155
PMCID:
PMC4993045
DOI:
10.1016/j.ygyno.2015.08.004
[Indexed for MEDLINE]
Free PMC Article

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