title: Predictors of early relapse in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial.
abstract: BACKGROUND
  Aromatase inhibitors are considered standard adjuvant endocrine treatment of postmenopausal women with hormone receptor-positive breast cancer, but it remains uncertain whether aromatase inhibitors should be given upfront or sequentially with tamoxifen. Awaiting results from ongoing randomized trials, we examined prognostic factors of an early relapse among patients in the BIG 1-98 trial to aid in treatment choices.
  
  
  METHODS
  Analyses included all 7707 eligible patients treated on BIG 1-98. The median follow-up was 2 years, and the primary end point was breast cancer relapse. Cox proportional hazards regression was used to identify prognostic factors.
  
  
  RESULTS
  Two hundred and eighty-five patients (3.7%) had an early relapse (3.1% on letrozole, 4.4% on tamoxifen). Predictive factors for early relapse were node positivity (P < 0.001), absence of both receptors being positive (P < 0.001), high tumor grade (P < 0.001), HER-2 overexpression/amplification (P < 0.001), large tumor size (P = 0.001), treatment with tamoxifen (P = 0.002), and vascular invasion (P = 0.02). There were no significant interactions between treatment and the covariates, though letrozole appeared to provide a greater than average reduction in the risk of early relapse in patients with many involved lymph nodes, large tumors, and vascular invasion present.
  
  
  CONCLUSIONS
  Upfront letrozole resulted in significantly fewer early relapses than tamoxifen, even after adjusting for significant prognostic factors.
authors.affiliation: French Breast Cancer Group, Institut Bergonié Bordeaux, France. mauriac@bergonie.org
authors.forename: L
authors.initials: L
authors.lastname: Mauriac
authors.forename: A
authors.initials: A
authors.lastname: Keshaviah
authors.forename: M
authors.initials: M
authors.lastname: Debled
authors.forename: H
authors.initials: H
authors.lastname: Mouridsen
authors.forename: J F
authors.initials: JF
authors.lastname: Forbes
authors.forename: B
authors.initials: B
authors.lastname: Thürlimann
authors.forename: R
authors.initials: R
authors.lastname: Paridaens
authors.forename: A
authors.initials: A
authors.lastname: Monnier
authors.forename: I
authors.initials: I
authors.lastname: Láng
authors.forename: A
authors.initials: A
authors.lastname: Wardley
authors.forename: J-M
authors.initials: JM
authors.lastname: Nogaret
authors.forename: R D
authors.initials: RD
authors.lastname: Gelber
authors.forename: M
authors.initials: M
authors.lastname: Castiglione-Gertsch
authors.forename: K N
authors.initials: KN
authors.lastname: Price
authors.forename: A S
authors.initials: AS
authors.lastname: Coates
authors.forename: I
authors.initials: I
authors.lastname: Smith
authors.forename: G
authors.initials: G
authors.lastname: Viale
authors.forename: M
authors.initials: M
authors.lastname: Rabaglio
authors.forename: N
authors.initials: N
authors.lastname: Zabaznyi
authors.forename: A
authors.initials: A
authors.lastname: Goldhirsch
mesh_terms: D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D047072:Aromatase Inhibitors / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077289:Letrozole; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy*; D009570:Nitriles / Q000008:administration & dosage; D017698:Postmenopause; D011379:Prognosis; D013629:Tamoxifen / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage
chemical_list: D018931:Antineoplastic Agents, Hormonal; D047072:Aromatase Inhibitors; D009570:Nitriles; D014230:Triazoles; D013629:Tamoxifen; D000077289:Letrozole