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Phase II Study of Combination Therapy with S-1 and Irinotecan for Advanced Non–Small Cell Lung Cancer: West Japan Thoracic Oncology Group 3505

Authors' Affiliations: ¹ Department of Medical Oncology, Kinki University School of Medicine; ² Clinical Research Center, National Hospital Organization, Kinki-chuo Chest Medical Center; ³ Department of Clinical Oncology, Osaka City General Hospital; ⁴ Kinki University School of Medicine, Sakai Hospital, Osaka, Japan; ⁵ Department of Pulmonary Medicine, Kobe City General Hospital; ⁶ Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Kobe, Japan; ⁷ Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan; ⁸ Pulmonary Medicine, Iizuka Hospital, Iizuka, Japan; and ⁹ Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan

Requests for reprints: Isamu Okamoto, Department of Medical Oncology, Kinki University School of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, Japan. Phone: 81-72-366-0221; Fax: 81-72-360-5000; E-mail: chi-okamoto{at}dotd.med.kindai.ac.jp.

Purpose: To evaluate the efficacy and toxicity of combination therapy with the oral fluoropyrimidine formulation S-1 and irinotecan for patients with advanced NSCLC.

Experimental Design: Chemotherapy-naive patients with advanced NSCLC were treated with i.v. irinotecan (150 mg/m²) on day 1 and with oral S-1 (80 mg/m²) on days 1 to 14 every 3 weeks.

Results: Fifty-six patients (median age, 63 years; range, 40-74 years) received a total of 286 treatment cycles (median, 5; range, 1-15). No complete responses and 16 partial responses were observed, giving an overall response rate of 28.6% [95% confidence interval (95% CI), 17.3-42.2%]. Twenty-four patients (42.9%) had stable disease and 12 patients (21.4%) had progressive disease as the best response. The overall disease control rate (complete response + partial response + stable disease) was thus 71.4% (95% CI, 57.8-82.7%). Median progression-free survival was 4.9 months (95% CI, 4.0-6.4 months), whereas median overall survival was 15 months. Hematologic toxicities of grade 3 or 4 included neutropenia (25%), thrombocytopenia (3.6%), and anemia (3.6%), with febrile neutropenia being observed in four patients (7.1%). The most common nonhematologic toxicities of grade 3 or 4 included anorexia (14.3%), fatigue (8.9%), and diarrhea (8.9%). There were no deaths attributed to treatment.

Conclusions: The combination of S-1 and irinotecan is a potential alternative option with a favorable toxicity profile for the treatment of advanced NSCLC. This nonplatinum regimen warrants further evaluation in randomized trials.