title: Phase II study of S-1 as first-line treatment for elderly patients over 75 years of age with advanced gastric cancer: the Tokyo Cooperative Oncology Group study.
abstract: OBJECTIVE
  This prospective multicenter phase II study was carried out to investigate the efficacy, safety and pharmacokinetics of S-1 monotherapy in elderly patients over 75 years of age, with unresectable advanced or recurrent gastric cancer.
  
  
  METHODS
  Patients had measurable or evaluable lesions according to the Japanese Classification of Gastric Carcinoma. S-1 (25-60 mg determined by the body surface area and creatinine clearance) was given orally, twice daily. A course of treatment consisted of 4-week administration followed by a 2-week rest period, and the patients received repeated courses.
  
  
  RESULTS
  Thirty-three patients were enrolled. Pharmacokinetics of S-1 was studied in six patients, and the maximum plasma concentrations of respective metabolites after S-1 administration were found to be similar to those reported for younger cancer patients. The overall response rate in 33 patients was 21.2% (95% CI, 10.7-37.8%), and median progression-free survival was 3.9 months, with a median overall survival of 15.7 months. Frequently noted adverse events include leukopenia, neutropenia, anemia, anorexia, and fatigue. As for serious adverse events, relatively higher frequencies of anemia (9%) and anorexia (12%) of grade 3 severity were found, but there were no grade 4 episodes.
  
  
  CONCLUSIONS
  The results suggest that S-1 monotherapy is safe and useful for elderly patients with unresectable advanced or recurrent gastric cancer when the dose is selected with caution, taking into account renal function.
authors.affiliation: Department of Gastroenterology and Gastrointestinal Oncology, Kitasato University School of Medicine, Kitasato University East Hospital, 2-1-1 Asamizodai, Sagamihara, Kanagawa, 228-8520, Japan. office@tcog.jp
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
authors.forename: Toshikazu
authors.initials: T
authors.lastname: Akiya
authors.forename: Atsushi
authors.initials: A
authors.lastname: Sato
authors.forename: Toshikazu
authors.initials: T
authors.lastname: Sakuyama
authors.forename: Eisaku
authors.initials: E
authors.lastname: Sasaki
authors.forename: Takashi
authors.initials: T
authors.lastname: Tomidokoro
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Hamada
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Fujimori
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Kikuchi
authors.forename: Ken
authors.initials: K
authors.lastname: Shimada
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Mine
authors.forename: Kensei
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Tsuneo
authors.initials: T
authors.lastname: Sasaki
authors.forename: Minoru
authors.initials: M
authors.lastname: Kurihara
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D004338:Drug Combinations; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008657:Metabolic Clearance Rate; D009503:Neutropenia / Q000139:chemically induced; D010094:Oxonic Acid / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D005641:Tegafur / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid