title: A randomized phase II study comparing S-1 plus weekly split-dose cisplatin with S-1 plus standard-dose cisplatin as first-line chemotherapy for advanced gastric cancer.
abstract: BACKGROUND
  S-1 plus weekly split-dose cisplatin demonstrated promising results in previous phase I and II studies for advanced gastric cancer (AGC) patients.
  
  
  METHODS
  In this randomized phase II study, the efficacy and safety of S-1 plus weekly split-dose cisplatin (SWP, S-1 daily oral dose of 80-120 mg according to body surface area on days 1-14, and cisplatin 20 mg/m(2) i.v. on days 1 and 8 every 3 weeks) were compared with those of S-1 plus standard-dose cisplatin (SP) as first-line chemotherapy for AGC patients. The primary endpoint was 1-year survival rate.
  
  
  RESULTS
  Patients were randomized into two groups: 18 in the SWP arm and 19 in the SP arm. This trial was terminated early because of low patient enrollment. The 1-year survival rate was 61 % [95 % confidence interval (CI), 36-86 %] and 53 % (95 % CI, 30-75 %) in the SWP and SP arms, respectively. However, the median survival time was 12.3 months (9.9-14.6 months) and 15.7 months (4.0-27.4 months), respectively (P = 0.064). Progression-free survival was significantly shorter in the SWP arm than in the SP arm (P = 0.047). Toxicity tended to be milder in the SWP arm than in the SP arm. For approximately 40 % of patients in the SWP arm, cisplatin was omitted on day 8 and treatment delayed because of prolonged myelosuppression.
  
  
  CONCLUSIONS
  No clear benefits of adding cisplatin to S-1 in the SWP arm were demonstrated in this study. At this point, split-dose cisplatin combined with S-1 cannot be recommended for use in clinical practice.
authors.affiliation: Division of Gastroenterology, University of Tsukuba, Tennodai 1-1-1, Tsukuba, Ibaraki, 305-0006, Japan, tmoriwak@gmail.com.
authors.forename: Toshikazu
authors.initials: T
authors.lastname: Moriwaki
authors.forename: Shinji
authors.initials: S
authors.lastname: Hirai
authors.forename: Shuichi
authors.initials: S
authors.lastname: Hironaka
authors.forename: Kenji
authors.initials: K
authors.lastname: Amagai
authors.forename: Atsuko
authors.initials: A
authors.lastname: Soeda
authors.forename: Mikio
authors.initials: M
authors.lastname: Sato
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nihei
authors.forename: Mitsuaki
authors.initials: M
authors.lastname: Hirose
authors.forename: Kenji
authors.initials: K
authors.lastname: Matsuda
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohkawara
authors.forename: Taketo
authors.initials: T
authors.lastname: Yamaguchi
authors.forename: Mitsuharu
authors.initials: M
authors.lastname: Ozeki
authors.forename: Takashi
authors.initials: T
authors.lastname: Mamiya
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Murashita
authors.forename: Ichinosuke
authors.initials: I
authors.lastname: Hyodo
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D000077143:Docetaxel; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D011379:Prognosis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid