Predictors of early relapse in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial

L. Mauriac, A. Keshaviah, M. Debled, H. Mouridsen, J. F. Forbes, B. Thürlimann, R. Paridaens, A. Monnier, I. Láng, A. Wardley, J. M. Nogaret, R. D. Gelber, M. Castiglione-Gertsch, K. N. Price, A. S. Coates, I. Smith, G. Viale, M. Rabaglio, N. Zabaznyi, A. Goldhirsch

Research output: Contribution to journalArticlepeer-review


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. Patients and 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. Conclusion: Upfront letrozole resulted in significantly fewer early relapses than tamoxifen, even after adjusting for significant prognostic factors.

Original languageEnglish
Pages (from-to)859-867
Number of pages9
JournalAnnals of Oncology
Issue number5
Publication statusPublished - May 2007


  • Adjuvant endocrine therapy
  • Aromatase inhibitor
  • Breast cancer
  • Early relapse
  • Letrozole
  • Prognostic factors

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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