Henning Mouridsen, Aparna Keshaviah, Alan S Coates, Manuela Rabaglio, Monica Castiglione-Gertsch, Zhuoxin Sun, Beat Thürlimann, Louis Mauriac, John F Forbes, Robert Paridaens, Richard D Gelber, Marco Colleoni, Ian Smith, Karen N Price, Aron Goldhirsch
PURPOSE: Previous analyses of adjuvant studies of aromatase inhibitors versus tamoxifen, including the Breast International Group (BIG) 1-98 study, have suggested a small numerical excess of cardiac adverse events (AEs) on aromatase inhibitors, a reduction in the incidence of hypercholesterolemia on tamoxifen, and significantly higher incidence of thromboembolic AEs on tamoxifen. The purpose of the present study is to provide detailed updated information on these AEs in BIG 1-98. PATIENTS AND METHODS: Eight thousand twenty-eight postmenopausal women with receptor-positive early breast cancer were randomly assigned (double-blind) between March 1998 and May 2003 to receive 5 years of adjuvant endocrine therapy with letrozole, tamoxifen, or a sequence of these agents...
December 20, 2007: Journal of Clinical Oncology