A Phase II Study of S‐1 and Paclitaxel Combination Therapy as a First‐Line Treatment in Elderly Patients with Advanced Non‐Small Cell Lung Cancer

摘要

Abstract Lessons Learned Coadministration of S‐1 and paclitaxel in elderly patients with advanced non‐small cell lung cancer showed favorable efficacy. Coadministration of S‐1 and paclitaxel in elderly patients with advanced non‐small lung cancer showed tolerable toxicity. Background Although monotherapy with cytotoxic agents including docetaxel or vinorelbine are recommended for elderly patients with advanced non‐small cell lung cancer (NSCLC), the outcome is not satisfactory. We evaluated the efficacy and safety of S‐1 and paclitaxel (PTX) as a first‐line cotreatment in elderly patients with advanced NSCLC. Methods Oral S‐1 was administered on days 1–14 every 3 weeks at 80, 100, and 120 mg per day for patients with body surface area 1.25 m 2 , 1.25–1.5 m 2 , and 1.5 m 2 , respectively. PTX was administered at 80 mg/m 2 on days 1 and 8. The primary endpoint was response rate, and secondary endpoints were progression‐free survival (PFS), overall survival (OS), and safety. Results Seventeen patients were enrolled with response and disease control rates of 47.1% and 88.2%, respectively. Median PFS and OS were 5.6 and 35.0 months, respectively. Hematological grade 3 or 4 toxicities included leukopenia (55.8%), neutropenia (52.9%), febrile neutropenia (11.8%), and anemia (11.8%). Nonhematological grade 3 toxicities included stomatitis (23.5%), diarrhea (5.9%), and interstitial lung disease (5.9%), and grade 5 toxicities included interstitial lung disease (5.9%). Conclusion This S‐1 and PTX cotherapy dose and schedule showed satisfactory efficacy with mild toxicities in elderly patients with advanced NSCLC.