新发晚期卵巢癌患者使用拓扑替康/卡铂后使用紫杉醇/卡铂治疗的Ⅱ期研究  

Phase II study of sequential doublets: Topotecan and carboplatin, followed by paclitaxel and carboplatin, in patients with newly diagnosed advanced ovarian cancer

作　　者：Gordon A.N. Asmar L. Messing M.J. 张剑萍 

机构地区：[1]Texas Oncology, P.A., Ch arlesA. Sammons Cancer C., Dallas,TX, United States

出　　处：《世界核心医学期刊文摘（妇产科学分册）》2005年第1期60-61,共2页Core Journal in Obstetrics/Gynecology

摘　　要：Objective. Incorporating topotecan into standard platinum/taxane chem otherapy for advanced ovarian cancer has been complicated by myelosuppression. This study evaluated sequential doublets of topotecan and carboplatin, followed by paclita xel and carboplatin, in newly diagnosed advanced ovarian cancer patients. Method s. Forty-five patients (median age, 56 years; range, 38-77 years) with stage I II/IV disease and GOG performance status < 2 were enrolled and received four cyc les of topotecan (1.0 mg/m2/day on days 1 to 3) and carboplatin (AUC 4 on day 1) , followed by four cycles of paclitaxel (175 mg/m2 via 3-h IV infusion on day 1 ) and carboplatin (AUC 5 on day 1). All cycles were 21 days. Antitumor response was assessed after four and eight cycles; patients with clinical complete respon se (CR) underwent second-look laparotomy for determination of pathologic CR (PC R). Dose reductions were instituted for grade 4 neutropenia and thrombocytopenia , and for grade 3/4 nonhematologic toxicity. Results. Among 41 CA-125 evaluable patients, complete and partial responses were observed in 29 (70.7%) and 11 (26.8%) patients, r espectively. Of the 12 clinical CRs (43%) in 28 evaluable patients, 10 patients underwent second-look laparotomy, with 3 PCRs (30%). Median time to progressi on was 14 months and actuarial survival was 23 months. Neutropenia was the prima ry toxicity and cause of dose adjustments and delays, including two deaths. Conc lusion. The antitumor activity observed is comparable with other series, althoug h neutropenic complications were increased. Progression-free and actuarial surv ivals were slightly inferior. A Phase Ⅲtrial (GOG182) of sequential doublets in the reverse sequence is ongoing.Objective. Incorporating topotecan into standard platinum/taxane chem otherapy for advanced ovarian cancer has been complicated by myelosuppression. This study evaluated sequential doublets of topotecan and carboplatin, followed by paclita xel and carboplatin, in newly diagnosed advanced ovarian cancer patients. Method s. Forty-five patients (median age, 56 years; range, 38-77 years) with stage I II/IV disease and GOG performance status < 2 were enrolled and received four cyc les of topotecan (1.0 mg/m2/day on days 1 to 3) and carboplatin (AUC 4 on day 1) , followed by four cycles of paclitaxel (175 mg/m2 via 3-h IV infusion on day 1 ) and carboplatin (AUC 5 on day 1). All cycles were 21 days. Antitumor response was assessed after four and eight cycles; patients with clinical complete respon se (CR) underwent second-look laparotomy for determination of pathologic CR (PC R). Dose reductions were instituted for grade 4 neutropenia and thrombocytopenia , and for grade 3/4 nonhematologic toxicity. Results. Among 41 CA-125 evaluable patients, complete and partial responses were observed in 29 (70.7%) and 11 (26.8%) patients, r espectively. Of the 12 clinical CRs (43%) in 28 evaluable patients, 10 patients underwent second-look laparotomy, with 3 PCRs (30%). Median time to progressi on was 14 months and actuarial survival was 23 months. Neutropenia was the prima ry toxicity and cause of dose adjustments and delays, including two deaths. Conc lusion. The antitumor activity observed is comparable with other series, althoug h neutropenic complications were increased. Progression-free and actuarial surv ivals were slightly inferior. A Phase Ⅲtrial (GOG182) of sequential doublets in the reverse sequence is ongoing.

关 键 词：晚期卵巢癌 拓扑替康 标准化疗方案 抗肿瘤效应 非血液系统毒性 行为状况 紫杉烷类 肿瘤进展 剖腹探查术 完全缓解率 

分 类 号：R737.31[医药卫生—肿瘤]