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Originally published as JCO Early Release 10.1200/JCO.2006.08.8617 on January 2 2007

Journal of Clinical Oncology, Vol 25, No 5 (February 10), 2007: pp. 486-492
© 2007 American Society of Clinical Oncology.
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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

Alan S. Coates, Aparna Keshaviah, Beat Thürlimann, Henning Mouridsen, Louis Mauriac, John F. Forbes, Robert Paridaens, Monica Castiglione-Gertsch, Richard D. Gelber, Marco Colleoni, István Láng, Lucia Del Mastro, Ian Smith, Jacquie Chirgwin, Jean-Marie Nogaret, Tadeusz Pienkowski, Andrew Wardley, Erik H. Jakobsen, Karen N. Price, Aron Goldhirsch

From the International Breast Cancer Study Group (IBCSG); IBCSG Coordinating Center, Bern; Swiss Group for Clinical Cancer Research (SAKK), Senology Center of Eastern Switzerland, Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona, Switzerland; University of Sydney, Sydney; Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Newcastle Mater Hospital, Newcastle, New South Wales; Box Hill and Maroondah Hospitals, Melbourne, Australia; IBCSG Statistical Center, Dana-Farber Cancer Institute; Harvard School of Public Health; Frontier Science and Technology Research Foundation, Boston, MA; Danish Breast Cancer Group, Rigshospitalet, Copenhagen; Vejle Hospital, Vejle, Denmark; French Breast Cancer Group, Institut Bergonié, Bordeaux, France; Department of Medical Oncology, University Hospital Gasthuisberg, Catholic University of Leuven; Jules Bordet Institute; Brussels, Belgium; European Institute of Oncology, Milan; National Cancer Research Institute, Genoa, Italy; National Institute of Oncology, Budapest, Hungary; The Royal Marsden Hospital, London; Christie Hospital National Health Service Trust, South Manchester University Hospital Trust, Manchester, United Kingdom; and the Cancer Center Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw, Poland

Address reprint requests to International Breast Cancer Study Group Coordinating Center, Effingerstrasse 40, CH-3008 Bern, Switzerland; e-mail: alan.coates{at}ibcsg.org

Purpose Previous analyses of the Breast International Group (BIG) 1-98 four-arm study compared initial therapy with letrozole or tamoxifen including patients randomly assigned to sequential treatment whose information was censored at the time of therapy change. Because this presentation may unduly reflect early events, the present analysis is limited to patients randomly assigned to the continuous therapy arms and includes protocol-defined updated results.

Patients and Methods Four thousand nine hundred twenty-two of the 8,028 postmenopausal women with receptor-positive early breast cancer randomly assigned (double-blind) to the BIG 1-98 trial were assigned to 5 years of continuous adjuvant therapy with either letrozole or tamoxifen; the remainder of women were assigned to receive the agents in sequence. Disease-free survival (DFS) was the primary end point.

Results At a median follow-up time of 51 months, we observed 352 DFS events among 2,463 women receiving letrozole and 418 events among 2,459 women receiving tamoxifen. This reflected an 18% reduction in the risk of an event (hazard ratio, 0.82; 95% CI, 0.71 to 0.95; P = .007). No predefined subsets showed differential benefit. Adverse events were similar to previous reports. Patients on tamoxifen experienced more thromboembolic events, endometrial pathology, hot flashes, night sweats, and vaginal bleeding. Patients on letrozole experienced more bone fractures, arthralgia, low-grade hypercholesterolemia, and cardiovascular events other than ischemia and cardiac failure.

Conclusion The present updated analysis, which was limited to patients on monotherapy arms in BIG 1-98, yields results similar to those from the previous primary analysis but more directly comparable with results from other trials of continuous therapy using a single endocrine agent.

published online ahead of print at www.jco.org on January 2, 2007.

Supported by the Swedish Cancer Society, The Cancer Council Australia, Australian New Zealand Breast Cancer Trials Group, Frontier Science and Technology Research Foundation, Swiss Group for Clinical Cancer Research, National Cancer Institute Grant No. CA-75362, and the Foundation for Clinical Cancer Research of Eastern Switzerland (OSKK).

Presented in part at the 31st Congress of the European Society for Medical Oncology Conference, September 29-October 3, 2006, Istanbul, Turkey.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.


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