吉西他滨-卡铂方案后续贯性应用紫杉醇-卡铂方案作为晚期卵巢癌一线治疗方案:一项Ⅱ期研究

作     者：Menp J.U. Gréenman S.E. Jalkanen J.T. 朱国栋 

作者机构：Division of Gynecologic Oncology Department of Obstetrics and Gynecology University Hospital P.O. Box 2000 FI-33521 Tampere Finland 

出 版 物：《世界核心医学期刊文摘（妇产科学分册）》 (Core Journal in Obstetrics/Gynecology)

年 卷 期：2006年第2卷第9期

页      面：52-53页

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

主　　题：吉西他滨 晚期卵巢癌 治疗方案 紫杉醇 卡铂 中性粒细胞减少症 Ⅱ期研究 RECIST标准 

摘      要：Objective. To determine the feasibility and efficacy of sequential gemcitabine- carboplatin followed by paclitaxel- carboplatin in the first- line treatment of advanced epit-helial ovarian cancer, with the response rate as the primary endpoint. Methods. After primary laparotomy, 56 patients with FIGO Stages III- IV disease were given 4 cycles of gemcitabine 1000 mg/m2 d1,8 and carboplatin AUC5 (44 patients) or AUC6 (12 patients) d1 q3wk followed by 4 cycles of paclitaxel 175 mg/m2 d1 and carboplatin AUC5/6 q3wk. Of the tumors, 43 were serous, 6 clear cell, 4 endometrioid, and 3 anaplastic type. Thirty- seven (66.1% ) of the patients were suboptimally debulked. Results. Forty-seven patients were evaluable for response by CA- 125 criteria, and 46 (98% ) responded. Thirty patients (after gemcitabine- carboplatin) and 24 (after paclitaxel- carboplatin) were evaluable for response by CT (RECIST criteria), respectively. After the four gemcitabine- carboplatin cycles, the objective response rate was 83% (6 CR, 19 PR). Following completion of the whole sequential regimen, 7 patients showed a CR and 15 a PR, respectively, giving a response rate of 92% . The median progression- free survival was 12.8 months after a median follow- up of 19 months (range 7- 35 months)- .The median overall survival has not been reached yet. The main toxicity was neutropenia as 139/221 (62.9% ) of the gemcitabine- carboplatin cycles and 92/181 (50.8% ) of the paclitaxel- carboplatin cycles, respectively, were associated with Grades 3- 4 neutropenia. Neutropenia was reported as a serious adverse event in 5.7% of the cycles, and GCSF support was needed in 18.4% of the cycles. Only the gemcitabine- carboplatin cycles were associated with a marked thrombocytopenia (32.1% Grades 3- 4). Of the other side effects, marked allergy occurred in 14/52 (27% ) exposed to paclitaxel. A total of 14 patients discontinued the treatment prematurely: 3 due to lack of efficacy, 1 due to protocol violation, and 10 due