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British Journal of Cancer (2005) 93, 884 889& 2005 Cancer Research UK All rights reserved 0007 0920/05 $30.00www.bjcancer.comRandomized scheduling feasibility study of S-1 for adjuvant
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[notdef]ClinicalM Tsukuda*,1, A Kida2, M Fujii3, N Kono4, T Yoshihara5, Y Hasegawa6, M Sugita7 and Chemotherapy Study
Group of Head and Neck Cancer1Department of Biology and Function in the Head and Neck, Yokohama City University Graduate School of Medicine, Kanazawa-ku, Yokohama, Japan;2Department of Otorhinolaryngology Head and Neck Surgery, Nihon University School of Medicine, Itabashi-ku, Tokyo, Japan; 3Division of Hearing and
Balance Research, National Institute of Sensory Organs, National Tokyo Medical Center, Meguro-ku, Tokyo, Japan;4Department of Otorhinolaryngology Studies6Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Chikusa-ku, Nagoya, Japan; 7Department
of Environmental and Occupational Health, Toho University School of Medicine, Ota-ku, Tokyo, JapanHead and Neck Surgery, Kyorin University School of Medicine, Mitaka-City, Tokyo, Japan;5Department of Otolaryngology, Tokyo Womens Medical
University, Shinjyuku-ku, Tokyo, Japan;The purpose of this study was to determine the feasible adjuvant therapy administration schedule of S-1 for locoregionally advanced
squamous cell carcinoma of the head and neck (SCCHN). Patients receiving definitive treatments were randomly assigned to either
arm A (51 cases) receiving oral S-1 of 2-week administration followed by 1-week rest for 6 months, or arm B receiving S-1 of 4-week
administration followed by 2-week rest for 6 months. Planned treatment was given in 40% of patients in arm A and 29% in arm B. The
cumulative rates of the relative total administration dose of S-1 at 100% were 54.9% (95% CI: 40.169.7%) in arm A and 34.3% (95%
CI: 21.147.4%) in arm B, respectively (P 0.054). Adverse events were recorded in 41 patients (82.0%) in arm A and 48 patients(94.1%) in arm B (P 0.060). The incidences of diarrhoea (10 vs 28%; Po0.05) and skin toxicities (18 vs 37%; Po0.05) were
significantly higher in arm B. One-year disease-free survival was similar in both arms: arm A 81.2% (95% CI:...