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目的 研究培美曲塞联合铂类药物一线用药治疗晚期非小细胞肺癌(NSCLC)的近期及远期疗效,分析胸苷酸合酶(TS)表达与培美曲塞联合铂类药物疗效的关系.方法 回顾性分析2008年1月至2009年10月在北京肿瘤医院接受培美曲塞联合铂类药物一线化疗的51例Ⅲb/Ⅳ期非鳞癌NSCLC患者.共35例患者接受培美曲塞联合顺铂方案化疗,16例接受培美曲塞联合卡铂方案化疗.对其中30例的组织标本采用免疫组织化学法检测TS的表达.主要研究终点为总生存期,次要终点为缓解率、无进展生存期及不良反应.采用SPSS 16.0软件进行统计学分析.运用卡方检验分析临床因素等与化疗疗效的相关性,采用Kaplan-Merier曲线法和log-rank检验进行生存分析.结果 51例患者中1例失访(但可评价疗效及无进展生存期),余50例资料完整.客观有效率(完全缓解+部分缓解)为37％(19/51),疾病控制率(完全缓解+部分缓解+稳定)为71％ (36/51).中位无进展生存(PFS)为5.3个月(95％ CI为3.9 ～6.7),中位总生存期为19.0个月(95％ CI为11.6～26.4).单因素分析结果显示,性别、病理类型、吸烟状态和疗效与生存期相关.多因素分析结果显示,病理类型是影响患者总生存期的独立预后因素.根据美国国立癌症研究所常见毒性分级标准,3～4级不良反应的发生率低,主要包括白细胞减少(5/51)、中性粒细胞减少(10/51)及消化道反应(2/51).30例患者的标本中TS表达阳性10例.卡方分析结果显示,TS表达与疗效无关.多因素分析结果显示,病理类型、疗效及TS表达水平与总生存期相关(均P＜0.01).结论 培美曲塞联合铂类药物一线用药治疗晚期非鳞癌NSCLC疗效确切,患者耐受性好.TS表达水平与患者生存期相关.“,”Objective To evaluate the effect of pemetrexed plus platinum for chemotherapy-naive advanced non-small cell lung cancer (NSCLC),and to explore thymidylate synthetase (TS) expression as the predictive and prognostic factor for this treatment. Methods This retrospective study enrolled 51 patients with chemotherapy-naive advanced NSCLC (non-squamous) treated at Department of Thoracic Medical Oncology in Beijing Cancer Hospital from Jan 2008 to Oct 2009.All patients received pemetrexed plus platinum as first-line treatment. TS expression was detected in 30 patients who had enough tissue samples by immunohistochemistry. Results The objective response rate (ORR) was 37.3％. Median progression-free surrival (PFS) was 5.3 months (95％ CI:3.9 - 6.7 ),and median overall surrival (OS)was 19.0 months (95％ CI:11.6 - 26.4). Univariate analysis showed that gender,pathology,smoking status and response were significantly correlated with OS. Cox-regression analysis showed that pathology was an independent prognostic factor.Rate of Grade 3/4 adverse events was low.In 30 patients with enough tissue samples were available,TS expression positive rate was 33.3％ ( 10/30). Chi-square test showed that TS expression was not associated with ORR. Multivariate analysis showed that pathology,response and TS expression (P =0.003,0.005 and 0.001,respectively) were the prognostic factors.Conclusion The therapeutic effect and tolerance of pemetrexed plus platinum regiment were definite as first-line treatment for chemotherapy-naive advanced NSCLC,and TS expression was an independent prognostic factor.