title: Oral uracil and tegafur compared with classic cyclophosphamide, methotrexate, fluorouracil as postoperative chemotherapy in patients with node-negative, high-risk breast cancer: National Surgical Adjuvant Study for Breast Cancer 01 Trial.
abstract: OBJECTIVE
  The primary aim of this study was to compare the effectiveness of oral uracil-tegafur (UFT) with that of classical cyclophosphamide, methotrexate, and fluorouracil (CMF) given as postoperative adjuvant treatment to women with node-negative, high-risk breast cancer.
  
  
  METHODS
  Women with node-negative, high-risk breast cancer were randomly assigned to receive either 2 years of UFT or six cycles of CMF after surgery. The primary end point was relapse-free survival (RFS). Overall survival (OS), toxicity, and quality of life (QOL) were secondary end points. The hypothesis was that UFT was not inferior to CMF in terms of RFS.
  
  
  RESULTS
  Between October 1996 and April 2001, a total of 733 patients were randomly assigned to receive either treatment. The median follow-up time was 6.2 years. The RFS rates at 5 years were 88.0% in the CMF arm and 87.8% in the UFT arm. OS rates were 96.0% and 96.2%, respectively. The hazard ratios of the UFT arm relative to the CMF arm were 0.98 for RFS (95% CI, 0.66 to 1.45; P = .92) and 0.81 for OS (95% CI, 0.44 to 1.48; P = .49). The toxicity profiles differed between the two groups. The QOL scores were better for patients given UFT than those given CMF.
  
  
  CONCLUSIONS
  RFS and OS with oral UFT were similar to those with classical CMF. Given the higher QOL scores, oral UFT is a promising alternative to CMF for postoperative adjuvant chemotherapy in women with node-negative, high-risk breast cancer.
authors.affiliation: Department of Medicine, Hamamatsu Oncology Center, Hamamatsu, Shizuoka, 430-0929, Japan. twatanab@oncoloplan.com
authors.forename: Toru
authors.initials: T
authors.lastname: Watanabe
authors.forename: Muneaki
authors.initials: M
authors.lastname: Sano
authors.forename: Shigemitsu
authors.initials: S
authors.lastname: Takashima
authors.forename: Tomoki
authors.initials: T
authors.lastname: Kitaya
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tokuda
authors.forename: Masataka
authors.initials: M
authors.lastname: Yoshimoto
authors.forename: Norio
authors.initials: N
authors.lastname: Kohno
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagami
authors.forename: Hiroji
authors.initials: H
authors.lastname: Iwata
authors.forename: Kojiro
authors.initials: K
authors.lastname: Shimozuma
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sonoo
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Tsuda
authors.forename: Goi
authors.initials: G
authors.lastname: Sakamoto
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
mesh_terms: D000284:Administration, Oral; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008207:Lymphatic Metastasis; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009367:Neoplasm Staging; D011788:Quality of Life; D012307:Risk Factors; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D005641:Tegafur; D014498:Uracil; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate