title: Tamoxifen plus tegafur-uracil (TUFT) versus tamoxifen plus Adriamycin (doxorubicin) and cyclophosphamide (ACT) as adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC): results of Japan Clinical Oncology Group Study 9404.
abstract: OBJECTIVE
  A prospective randomized clinical trial was conducted to evaluate the efficacy of tamoxifen plus doxorubicin and cyclophosphamide compared to tamoxifen plus tegafur-uracil as an adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC).
  
  
  METHODS
  Eligibility criteria included pathologically node-positive (n = 1-9) preMBC with curative resection, in stages I-IIIA. Patients were randomized to receive either tamoxifen 20 mg/day plus tegafur-uracil 400 mg/day (TU) for 2 years or six courses of a 28-day cycle of doxorubicin 40 mg/m(2) plus cyclophosphamide 500 mg/m(2) on day 1 along with tamoxifen (ACT) given for 2 years as adjuvant therapy. Primary endpoint was overall survival (OS), and secondary endpoint was recurrence-free survival (RFS).
  
  
  RESULTS
  In total, 169 patients were recruited (TU arm 87, ACT arm 82) between October 1994 and September 1999. The HR for OS was 0.76 (95 % CI 0.35, 1.66, log-rank p = 0.49) and that for RFS was 0.77 (95 % CI 0.44, 1.36, log-rank p = 0.37), with ACT resulting in a better HR. The 5-year OS was 79.7 % for patients in the TU arm and 83 % for those in the ACT arm. The 5-year RFS was 66.1 % for patients in the TU arm and 70.6 % for those in the ACT arm. A higher proportion of patients in the ACT arm experienced grade 3 leucopenia (0 % in the TU arm, 4 % in the ACT arm).
  
  
  CONCLUSIONS
  There were no significant differences in the efficacy of TU and ACT as adjuvant therapy.
authors: Department of Breast and Endocrine Surgery, Okayama University Hospital, Okayama, 700-8558, Japan, tshien@md.okayama-u.ac.jp.
authors: Tadahiko
authors: T
authors: Shien
authors: Hiroji
authors: H
authors: Iwata
authors: Takashi
authors: T
authors: Fukutomi
authors: Kenichi
authors: K
authors: Inoue
authors: Kenjiro
authors: K
authors: Aogi
authors: Takayuki
authors: T
authors: Kinoshita
authors: Jiro
authors: J
authors: Ando
authors: Seiki
authors: S
authors: Takashima
authors: Kenichi
authors: K
authors: Nakamura
authors: Taro
authors: T
authors: Shibata
authors: Haruhiko
authors: H
authors: Fukuda
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology*; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology; D008875:Middle Aged; D017697:Premenopause; D011446:Prospective Studies; D013629:Tamoxifen / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage
chemical_list: D013629:Tamoxifen; D005641:Tegafur; D014498:Uracil; D004317:Doxorubicin; D003520:Cyclophosphamide