title: Phase II study of preoperative chemotherapy with S-1 and cisplatin followed by gastrectomy for clinically resectable type 4 and large type 3 gastric cancers (JCOG0210).
abstract: OBJECTIVE
  We conducted a phase II study to evaluate the safety and efficacy of preoperative chemotherapy with S-1 + cisplatin followed by gastrectomy in patients with linitis plastica (type 4) or large ulcero-invasive-type (type 3) gastric cancer.
  
  
  METHODS
  Eligibility criteria included histologically proven adenocarcinoma of the stomach; clinically resectable gastric cancer of type 4 or type 3. Patients received two 28-day courses of preoperative chemotherapy of S-1 (80-120 mg/body, p.o., days 1-21) and cisplatin (CDDP; 60 mg/m(2), i.v., day 8). Primary endpoints were completion of protocol treatment and incidence of treatment-related death (TRD).
  
  
  RESULTS
  Among the 49 eligible patients with the median age of 61 years, 36 completed the protocol treatment comprising two courses of preoperative chemotherapy and R0/1 resection (73.5% completion, 80% CI, 63.7-81.7%). One TRD was observed during the first course of chemotherapy. Median survival and 3-year overall survival were 17.3 months and 24.5%, respectively.
  
  
  CONCLUSIONS
  Preoperative chemotherapy with S-1 + CDDP followed by gastrectomy is a safe and promising treatment for type 4 and large type 3 gastric cancers. Based on the results of this study, we are now conducting a phase III study (JCOG0501) to confirm the superiority of this treatment.
authors: Department of Surgery, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan. iwasaki@cick.jp
authors: Yoshiaki
authors: Y
authors: Iwasaki
authors: Mitsuru
authors: M
authors: Sasako
authors: Seiichiro
authors: S
authors: Yamamoto
authors: Kenichi
authors: K
authors: Nakamura
authors: Takeshi
authors: T
authors: Sano
authors: Hitoshi
authors: H
authors: Katai
authors: Toshimasa
authors: T
authors: Tsujinaka
authors: Atsushi
authors: A
authors: Nashimoto
authors: Norimasa
authors: N
authors: Fukushima
authors: Akira
authors: A
authors: Tsuburaya
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005743:Gastrectomy / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008039:Linitis Plastica / Q000188:drug therapy / Q000601:surgery; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D013276:Stomach Ulcer / Q000150:complications / Q000188:drug therapy / Q000601:surgery; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin