Background The aromatase inhibitor letrozole is a more effectivetreatment for metastatic breast cancer and more effective inthe neoadjuvant setting than tamoxifen. We compared letrozolewith tamoxifen as adjuvant treatment for steroid-hormone-receptor–positivebreast cancer in postmenopausal women.
Methods The Breast International Group (BIG) 1-98 study is arandomized, phase 3, double-blind trial that compared five yearsof treatment with various adjuvant endocrine therapy regimensin postmenopausal women with hormone-receptor–positivebreast cancer: letrozole, letrozole followed by tamoxifen, tamoxifen,and tamoxifen followed by letrozole. This analysis comparesthe two groups assigned to receive letrozole initially withthe two groups assigned to receive tamoxifen initially; eventsand follow-up in the sequential-treatment groups were includedup to the time that treatments were switched.
Results A total of 8010 women with data that could be assessedwere enrolled, 4003 in the letrozole group and 4007 in the tamoxifengroup. After a median follow-up of 25.8 months, 351 events hadoccurred in the letrozole group and 428 events in the tamoxifengroup, with five-year disease-free survival estimates of 84.0percent and 81.4 percent, respectively. As compared with tamoxifen,letrozole significantly reduced the risk of an event endinga period of disease-free survival (hazard ratio, 0.81; 95 percentconfidence interval, 0.70 to 0.93; P=0.003), especially therisk of distant recurrence (hazard ratio, 0.73; 95 percent confidenceinterval, 0.60 to 0.88; P=0.001). Thromboembolism, endometrialcancer, and vaginal bleeding were more common in the tamoxifengroup. Women given letrozole had a higher incidence of skeletaland cardiac events and of hypercholesterolemia.
Conclusions In postmenopausal women with endocrine-responsivebreast cancer, adjuvant treatment with letrozole, as comparedwith tamoxifen, reduced the risk of recurrent disease, especiallyat distant sites. (ClinicalTrials.gov number, NCT00004205
[ClinicalTrials.gov]
.)
Source Information
The Writing Committee (Beat Thürlimann, M.D., chair, Aparna Keshaviah, Sc.M., Alan S. Coates, M.D., Henning Mouridsen, M.D., Louis Mauriac, M.D., John F. Forbes, F.R.A.C.S., Robert Paridaens, M.D., Ph.D., Monica Castiglione-Gertsch, M.D., Richard D. Gelber, Ph.D., Manuela Rabaglio, M.D., Ian Smith, M.D., Andrew Wardly, M.D., Karen N. Price, B.S., and Aron Goldhirsch, M.D.) takes responsibility for the content of this article. The affiliations of the Writing Committee members are listed in the Appendix.
Address reprint requests to the International Breast Cancer Study Group Coordinating Center, Effingerstrasse 56, 3088 Bern, Switzerland, or at ibcsg.big198{at}ibcsg.org.
Letrozole or Tamoxifen in Early Breast Cancer
Buzdar A. U., Baum M., Cuzick J., Erban J. K., Chlebowski R. T., Coates A. S., Mouridsen H., Mauriac L., the BIG 1-98 Collaborative Group
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N Engl J Med 2006;
354:1528-1530, Apr 6, 2006.
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A correction has been published: N Engl J Med 2006;354(20):2200.
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