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N Engl J Med. 2011 Jun 23;364(25):2381-91. doi: 10.1056/NEJMoa1103507. Epub 2011 Jun 4.

Exemestane for breast-cancer prevention in postmenopausal women.

Collaborators (143)

Goss PE, Ingle J, Ales-Martinez JE, Chlebowski R, Sarto G, Garber J, Fabian C, Richardson H, Maunsell E, Tu D, Farmer P, Goss P, Richardson H, Shepherd L, Hiltz A, O'Brien P, Scarth HM, Provencher L, Dube P, Mayrand MH, Nassif E, Falkson C, Verma S, Dworkin B, Wright JR, Rahim YH, Cheung A, Eisen A, Lickley L, Winquist EW, Hey A, Spadafora S, Cooke AL, Gelmon K, Ellard S, Callet N, Dupre PF, Chabbert-Buffet N, Gauthier T, Berthet P, Pujol P, Jouannaud C, Ruiz A, Chacón JI, Lluch Hernández A, Ramos M, Xercavins J, Aguirre E, Barnadas A, Jara C, Alés JE, González S, Plazaola A, Florián J, Andrés R, Sánchez P, Frau A, García JA, Zamora P, Batista N, López JM, Seguí MÁ, Adrover E, Zanón G, Tusquets JI, Brunet J, Blanco JI, Urricoechea, Ruiz Borrego M, Mariscal, Rodríguez Á, Méndez M, Calvo L, Torres A, Robles L, Alba E, Piñero A, Lorenzo I, González E, Miguel A, Calvo MI, Calvo I, Martínez P, Murias A, Lorenzo M, Antón A, de la Haba J, Cassinello J, Arcusa A, García E, Bayo J, Rodriguez C, del Mar Muñoz M, Hernando B, García J, Peñuelas AL, García A, Albiol, Olopade OF, Qadir MU, Frank RC, Hendrix S, Anderson JE, McTiernan A, Sparano JA, Robbins J, Shaughnessy EA, Decker D, Avisar E, Perez-Tamayo A, Ganschow PS, Constantinou CL, Lo SS, Migas J, Helsten T, Domchek S, Chlebowski R, Barnabei V, Rastelli A, Claudio J, Aroda VR, Sarto GE, Saleh M, Storniolo AM, Pagan JS, Goss P, Elias AD, Cyr M, Fabian C, Wood ME, Hines S, Pliner LF, Hendricks C, Dooley WC, Rowland KM, Krontiras H, Pruthi S, Johnson KC, Garber JE, Ashford RS 2nd, Martin LW, Weisberg TF, Brewer MA.

Author information

  • 1Massachusetts General Hospital Cancer Center, Boston, MA 02114, USA. pgoss@partners.org

Erratum in

  • N Engl J Med. 2011 Oct 6;365(14):1361.

Abstract

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.).

Comment in

PMID:
21639806
[PubMed - indexed for MEDLINE]
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