Annals of Oncology Advance Access published online on February 14, 2007
Annals of Oncology, doi:10.1093/annonc/mdm001
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© 2007 European Society for Medical Oncology
Predictors of early relapse in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial
1 French Breast Cancer Group, Institut Bergonié Bordeaux, France
2 International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA
3 Institut Bergonié, Bordeaux, France
4 Danish Breast Cancer Cooperative Group, Rigshospitalet, Copenhagen, Denmark
5 Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Newcastle Mater Hospital, Newcastle, New South Wales, Australia
6 Senology Center of Eastern Switzerland, Switzerland, Swiss Group for Clinical Cancer Research, Kantonsspital, St Gallen
7 University Hospital Gasthuisberg, Catholic University of Leuven, Belgium
8 Centre Hospitalier Belfort, Montbeliard, France
9 National Institute of Oncology, Budapest, Hungary
10 Christie Hospital NHS Trust, South Manchester University Hospital Trust, Manchester, UK
11 Jules Bordet Institute, Brussels, Belgium
12 International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health and Frontier Science and Technology Research Foundation, Boston, MA, USA
13 International Breast Cancer Study Group Coordinating Center and Inselspital, Berne, Switzerland
14 International Breast Cancer Study Group Statistical Center and Frontier Science and Technology Research Foundation, Boston, MA, USA
15 International Breast Cancer Study Group, Berne, Switzerland and University of Sydney, Australia
16 The Royal Marsden Hospital, London, UK
17 European Institute of Oncology, Milan, Italy
18 Moscow Municipal Oncology Hospital #62, Stepanovskoe, Krasnogorski Province, Moscow Region, Russia
19 European Institute of Oncology, Milan, Italy and Oncology Institute of Southern Switzerland, Bellinzona, Switzerland
* Correspondence to: Dr L. Mauriac, Institut Bergonié 229 cours de l'Argonne, 33076 Bordeaux Cedex, France. Tel: +33-5-56-33-32-58; Fax: +33-5-56-33-32-85; E-mail: mauriac{at}bergonie.org
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.
adjuvant endocrine therapy, aromatase inhibitor, breast cancer, early relapse, letrozole, prognostic factors
Received for publication October 31, 2006. Revision received January 2, 2007. Accepted for publication January 3, 2007.
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