title: Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients.
abstract: BACKGROUND
  A prospective feasibility study was planned to clarify the proportion of compliance and adverse events in the administration of capecitabine as adjuvant chemotherapy for colon cancer in Japanese patients.
  
  
  METHODS
  We aimed initially to register 92 cases of R0 stage III colon cancer. Capecitabine (2,500 mg/m(2)/day) was given orally on days 1-14 every 3 weeks for 8 cycles. The proportion of treatments completed as planned was selected as the primary endpoint.
  
  
  RESULTS
  Ninety-seven cases were registered and treated between September 2008 and August 2009. The proportion of treatments completed in the full analysis set was 64/97 [66.0%; 95% confidence interval (CI), 55.7-75.3%] and in the per protocol set was 64/91 (70.3%; 95% CI, 59.8-79.5%). Adverse events which led to treatment discontinuation included hand-foot syndrome (HFS) (7), haematotoxicity (5) and increased hepatic damage (4). The proportions of patients with major grade 3/4 adverse events were HFS 22.7%, neutropenia 7.2%, diarrhoea 2.1%, and increased bilirubin 0.0%.
  
  
  CONCLUSIONS
  This collaborative multi-facility study, the first of its kind in Japan, presented results of a safety confirmation experiment on capecitabine as adjuvant chemotherapy for stage III colon cancer. The results suggest that capecitabine may be administered safely to Japanese patients.
authors.affiliation: Department of Surgery, Saiseikai Fukuoka General Hospital, 1-3-46 Tenjin, Chuou-ku, Fukuoka, 810-0001, Japan. emi-y@saiseikai-hp.chuo.fukuoka.jp
authors.forename: Yasunori
authors.initials: Y
authors.lastname: Emi
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Kakeji
authors.forename: Eiji
authors.initials: E
authors.lastname: Oki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saeki
authors.forename: Koji
authors.initials: K
authors.lastname: Ando
authors.forename: Masaki
authors.initials: M
authors.lastname: Kitazono
authors.forename: Yoshihisa
authors.initials: Y
authors.lastname: Sakaguchi
authors.forename: Masaru
authors.initials: M
authors.lastname: Morita
authors.forename: Hironori
authors.initials: H
authors.lastname: Samura
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Ogata
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Akagi
authors.forename: Shoji
authors.initials: S
authors.lastname: Natsugoe
authors.forename: Kazuo
authors.initials: K
authors.lastname: Shirouzu
authors.forename: Shoji
authors.initials: S
authors.lastname: Tokunaga
authors.forename: Florin
authors.initials: F
authors.lastname: Sirzen
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Maehara
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced / Q000473:pathology*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D060831:Hand-Foot Syndrome / Q000473:pathology; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil