title: Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205).
abstract: OBJECTIVE
  To compare fluorouracil (FU) alone with FU plus cisplatin (FP) and with uracil and tegafur plus mitomycin (UFTM) for patients with advanced gastric cancer in a prospective, randomized, controlled trial.
  
  
  METHODS
  A total of 280 patients with advanced gastric cancer were randomly allocated and analyzed for survival, response, and toxicity. The survival curves were compared between groups by log-rank test on an intent-to-treat basis.
  
  
  RESULTS
  At the interim analysis, the UFTM arm showed a significantly inferior survival with higher incidences of hematologic toxic effects than did control arm FU alone, and the registration to UFTM was terminated. Both investigational regimens, FP and UFTM, had a significantly higher incidence of hematologic toxic effects than FU alone, although the effects were manageable. The overall response rates of the FU-alone, FP, and UFTM arms were 11%, 34%, and 9%, respectively. The median progression-free survival was 1.9 months with FU alone, 3.9 months with FP, and 2.4 months with UFTM, respectively. Although FP demonstrated a higher response rate (P <.001) and longer progression-free survival than did FU alone (P <.001), no differences in overall survival were observed between the arms. The median survival times and 1-year survival rates were 7.1 months and 28% with FU, 7.3 months and 29% with FP, and 6.0 months and 16% with UFTM, respectively.
  
  
  CONCLUSIONS
  Neither investigational regimen, FP nor UFTM, showed a survival advantage as compared with FU alone. FU alone will remain a reference arm in our future trial for advanced gastric cancer.
authors.affiliation: Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. aohtsu@east.ncc.go.jp
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohtsu
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Shirao
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Ichinosuke
authors.initials: I
authors.lastname: Hyodo
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saito
authors.forename: Noboru
authors.initials: N
authors.lastname: Yamamichi
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Miyata
authors.forename: Nobumasa
authors.initials: N
authors.lastname: Ikeda
authors.forename: Seiichiro
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Fukuda
authors.forename: Shigeaki
authors.initials: S
authors.lastname: Yoshida
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000627:therapeutic use; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D005641:Tegafur / Q000627:therapeutic use; D014498:Uracil / Q000627:therapeutic use
chemical_list: D000964:Antimetabolites, Antineoplastic; D005641:Tegafur; D016685:Mitomycin; D014498:Uracil; D002945:Cisplatin; D005472:Fluorouracil