The aim of this study was to evaluate the efficacy and toxicity of a novel oral 5-fluorouracil formulation (S-1) as second-line therapy after platinum agent chemotherapy for advanced non-small cell lung cancer (NSCLC).

METHODS: S-1 was administered orally at a dose of 80mg/m(2) for 28 days, followed by 14 days of rest (1 cycle); treatment was repeated until disease progression, unacceptable toxicity, or patient refusal.

RESULTS: Of the 46 patients enrolled in this study, 44 were evaluable. Six patients (14%) exhibited a partial response and 28 (64%) showed stable disease. Disease-control rate was 77.3% (34/44) (95% CI, 64.9-89.7%). The overall response rate was 14% (6/44) (95% CI, 3.5-23.8%). Median progression-free survival was 4.2 months. The median survival time was 16.4 months, and the one-year survival rate 60.3%. Grade 3/4 hematological toxicities were minor. All of those adverse reactions were tolerable and reversible.

CONCLUSION: This study demonstrated the efficacy of S-1 monotherapy as second-line treatment for advanced NSCLC.