title: A phase II study of doxifluridine in elderly patients with advanced gastric cancer: the Japan Clinical Oncology Group Study (JCOG 9410).
abstract: BACKGROUND
  A previous phase II study of doxifluridine in non-elderly patients with advanced gastric cancer demonstrated a favorable survival with mild toxicity, despite a low response rate. The objectives of this study were to evaluate efficacy and feasibility of this agent for elderly patients.
  
  
  METHODS
  This study protocol required elderly patients, aged 76-80 years, with advanced gastric cancer and having no prior chemotherapy. Doxifluridine, at a dose of 1400 mg/m(2)/day, was administered for four consecutive days followed by a 10-day rest.
  
  
  RESULTS
  Between October 1994 and March 1998, 18 patients were registered. The study was then closed because of poor accrual. Toxicity was moderate; three patients suffered from grade 3 anemia and one patient each had grade 3 thrombocytopenia, nausea/vomiting and grade 4 diarrhea. There was one partial response, seven with no change and 10 with progressive disease, yielding a response rate of 5.6%. The median progression-free survival and median survival time for the 18 patients were 55 and 164 days, respectively, with a 1-year survival rate of 5.6%.
  
  
  CONCLUSIONS
  Although the number of patients was too small to draw any definitive conclusions, this study failed to demonstrate the survival advantage of doxifluridine.
authors.affiliation: Department of Internal Medicine, Mitoyo General Hospital, Mitoyo-gun, Kagawa, Japan.
authors.forename: Nobumasa
authors.initials: N
authors.lastname: Ikeda
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohtsu
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Tsuji
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saito
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Iwase
authors.forename: Shigeaki
authors.initials: S
authors.lastname: Yoshida
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D012042:Registries; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate
chemical_list: D000964:Antimetabolites, Antineoplastic; D005467:Floxuridine; C025034:doxifluridine