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 6-10 cycles; 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 58.2 months 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.
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