title: Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine.
abstract: BACKGROUND
  Advanced gastric cancer can respond to S-1, an oral fluoropyrimidine. We tested S-1 as adjuvant chemotherapy in patients with curatively resected gastric cancer.
  
  
  METHODS
  Patients in Japan with stage II or III gastric cancer who underwent gastrectomy with extended (D2) lymph-node dissection were randomly assigned to undergo surgery followed by adjuvant therapy with S-1 or to undergo surgery only. In the S-1 group, administration of S-1 was started within 6 weeks after surgery and continued for 1 year. The treatment regimen consisted of 6-week cycles in which, in principle, 80 mg of oral S-1 per square meter of body-surface area per day was given for 4 weeks and no chemotherapy was given for the following 2 weeks. The primary end point was overall survival.
  
  
  RESULTS
  We randomly assigned 529 patients to the S-1 group and 530 patients to the surgery-only group between October 2001 and December 2004. The trial was stopped on the recommendation of the independent data and safety monitoring committee, because the first interim analysis, performed 1 year after enrollment was completed, showed that the S-1 group had a higher rate of overall survival than the surgery-only group (P=0.002). Analysis of follow-up data showed that the 3-year overall survival rate was 80.1% in the S-1 group and 70.1% in the surgery-only group. The hazard ratio for death in the S-1 group, as compared with the surgery-only group, was 0.68 (95% confidence interval, 0.52 to 0.87; P=0.003). Adverse events of grade 3 or grade 4 (defined according to the Common Toxicity Criteria of the National Cancer Institute) that were relatively common in the S-1 group were anorexia (6.0%), nausea (3.7%), and diarrhea (3.1%).
  
  
  CONCLUSIONS
  S-1 is an effective adjuvant treatment for East Asian patients who have undergone a D2 dissection for locally advanced gastric cancer. (ClinicalTrials.gov number, NCT00152217 [ClinicalTrials.gov].).
authors.affiliation: Department of Surgery, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan. sakura@med.kitasato-u.ac.jp
authors.forename: Shinichi
authors.initials: S
authors.lastname: Sakuramoto
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Sasako
authors.forename: Toshiharu
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Taira
authors.initials: T
authors.lastname: Kinoshita
authors.forename: Masashi
authors.initials: M
authors.lastname: Fujii
authors.forename: Atsushi
authors.initials: A
authors.lastname: Nashimoto
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Furukawa
authors.forename: Toshifusa
authors.initials: T
authors.lastname: Nakajima
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Imamura
authors.forename: Masayuki
authors.initials: M
authors.lastname: Higashino
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Yamamura
authors.forename: Akira
authors.initials: A
authors.lastname: Kurita
authors.forename: Kuniyoshi
authors.initials: K
authors.lastname: Arai
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000517:prevention & control; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D015996:Survival Rate; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid