Exemestane for Breast-Cancer Prevention in Postmenopausal Women
| Autor: | Goss, Paul E., Ingle, James N., Alés Martínez, José Enrique, Cheung, Angela M., Chlebowski, Rowan T., Wactawski-Wende, Jean, McTiernan, Anne, Robbins, John, Johnson, Karen C., Martin, Lisa W., Winquist, Eric, Sarto, Gloria E., Garber, Judy, Fabian, Carol J., Pujol, Pascal, Maunsell, Elizabeth, Farmer, Patricia, Gelmon, Karen A., Tu, Dongsheng, Richardson, Harriet, NCIC CTG MAP.3 Study Investigators |
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| Přispěvatelé: | Universitat de Barcelona |
| Rok vydání: | 2011 |
| Předmět: |
Adult
Oncology medicine.medical_specialty medicine.drug_class medicine.medical_treatment Breast Neoplasms Càncer de mama chemistry.chemical_compound Breast cancer Double-Blind Method Exemestane Risk Factors Ús terapèutic Internal medicine medicine Humans Neoplasm Invasiveness Testosterone Raloxifene skin and connective tissue diseases Testosterona Aged Aged 80 and over Gynecology Aromatase inhibitor Aromatase Inhibitors business.industry Incidence Therapeutic use Cancer General Medicine Middle Aged medicine.disease Androstadienes Postmenopause Carcinoma Intraductal Noninfiltrating chemistry Quality of Life Female Breast disease business Tamoxifen Mastectomy Follow-Up Studies medicine.drug |
| Zdroj: | Dipòsit Digital de la UB Universidad de Barcelona Recercat. Dipósit de la Recerca de Catalunya instname |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa1103507 |
| Popis: | 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 treatmentrelated 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.) |
| Databáze: | OpenAIRE |
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