伊立替康联合顺铂与依托泊苷联合顺铂方案一线治疗广泛期小细胞肺癌的多中心临床研究结果

Irinotecan plus cisplatin versus etoposide plus cisplatin as the first-line therapy for extensive-disease small cell lung cancer:Preliminary results of a multicenter clinical study

背景与目的:依托泊苷联合顺铂(EP)方案是否是广泛期小细胞肺癌(small cell lungcancer,SCLC)的最佳治疗方案目前仍不确定,本研究的目的是比较伊立替康联合顺铂(IP)和EP方案一线治疗广泛期SCLC的疗效和生存期。方法:在开放、两组随机、多中心、前瞻性临床研究中,符合入组条件的广泛期SCLC患者,随机接受IP或EP一线化疗,用药方案IP组:伊立替康65 mg/m^2,第1、8天,顺铂30 mg/m^2,第1、8天,21 d为1个周期,连续4个周期;EP组:VP-16为100 mg/m^2,顺铂25 mg/m^2,第1～3天,21 d为1个周期,连续4个周期。比较两组患者的疗效、生存期及不良反应。结果:2008年12月—2010年7月,共64例广泛期SCLC患者进入研究,其中IP组35例,EP组29例。IP和EP组的客观缓解率分别是66.7%和60.7%(P=0.202);无进展生存期分别是5.7和7.1个月(P=0.719);总生存期分别是未达到和12个月(P=0.591)。IP组最常见的不良反应是粒细胞减少、腹泻、消化道反应和血小板减少,发生率分别是88.2%、40%、29.4%和26.5%;EP组最常见的不良事件是粒细胞减少、消化道反应和贫血,发生率分别是80.8%、73.1%和38.5%。结论:IP和EP方案一线治疗广泛期SCLC的疗效和生存期相同,不良反应可耐受。

Background and purpose：It is unclear whether etoposide plus cisplatin（EP）regimen is the optimal chemotherapy regimen in the treatment of patients with extensive-disease（ED）small cell lung cancer （SCLC）.This study was aimed to evaluate the efficacy,survival and adverse effects of irinotecan plus cisplatin（IP）and EP as the first-line therapy for ED-SCLC.Methods：In open,controlled,randomized,multicenter and prospective clinical study,meeting experimental criteria patients were randomly assigned to IP（irinotecan 65 mg/m^2 on days 1, 8 and cisplatin 30 mg/m^2 on days 1,8）or EP（etoposide 100 mg/m^2 on days 1-3 and cisplatin 25 mg/m^2 on days 1-3）. Courses were repeated every 3 weeks with 4 cycles planned.The efficacy,survival and adverse effects of two therapies were compared.Results：Between Dec.2008 and Jul.2010,64 patients with ED-SCLC were enrolled（IP,n=35;EP, n=29）.The objective response rates（ORR）with IP and EP were 66.7%and 60.7%,respectively（P=0.202）.Median progression-free survival（PFS）for IP and EP was 5.7 and 7.1 months,respectively（P=0.719）.Overall survival（OS） for IP and EP was failed to achieve and 12 months,respectively（P=0.591）.The common adverse effects of IP included neutropenia（73.5%）,diarrhea（40%）,nausea（29.4%）and thrombocytopenia（26.5%）.The common adverse effects of EP included neutropenia（73.1%）,nausea（73.1%）and anemia（38.5%）.Conclusion：This study showed that there is no significant difference of the efficacy and survival of IP and EP as the first-line therapy for ED-SCLC and the adverse effects are tolerant.