Phase II tailored S-1 regimen study of first-line chemotherapy in elderly patients with advanced and recurrent non-small cell lung cancer.

Abstract

e18141 Background: The aim of this study was to evaluate the efficacy and toxicity of a novel oral 5-fluorouracil (5-FU) formulation (S-1), administered according to a tailored dose regimen based on body surface area (BSA) and creatinine clearance (Ccr), in patients with advanced non-small-cell lung cancer who were 75 years or older. Pharmacokinetic analysis was also performed to evaluate the adequacy of the tailored S-1 dose. Methods: S-1 was administered orally for 28 days, followed by 14 days, in 23 patients who received a tailored dose of S-1, adjusted on the basis of individual creatinine clearance (Ccr) and body surface area (BSA). In 8 of the patients pharmacokinetic study were performed on the 5 times points on seventh day after S-1 administration. Results: Of the 23 patients enrolled in this study, 2 (8.7%) had a partial response and 14 (60.9%) had stable disease. The disease control rate was 69.6% (16/23) (95% confidence interval, 50.8-88.4%). Grade 3/4 hematologic and non-hematologic toxicities were minor. In the pharmacokinetic study group the maximum plasma concentration (Cmax) and the area under the plasma concentration curve (AUC) of 5-FU at all 5 times points after administration of the tailored S-1 dose regimen were similar to the values reported in a previous study describing cancer patients with normal renal function who received a standard dose of S-1 (80 mg/m2/day). Conclusions: Our results suggest that tailored S-1 monotherapy is safe and therapeutically useful as first-line treatment for elderly patients with advanced and recurrent non-small-cell lung cancer.