title: Final report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japan.
abstract: BACKGROUND
  The impact of oral capecitabine as adjuvant chemotherapy for Japanese patients with resected colon cancer was unclear. We previously planned and conducted a prospective feasibility study (KSCC0803) and reported on the safety of oral capecitabine as adjuvant chemotherapy for Japanese patients with resected stage III colon cancer. The purpose of the current study was to assess the survival results from that study.
  
  
  METHODS
  The study subjects were Japanese patients with resected stage III colon cancer. The protocol adjuvant regimen consisted of oral capecitabine 1250 mg/m2twice daily on days 1-14 of a 3-week cycle for a total of eight cycles. The 3- and 5-year disease free survival (DFS) rates and overall survival (OS) rates were analyzed in the eligible cohort.
  
  
  RESULTS
  Ninety-seven patients were registered between September 2008 and August 2009 and treated with the protocol regimen. The median follow-up time was 60.7 months. The 3- and 5-year DFS rates were 71.2% [95% confidence interval (CI): 61.7-79.8%] and 69.7% (95% CI: 59.4-77.8%), respectively. The 3- and 5-year OS rates were 92.6% (95% CI: 85.2-96.4%) and 84.5% (95% CI: 75.1-90.5%), respectively.
  
  
  CONCLUSIONS
  The survival results in this study are in line with those of previously reported, reliable, studies. The safety and tolerability of the protocol regimen have already been confirmed. Oral capecitabine is acceptable as adjuvant chemotherapy for Japanese patients with resected stage III colon cancer.
authors.affiliation: Department of Gastroenterological Surgery, National Kyushu Cancer Center, Notame 3-1-1, Minami-ku, Fukuoka, 811-1395, Japan. minami.k@nk-cc.go.jp.
authors.forename: Kazuhito
authors.initials: K
authors.lastname: Minami
authors.affiliation: Department of Gastroenterological Surgery, National Kyushu Cancer Center, Notame 3-1-1, Minami-ku, Fukuoka, 811-1395, Japan.
authors.forename: Masaru
authors.initials: M
authors.lastname: Morita
authors.affiliation: Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Emi
authors.affiliation: Department of Surgery, Oita Red Cross Hospital, Oita, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Okamoto
authors.affiliation: Department of Surgery, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Tanaka
authors.affiliation: Department of Surgery, Nakatsu Municipal Hospital, Oita, Japan.
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Nagata
authors.affiliation: Department of Surgery, Nakagami Hospital, Okinawa, Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Touyama
authors.affiliation: Department of Gastrointestinal Surgery, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.
authors.forename: Kippei
authors.initials: K
authors.lastname: Ohgaki
authors.affiliation: Department of Surgery, Social Insurance Tagawa Hospital, Fukuoka, Japan.
authors.forename: Takaho
authors.initials: T
authors.lastname: Tanaka
authors.affiliation: Department of Surgery, Kagoshima Kouseiren Hospital, Kagoshima, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Okumura
authors.affiliation: Department of Surgery, Nanpuh Hospital, Kagoshima, Japan.
authors.forename: Toyokuni
authors.initials: T
authors.lastname: Suenaga
authors.affiliation: Medical Information Center, Kyushu University Hospital, Fukuoka, Japan.
authors.forename: Shoji
authors.initials: S
authors.lastname: Tokunaga
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Oki
authors.affiliation: Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, Kobe, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Kakeji
authors.affiliation: Department of Surgery, Kurume University School of Medicine, Kurume, Japan.
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Akagi
authors.affiliation: Department of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Baba
authors.affiliation: Department of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
authors.forename: Shoji
authors.initials: S
authors.lastname: Natsugoe
authors.affiliation: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Maehara
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D000069287:Capecitabine / Q000008:administration & dosage / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015996:Survival Rate
chemical_list: D000069287:Capecitabine
keywords: Adjuvant chemotherapy; Capecitabine; Colon cancer; Feasibility study; Japanese; X-ACT trial