Résumé :
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[BDSP. Notice produite par INIST-CNRS lR0xPo3z. Diffusion soumise à autorisation]. Context As endogenous estradiol increases, risk of breast cancer increases. Raloxifene competes with endogenous estrogen for binding to estrogen receptors in breast tissue. A woman's estradiol level may alter the effects of raloxifene on breast cancer and other outcomes. Objective To test the hypothesis that raloxifene reduces breast cancer risk more in women with relatively high estradiol levels than in women with very low estradiol levels. Design Analysis of the Multiple Outcomes of Raloxifene Evaluation, a randomized, double-blind, placebo-controlled trial conducted from 1994 to 1999. Setting One hundred eighty community settings and medical practices in 25 countries including the United States. Participants A total of 7290 postmenopausal women aged 80 years or younger with osteoporosis who had baseline serum estradiol concentrations measured by a central laboratory using a sensitive assay. Women with a history of breast cancer or estrogen use were excluded. Intervention Participants were randomly assigned to receive 60 mg/d or 120 mg/d of raloxifene (n=4843) or matching placebo (n=2447) for 4 years. Main Outcome Measure New cases of histopathologically confirmed breast cancer in the treatment and placebo groups, stratified by estradiol levels. Results In the placebo group, women with estradiol levels greater than 10 pmol/L (2.7 pg/mL) had a 6.8-fold higher rate of breast cancer (3.0% per 4 years ; 95% confidence interval [CI], 1.8% - 4.1%) than that of women with undetectable estradiol levels (0.6% per 4 years ; 95% Cl, 0% - 1.1% ; P=005 for trend). Women with estradiol levels greater than 10 pmol/L in the raloxifene group had a rate of breast cancer that was 76% (95% CI, 53% - 88%) lower than that of women with estradiol levels greater than 10 pmol/L in the placebo group (absolute rate reduction, 2.2% [95% CI, 1.0% - 3.5% ; number needed to treat=45]). (...)
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