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

被引:1051
作者
Aghajanian, Carol [1 ,2 ]
Blank, Stephanie V. [3 ]
Goff, Barbara A. [4 ]
Judson, Patricia L. [5 ]
Teneriello, Michael G. [6 ]
Husain, Amreen [7 ]
Sovak, Mika A. [7 ]
Yi, Jing [7 ]
Nycum, Lawrence R. [8 ]
机构
[1] Mem Sloan Kettering Canc Ctr, Gynecol Med Oncol Serv, New York, NY 10065 USA
[2] Weill Cornell Med Coll, New York, NY USA
[3] NYU, Sch Med, New York, NY USA
[4] Univ Washington, Sch Med, Seattle, WA USA
[5] H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA
[6] US Oncol, Texas Oncol, Austin, TX USA
[7] Genentech Inc, San Francisco, CA 94080 USA
[8] Forsyth Reg Canc Ctr, Winston Salem, NC USA
关键词
ONCOLOGY-GROUP; CARBOPLATIN; PROGRESSION;
D O I
10.1200/JCO.2012.42.0505
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose This 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 Methods Patients 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. Results Overall, 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. Conclusion GC plus BV followed by BV until progression resulted in a statistically significant improvement in PFS compared with GC plus PL in platinum-sensitive ROC.
引用
收藏
页码:2039 / 2045
页数:7
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