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高剂量紫杉醇用于铂耐药上皮性卵巢癌的II期研究。

Phase II study of high-dose paclitaxel in platinum-refractory epithelial ovarian cancer.

作者信息

Wilailak S, Tresukosol D, Linasmita V, Termrungruanglert W

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Eur J Gynaecol Oncol. 2000;21(6):610-2.

PMID:11214622
Abstract

The purposes of this study were to determine the efficacy of paclitaxel, using a dose of 200 mg/m2 intravenous continuous infusion over 24 hours every three weeks in the treatement of platinum-refractory epithelial ovarian cancer (EOC) and to evaluate the toxicities. Eligibility criteria included: histologically proven EOC, platinum resistance, measurable disease, Zubrod performance status grade 0-2, expected survival of > 3 months and adequate hematological function. Response was assessed at three-cycle intervals or earlier if required. Twenty-one patients were recruited in this study. The response rate was 52% (2 CR, 9 PR) with a median duration of response of six months. The median progression-free interval was eight months and the median survival was 12 months. Leukopenia was the predominant toxic effect. Eighty-six percent of patients required granulocyte-colony stimulation factor (G-CSF). All patients had alopecia grade 3. In conclusion, high-dose paclitaxel is active in platinum-refractory EOC with manageable toxicities.

摘要

本研究的目的是确定紫杉醇的疗效,采用每三周一次、剂量为200mg/m²静脉持续输注24小时的方案治疗铂类难治性上皮性卵巢癌(EOC),并评估其毒性。入选标准包括:组织学确诊的EOC、铂类耐药、可测量病灶、Zubrod体能状态分级为0 - 2级、预期生存期>3个月以及血液学功能正常。根据需要在三个周期或更早时间评估疗效。本研究共招募了21名患者。缓解率为52%(2例完全缓解,9例部分缓解),中位缓解持续时间为6个月。中位无进展生存期为8个月,中位生存期为12个月。白细胞减少是主要的毒性反应。86%的患者需要粒细胞集落刺激因子(G-CSF)。所有患者均出现3级脱发。总之,高剂量紫杉醇对铂类难治性EOC有效,且毒性可控。

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