title: Phase II trial of S-1 plus low-dose cisplatin for unresectable and recurrent gastric cancer (JFMC27-9902 Step2).
abstract: OBJECTIVE
  The efficacy and the toxicity of oral fluorouracil derivative S-1 plus low-dose cisplatin in unresectable or recurrent gastric cancer were evaluated by a phase II study.
  
  
  METHODS
  S-1 was administered orally for 28 days following 14 days' rest at 80-120 mg/body/day, depending on body surface area. During administration of S-1, cisplatin was given twice a week at the recommended dose (10 mg/m(2)), which was determined by a phase I study. Data from 34 patients in phase II and 8 patients treated with the recommended dose of cisplatin in phase I were analyzed. The primary endpoint was objective response.
  
  
  RESULTS
  The response rate was 47.1%. The median survival time was 11.0 months and the median progression-free survival was 6.9 months. The grade 3/4 toxicities observed in 10% or more of the treated patients were neutropenia (16.7%), anemia (16.7%) and anorexia (11.9%). The serum concentration of cisplatin was 794 ± 341 ng/ml at day 25 of the first course.
  
  
  CONCLUSIONS
  S-1 plus low-dose cisplatin may be a clinically useful regimen for unresectable or recurrent gastric cancer because of its infrequent adverse events in spite of considerable efficacy and its convenience of no hydration and no hospitalization.
authors: Department of Surgical Oncology, Osaka City University Graduate School of Medicine, Abeno-ku, Osaka, Japan. bunzo@med.osaka-cu.ac.jp
authors: Bunzo
authors: B
authors: Nakata
authors: Akihito
authors: A
authors: Tsuji
authors: Yasushi
authors: Y
authors: Mitachi
authors: Naoyuki
authors: N
authors: Taenaka
authors: Toshiki
authors: T
authors: Kamano
authors: Keisuke
authors: K
authors: Oikawa
authors: Naoyoshi
authors: N
authors: Onoda
authors: Mariko
authors: M
authors: Kambe
authors: Masahiro
authors: M
authors: Takahashi
authors: Tetsuhiko
authors: T
authors: Shirasaka
authors: Satoshi
authors: S
authors: Morita
authors: Junichi
authors: J
authors: Sakamoto
authors: Yukari
authors: Y
authors: Tanaka
authors: Shigetoyo
authors: S
authors: Saji
authors: Kosei
authors: K
authors: Hirakawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010094:Oxonic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D013274:Stomach Neoplasms / Q000188:drug therapy*; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin