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Exemestane for breast-cancer prevention in postmenopausal women
New England Journal of Medicine, 06/07/2011
Clinical Article
Goss PE et al. – Exemestane significantly reduced invasive breast cancers in postmenopausal women who were at moderately increased risk for breast cancer. During a median follow-up period of 3 years, exemestane was associated with no serious toxic effects and only minimal changes in health-related quality of life.
Methods- Randomized, placebo-controlled, double-blind trial of exemestane
- Study designed to detect 65% relative reduction in invasive breast cancer, eligible postmenopausal women 35 years of age or older had at least 1 of the following risk factors: 60 years of age or older; Gail 5-year risk score greater than 1.66% (chances in 100 of invasive breast cancer developing within 5 years); prior atypical ductal or lobular hyperplasia or lobular carcinoma in situ; or ductal carcinoma in situ with mastectomy
- Toxic effects and health-related and menopause-specific qualities of life measured
- 4560 women for whom median age was 62.5 years and median Gail risk score was 2.3% were randomly assigned to either exemestane or placebo
- At median follow-up of 35 months, 11 invasive breast cancers detected in those given exemestane and in 32 of those given placebo, with 65% relative reduction in annual incidence of invasive breast cancer (0.19% vs. 0.55%; HR, 0.35; 95% CI, 0.18 to 0.70; P=0.002)
- Annual incidence of invasive plus noninvasive (ductal carcinoma in situ) breast cancers was 0.35% on exemestane and 0.77% on placebo (HR, 0.47; 95% CI, 0.27 to 0.79; P=0.004)
- AEs occurred in 88% of exemestane group and 85% of placebo group (P=0.003), with no significant differences between 2 groups in terms of skeletal fractures, cardiovascular events, other cancers, or treatment-related deaths
- Minimal QOL differences observed