title: Uracil-tegafur and tamoxifen vs cyclophosphamide, methotrexate, fluorouracil, and tamoxifen in post-operative adjuvant therapy for stage I, II, or IIIA lymph node-positive breast cancer: a comparative study.
abstract: BACKGROUND
  It has been reported that treatment with uracil-tegafur (UFT) has shown significantly better survival and relapse-free survival (RFS) than surgery alone. Therefore, we compared UFT with a combination therapy of cyclophosphamide, methotrexate, and fluorouracil (CMF) in patients who had undergone curative surgery for axillary lymph node-positive breast cancer.
  
  
  METHODS
  A total of 377 node-positive patients with stage I, II, or IIIA disease were registered from September 1996 through July 2000 and were randomly assigned to either 6 cycles of CMF or 2 years of UFT. In both arms, tamoxifen (TAM) was concurrently administered for 2 years. The primary end point in this study was the non-inferiority of UFT to CMF.
  
  
  RESULTS
  No statistically significant difference between the two groups was observed with regard to the 5-year RFS rate (72.2% in the UFT and 76.3% in the CMF). Adverse event profiles differed between the two groups, with a significantly lower incidence of leukopenia and anaemia in the UFT group, as well as anorexia, nausea/vomiting, stomatitis, and alopecia, which have implications for quality of life.
  
  
  CONCLUSIONS
  UFT administered in combination with TAM holds promise in the treatment of lymph node-positive early breast cancer. On stratified analysis, the recurrence rate in the UFT group was found to be better in oestrogen receptor (ER)-positive patients. Tegafur-based treatment should be evaluated by a prospective randomised trial conducted in ER-positive patients.
authors.affiliation: Department of Surgery, Toho University School of Medicine, Sakura Hospital, 564-1 Shimoshizu, Sakura 285-8741, Japan. youngjinpark@sakura.med.toho-u.ac.jp
authors.forename: Y
authors.initials: Y
authors.lastname: Park
authors.forename: K
authors.initials: K
authors.lastname: Okamura
authors.forename: S
authors.initials: S
authors.lastname: Mitsuyama
authors.forename: T
authors.initials: T
authors.lastname: Saito
authors.forename: J
authors.initials: J
authors.lastname: Koh
authors.forename: S
authors.initials: S
authors.lastname: Kyono
authors.forename: K
authors.initials: K
authors.lastname: Higaki
authors.forename: M
authors.initials: M
authors.lastname: Ogita
authors.forename: T
authors.initials: T
authors.lastname: Asaga
authors.forename: H
authors.initials: H
authors.lastname: Inaji
authors.forename: H
authors.initials: H
authors.lastname: Komichi
authors.forename: N
authors.initials: N
authors.lastname: Kohno
authors.forename: K
authors.initials: K
authors.lastname: Yamazaki
authors.forename: F
authors.initials: F
authors.lastname: Tanaka
authors.forename: T
authors.initials: T
authors.lastname: Ito
authors.forename: H
authors.initials: H
authors.lastname: Nishikawa
authors.forename: A
authors.initials: A
authors.lastname: Osaki
authors.forename: H
authors.initials: H
authors.lastname: Koyama
authors.forename: T
authors.initials: T
authors.lastname: Suzuki
mesh_terms: D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000473:pathology / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008207:Lymphatic Metastasis / Q000473:pathology; D008408:Mastectomy; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen; D005641:Tegafur; D014498:Uracil; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate