A Phase I and Extension Study of S-1 and Carboplatin for Previously Untreated Patients Aged 75 Years or More with Advanced Non-Small Cell Lung Cancer

Abstract Background Combination carboplatin and S-1 is active in the treatment of non-small cell lung cancer (NSCLC). However, data on this combination for elderly patients with NSCLC are insufficient. Methods Eligibility criteria were no prior chemotherapy, stage IIIB or IV NSCLC, performance status 0-1, age >75 y, and adequate hematological, hepatic, and renal functions. Carboplatin was administered on day 1 and S-1 was administered orally, twice a day, between days 1 and 14, repeated every 3 weeks. In phase I, the primary end-point was determination of the recommended dose. Starting doses of carboplatin and S-1 were area under the curve (AUC) of 4 and 80 mg/m2/day, respectively. In the extension study, the effects and tolerability of this combination therapy of recommended dose were confirmed. Results A total of 10 patients were entered into phase I and 14 patients were entered into the extension study. The recommended doses for this drug combination are AUC 5 for carboplatin and 80 mg/m2/day every 3 weeks for S-1. With carboplatin and S-1 combination therapy at the recommended dose, the response rate was 30.0% (95% confidence interval (CI): 12-54%) and the disease control rate was 90.0% (95%CI: 68-99%). Thrombocytopenia and neutropenia were major adverse events. Conclusions The recommended doses for this combination therapy are carboplatin AUC 5 and S-1 80 mg/m2/day every 3 weeks, and this combination is effective with tolerable toxicities for advanced NSCLC patients >75 y old. Legal entity responsible for the study University Hospital Medical Information Network. Funding Tokyo Clinical Oncology Group. Disclosure All authors have declared no conflicts of interest.