title: Retrospective analysis of clinical results and predictors of response in chemo-naive patients with advanced gastric cancer treated with S-1, an oral fluoropyrimidine derivative, as single-agent chemotherapy.
abstract: BACKGROUND
  Despite the fact that there are only a few reports of phase II studies, S-1 is widely used in single-agent or combination therapies for patients with advanced gastric cancer in Japan. We retrospectively analyzed the effectiveness of S-1 as single-agent chemotherapy for patients with advanced gastric cancer.
  
  
  METHODS
  A total of 119 patients with advanced or recurrent gastric cancer were treated with S-1 as first-line monochemotherapy from September 1999 to March 2003 at the National Cancer Center Hospital. S-1 was administered orally twice daily, at a standard dose of 80 mg/m2 per day for 28 days, followed by a 14-day rest.
  
  
  RESULTS
  One hundred and eleven patients were analyzed retrospectively. The overall response rate was 26.1% (29/111; 95% confidence interval [CI], 17.8% to 34.1%). Median time to progression and median overall survival were 141 days (95% CI, 108 to 175 days) and 378 days (95% CI, 310 to 447 days), respectively. The response rate of ascites, according to the Japanese classification of gastric carcinoma, was 36.8% (14/38; 95% CI, 25.4% to 56.6%). Among all of the pretreatment variables examined, hemoglobin level and the presence of lymph node metastasis were related to the response.
  
  
  CONCLUSIONS
  Single-agent chemotherapy of S-1 for chemo-naive patients with advanced gastric cancer was modestly effective and well-tolerated in the outpatient setting.
authors.affiliation: Department of Medical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
authors.forename: Kan
authors.initials: K
authors.lastname: Yonemori
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
authors.forename: Ayumu
authors.initials: A
authors.lastname: Goto
authors.forename: Takashi
authors.initials: T
authors.lastname: Ura
authors.forename: Tatsuhiro
authors.initials: T
authors.lastname: Arai
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Hamaguchi
authors.forename: Kei
authors.initials: K
authors.lastname: Muro
authors.forename: Yasuhide
authors.initials: Y
authors.lastname: Yamada
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Shirao
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D012189:Retrospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005641:Tegafur / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; D006454:Hemoglobins; D011725:Pyridines; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid