Archive | 2021
Phase II study of daily S-1 combined with weekly irinotecan in previously treated patients with advanced or recurrent squamous cell lung cancer: North Japan Lung Cancer Group 1101 (NJLCG1101)
Abstract
\n Purpose\n\nThis phase II study was designed to evaluate the efficacy and safety of S-1 combined with weekly irinotecan as second- or third-line treatment for patients with advanced or recurrent squamous cell lung cancer.\nMethods\n\nPatients received oral S-1 on days 1–14 at 80 mg/day for patients with a body surface area of <\u20091.25 m2, 100 mg/day for patients with a body surface area of 1.25–1.5 m2, and 120 mg/day for patients with a body surface area of >\u20091.5 m2 and irinotecan (70 mg/m2) on days 1 and 8 every 3 weeks. The primary endpoint was overall response rate, and the secondary endpoints were progression-free survival, overall survival, and the frequency and the degree of adverse effects. The trial was registered in the University Hospital Medical Information Network Clinical Trials Registry, number UMIN000006065.\nResults\n\nBetween September 2011 and December 2014, 30 patients were enrolled in this study. The overall response rate was 6.7% (95% CI 0.8–22.1) and the disease control rate was 73.3%. The median progression-free survival was 3.0 months (95% CI 2.5–3.4) and median overall survival was 10.5 months (95% CI 5.6–13.7). Grade 3 or 4 treatment-related toxicities were reported in ≥\u200910% of patients including leukopenia (21%), neutropenia (21%), anemia (17%), anorexia (10%), and hypokalemia (10%).\nConclusion\n\nAdding weekly irinotecan to S-1 did not show the expected effect though toxicities were manageable.