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Gynecol Oncol. 2014 Aug;134(2):262-6. doi: 10.1016/j.ygyno.2014.05.030. Epub 2014 Jun 5.

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

Author information

1
Division of Gynecologic Oncology, The Ohio State University College of Medicine, Columbus, OH, USA. Electronic address: eric.eisenhauer@uc.edu.
2
Division of Gynaecology, European Institute of Oncology, Milano, Italy.
3
Division of Gynecologic Oncology, The Ohio State University College of Medicine, Columbus, OH, USA.
4
Division of Gynecologic Oncology, St. Vincent Indianapolis Hospital, Indianapolis, IN, USA.

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/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.

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.

KEYWORDS:

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

PMID:
24910452
DOI:
10.1016/j.ygyno.2014.05.030
[Indexed for MEDLINE]

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