title: A phase I study of concurrent chemoradiotherapy using oral s-1 for head and neck cancer.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Otorhinolaryngology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan. yasushifujimoto1@mac.com.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Fujimoto
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kato
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Itoh
authors.forename: Shinji
authors.initials: S
authors.lastname: Naganawa
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Nakashima
mesh_terms: D000230:Adenocarcinoma / Q000473:pathology / Q000628:therapy*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy; D019583:Dose Fractionation, Radiation; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000627:therapeutic use*; D011379:Prognosis; D005641:Tegafur / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid
keywords: Concurrent chemoradiotherapy; S-1; head and neck cancer; mucositis; recommended dose