A phase II study of gemcitabine, carboplatin and bevacizumab for the treatment of platinum-sensitive recurrent ovarian cancer

作者：Eisenhauer Eric L^*; Zanagnolo Vanna; Cohn David E; Salani Ritu; O' Malley David M; Sutton Gregory; Callahan Michael J; Cobb Bobbi; Fowler Jeffrey M; Copeland Larry J

来源：Gynecologic Oncology, 2014, 134(2): 262-266.

DOI：10.1016/j.ygyno.2014.05.030

• Ovarian cancer
• Chemotherapy
• Platinum-sensitive
• Recurrent
• Gemcitabine
• Bevacizumab

Purpose. The doublet gemcitabine and carboplatin is effective for the treatment of recurrent ovarian cancer, while multi-agent chemotherapy with bevacizumab may add additional benefit. This phase II study tested the efficacy and safety of a biweekly gemcitabine, carboplatin, and bevacizumab combination in patients with platinum-sensitive recurrent ovarian, peritoneal, or tubal cancer (ROC). %26lt;br%26gt;Patients and methods. Eligible patients received concurrent gemcitabine 1000 mg/m(2), carboplatin area under the curve 3, and bevacizumab 10 mg/kg administered intravenously on days 1 and 15 every 28 days for six cycles or up to 24 cycles if clinical benefit occurred. The primary end points were progression-free survival (PFS) by RECIST, and safety; the secondary end points were objective response rates and overall survival. %26lt;br%26gt;Results. Overall, 45 patients were enrolled. The median PFS was 13.3 months (95% CI, 11.3 to 153). The objective response rate was 69%. Grade 4 hematologic toxicities included neutropenia (27%) and thrombocytopenia (2%). Grades 3 and 4 non-hematologic toxicities included fatigue (18%), pain (9%), and nausea/vomiting (4%). There were 2 episodes of cerebrovascular accidents, 2 noted DVTs, and no episodes of bowel perforation. Median OS was 36.1 months (95% CI, 26.7 to 45.5). %26lt;br%26gt;Conclusion. Biweekly gemcitabine, carboplatin, and bevacizumab were an effective regimen in recurrent ovarian cancer, with comparable toxicity to recently reported day 1 gemcitabine, carboplatin, bevacizumab, and day 8 gemcitabine. Response rate and PFS are improved from reported outcomes of the gemcitabine carboplatin doublet. The degree to which biweekly dosing may present a more rationale schedule for this triplet should be evaluated further.

• 出版日期2014-8