Phase II clinical trial of docetaxel in refractory squamous cell carcinoma of the cervix - A gynecologic oncology group study
Phase II clinical trial of docetaxel in refractory squamous cell carcinoma of the cervix - A gynecologic oncology group study
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DOI：
10.1097/coc.0b013e31803377c8
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发表时间：
2007-08-01
影响因子：
2.6
通讯作者：
Roman, Lynda D.
中科院分区：
文献类型：
--
作者：
Garcia, Agustin A.;Blessing, John A.;Roman, Lynda D.
目的：开展一项II期研究，评估多西他赛对既往治疗过的宫颈鳞状细胞癌患者的抗肿瘤活性和不良反应。方法：符合条件的患者均为可测量的疾病，且既往化疗方案不超过一种。多西紫杉醇100 mg/m(2)静脉给予1小时以上。这种治疗每21天重复一次，直到疾病进展或不良反应禁止进一步治疗。结果：27例患者进入本研究，其中23例符合条件并可评估。2例（8.7%）部分缓解。病情稳定者8例（34.8%），病情加重者9例（39.1%）。中位进展时间为3.8个月（1.2-11.7个月），中位生存时间为7.0个月（1.8-23.0个月）。最常见的不良事件是中性粒细胞减少、感染、胃肠道和体质。结论：多西紫杉醇在治疗难治性宫颈鳞状细胞癌的剂量和治疗方案中具有极小的活性。
Objective: A phase II study was conducted to evaluate the antitumor activity and adverse effects of docetaxel in patients with previously treated squamous cell carcinoma of the cervix.Methods: Eligible patients were to have measurable disease and not more than one prior chemotherapy regimen. Docetaxel 100 mg/m(2) was administered intravenously over 1 hour. This treatment was repeated every 21 days until progression of disease or adverse effects prohibited further therapy.Results: Twenty-seven patients were entered onto this study, of whom 23 were eligible and evaluable. There were 2 (8.7%) partial responses. Eight patients (34.8%) had stable disease and 9 patients (39.1 %) had increasing disease. The median time to progression was 3.8 months (range, 1.2-11.7 months), while median survival time was 7.0 months (range, 1.8-23.0 months). The most frequently reported adverse events were neutropenia, infection, gastrointestinal, and constitutional.Conclusions: Docetaxel has minimal activity in refractory squamous cell carcinoma of the cervix at the dose and schedule tested.