A randomized phase III trial comparing S-1 versus UFT as adjuvant chemotherapy for stage II/III rectal cancer (JFMC35-C1: ACTS-RC) |
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| Affiliation: | 1. Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka;2. Department of Gastroenterological Surgery, Hirosaki University Graduate School of Medicine, Aomori;3. Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu;4. Department of Surgical Oncology, Osaka City University Graduate School of Medicine, Osaka;5. Department of Surgery, Gastrointestinal Center, National Hospital Organization Kyushu Medical Center, Fukuoka;6. Department of Surgery, Fukui-ken Saiseikai Hospital, Fukui;7. Department of Surgery, Otaru Ekisaikai Hospital, Hokkaido;8. Department of Surgery, Osaka General Medical Center, Osaka;9. Department of Surgery, Kouseiren Takaoka Hospital, Toyama;10. Gastroenterological Surgery, Nanpuh Hospital, Kagoshima;11. Department of Surgery, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima;12. Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka;13. Devision of Gastrointestinal Surgery, Kobe University Hospital, Kobe;14. Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto;15. Faculty of Engineering, Tokyo University of Science, Tokyo;16. Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan |
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| Abstract: | BackgroundsPreventing distant recurrence and achieving local control are important challenges in rectal cancer treatment, and use of adjuvant chemotherapy has been studied. However, no phase III study comparing adjuvant chemotherapy regimens for rectal cancer has demonstrated superiority of a specific regimen. We therefore conducted a phase III study to evaluate the superiority of S-1 to tegafur–uracil (UFT), a standard adjuvant chemotherapy regimen for curatively resected stage II/III rectal cancer in Japan, in the adjuvant setting for rectal cancer.Patients and methodsThe ACTS-RC trial was an open-label, randomized, phase III superiority trial conducted at 222 sites in Japan. Patients aged 20–80 with stage II/III rectal cancer undergoing curative surgery without preoperative therapy were randomly assigned to receive UFT (500–600 mg/day on days 1–5, followed by 2 days rest) or S-1 (80–120 mg/day on days 1–28, followed by 14 days rest) for 1 year. The primary end point was relapse-free survival (RFS), and the secondary end points were overall survival and adverse events.ResultsIn total, 961 patients were enrolled from April 2006 to March 2009. The primary analysis was conducted in 480 assigned to receive UFT and 479 assigned to receive S-1. Five-year RFS was 61.7% [95% confidence interval (CI) 57.1% to 65.9%] for UFT and 66.4% (95% CI 61.9% to 70.5%) for S-1 [P = 0.0165, hazard ratio (HR): 0.77, 95% CI 0.63–0.96]. Five-year survival was 80.2% (95% CI 76.3% to 83.5%) for UFT and 82.0% (95% CI 78.3% to 85.2%) for S-1. The main grade 3 or higher adverse events were increased alanine aminotransferase and diarrhea (each 2.3%) in the UFT arm and anorexia, diarrhea (each 2.6%), and fatigue (2.1%) in the S-1 arm.ConclusionOne-year S-1 treatment is superior to UFT with respect to RFS and has therefore become a standard adjuvant chemotherapy regimen for stage II/III rectal cancer following curative resection. |
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