口服拓扑替康/静脉顺铂与静脉注射依托泊甙/顺铂治疗小细胞肺癌的临床研究  

Comparison of Oral Topotecan/Intravenous Cisplatin(TC) with Intravenous Etoposide/Cisplatin(EP) as First Line Chemotherapy in Untreated Small Cell Lung Cancer Patient

作　　者：孟弃逸[1] 朱允中[1] 张树才[1] 徐丽艳[1] 刘喆[1] 游永红[1] 唐俊舫[1] 

机构地区：[1]北京胸科医院肿瘤内科,北京101149

出　　处：《中国肺癌杂志》2009年第2期176-178,共3页Chinese Journal of Lung Cancer

摘　　要：背景与目的盐酸拓扑替康针剂是小细胞肺癌一线及二线治疗非常有效药物,但血液学毒性较高,口服拓扑替康是新剂型,2008年美国FDA批准用于广泛期小细胞肺癌的治疗。本研究评价国产口服拓扑替康/顺铂(oral topotecan/intravenous cisplatin,TC组)对比依托泊甙/顺铂(intravenous etoposide/cisplatin,EP组)治疗小细胞肺癌的疗效和毒副反应。方法TC组30例,EP组36例。化疗至少3个周期以上评价疗效。结果治疗组均可评价疗效30例,对照组35例可评价疗效,TC组、EP组有效率分别为53.3%(16/30)、60.0%(21/35),两组疗效差异无统计学意义。平均生存期14.58月/12.19月;中位生存期14.0月/10.1月(P>0.05)。TC组副反应Ⅲ以上粒细胞下降10%、血小板下降3.4%,EP组Ⅲ以上粒细胞下降42.9%、血小板下降11.4%。非血液学毒性以消化道反应、腹泻、脱发为主。总血液学毒性差异无统计学意义,Ⅲ度以上血液学毒性对照组高于治疗组,但差异无统计学意义。非血液学毒性脱发EP组高于TC组,腹泻EP组低于TC组。结论口服拓扑替康/顺铂与依托泊甙/顺铂治疗小细胞肺癌疗效相近,耐受性好。Background and objective Topotecon is a specific inhibitor of topoisomerase Ⅰ . It is an effective drug of small cell lung cancer. An oral formulation of topotecan is available and has just rectified to treat extensivedisease small cell lung cancer by FDA this year. The aim of this trial is to compare oral topotecan/intravenous cisplatin （TC） with intravenous etoposide/cisplatin （EP） in patients untreated small cell lung cancer. Methods Sixty-six patients were enrolled. Thirty patients were assigned to oral topotecan 1.4 mg ·m^-2 ·d^-1, from dl to d5, with cisplatin 75 mg/m^2 on dl. Thirty-six patients were assigned to etoposide 100 mg ·m^-2 ·d^-1, from dl to d3, with cisplatin 75 mg/m^2 on dl every 21 days. Results Response rate was similar between groups TC, 53.3% vs EP, 60.0%. Overall survival was little different TC, 14.58 month vs EP, 12.19 months. The regimens were similarly tolerable. Grade 3/4 neutropenia and thrombocytopenia occurred more frequently with EP （42.8% vs 10.0% and 11.4% vs 3.3%, respectively）, whereas grade 3/4 anaemia occurred more frequently with TC （10% vs 2.8%）. Conclusion Oral topotecan/cisplatin provide similar efficacy and tolerability to the standard etoposide/cisplatin in patient untreated small cell lung cancer. It may provide more convenience method to intravenous treatment.

关 键 词：口服治疗 拓扑替康 顺铂 肺肿瘤 

分 类 号：R734.2[医药卫生—肿瘤]