title: Phase I study of S-1 plus nedaplatin in patients with advanced/recurrent head and neck cancer.
abstract: BACKGROUND
  Cisplatin plus fluorouracil is widely used for the treatment of head and neck cancer. However, the cisplatin plus fluorouracil regimen necessitates hospitalization. Therefore, we planned to develop a new regimen that can be administered on an outpatient basis and performed a phase I study of S-1 + nedaplatin.
  
  
  METHODS
  S-1 was given orally at a fixed dose for 14 days, and nedaplatin was administered intravenously on day 8 of S-1 administration. The dose of nedaplatin was increased in 10-mg/m(2) steps to find the maximum tolerated dose, depending on the appearance of dose-limiting toxicities.
  
  
  RESULTS
  A total of 14 patients were registered. The maximum tolerated dose of nedaplatin was determined to be 90 mg/m(2). The main toxicities were neutropenia and thrombocytopenia. The response rate was 57.1%.
  
  
  CONCLUSIONS
  The recommended dose of nedaplatin for a phase II study was determined to be 80 mg/m(2). We concluded that our regimen was well tolerated and that the response rate was acceptable.
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo, Japan.
authors.forename: Yasunao
authors.initials: Y
authors.lastname: Kogashiwa
authors.forename: Kohichi
authors.initials: K
authors.lastname: Yamauchi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nagafuji
authors.forename: Takehiro
authors.initials: T
authors.lastname: Matsuda
authors.forename: Toshihito
authors.initials: T
authors.lastname: Tsubosaka
authors.forename: Takehiro
authors.initials: T
authors.lastname: Karaho
authors.forename: Takeshi
authors.initials: T
authors.lastname: Maruyama
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Kohno
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D002277:Carcinoma / Q000188:drug therapy; D002294:Carcinoma, Squamous Cell; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use; D018450:Disease Progression; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D018307:Neoplasms, Squamous Cell / Q000188:drug therapy; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000077195:Squamous Cell Carcinoma of Head and Neck; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D004338:Drug Combinations; D009944:Organoplatinum Compounds; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; C053989:nedaplatin; D002945:Cisplatin; D005472:Fluorouracil