title: Phase I pharmacokinetic study of S-1 granules and nedaplatin for advanced head and neck cancer.
abstract: OBJECTIVE
  We performed a pharmacokinetic phase I trial of the combination of S-1 granules and nedaplatin for head and neck squamous cell carcinoma (HNSCC).
  
  
  METHODS
  Patients were treated with both nedaplatin on day 1 at a dose starting at 80 mg/m(2) (level 1) escalating up to 90 mg/m(2) (level 2), and S-1 granules at a daily dose of 80 mg/m(2) on days 1 to 14 every three weeks. The primary end-point was determination of the recommended dose.
  
  
  RESULTS
  Twenty patients were enrolled. Dose-limiting toxicities occurred in one out of six patients at dose level 1 (neutropenia) and in all three patients at level 2 (neutropenia and thrombocytopenia). The recommended dose was determined as level 1. Pharmacokinetic parameters of S-1 granule did not differ from the capsula formulation. The response rate was 42.1%.
  
  
  CONCLUSIONS
  This combination was well-tolerated and manifested a promising activity against HNSCC.
authors: Center for Clinical and Translational Research, Kyushu University Hospital, 3-1-1 Maidashi, Higashiku, Fukuoka 812-8582, Japan. okamotoi@kokyu.med.kyushu-u.ac.jp.
authors: Hidetoshi
authors: H
authors: Hayashi
authors: Isamu
authors: I
authors: Okamoto
authors: Shinya
authors: S
authors: Ueda
authors: Kaoru
authors: K
authors: Tanaka
authors: Kunio
authors: K
authors: Okamoto
authors: Hisato
authors: H
authors: Kawakami
authors: Shinichi
authors: S
authors: Nishina
authors: Masayuki
authors: M
authors: Takeda
authors: Yasuhito
authors: Y
authors: Fujisaka
authors: Taroh
authors: T
authors: Satoh
authors: Kyoichi
authors: K
authors: Terao
authors: Yasumasa
authors: Y
authors: Nishimura
authors: Katsumi
authors: K
authors: Doi
authors: Kazuhiko
authors: K
authors: Nakagawa
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D004338:Drug Combinations; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D010094:Oxonic Acid / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D005641:Tegafur / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use
chemical_list: D004338:Drug Combinations; D009944:Organoplatinum Compounds; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; C053989:nedaplatin
keywords: Head and neck cancer; S-1; granule formulation; nedaplatin; phase I study