作者: SHUNSUKE OKUMURA , TAKAAKI SASAKI , KAZUHIRO SATOH , MASAHIRO KITADA , ATSUSHI NAGASE
DOI: 10.3892/MCO.2012.6
关键词: Renal function 、 Internal medicine 、 Clinical endpoint 、 Phases of clinical research 、 Cancer 、 Mann–Whitney U test 、 Stage (cooking) 、 Gastroenterology 、 Surgery 、 Medicine 、 Lung cancer 、 Subgroup analysis
摘要: The efficacy of adjuvant chemotherapy with S-1 in patients completely resected non-small cell lung cancer (NSCLC) has yet to be clarified, and the appropriate schedule for remains unknown. A phase II study was conducted evaluate feasibility S-1. Patients enrolled this were 20-75 years old, had pathological stage IB-IIIA NSCLC, received complete resection NSCLC. (80 mg/m2) administered orally four weeks followed by a two-week rest period (conventional schedule), maximum eight cycles. primary endpoint relative dose intensity (RDI), while secondary endpoints safety 1 year disease-free survival (1y-DFS). Between May 2007 October 2009, 28 enrolled. RDI 63.1% (95% CI, 48.6-77.7). No grade 3 or worse hematological toxicity observed. Grade non-hematological toxicities observed patients. 4 detected. probability 1y-DFS 85.7% 72.8-98.6). In subgroup analysis, median over 65 old lower compared other (44.8 vs. 100%; P=0.013; Mann-Whitney U test). Creatinine clearance (CCr) older group, more 2 elderly These results suggest that conventional is not likely feasible