Prospective exploratory study of gemcitabine and S-1 against elderly patients with advanced non-small cell lung cancer.

A prospective study was conducted to investigate the efficacy of a combined regimen of gemcitabine and S-1 for the treatment of elderly patients (>70 years) with advanced non-small cell lung cancer (NSCLC) as a first-line setting based on the dosage recommended in a previous phase I study. Chemotherapy-naïve patients with advanced NSCLC received gemcitabine plus S-1. S-1 (40 mg/m(2)) was administered orally twice daily for 14 days while gemcitabine (1,000 mg/m(2)) was administered on days 1 and 15 of each cycle, and this regimen was repeated every 4 weeks. A total of 20 patients were included in the present study. Of these, 8 patients achieved an overall response rate of 40.0%, and the overall disease control rate was 65.0%. According to the histological type, the response rate in patients with NSCLC and adenocarcinoma was 38.5%, and that for non-adenocarcinoma was 42.9%. Progression-free survival and median survival times were 6.4 months and 17.8 months, respectively. Grade 3 or 4 hematological toxicities observed were leukopenia (29%) and neutropenia (24%), while febrile neutropenia was not observed in any patient. The only non-hematological adverse event observed was grade 3 skin rash (10%). Therefore, the combination of gemcitabine and S-1 may be a promising and feasible regimen in the first-line setting for elderly patients with advanced NSCLC.