title: Randomized adjuvant trial to evaluate the addition of tamoxifen and PSK to chemotherapy in patients with primary breast cancer. 5-Year results from the Nishi-Nippon Group of the Adjuvant Chemoendocrine Therapy for Breast Cancer Organization.
abstract: BACKGROUND
  A randomized adjuvant trial was conducted from October 1982 to January 1985 to evaluate the addition of tamoxifen (TAM) to combination chemotherapy with perioperative mitomycin C (MMC) and ftorafur (FT) for patients with estrogen receptor (ER)-positive tumors and the addition of PSK, a biologic response modifier, to MMC+FT chemotherapy for patients with ER-negative tumors in operable Stage IIA, IIB, and IIIA cancer. The doses used were 20 mg of oral TAM daily, 600 mg of oral FT daily, and 3 g of oral PSK daily for 2 years. Intravenous MMC (13 mg/m2) was given on the day of operation.
  
  
  METHODS
  A total of 967 patients were entered and randomized by stratification based on ER status and staging (1978 International Union Against Cancer [UICC] criteria at the time of trial execution). Of 967 patients, 914 (94.5%) were evaluable. At 5-year follow-up, significant prolonged overall survival (OS) and relapse-free survival (RFS) times were seen with the addition of TAM in patients with ER-positive and Stage IIIA T3N0 cancer (1987 UICC-American Joint Committee on Cancer [AJCC] criteria); however, no significant survival benefit from TAM was seen in patients with ER-positive and Stage IIA T2N1 cancer. There was no significant difference between regimens, with or without PSK, in patients with ER-negative disease.
  
  
  RESULTS
  Results of subset analyses suggested a benefit from TAM in postmenopausal patients with ER-positive and Stage IIA T2N1 cancer and a benefit from PSK in patients with node-negative, ER-negative, and Stage IIA T2N1 cancer.
  
  
  CONCLUSIONS
  The 5-year results of the current trial showed a survival advantage by the addition of TAM to chemotherapy in patients with ER-positive and Stage IIIA T3N0 cancer.
authors.affiliation: Department of Surgery, Hiroshima University, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Toi
authors.forename: T
authors.initials: T
authors.lastname: Hattori
authors.forename: M
authors.initials: M
authors.lastname: Akagi
authors.forename: K
authors.initials: K
authors.lastname: Inokuchi
authors.forename: K
authors.initials: K
authors.lastname: Orita
authors.forename: K
authors.initials: K
authors.lastname: Sugimachi
authors.forename: K
authors.initials: K
authors.lastname: Dohi
authors.forename: Y
authors.initials: Y
authors.lastname: Nomura
authors.forename: Y
authors.initials: Y
authors.lastname: Monden
authors.forename: Y
authors.initials: Y
authors.lastname: Hamada
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000628:therapy; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D011509:Proteoglycans / Q000627:therapeutic use*; D016019:Survival Analysis; D013629:Tamoxifen / Q000627:therapeutic use*; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D000276:Adjuvants, Immunologic; D011509:Proteoglycans; D013629:Tamoxifen; D005641:Tegafur; C010770:polysaccharide-K; D016685:Mitomycin