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

Eric L. Eisenhauer, Vanna Zanagnolo, David E. Cohn, Ritu Salani, David M. O'Malley, Gregory Sutton, Michael J. Callahan, Bobbi Cobb, Jeffrey M. Fowler, Larry J. Copeland

Research output: Contribution to journalArticlepeer-review

Abstract

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). Patients and methods Eligible patients received concurrent gemcitabine 1000 mg/m2, 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. Results Overall, 45 patients were enrolled. The median PFS was 13.3 months (95% CI, 11.3 to 15.3). 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). 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.

Original languageEnglish
Pages (from-to)262-266
Number of pages5
JournalGynecologic Oncology
Volume134
Issue number2
DOIs
Publication statusPublished - 2014

Keywords

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

ASJC Scopus subject areas

  • Obstetrics and Gynaecology
  • Oncology

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