title: Safety of UFT/LV and S-1 as adjuvant therapy for stage III colon cancer in phase III trial: ACTS-CC trial.
abstract: BACKGROUND
  The Adjuvant Chemotherapy Trial of TS-1 for Colon Cancer (ACTS-CC) is a phase III trial designed to validate the non-inferiority of S-1 to UFT/leucovorin (LV) as postoperative adjuvant chemotherapy for stage III colon cancer. We report the results of a planned safety analysis.
  
  
  METHODS
  Patients aged 20-80 years with curatively resected stage III colon cancer were randomly assigned to receive UFT/LV (UFT, 300 mg m(-2) per day as tegafur; LV, 75 mg per day on days 1-28, every 35 days, 5 courses) or S-1 (80, 100, or 120 mg per day on days 1-28, every 42 days, 4 courses). Treatment status and safety were evaluated.
  
  
  RESULTS
  Of 1535 enrolled patients, a total of 1504 (756 allocated to S-1 and 748 to UFT/LV) were analysed. The completion rate of protocol treatment was 77% in the S-1 group and 73% in the UFT/LV group. The overall incidence of adverse events (AEs) were 80% in S-1 and 74% in UFT/LV. Stomatitis, anorexia, hyperpigmentation, and haematological toxicities were common in S-1, whereas increased alanine aminotransferase and aspartate aminotransferase were common in UFT/LV. The incidences of grade 3 AEs were 16% and 14%, respectively.
  
  
  CONCLUSIONS
  Although AE profiles differed between the groups, feasibility of the protocol treatment was good. Both S-1 and UFT/LV could be safely used as adjuvant chemotherapy.
authors.affiliation: Department of Gastroenterological Surgery, Iwate Central Prefectural Hospital, 1-4-1 Ueda, Morioka, Iwate 020-0066, Japan.
authors.forename: I
authors.initials: I
authors.lastname: Mochizuki
authors.forename: H
authors.initials: H
authors.lastname: Takiuchi
authors.forename: K
authors.initials: K
authors.lastname: Ikejiri
authors.forename: Y
authors.initials: Y
authors.lastname: Nakamoto
authors.forename: Y
authors.initials: Y
authors.lastname: Kinugasa
authors.forename: A
authors.initials: A
authors.lastname: Takagane
authors.forename: T
authors.initials: T
authors.lastname: Endo
authors.forename: H
authors.initials: H
authors.lastname: Shinozaki
authors.forename: Y
authors.initials: Y
authors.lastname: Takii
authors.forename: Y
authors.initials: Y
authors.lastname: Takahashi
authors.forename: H
authors.initials: H
authors.lastname: Mochizuki
authors.forename: K
authors.initials: K
authors.lastname: Kotake
authors.forename: S
authors.initials: S
authors.lastname: Kameoka
authors.forename: K
authors.initials: K
authors.lastname: Takahashi
authors.forename: T
authors.initials: T
authors.lastname: Watanabe
authors.forename: M
authors.initials: M
authors.lastname: Watanabe
authors.forename: N
authors.initials: N
authors.lastname: Boku
authors.forename: N
authors.initials: N
authors.lastname: Tomita
authors.forename: Y
authors.initials: Y
authors.lastname: Matsubara
authors.forename: K
authors.initials: K
authors.lastname: Sugihara
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000601:surgery; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects; D014498:Uracil / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; C096910:UFT(R) drug; C079198:S 1 (combination); D005641:Tegafur; D014498:Uracil; D010094:Oxonic Acid; D002955:Leucovorin