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目的观察替吉奥胶囊单药治疗晚期非小细胞肺癌（NSCLC）的临床疗效及安全性。方法回顾性分析2011年8月至2014年10月本科43例经病理学确诊的二线或二线以上治疗失败的晚期NSCLC患者的临床资料，患者据体表面积（BSA）口服替吉奥胶囊80～120 mg／d ，即BSA＜1．25 m2予80 mg／d ，1．25 m2≤BSA＜1．5 m2时予100 mg／d ，BSA≥1．5 m2时予120 mg／d ，分2次口服，d1～d14，21 d为l周期。2个周期后评价疗效，疗效稳定或有效患者每6周接受一次CT和其它影像学检查进行疗效评价，记录最好疗效。计算有效率（RR）、疾病控制率（DCR）、总生存期（OS）、无进展生存期（PFS）以及不良反应。结果既往接受化疗方案的中位周期数为3（2～5），接受替吉奥胶囊治疗的中位周期数为4（1～8）。38例患者可评价疗效，无CR病例，PR 5例（11．6％），SD 11例（25．6％），PD 22例（51．2％），有效率（CR＋ PR）为11．6％，疾病控制率（CR＋ PR＋SD）为37．2％；OS为5．5个月（95％ CI：4．9～6．1），PFS为3．0个月（95％ CI：2．6～3．4）。主要不良反应是消化道反应及骨髓抑制，多为1～2级；无Ⅳ度血液学毒性，无治疗相关性死亡。结论替吉奥胶囊单药治疗三线及以上晚期NSCLC有一定的疗效，且不良反应可以耐受。“,”[Objective] To explore the efficacy and safety of S‐1 monotherapy for patients with advanced or recurrent non‐small cell lung cancer (NSCLC) after the failure of two or more prior chemotherapy regimens .[Methods] Retrospective reviews were conducted for 43 patients with advanced or recurrent NSCLC on S‐1 monotherapy between August 2011 and October 2014 after failed previous chemotherapy .S‐1 was administered orally twice daily at days 1~14 every 3 weeks .The dose of S‐1 was 80 mg/day [body surface area (BSA) <1 .25 m2 ] ,100 mg/day (BSA ≥1 .25 and <1 .50 m2 ) or 120 mg/day (BSA ≥1 .50 m2 ) .[Results] The medi‐an number of prior chemotherapy regimens was 5 (range ,2~ 5) and the median course 4 (range ,1~ 8) . Treatment response was assessed in 38 patients .None achieved complete response .The outcomes were partial response ( n =5 ,11 .6% ) ,stable disease ( n =11 ,25 .6% ) and progressive disease ( n=22 ,51 .2% ) .The median progression‐free survival was 3 months (95% CI:2 .6 ~ 3 .4) and the median overall survival 5 .5 months (95% CI:4 .9~6 .1) .No grade IV hematological toxicity was noted .The side effects were generally mild and consisted of gastrointestinal reactions and hematological toxicity .No drug‐related death occurred .[Conclusion] S‐1 monotherapy is efficacious with acceptable toxicity as third‐line or subsequent chemotherapy for advanced NSCLC .