A phase I study of concurrent chemoradiotherapy using oral s-1 for head and neck cancer

Anticancer Res. 2014 Jan;34(1):209-13.


Aim: S-1 is a novel oral anticancer agent containing a combination of two modulators and tegafur. We conducted a phase I study of concurrent chemoradiotherapy with S-1 for head and neck cancer.

Patients and methods: S-1 was administered once daily, and radiotherapy was performed by 2 Gy/day, five days/week, for a total of 30 fractions. S-1 dosage was started at level 1 (55.3 mg/m(2)/day), and was increased to level 2 (66.7 mg/m(2)/day).

Results: A total of 12 patients were registered. Concerning hematological toxicities, no grade ≥3 or more hematological toxicity was confirmed at any level. With regard to non-hematological toxicities, at level 2, three cases of grade 3 mucositis and two cases of grade 3 dermatitis were confirmed.

Conclusion: The results showed that the maximum tolerated dose was level 2 and that dose-limiting toxicity was mucositis. Having determined that the recommended dose is level 1, we have begun the phase II clinical study.

Keywords: Concurrent chemoradiotherapy; S-1; head and neck cancer; mucositis; recommended dose.

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / pathology
  • Adenocarcinoma / therapy*
  • Administration, Oral
  • Adult
  • Aged
  • Carcinoma, Squamous Cell / pathology
  • Carcinoma, Squamous Cell / therapy*
  • Chemoradiotherapy
  • Dose Fractionation, Radiation
  • Dose-Response Relationship, Drug
  • Drug Combinations
  • Female
  • Follow-Up Studies
  • Head and Neck Neoplasms / pathology
  • Head and Neck Neoplasms / therapy*
  • Humans
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Neoplasm Staging
  • Oxonic Acid / therapeutic use*
  • Prognosis
  • Tegafur / therapeutic use*
  • Young Adult


  • Drug Combinations
  • S 1 (combination)
  • Tegafur
  • Oxonic Acid