Japanese Journal of Clinical Oncology Advance Access published online on November 23, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyp153
© The Author (2009). Published by Oxford University Press. All rights reserved
Phase I/II Study of S-1 plus Cisplatin Combination Chemotherapy in Patients with Advanced/Recurrent Head and Neck Cancer
1 Division of Hearing and Balance Research, National Institute of Sensory Organs, National Tokyo Medical Center, Tokyo
2 Department of Head and Neck, National Kyushu Cancer Center Hospital, Fukuoka
3 Department of Head and Neck Surgery, Saitama Cancer Center Hospital, Saitama
4 Department of Otorhinolaryngology and Head and Neck Surgery, Yokohama City University Graduate School of Medicine, Kanagawa
5 Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Aichi
6 Department of Otorhinolaryngology, Yokohama City University Medical Center, Kanagawa
7 Department of Otorhinolaryngology, Graduate School of Medicine, Osaka City University, Osaka
8 Department of Otorhinolaryngology and Head and Neck Surgery, Hokkaido University Graduate School of Medicine, Sapporo
9 Department of Otorhinolaryngology and Head and Neck Surgery, Keio University School of Medicine, Tokyo, Japan
For reprints and all correspondence: Masato Fujii; Division of Hearing and Balance Research, National Institute of Sensory Organs, National Tokyo Medical Center, 2-5-1, Higashigaoka, Meguro-ku, Tokyo 152-8902, Japan. E-mail: fujiimasato{at}kankakuki.go.jp
Received June 28, 2009; accepted October 14, 2009
Objective: The objectives of this study were to determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 plus cisplatin (CDDP) and to evaluate safety and efficacy using the defined RD in advanced/recurrent head and neck cancer (HNC).
Methods: S-1 was administered orally at 40 mg/m2 twice daily for 14 consecutive days, and CDDP was infused on day 8 at a dose of 60 and 70 mg/m2. Each course was repeated every 4 weeks.
Results: A total of 38 patients were registered, 10 patients for the Phase I study and an additional 28 patients for the Phase II study. Although no dose-limiting toxicity (DLT) was observed in the CDDP 60 mg/m2 (Level 1) group, two of six patients in the CDDP 70 mg/m2 (Level 2) group exhibited DLT (fatigue/diarrhea). The MTD was not achieved in the Phase I study. Level 2 was therefore determined as the RD. In the Phase II study, 34 patients, including 6 patients from the Phase I study, were evaluated. At the termination of treatment, the confirmed response rate was 44.1% (15/34, 95% CI: 27.4–60.8). The best response rate without an adequate duration time was 67.6% (95% CI: 51.9–83.4). The median survival period was 16.7 months, and the 1-year survival rate was 60.1%. The main toxicities of Grade 3 or above were anorexia (26.5%), nausea (14.7%), neutropenia/thrombocytopenia (11.8%) and anemia/fatigue (8.8%).
Conclusions: This is considered to be an effective regimen with acceptable toxicities for HNC.
Key Words: head and neck cancer • S-1 • CDDP • chemotherapy