title: Adjuvant capecitabine plus oxaliplatin after D2 gastrectomy in Japanese patients with gastric cancer: a phase II study.
abstract: BACKGROUND
  Adjuvant chemotherapy with XELOX (capecitabine plus oxaliplatin) has been shown to be beneficial following resection of gastric cancer in South Korean, Chinese, and Taiwanese patients. This phase II study (J-CLASSIC-PII) was undertaken to evaluate the feasibility of XELOX in Japanese patients with resected gastric cancer.
  
  
  METHODS
  Patients with stage II or III gastric cancer who underwent curative D2 gastrectomy received adjuvant XELOX (eight 3-week cycles of oral capecitabine, 1000 mg/m2twice daily on days 1-14, plus intravenous oxaliplatin 130 mg/m2on day 1). The primary endpoint was dose intensity. Secondary endpoints were safety, proportion of patients completing treatment, and 1-year disease-free survival (DFS) rate.
  
  
  RESULTS
  One hundred patients were enrolled, 76 of whom completed the study as planned. The mean dose intensity was 67.2 % (95 % CI, 61.9-72.5 %) for capecitabine and 73.4 % (95 % CI, 68.4-78.4 %) for oxaliplatin, which were higher than the predefined age-adjusted threshold values of 63.4 % and 69.4 %, respectively, and the study therefore met its primary endpoint. The 1-year DFS rate was 86 % (95 % CI, 77-91 %). No new safety signals were identified.
  
  
  CONCLUSIONS
  The feasibility of adjuvant XELOX in Japanese patients with resected gastric cancer is similar to that observed in South Korean, Chinese, and Taiwanese patients in the Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer (CLASSIC) study. Based on findings from this study and the CLASSIC study, the XELOX regimen can be considered an adjuvant treatment option for Japanese gastric cancer patients who have undergone curative resection.
authors.affiliation: Department of Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. nofuse@east.ncc.go.jp.
authors.forename: Nozomu
authors.initials: N
authors.lastname: Fuse
authors.affiliation: Department of Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Bando
authors.affiliation: Department of Gastroenterology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Keisho
authors.initials: K
authors.lastname: Chin
authors.affiliation: Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Aichi, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Ito
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa, Japan.
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Tsuburaya
authors.affiliation: Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Terashima
authors.affiliation: Division of Gastroenterological Surgery, Saitama Cancer Center, Saitama, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Kawashima
authors.affiliation: Department of Gastroenterological and General Surgery, St. Marianna University School of Medicine, Kanagawa, Japan.
authors.forename: Tetsu
authors.initials: T
authors.lastname: Fukunaga
authors.affiliation: Cancer Chemotherapy Center, Osaka Medical College, Osaka, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Gotoh
authors.affiliation: Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Emi
authors.affiliation: Department of Surgical Oncology, Graduate School of Medicine, Gifu University, Gifu, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yoshida
authors.affiliation: Department of Surgery and Science, Kyusyu University Hospital, Fukuoka, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Oki
authors.affiliation: Pharmaceutical Research and Development Department, Yakult Honsha Co., Ltd., Tokyo, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Takahashi
authors.affiliation: Clinical Science and Strategy Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kuriki
authors.affiliation: Clinical Science and Strategy Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
authors.forename: Kumi
authors.initials: K
authors.lastname: Sato
authors.affiliation: Upper GI Division, Department of Surgery, Hyogo College of Medicine, Hyogo, Japan.
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Sasako
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005500:Follow-Up Studies; D005743:Gastrectomy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D010071:Oxaloacetates; D011379:Prognosis; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate
chemical_list: D010071:Oxaloacetates; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil
keywords: Adjuvant treatment; Feasibility study; Gastric cancer; Japanese study; XELOX