title: Phase II trial of preoperative S-1 plus cisplatin followed by surgery for initially unresectable locally advanced gastric cancer.
abstract: BACKGROUND
  The aim of this study was to evaluate the efficacy and feasibility of preoperative chemotherapy with S-1 plus cisplatin in patients with initially unresectable locally advanced gastric cancer.
  
  
  METHODS
  We enrolled patients with initially unresectable locally advanced gastric cancer because of severe lymph node metastases or invasion of adjacent structures. Preoperative chemotherapy consisted of S-1 at 80 mg/m(2) divided in two daily doses for 21 days and cisplatin at 60 mg/m(2) intravenously on day 8, repeated every 35 days. If a tumor decreased in size, patients received 1 or 2 more courses. Surgery involved radical resection with D2 lymphadenectomy.
  
  
  RESULTS
  Between December 2000 and December 2007, 27 patients were enrolled on the study. No CR was obtained, but PR was seen in 17 cases, and the response rate was 63.0%. Thirteen patients (48.1%) had R0 resections. There were no treatment related deaths. The median overall survival time (MST) and the 3-year overall survival (OS) of all patients were 31.4 months and 31.0%, respectively. Among the 13 patients who underwent curative resection, the median disease-free survival (DFS) and the 3-year DFS were 17.4 months and 23.1%, respectively. The MST and the 3-year OS were 50.1 months and 53.8%, respectively. The most common site of initial recurrence after the R0 resection was the para-aortic lymph nodes.
  
  
  CONCLUSIONS
  Preoperative S-1 plus cisplatin can be safely delivered to patients undergoing radical gastrectomy. This regimen is promising as neoadjuvant chemotherapy for resectable gastric cancer. For initially unresectable locally advanced gastric cancer, new trials using more effective regimens along with extended lymph node dissection are necessary.
authors.affiliation: Department of Surgery, Kansai Medical University, Shinmachi 2-3-1, Hirakata city, Osaka 573-1191, Japan. inoueke@hirakata.kmu.ac.jp
authors.forename: K
authors.initials: K
authors.lastname: Inoue
authors.forename: Y
authors.initials: Y
authors.lastname: Nakane
authors.forename: M
authors.initials: M
authors.lastname: Kogire
authors.forename: K
authors.initials: K
authors.lastname: Fujitani
authors.forename: Y
authors.initials: Y
authors.lastname: Kimura
authors.forename: H
authors.initials: H
authors.lastname: Imamura
authors.forename: S
authors.initials: S
authors.lastname: Tamura
authors.forename: S
authors.initials: S
authors.lastname: Okano
authors.forename: A H
authors.initials: AH
authors.lastname: Kwon
authors.forename: Y
authors.initials: Y
authors.lastname: Kurokawa
authors.forename: T
authors.initials: T
authors.lastname: Shimokawa
authors.forename: H
authors.initials: H
authors.lastname: Takiuchi
authors.forename: T
authors.initials: T
authors.lastname: Tsujinaka
authors.forename: H
authors.initials: H
authors.lastname: Furukawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005743:Gastrectomy / Q000379:methods / Q000401:mortality; D006801:Humans; D007150:Immunohistochemistry; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D009361:Neoplasm Invasiveness / Q000473:pathology; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage*; D011292:Premedication; D018570:Risk Assessment; D013274:Stomach Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin