title: Survival results of a randomised two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with two and four courses of S-1 plus cisplatin (SC) and paclitaxel plus cisplatin (PC) followed by D2 gastrectomy for resectable advanced gastric cancer.
abstract: The prognosis for stage III gastric cancer is unsatisfactory by D2 gastrectomy and S-1 adjuvant chemotherapy. Both S-1 plus cisplatin (SC) and paclitaxel plus cisplatin (PC) are promising regimens as neoadjuvant chemotherapy; however, the optimal duration remains unclear.
  
  
  
  In this 2×2 randomised phase II trial, stage III gastric cancer patients, those with a prognosis corresponding to stage III, and macroscopically resectable stage IV cases were randomised to two or four courses of S-1 (80 mg/m(2) for 21 d with 1 week rest)/cisplatin (60 mg/m(2) at day 8) or PC (80 and 25 mg/m(2), respectively, on days 1, 8, and 15 with 1 week rest) as neoadjuvant chemotherapy. The primary end-point was the 3-year overall survival (OS).
  
  
  
  Between October 2009 and July 2011, 83 patients received 2 courses of SC (n=21), 4 courses of SC (n=20), 2 courses of PC (n=21) and 4 courses of PC (n=21). The 3-year OS was 60.9% for SC and 64.3% for PC and 64.3% for the two courses and 61.0% for the four courses. Subset analyses demonstrated no subgroup which showed any potential survival benefit by PC in comparison to SC or by four courses as in comparison to two courses.
  
  
  
  Two courses of SC as neoadjuvant chemotherapy are recommended as a test arm of a future phase III study for patients with locally advanced gastric cancer.
  
  
  
  UMIN-000002595.
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan. Electronic address: yoshikawat@kcch.jp.
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.affiliation: Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.affiliation: Department of Gastroenterological and Transplant Surgery, Hiroshima University, Hiroshima, Japan.
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Tanabe
authors.affiliation: Department of Surgery, Osaka National Hospital, Osaka, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Nishikawa
authors.affiliation: Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Ito
authors.affiliation: Department of Gastroenterological Surgery, Aichi Cancer Center Aichi Hospital, Okazaki, Japan.
authors.forename: Takanori
authors.initials: T
authors.lastname: Matsui
authors.affiliation: Department of Surgery, Osaka General Medical Center, Osaka, Japan.
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Fujitani
authors.affiliation: Department of Surgery, Sakai City Medical Center, Sakai, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kimura
authors.affiliation: Department of Surgery, NTT West Osaka Hospital, Osaka, Japan.
authors.forename: Junya
authors.initials: J
authors.lastname: Fujita
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Aoyama
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Hayashi
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Cho
authors.affiliation: Department of Gastroenterological Surgery, Yokohama City University Medical Center, Yokohama, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Tsuburaya
authors.affiliation: Data center, Nonprofit Organization ECRIN, Aichi, Japan.
authors.forename: Yumi
authors.initials: Y
authors.lastname: Miyashita
authors.affiliation: Tokai Central Hospital, Gifu, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000379:methods; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005743:Gastrectomy; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D010094:Oxonic Acid / Q000008:administration & dosage; D017239:Paclitaxel / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000628:therapy*; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel; D002945:Cisplatin
keywords: Gastric cancer; chemotherapy; duration; neoadjuvant; surgery; survival