Purpose The purpose of this phase I/II study was to evaluate the feasibility and efficacy of S-1 plus cisplatin at the recom- mended schedule with concurrent thoracic radiotherapy for locally advanced non-small cell lung cancer (LA-NSCLC). Methods Eligible patients with LA-NSCLC were treated with cisplatin intravenously at a dose of 60 mg/m on day 8 plus oral S-1 at a dosage of 40 mg/m twice per day for two different treatment schedules for up to 4 cycles. Patients also concur - rently received 60 Gy of thoracic radiation in 30 fractions. The primary endpoint of the phase II study was the proportion of patients who survived for more than 2 years. Results Between August 2005 and October 2010, a total of 45 patients were enrolled in this phase I/II study; their long-term survival was then followed for a median period of 5.8 years. Nineteen of the 39 patients in the phase II study survived for more than 2 years and met the primary endpoint of the study. The median overall survival period was 24.9 months [95% confidence interval (CI) 17.4–74.5 months], and the 2- and 5-year overall survival rates were 51.0 and 43.0%, respectively. The response rate was 85%, and the median progression-free survival period was 13.8 months (95%
Cancer Chemotherapy and Pharmacology – Springer Journals
Published: Jan 31, 2018
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