Phase II study of gemcitabine and cisplatin in chemonaive patients with advanced epithelial ovarian cancer
作者:
Miquel Nogué,
Lluis Cirera,
Angels Arcusa,
Eduard Batiste-Alentorn,
Anna Balil,
Albert Font,
Jose Perez-Gracia,
Eva Carrasco,
Ignasi Tusquets,
期刊:
Anti-Cancer Drugs
(OVID Available online 2002)
卷期:
Volume 13,
issue 8
页码: 839-845
ISSN:0959-4973
年代: 2002
出版商: OVID
关键词: Gemcitabine;chemonaive;cisplatin;ovarian cancer
数据来源: OVID
摘要:
This phase II study evaluated the activity of gemcitabine (Gemzar) plus cisplatin (Platinol) as first-line treatment of advanced epithelial ovarian cancer. Forty-two chemonaive patients with advanced (stage III and IV) epithelial ovarian cancer received gemcitabine 1250 mg/m2on days 1 and 8 and cisplatin 100 mg/m2on day 1, every 3 weeks, up to eight cycles. The median number of cycles completed was 5 (range 2–8). Of the 41 patients evaluable for tumor response, 20 had a partial response and nine had a complete response, for an overall clinical and pathologic response rate of 70.7% (95% CI 56.8–84.6%). Median overall survival for all 42 patients was 23.4 months (95% CI 15.9–29.9 months) and the median progression-free survival time was 10.4 months (95% CI 9.4–13.5 months). The combination was generally manageable. Hematologic toxicity (grade 3/4 neutropenia: 31.0/21.4%; grade 3/4 thrombocytopenia: 9.5/4.8%; grade 3/4 anemia: 11.9/0%) and nausea and vomiting (grade 3/4: 35.7/31.0%) were the most common toxicities. There was one toxic death (septic shock due to hematologic toxicity-induced infection). We conclude that gemcitabine plus cisplatin is active and feasible as first-line treatment of advanced epithelial ovarian cancer. Further clinical trials with the addition of gemcitabine to first-line treatment appear warranted.
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