title: Phase II multi-institutional prospective randomised trial comparing S-1+paclitaxel with S-1+cisplatin in patients with unresectable and/or recurrent advanced gastric cancer.
abstract: BACKGROUND
  A combination of S-1 and cisplatin has been shown to be effective with acceptable safety for the first-line treatment of far-advanced gastric cancer in Japan. This is the first randomised phase II trial to compare S-1+paclitaxel with S-1+cisplatin in this setting.
  
  
  METHODS
  Patients with unresectable and/or recurrent advanced gastric cancer were randomly assigned to receive one of the two regimens: S-1 (40 mg m(-2) twice daily) on days 1-14 plus paclitaxel (60 mg m(-2)) on days 1, 8, and 15 of a 4-week cycle (S-1+paclitaxel) or S-1 (40 mg m(-2) twice daily) on days 1-21 plus cisplatin (60 mg m(-2)) on day 8 of a 5-week cycle (S-1+cisplatin). The primary end point was the response rate (RR). Secondary end points included progression-free survival (PFS), overall survival (OS), and safety.
  
  
  RESULTS
  A total of 83 patients were eligible for safety and efficacy analyses. In the S-1+paclitaxel and S-1+cisplatin groups, RRs (52.3% vs 48.7%; P=0.74) and median PFS (9 vs 6 months; P=0.50) were similar. The median OS was similar in the S-1+paclitaxel and S-1+cisplatin groups (16 vs 17 months; P=0.84). The incidence of grade 3 or higher haematological toxicity was 19.0% with S-1+paclitaxel and 19.5% with S-1+cisplatin. The incidence of grade 3 or higher non-haematological toxicity was 14.2% with S-1+paclitaxel and 17.1% with S-1+cisplatin.
  
  
  CONCLUSIONS
  S-1+paclitaxel was suggested to be a feasible and effective non-platinum-based regimen for chemotherapy in patients with advanced gastric cancer. Our results should be confirmed in multicenter, phase III-controlled clinical trials.
authors.affiliation: Department of General Surgical Science, Graduate School of Medicine, Gunma University, 3-39-22, Showa-machi, Maebashi, Gunma 371-8511, Japan. emochiki@gunma-u.ac.jp
authors.forename: E
authors.initials: E
authors.lastname: Mochiki
authors.forename: K
authors.initials: K
authors.lastname: Ogata
authors.forename: T
authors.initials: T
authors.lastname: Ohno
authors.forename: Y
authors.initials: Y
authors.lastname: Toyomasu
authors.forename: N
authors.initials: N
authors.lastname: Haga
authors.forename: Y
authors.initials: Y
authors.lastname: Fukai
authors.forename: R
authors.initials: R
authors.lastname: Aihara
authors.forename: H
authors.initials: H
authors.lastname: Ando
authors.forename: N
authors.initials: N
authors.lastname: Uchida
authors.forename: T
authors.initials: T
authors.lastname: Asao
authors.forename: H
authors.initials: H
authors.lastname: Kuwano
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage*; D017239:Paclitaxel / Q000008:administration & dosage*; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D005641:Tegafur / Q000008:administration & dosage*
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel; D002945:Cisplatin