Feasibility Trial of Postoperative Adjuvant Chemotherapy with S-1, an Oral Fluoropyrimidine, for Elderly Patients with Non-Small Cell Lung Cancer: Report of the Lung Oncology Group in KYUSHU (LOGIK) Protocol 0901

ABSTRACT Objective The present study was designed to determine whether adjuvant chemotherapy with S-1 after surgical resection is feasible in elderly patients with non-small-cell lung cancer (NSCLC) in a multi-institutional trial. Methods Adjuvant chemotherapy consisted of eight cycles (2-week administration and 1-week withdrawal) of S-1, at 50-100 mg/body per day in an outpatient setting. The primary end point of this trial was the completion rate of eight cycles. Results From July 2009 to July 2011, 25 patients were enrolled in the study. However, one patient withdrew the consent before administration of S-1. Patient characteristics: male/female = 16/9, median age = 76 (range 71–85), ECOG PS 0/1 = 17/8, pathological stage IB/IIA/IIB/IIIA/IIIB = 10/6/3/5/1, and adenocarcinoma (Ad)/non-Ad = 17/8. Toxicity was generally mild. Only one patient experienced grade 3 anorexia. No hematological toxic effects ≥grade 3 occurred. The completion rate of eight cycles was 70.8% (90% confidence interval (CI), 52.1% to 85.4%). The reasons for incomplete cycles were patient refusal in four patients, anorexia in two and thrombocytopenia in one. Conclusions Adjuvant chemotherapy with S-1 in the reduced doses and schedule was found to be a feasible treatment of Japanese elderly patients following surgical resection for NSCLC.