Abstract [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 .
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