OCEANS:
A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of
Chemotherapy With or Without Bevacizumab in Patients With
Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or
Fallopian Tube Cancer.
Source
Carol
Aghajanian, Memorial Sloan-Kettering Cancer Center and Weill Cornell
Medical College; Stephanie V. Blank, New York University School of
Medicine, New York, NY; Barbara A. Goff, University of Washington School
of Medicine, Seattle, WA; Patricia L. Judson, H. Lee Moffitt Cancer
Center and Research Institute, Tampa, FL; Michael G. Teneriello, US
Oncology, Texas Oncology, Austin, TX; Amreen Husain, Mika A. Sovak, and
Jing Yi, Genentech, South San Francisco, CA; and Lawrence R. Nycum,
Forsyth Regional Cancer Center, Winston-Salem, NC.
Abstract
PURPOSEThis
randomized, multicenter, blinded, placebo-controlled phase III trial
tested the efficacy and safety of bevacizumab (BV) with gemcitabine and
carboplatin (GC) compared with GC in platinum-sensitive recurrent
ovarian, primary peritoneal, or fallopian tube cancer (ROC). PATIENTS
AND METHODSPatients with platinum-sensitive ROC (recurrence ≥ 6 months
after front-line platinum-based therapy) and measurable disease were
randomly assigned to GC plus either BV or placebo (PL) for six to 10
cycles. BV or PL, respectively, was then continued until disease
progression. The primary end point was progression-free survival (PFS)
by RECIST; secondary end points were objective response rate, duration
of response (DOR), overall survival, and safety.ResultsOverall, 484
patients were randomly assigned. PFS for the BV arm was superior to that
for the PL arm (hazard ratio [HR], 0.484; 95% CI, 0.388 to 0.605;
log-rank P < .0001); median PFS was 12.4 v 8.4 months, respectively.
The objective response rate (78.5% v 57.4%; P < .0001) and DOR (10.4 v
7.4 months; HR, 0.534; 95% CI, 0.408 to 0.698) were significantly
improved with the addition of BV. No new safety concerns were noted.
Grade 3 or higher hypertension (17.4% v < 1%) and proteinuria (8.5% v
< 1%) occurred more frequently in the BV arm. The rates of
neutropenia and febrile neutropenia were similar in both arms. Two
patients in the BV arm experienced GI perforation after study treatment
discontinuation. CONCLUSIONGC plus BV followed by BV until progression
resulted in a statistically significant improvement in PFS compared with
GC plus PL in platinum-sensitive ROC.
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