Adherence and feasibility of 2 treatment schedules of S-1 as adjuvant chemotherapy for patients with completely resected advanced lung cancer: a multicenter randomized controlled trial.

摘要: We conducted a multicenter randomized study of adjuvant S-1 administration schedules for surgically treated pathological stage IB-IIIA non-small cell lung cancer patients. Patients receiving curative surgical resection were centrally to arm A (4 weeks oral and 2-week rest over 12 months) or B (2 weeks 1-week 12 months). The primary endpoints completion the scheduled chemotherapy 12 months, secondary relative total dose, toxicity, 3-year disease-free survival. From April 2005 January 2012, 80 patients enrolled, whom 78 eligible assessable. planned 12 months was accomplished 28 in 38 (73.7%) 18 40 (45.0%, p = 0.01). average dose intensity 77.2% 58.4% (p = 0.01). Drug-related grade 3 adverse events recorded 11% 5% (p = 0.43). Grade 1–3 elevation bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine transaminase more frequently than B. survival rate 79.0% 79.3% (p = 0.94). superiority feasibility shorter schedule not recognized present study. conventional showed higher rates (p = 0.01) Toxicity no significant difference among schedule, except bilirubin. This retrospectively registered with UMIN-CTR (UMIN000016086, registration date December 30, 2014).