A phase II study of S-1 chemotherapy with concurrent thoracic radiotherapy in elderly patients with locally advanced non-small-cell lung cancer: The Okayama Lung Cancer Study Group Trial 0801

Abstract

BackgroundAlthough thoracic irradiation (TRT) is a standard treatment for elderly patients with locally advanced non-small-cell lung cancer (LA-NSCLC), treatment outcomes are poor. We previously reported a phase I trial combining S-1, an oral 5-fluorouracil derivative, and thoracic radiation, which yielded safe and effective outcomes. MethodsIn this phase II trial, 30 patients aged 76years or older with LA-NSCLC received S-1 (80mg/m2 on days 1–14 and 29–42) and TRT (60Gy). The primary end-point was the response rate. ResultsThe median age and pre-treatment Charlson score were 79years and 1, respectively. The mean proportions of the actual doses of S-1 and TRT delivered relative to the planned doses were 95% and 98%, respectively. Partial responses were observed in 19 patients (63%; 95% confidence interval: 45–82%), which did not attain the end-point. At a median follow-up time of 23.7months, the median progression-free survival and median survival times were 13.0months and 27.9months, respectively. No difference in efficacy was observed upon stratification by tumour histology. Toxicities were generally mild, except for grade 3 or greater febrile neutropenia and pneumonitis in 7% and 10% of patients, respectively. No patient developed severe oesophagitis. ConclusionsAlthough the primary end-point was not met, concurrent S-1 chemotherapy and radiotherapy yielded favourable survival data. Also, the combined treatment was well-tolerated in elderly patients with LA-NSCLC.