1. ¹Department of Biology and Function in the Head and Neck, Yokohama City University Graduate School of Medicine, Kanazawa-ku, Yokohama, Japan
2. ²Department of Otorhinolaryngology – Head and Neck Surgery, Nihon University School of Medicine, Itabashi-ku, Tokyo, Japan
3. ³Division of Hearing and Balance Research, National Institute of Sensory Organs, National Tokyo Medical Center, Meguro-ku, Tokyo, Japan
4. ⁴Department of Otorhinolaryngology – Head and Neck Surgery, Kyorin University School of Medicine, Mitaka-City, Tokyo, Japan
5. ⁵Department of Otolaryngology, Tokyo Women's Medical University, Shinjyuku-ku, Tokyo, Japan
6. ⁶Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Chikusa-ku, Nagoya, Japan
7. ⁷Department of Environmental and Occupational Health, Toho University School of Medicine, Ota-ku, Tokyo, Japan

Correspondence: Dr M Tsukuda, E-mail: mtsukuda@med.yokohama-cu.ac.jp

Received 22 June 2005; Revised 25 August 2005; Accepted 25 August 2005; Published online 27 September 2005.

Abstract

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: 40.1–69.7%) in arm A and 34.3% (95% CI: 21.1–47.4%) 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%; P<0.05) and skin toxicities (18 vs 37%; P<0.05) were significantly higher in arm B. One-year disease-free survival was similar in both arms: arm A 81.2% (95% CI: 70.0–92.4%); arm B 77.0% (95% CI: 65.0–89.0%). The schedule of 2-week administration followed by 1-week rest seems to be more feasible for oral 6-month administration of S-1 in adjuvant chemotherapy of locoregionally advanced SCCHN.