Exemestane significantly reduced invasive breast cancers in postmenopausal women who were at moderately increased risk for breast cancer

Background

• Tamoxifen and raloxifene have limited patient acceptance for primary prevention of breast cancer.
• Aromatase inhibitors prevent more contralateral breast cancers and cause fewer side effects than tamoxifen in patients with early-stage breast cancer.

Methods

• In a randomized, placebo-controlled, double-blind trial of exemestane designed to detect a 65% relative reduction in invasive breast cancer, eligible postmenopausal women 35 years of age or older had at least one of the following risk factors:
1. 60 years of age or older
2. Gail 5-year risk score greater than 1.66% (chances in 100 of invasive breast cancer developing within 5 years)
3. prior atypical ductal or lobular hyperplasia or lobular carcinoma in situ;
4. Ductal carcinoma in situ with mastectomy.
• Toxic effects and health-related and menopause-specific qualities of life were measured.

Results

• A total of 4560 women for whom the median age was 62.5 years and the median Gail risk score was 2.3% were randomly assigned to either exemestane or placebo.
• At a median follow-up of 35 months, 11 invasive breast cancers were detected in those given exemestane and in 32 of those given placebo, with a 65% relative reduction in the annual incidence of invasive breast cancer (0.19% vs. 0.55%; hazard ratio, 0.35; 95% confidence interval [CI], 0.18 to 0.70; P=0.002).
• The annual incidence of invasive plus noninvasive (ductal carcinoma in situ) breast cancers was 0.35% on exemestane and 0.77% on placebo (hazard ratio, 0.47; 95% CI, 0.27 to 0.79; P=0.004).
• Adverse events occurred in 88% of the exemestane group and 85% of the placebo group (P=0.003), with no significant differences between the two groups in terms of skeletal fractures, cardiovascular events, other cancers, or treatment-related deaths.
• Minimal quality-of-life differences were observed.

Conclusions

• 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.

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