title: Randomized trial of tamoxifen versus tamoxifen plus aminoglutethimide as adjuvant treatment in postmenopausal breast cancer patients with hormone receptor-positive disease: Austrian breast and colorectal cancer study group trial 6.
abstract: OBJECTIVE
  To determine whether the addition of aminoglutethimide to tamoxifen is able to improve the outcome in postmenopausal patients with hormone receptor-positive, early-stage breast cancer.
  
  
  METHODS
  A total of 2,021 postmenopausal women were randomly assigned to receive either tamoxifen for 5 years alone or tamoxifen in combination with aminoglutethimide (500 mg/d) for the first 2 years of treatment. Tamoxifen was administered at 40 mg/d for the first 2 years and at 20 mg/d for 3 years.
  
  
  RESULTS
  All randomized and eligible patients were included in the analysis according to the intention-to-treat principle. After a median follow-up of 5.3 years, the 5-year disease-free survival in the aminoglutethimide plus tamoxifen group was 83.6% versus 83.7% in the monotherapy group (P =.89). The corresponding data for overall survival at 5 years were 91.4% and 91.2%, respectively (P =.74). More patients failed to complete combination treatment (13.7%) because of side effects as compared to tamoxifen alone (5.2%; P =.0001).
  
  
  CONCLUSIONS
  Aminoglutethimide given for 2 years in addition to tamoxifen for 5 years does not improve the prognosis of postmenopausal patients with receptor-positive, lymph node-negative or lymph node-positive breast cancer.
authors.affiliation: Medical Department, Graz University, and Second Department of Surgery, Graz Hospital, Graz, Austria. marianne.shmid@kfunigraz.ac.at
authors.forename: Marianne
authors.initials: M
authors.lastname: Schmid
authors.forename: Raimund
authors.initials: R
authors.lastname: Jakesz
authors.forename: Hellmut
authors.initials: H
authors.lastname: Samonigg
authors.forename: Ernst
authors.initials: E
authors.lastname: Kubista
authors.forename: Michael
authors.initials: M
authors.lastname: Gnant
authors.forename: Christian
authors.initials: C
authors.lastname: Menzel
authors.forename: Michael
authors.initials: M
authors.lastname: Seifert
authors.forename: Karin
authors.initials: K
authors.lastname: Haider
authors.forename: Susanne
authors.initials: S
authors.lastname: Taucher
authors.forename: Brigitte
authors.initials: B
authors.lastname: Mlineritsch
authors.forename: Peter
authors.initials: P
authors.lastname: Steindorfer
authors.forename: Werner
authors.initials: W
authors.lastname: Kwasny
authors.forename: Michael
authors.initials: M
authors.lastname: Stierer
authors.forename: Christoph
authors.initials: C
authors.lastname: Tausch
authors.forename: Michael
authors.initials: M
authors.lastname: Fridrik
authors.forename: Viktor
authors.initials: V
authors.lastname: Wette
authors.forename: Günther
authors.initials: G
authors.lastname: Steger
authors.forename: Hubert
authors.initials: H
authors.lastname: Hausmaninger
mesh_terms: D000368:Aged; D000616:Aminoglutethimide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001317:Austria; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D018450:Disease Progression; D004334:Drug Administration Schedule; D020847:Estrogen Receptor Modulators / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D016609:Neoplasms, Second Primary / Q000209:etiology; D017698:Postmenopause; D011960:Receptors, Estrogen / Q000032:analysis; D011980:Receptors, Progesterone / Q000032:analysis; D016019:Survival Analysis; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D020847:Estrogen Receptor Modulators; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D013629:Tamoxifen; D000616:Aminoglutethimide