Phase II study of S-1, a novel oral fluoropyrimidine, and biweekly administration of docetaxel for previously treated advanced non-small-cell lung cancer

PURPOSE: We examined the safety and efficacy of the combination of S-1 and biweekly docetaxel in patients with previously treated advanced non-small-cell lung cancer (NSCLC). METHODS: Patients with previously treated advanced NSCLC were eligible if they had a performance status of 2 or less, were 80 years or younger, and had adequate organ function. Forty-nine patients (38 men and 11 women; median age, 66 years; range 43–79 years) were enrolled. Patients were treated with the combination of 80 mg/m(2) per day of S-1 for 14 consecutive days and 35 mg/m(2) of docetaxel on days 1 and 15 every 4 weeks. RESULTS: The overall response rate was 16.3% (95% confidence interval, 7.6–30.5%). The disease-control rate was 49.0% (95% confidence interval, 34.4–63.7%). The median survival time after this treatment was 9 months (range 1–22 months). The median progression-free survival time was 3 months (range 1–11 months). Response rates and survival times did not differ significantly according to the histological type. Grade 3–5 toxicities included neutropenia in 51.0% of patients, thrombocytopenia in 2.0%, anemia in 20.4%, infection in 24.5%, anorexia in 12.2%, diarrhea in 14.3%, nausea in 6.1%, and dehydration in 4.2%. There was 1 treatment-related death due to severe anorexia, stomatitis, diarrhea, and, as consequence, dehydration. CONCLUSIONS: The combination of S-1 and biweekly docetaxel is an acceptable therapeutic option in patients with previously treated advanced NSCLC regardless of the histological type.