| Abstract: |
Tamoxifen has been used in 4 large, cooperative phase III trials for prevention of breast cancer in women at increased risk: the National Surgical Adjuvant Breast and Bowel Project P-1 (NSABP P-1) study in the United States, and the Royal Marsden Hospital trial, the Italian Tamoxifen Prevention Study, and the International Breast Cancer Intervention Study (IBIS) in Europe. Each of the European studies is now in the follow-up period. With adequate follow-up, these 3 studies will provide definitive evidence of the chemopreventive effect of tamoxifen. Differences in the findings of the European trials with respect to the NSABP-P1 study in terms of risk reduction and side effects necessitate a reconsideration of the risks and benefits of tamoxifen chemoprevention. The following article is a review of the European trials; their respective designs, findings, and limitations; and a discassion of the HOT (Hormone Replacement Therapy and Low-Dose Tamoxifen) study, a second-generation, multi-institutional, phase III trial of breast cancer prevention with low-dose tamoxifen in hormone replacement therapy users. © 2003 Elsevier Inc. All rights reserved. |
