Phase II Study of Irinotecan plus S-1 in Treatment of Advanced Gastric Cancer

Hideki Bou, Akira Tokunaga, Hideyuki Suzuki, Nobuo Murata, Yasuyuki Sugiyama, Naoto Fukuda, Masahiro Ishimaru, Hiroyuki Suzuki

Department of Surgery, Kanto Rosai Hospital, Kawasaki, Japan.
Department of Surgery, University Hospital of Mizonokuchi, Teikyo University School of Medicine, Kawasaki, Japan.
Institute of Gastroenterology, Nippon Medical School Musashi Kosugi Hospital, Kawasaki, Japan.

DOI: 10.4236/jct.2013.42074                

Abstract

Objective: The efficacy and safety of irinotecan hydrochloride (CPT-11) plus oral fluoropyrimidine S-1 combination therapy in patients with previously untreated advanced gastric cancer was evaluated. Methods: The regimen comprised CPT-11 plus S-1: CPT-11, 60 mg/m² (days 1, 15); S-1, 40 - 60 mg/body twice daily (days 1 - 21) followed by a 1-week rest, every 4 weeks. Primary endpoint was response rate. Secondary endpoints were tumor control rate, adverse events, relative dose intensity, and overall survival. Results: Twenty-five patients were enrolled; median age was 66 years. Response rate was 40% (95% confidence interval, 21.1% - 61.3%; complete response in 1; partial response in 9). Tumor control rate was 56.0%, median survival time was 436 days and relative dose intensities were 0.83 for CPT-11 and 0.85 for S-1. Incidence of grade 3 or greater neutropenia, anemia and diarrhea was 16%, 12%, and 12%, respectively.Conclusion: The present results indicate that CPT-11 plus S-1 offers lower treatment-related toxicity than regimens including cisplatin and is effective in patients with advanced gastric cancer.

Keywords

Advanced Gastric Cancer; Systemic Chemotherapy; Irinotecan; S-1

Conflicts of Interest

The authors declare no conflicts of interest.

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