伊立替康联合奈达铂对比联合顺铂二线治疗复发或难治性小细胞肺癌的疗效及毒副作用回顾分析

A Retrospective Study of the Efficacy and Toxicity of Irinotecan in Combination with Nedaplatin versus Irinotecan in Combination with Cisplatin as Salvage Treatment in Refractory or Relapsed Small Cell Lung Cancer

背景与目的对初治进展或复发的小细胞肺癌,目前尚无标准的二线方案,本研究旨在比较伊立替康联合奈达铂或联合顺铂治疗敏感复发或难治性小细胞肺癌的疗效和安全性。方法回顾了中国医学科学院肿瘤医院2009年4月-2012年4月诊治的1,140例小细胞肺癌患者,筛选二线接受伊立替康联合奈达铂(IN)或伊立替康联合顺铂(IC)方案化疗的患者进行分析。结果入组的54例患者中,中位无进展生存时间(progression free survival,PFS)为4.9个月,中位总生存时间(overall survival,OS)为13.3个月,IC组的PFS为4.3个月,IN组的PFS为5.4个月(P=0.465)。两组OS分别为13.3个月和14.3个月(P=0.704)。对生存时间的Cox多因素分析显示:二线治疗前的PS评分(P=0.003)、二线治疗前的转移部位个数(P=0.023)、接受化疗的周期数(P=0.003)是独立预后因素。整体的不良反应可耐受,IN组血液学毒性较重,IC组腹泻发生率较高,但均无统计学意义。结论伊立替康联合铂类是对于敏感复发和难治性小细胞肺癌有效且耐受性好的方案,伊立替康联合奈达铂在疗效及安全性方面都不劣于其联合顺铂。

Background and objective At present no standard second-line combination has been established for recurrent small cell lung cancer（SCLC）.Therefore we evaluate the efficacy and safety of irinotecan in combination with nedaplatin/cisplatin against refractory or relapsed small cell lung cancer.Methods In this retrospective study,we analyzed the data of 1,140 patients who diagnosed small cell lung cancer at our hospital from April 2009 to April 2012.Of all the patients,34 patients were treated with irinotecan and nedaplatin（irinotecan 60 mg/m2on days 1,8 nedaplatin 85 mg/m2day 1,every 3 weeks）,and 20 patients were treated with irinotecan and cisplatin（irinotecan 60 mg/m2on days 1,8 cisplatin 75 mg/m2day 1,every 3 weeks） as the second-line treatment.Prognostic factors of overall survival（OS） were estimated by Kaplan-Meier and Cox’s Regressionproportional hazards model.Results Of all the 54 eligible patients,median progression free survival（PFS） was 4.9 months,and median OS was 13.3 months.Median PFS was 5.4 months for irinotecan plus nedaplatin（IN） and 4.9 months for irinotecan plus cisplatin（IC）,respectively（P=0.465）.Median OS was 14.3 months and 13.3 months,respectively（P=0.704）.In multivariate analysis,ECOG PS,number of metastases and cycles of chemotherapy were independent prognostic factors.The toxicities were mild,while toxicity profile was slightly different for each of the arms： hematologic toxicity was higher in IN group,and diarrhea was higher in IC group.Conclusion Irinotecan plus platinum is effective and tolerable for refractory and relapsed small cell lung cancer.Irinotecan plus nedaplatin is non-inferior to irinotecan plus cisplatin in terms of efficacy and safety.