A Phase Ii Study Of S-1 And Concurrent Thoracic Radiotherapy (Trt) For Elderly Pts With Locally Advanced Non-Small Cell Lung Cancer (La-Nsclc): Okayama Lung Cancer Study Group Trial 0801.

7576 Background: Although thoracic irradiation is one of the standard therapies in elderly pts with LA-NSCLC, its treatment outcome is still poor. We previously reported safety profiles of S-1, an oral fluoropyrimidine possessing a radio-sensitizing effect, and concurrent TRT in such population [Lung Cancer 2011]. The objective of this study was to assess the efficacy and safety of S-1 with concurrent TRT for elderly pts with LA-NSCLC. Methods: Pts with stage III, aged ≥76 years and PS 0-1, and without any prior chemotherapy were eligible for this study. ps were treated with S-1 (40 mg/m²/dose b.i.d. on days 1-14 and 29-42) and TRT (60 Gy/30 fr over 6 weeks starting on day 1). Primary endpoint was response rate (RR), and required sample size was 30 pts, with a rate of 50% would be the lower limit of interest, with α = 0.05 and s = 0.20. Results: Between 2007 and 2012, 30 pts were enrolled (24 men; median age, 79 years; PS 0, 15; IIIA, 20; Sq, 12). Median Charlson score was 1 ranging from 0 to 3. The propo...