title: A phase II study of neoadjuvant chemotherapy with S-1 and cisplatin for stage III gastric cancer: KUGC03.
abstract: OBJECTIVE
  A multi-center phase II study was conducted to evaluate the safety and efficacy of neoadjuvant chemotherapy (NAC) with S-1 plus cisplatin for advanced gastric cancer.
  
  
  METHODS
  The eligibility criteria were clinical T3/T4 or N2, not Stage IV. Patients received two 35-day cycles of S-1 plus cisplatin, and then underwent D2 gastrectomy. The primary endpoint was 3-year progression free survival (PFS). Secondary endpoints were ratio of R0 resection, response rate, adverse events, and overall survival. A sample size of 49 was determined to have 80% power for detecting 15% improvement in the 3-year PFS over 55% at a one-sided alpha of 0.1.
  
  
  RESULTS
  Among 53 patients enrolled, 44 patients completed two cycles of NAC (83%), and 48 patients underwent R0 resection (91%). Postoperative complications occurred in 13 patients (26%). A pathological response was confirmed in 24 patients (45%), including four complete responses. The 3-year PFS was 50.7%, while the 3-year OS was 74.9%.
  
  
  CONCLUSIONS
  Although the observed 3-year PFS rate was worse than expected, NAC with S1 plus cisplatin was safe and led to a high rate of R0 resection. A randomized controlled trial is needed to make conclusions about the effectiveness of NAC in Japanese patients undergoing D2 resection.
authors.affiliation: Department of Surgery, Graduate School of Medicine Kyoto University, Kyoto, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Okabe
authors.affiliation: Department of Surgery, Kyoto Medical Center, Kyoto, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Hata
authors.affiliation: Department of Gastroenterological Surgery, Kitano Hospital, Osaka, Japan.
authors.forename: Shugo
authors.initials: S
authors.lastname: Ueda
authors.affiliation: Department of Surgery, Shiga Medical Center for Adults, Shiga, Japan.
authors.forename: Masazumi
authors.initials: M
authors.lastname: Zaima
authors.affiliation: Department of Surgery, Shimane Prefectural Central Hospital, Shimane, Japan.
authors.forename: Atsuo
authors.initials: A
authors.lastname: Tokuka
authors.affiliation: Department of Abdominal Surgery, Tenri Hospital, Nara, Japan.
authors.forename: Tsunehiro
authors.initials: T
authors.lastname: Yoshimura
authors.affiliation: Department of Surgery, Saiseikai Noe Hospital, Osaka, Japan.
authors.forename: Shuichi
authors.initials: S
authors.lastname: Ota
authors.affiliation: Department of Surgery, Graduate School of Medicine Kyoto University, Kyoto, Japan.
authors.forename: Yousuke
authors.initials: Y
authors.lastname: Kinjo
authors.affiliation: Innovative Clinical Research Center, Kanazawa University Hospital, Ishikawa, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Yoshimura
authors.affiliation: Department of Surgery, Graduate School of Medicine Kyoto University, Kyoto, Japan.
authors.forename: Yoshiharu
authors.initials: Y
authors.lastname: Sakai
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005743:Gastrectomy; D006801:Humans; D053208:Kaplan-Meier Estimate; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin
keywords: clinical stage III; gastric cancer; neoadjuvant chemotherapy; phase II