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document
Exemestane for breast-cancer prevention in postmenopausal women . 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 : 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 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 . ( Funded by Pfizer and others ; NCIC CTG MAP.3 ClinicalTrials.gov number , NCT00083174 . ) .
50564
Intervention_Pharmacological
Exemestane
50565
Intervention_Control
placebo-controlled
50566
Intervention_Pharmacological
exemestane
50567
Intervention_Pharmacological
exemestane
50568
Intervention_Control
placebo
50569
Intervention_Pharmacological
exemestane
50570
Intervention_Control
placebo
50571
Intervention_Control
placebo
50572
Intervention_Pharmacological
Exemestane
50573
Outcome_Physical
Toxic effects and
50574
Outcome_Other
health-related and menopause-specific qualities of life
50575
Outcome_Other
median Gail risk score
50576
Outcome_Other
reduction in the annual incidence of invasive breast cancer
50577
Outcome_Other
annual incidence of invasive plus noninvasive ( ductal carcinoma in situ ) breast cancers
50578
Outcome_Adverse-effects
Adverse events
50579
Outcome_Physical
skeletal fractures
50580
Outcome_Physical
cardiovascular events
50581
Outcome_Adverse-effects
other
50582
Outcome_Physical
cancers
50583
Outcome_Mortality
treatment-related deaths
50584
Outcome_Other
quality-of-life
50585
Participant_Condition
patients with early-stage breast cancer .