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

American Society of Clinical Oncology (ASCO) - Tập 30 Số 17 - Trang 2039-2045 - 2012
Carol Aghajanian1, Stephanie V. Blank1, Barbara A. Goff1, Patricia L. Judson1, Michael Teneriello1, Amreen Husain1, Mika A. Sovak1, Jing Yi1, Lawrence R. Nycum1
1Carol 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...

Tóm tắt

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.

Từ khóa


Tài liệu tham khảo

10.3322/caac.20138

10.1056/NEJMra041842

10.1016/S0140-6736(03)13718-X

10.1200/JCO.2006.06.0913

10.1200/JCO.2009.25.7519

10.1200/JCO.2007.11.5345

10.1200/JCO.2007.12.1939

10.1200/JCO.2007.12.0782

10.1093/jnci/92.3.205

10.1097/00000421-198212000-00014

10.1200/JCO.1989.7.11.1748

10.7326/0003-4819-79-4-604

10.1080/01621459.1958.10501452

10.2307/2530286

10.1097/IGC.0b013e31821b2568

10.1200/jco.2011.29.15_suppl.5052

10.1056/NEJMoa1104390

10.1200/jco.2011.29.15_suppl.5023

10.1056/NEJMoa1103799

10.1200/jco.2011.29.18_suppl.lba5006

10.1016/j.ejca.2008.10.042

10.1093/jnci/djk091

Thông tin
Thông tin xuất bản

American Society of Clinical Oncology (ASCO)

Tập 30 Số 17

2039-2045

Thông tin tác giả