Phase I/II Study of S-1 plus Cisplatin combination chemotherapy in patients with advanced/recurrent head and neck cancer

Masato Fujii, Kitinobu Tomita, Wataru Nishijima, Mamoru Tsukuda, Yasuhisa Hasegawa, Junichi Ishitoya, Hideo Yamane, Akihiro Homma, Toshiki Tomita

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14 Citations (Scopus)


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.

Original languageEnglish
Article numberhyp153
Pages (from-to)214-221
Number of pages8
JournalJapanese journal of clinical oncology
Issue number3
Publication statusPublished - 2009 Nov 23
Externally publishedYes


  • CDDP
  • Chemotherapy
  • Head and neck cancer
  • S-1

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research


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