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多西他赛联合卡铂治疗局部晚期或复发性宫颈癌的 II 期临床研究。

Phase II study of combination chemotherapy with docetaxel and carboplatin for locally advanced or recurrent cervical cancer.

机构信息

Department of Gynecologic Oncology, Hyogo Cancer Center, Akashi, Japan.

出版信息

Int J Gynecol Cancer. 2010 Dec;20(9):1563-8.

PMID:21370599
Abstract

The efficacy and toxicity of combination chemotherapy with docetaxel + carboplatin were evaluated in patients with locally advanced or recurrent cervical cancer. A total of 71 patients with cervical cancer were enrolled into this trial, and 66 patients were considered eligible. The patients were administered docetaxel at 60 mg/m2 followed by carboplatin based on area under the curve of 6, both by intravenous infusion, every 3 weeks, with the treatment repeated for 1 to 6 cycles depending on the goal of the therapy. The response was evaluated based on the Response Evaluation Criteria in Solid Tumors criteria. Toxicity to chemotherapy was evaluated according to the National Cancer Institute Common Toxicity Criteria. Of the 66 eligible patients, 62 had locally advanced cervical cancer with no history of previous treatment, whereas 4 patients had recurrent cervical cancer. A total 149 cycles of chemotherapy were administered, with a median of 2.3 cycles (range, 1-6) per patient. The overall clinical response rate was 63.7% (44/66, 95% confidence interval, 52.1-75.3). In the neoadjuvant chemotherapy setting, the overall clinical response rate was 69.3% (43/62; 43/62, 95% confidence interval, 57.8-80.8), and the response rates in patients with squamous cell carcinoma and nonsquamous cell carcinoma were 69.7% (23/33, 95% confidence interval, 54.0-85.4) and 68.9% (20/29, 95% confidence interval, 52.1-85.7), respectively. On the other hand, in patients with recurrent cervical cancer, the overall response rate was 25.0% (1/4, 95% confidence interval, -17.4 to 67.4). Nonhematological toxicities were mainly grade 1 or 2. Hematological toxicity was encountered mostly in the form of neutropenia and thrombocytopenia. Combination chemotherapy with docetaxel + carboplatin is a safe and well-tolerated treatment for patients with advanced cervical cancer and is effective against not only squamous cell carcinoma, but also adenocarcinoma.

摘要

这项研究评估了多西他赛+卡铂联合化疗治疗局部晚期或复发性宫颈癌患者的疗效和毒性。共有 71 例宫颈癌患者入组该试验,其中 66 例患者符合条件。患者接受多西他赛 60mg/m2,随后给予基于曲线下面积 6 的卡铂静脉滴注,每 3 周重复治疗 1-6 个周期,取决于治疗目标。根据实体瘤反应评价标准评价疗效。根据国家癌症研究所常见毒性标准评价化疗毒性。66 例符合条件的患者中,62 例为局部晚期宫颈癌,无既往治疗史,4 例为复发性宫颈癌。共进行了 149 个周期的化疗,中位数为 2.3 个周期(范围 1-6 个周期)/例患者。总临床缓解率为 63.7%(44/66,95%置信区间,52.1-75.3)。在新辅助化疗环境中,总临床缓解率为 69.3%(43/62;43/62,95%置信区间,57.8-80.8),鳞癌和非鳞癌患者的缓解率分别为 69.7%(23/33,95%置信区间,54.0-85.4)和 68.9%(20/29,95%置信区间,52.1-85.7)。另一方面,在复发性宫颈癌患者中,总缓解率为 25.0%(1/4,95%置信区间,-17.4 至 67.4)。非血液学毒性主要为 1 级或 2 级。血液学毒性主要表现为中性粒细胞减少和血小板减少。多西他赛+卡铂联合化疗是治疗晚期宫颈癌安全且耐受良好的方法,不仅对鳞癌有效,对腺癌也有效。

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