title: Phase II study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer.
abstract: OBJECTIVE
  We evaluated the activity and toxicity of docetaxel, cisplatin, and S-1 (DCS) combination chemotherapy in patients with unresectable metastatic gastric cancer.
  
  
  METHODS
  Patients with histologically proven, unresectable metastatic gastric adenocarcinoma, performance status (PS) 0-2, and no prior chemotherapy were eligible. Patients received oral S-1 (40 mg/m(2) b.i.d.) on days 1-14 and intravenous cisplatin (60 mg/m(2)) and docetaxel (60 mg/m(2)) on day 8 every 3 weeks.
  
  
  RESULTS
  Thirty-four patients were enrolled between March 2005 and April 2007. Three patients were considered ineligible and did not receive the DSC therapy. Clinical characteristics were as follows: median age, 63 years (range, 44-77); PS, 0/1/2: 23/8/0; women/men, 8/23; and well-differentiated/undifferentiated adenocarcinoma, 10/21. The objective response rate was 87.1% with 1 complete response (3.2%) and 26 partial responses (83.9%) in 31 assessable patients. Four had stable disease (12.9%) but none had progressive disease. Of these 27 responders, 8 (25.8%) achieved downstaging and 7 (22.6%) underwent curative surgery. The median survival time and progression-free survival were 687 days [confidence interval (95% CI), 600.0-1,138.1] and 226 days (95% CI, 182.5-379.3), respectively. Most common grade 3/4 hematologic toxicity was neutropenia (77.4%). Most common grade 3 nonhematologic toxicities included anorexia (35.5%) and nausea (32.3%). All treatment-related toxicities resolved, and no toxic deaths were observed.
  
  
  CONCLUSIONS
  DCS combination chemotherapy is highly active against unresectable metastatic gastric cancer and can be given safely with proper management of adverse events. Further studies of this combination are warranted.
authors.affiliation: Fourth Department of Internal Medicine, School of Medicine, Sapporo Medical University, South 1 West 16, Chuo-ku, Sapporo, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Sato
authors.forename: Tetsuji
authors.initials: T
authors.lastname: Takayama
authors.forename: Tamotsu
authors.initials: T
authors.lastname: Sagawa
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Takahashi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Ohnuma
authors.forename: Syunichi
authors.initials: S
authors.lastname: Okubo
authors.forename: Naoaki
authors.initials: N
authors.lastname: Shintani
authors.forename: Shingo
authors.initials: S
authors.lastname: Tanaka
authors.forename: Masaya
authors.initials: M
authors.lastname: Kida
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Sato
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Ohta
authors.forename: Koji
authors.initials: K
authors.lastname: Miyanishi
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Sato
authors.forename: Rishu
authors.initials: R
authors.lastname: Takimoto
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Kobune
authors.forename: Koji
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Koichi
authors.initials: K
authors.lastname: Hirata
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Niitsu
authors.forename: Junji
authors.initials: J
authors.lastname: Kato
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced / Q000188:drug therapy; D010094:Oxonic Acid / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D004338:Drug Combinations; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid; D002945:Cisplatin