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)

Purpose: This 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. Methods Patients received oral S-1 on days 1–14 at 80 mg/day for patients with a body surface area of  1.5 m 2 and irinotecan (70 mg/m 2 ) 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. Results Between 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 ≥ 10% of patients including leukopenia (21%), neutropenia (21%), anemia (17%), anorexia (10%), and hypokalemia (10%). Conclusion Adding weekly irinotecan to S-1 did not show the expected effect though toxicities were manageable.