Journal
GYNECOLOGIC ONCOLOGY
Volume 118, Issue 1, Pages 52-57Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.ygyno.2010.03.003
Keywords
Platinum-refractory/resistant ovarian cancer; Alternating chemotherapy; Carboplatin; Gemcitabine; Pegylated liposomal doxorubicin; Cyclophosphamide
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Objective. In this phase II study the efficacy and toxicity of an alternating chemotherapy regimen was examined in platinum-resistant relapsed epithelial ovarian cancer (EOC) patients. Methods. Forty-five patients with platinum-refractory/resistant relapsed EOC, previously treated with carboplatin + paclitaxel +/- epirubicin were included. The regimen was consisted of gemcitabine 800 mg/m(2) (days 1 + 8) and carboplatin AUC 5, alternating with pegylated liposomal doxorubicin 30 mg/m(2) and carboplatin AUC 5, alternating with carboplatin AUC 5 and cyclophosphamide 600 mg/m(2), every 3 weeks for a total of 9 cycles. Results. Among 38 patients with measurable disease, 39.4% (95% Cl: 23.2-55.7) responded (five complete response and 10 partial response), while 30 out of 40 (75%) patients assessable by CA125 criteria had a serological response. Responses were more frequent in patients with platinum-free interval (PFI) 3-6 months than in those with PFI 0-3 months, but this was not statistically-significant. After a median follow-up of 19.5 months (range, 1.0-37+ months) the median progression-free survival was 7.1 months (95% Cl: 3.4-10.8) and the median survival (OS) was 18.8 months (95% CI: 15.6-22.0). For patients with PFI 0-3 months PFS was 4.3 (95% Cl: 0.8-7.8) months, while for those with PFI 3-6 months PFS was 8.9 (95% Cl: 5.3-12.4) months (p = 0.062). The regimen was well-tolerated and the main grade 3-4 toxicity was myelosuppression, palmar-plantar erythrodysesthesia, allergy and fatigue. Conclusion. This alternating regimen, including carboplatin, gemcitabine, liposomal doxorubicin and cyclophosphamide, is an active and well-tolerated treatment in platinum relapsed/refractory EOC patients. (C) 2010 Elsevier Inc. All rights reserved.
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