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Previous Volume 353:2747-2757 December 29, 2005 Number 26 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Editorial by Swain, S. M. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article PubMed Citation

ABSTRACT

Background The aromatase inhibitor letrozole is a more effective treatment for metastatic breast cancer and more effective in the neoadjuvant setting than tamoxifen. We compared letrozole with tamoxifen as adjuvant treatment for steroid-hormone-receptor–positive breast cancer in postmenopausal women.

Methods The Breast International Group (BIG) 1-98 study is a randomized, phase 3, double-blind trial that compared five years of treatment with various adjuvant endocrine therapy regimens in postmenopausal women with hormone-receptor–positive breast cancer: letrozole, letrozole followed by tamoxifen, tamoxifen, and tamoxifen followed by letrozole. This analysis compares the two groups assigned to receive letrozole initially with the two groups assigned to receive tamoxifen initially; events and follow-up in the sequential-treatment groups were included up to the time that treatments were switched.

Results A total of 8010 women with data that could be assessed were enrolled, 4003 in the letrozole group and 4007 in the tamoxifen group. After a median follow-up of 25.8 months, 351 events had occurred in the letrozole group and 428 events in the tamoxifen group, with five-year disease-free survival estimates of 84.0 percent and 81.4 percent, respectively. As compared with tamoxifen, letrozole significantly reduced the risk of an event ending a period of disease-free survival (hazard ratio, 0.81; 95 percent confidence interval, 0.70 to 0.93; P=0.003), especially the risk of distant recurrence (hazard ratio, 0.73; 95 percent confidence interval, 0.60 to 0.88; P=0.001). Thromboembolism, endometrial cancer, and vaginal bleeding were more common in the tamoxifen group. Women given letrozole had a higher incidence of skeletal and cardiac events and of hypercholesterolemia.

Conclusions In postmenopausal women with endocrine-responsive breast cancer, adjuvant treatment with letrozole, as compared with tamoxifen, reduced the risk of recurrent disease, especially at 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.

Full Text of this Article

Related Letters:

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. Correspondence

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• Cuzick, J., Forbes, J. F., Sestak, I., Cawthorn, S., Hamed, H., Holli, K., Howell, A. (2007). Long-Term Results of Tamoxifen Prophylaxis for Breast Cancer--96-Month Follow-up of the Randomized IBIS-I Trial. JNCI J Natl Cancer Inst 99: 272-282 [Abstract] [Full Text]  
• Coates, A. S., Keshaviah, A., Thurlimann, B., Mouridsen, H., Mauriac, L., Forbes, J. F., Paridaens, R., Castiglione-Gertsch, M., Gelber, R. D., Colleoni, M., Lang, I., Del Mastro, L., Smith, I., Chirgwin, J., Nogaret, J.-M., Pienkowski, T., Wardley, A., Jakobsen, E. H., Price, K. N., Goldhirsch, A. (2007). Five Years of Letrozole Compared With Tamoxifen As Initial Adjuvant Therapy for Postmenopausal Women With Endocrine-Responsive Early Breast Cancer: Update of Study BIG 1-98. JCO 25: 486-492 [Abstract] [Full Text]  
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• Perey, L, Paridaens, R, Hawle, H, Zaman, K, Nole, F, Wildiers, H, Fiche, M, Dietrich, D, Clement, P, Koberle, D, Goldhirsch, A, Thurlimann, B (2007). Clinical benefit of fulvestrant in postmenopausal women with advanced breast cancer and primary or acquired resistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical Cancer Research Trial (SAKK 21/00). Ann Oncol 18: 64-69 [Abstract] [Full Text]  
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• Chlebowski, R. T., Blackburn, G. L., Thomson, C. A., Nixon, D. W., Shapiro, A., Hoy, M. K., Goodman, M. T., Giuliano, A. E., Karanja, N., McAndrew, P., Hudis, C., Butler, J., Merkel, D., Kristal, A., Caan, B., Michaelson, R., Vinciguerra, V., Del Prete, S., Winkler, M., Hall, R., Simon, M., Winters, B. L., Elashoff, R. M. (2006). Dietary Fat Reduction and Breast Cancer Outcome: Interim Efficacy Results From the Women's Intervention Nutrition Study. JNCI J Natl Cancer Inst 98: 1767-1776 [Abstract] [Full Text]