Exemestane for breast-cancer prevention in postmenopausal women

Paul E. Goss, James N. Ingle, José E. Alés-Martínez, Angela M. Cheung, Rowan T. Chlebowski, Jean Wactawski-Wende, Anne McTiernan, John Robbins, Karen Johnson, Lisa W. Martin, Eric Winquist, Gloria E. Sarto, Judy E. Garber, Carol J. Fabian, Pascal Pujol, Elizabeth Maunsell, Patricia Farmer, Karen A. Gelmon, Dongsheng Tu, Harriet Richardson

Research output: Contribution to journalArticle

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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.)

Original languageEnglish (US)
Pages (from-to)2381-2391
Number of pages11
JournalNew England Journal of Medicine
Volume364
Issue number25
DOIs
StatePublished - Jun 23 2011

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exemestane
Breast Neoplasms
Placebos
Carcinoma, Intraductal, Noninfiltrating
Poisons
Quality of Life
Tamoxifen
Confidence Intervals
Aromatase Inhibitors

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Goss, P. E., Ingle, J. N., Alés-Martínez, J. E., Cheung, A. M., Chlebowski, R. T., Wactawski-Wende, J., ... Richardson, H. (2011). Exemestane for breast-cancer prevention in postmenopausal women. New England Journal of Medicine, 364(25), 2381-2391. https://doi.org/10.1056/NEJMoa1103507

Exemestane for breast-cancer prevention in postmenopausal women. / Goss, Paul E.; Ingle, James N.; Alés-Martínez, José E.; Cheung, Angela M.; Chlebowski, Rowan T.; Wactawski-Wende, Jean; McTiernan, Anne; Robbins, John; Johnson, Karen; Martin, Lisa W.; Winquist, Eric; Sarto, Gloria E.; Garber, Judy E.; Fabian, Carol J.; Pujol, Pascal; Maunsell, Elizabeth; Farmer, Patricia; Gelmon, Karen A.; Tu, Dongsheng; Richardson, Harriet.

In: New England Journal of Medicine, Vol. 364, No. 25, 23.06.2011, p. 2381-2391.

Research output: Contribution to journalArticle

Goss, PE, Ingle, JN, Alés-Martínez, JE, Cheung, AM, Chlebowski, RT, Wactawski-Wende, J, McTiernan, A, Robbins, J, Johnson, K, Martin, LW, Winquist, E, Sarto, GE, Garber, JE, Fabian, CJ, Pujol, P, Maunsell, E, Farmer, P, Gelmon, KA, Tu, D & Richardson, H 2011, 'Exemestane for breast-cancer prevention in postmenopausal women', New England Journal of Medicine, vol. 364, no. 25, pp. 2381-2391. https://doi.org/10.1056/NEJMoa1103507
Goss PE, Ingle JN, Alés-Martínez JE, Cheung AM, Chlebowski RT, Wactawski-Wende J et al. Exemestane for breast-cancer prevention in postmenopausal women. New England Journal of Medicine. 2011 Jun 23;364(25):2381-2391. https://doi.org/10.1056/NEJMoa1103507
Goss, Paul E. ; Ingle, James N. ; Alés-Martínez, José E. ; Cheung, Angela M. ; Chlebowski, Rowan T. ; Wactawski-Wende, Jean ; McTiernan, Anne ; Robbins, John ; Johnson, Karen ; Martin, Lisa W. ; Winquist, Eric ; Sarto, Gloria E. ; Garber, Judy E. ; Fabian, Carol J. ; Pujol, Pascal ; Maunsell, Elizabeth ; Farmer, Patricia ; Gelmon, Karen A. ; Tu, Dongsheng ; Richardson, Harriet. / Exemestane for breast-cancer prevention in postmenopausal women. In: New England Journal of Medicine. 2011 ; Vol. 364, No. 25. pp. 2381-2391.
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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.)",
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T1 - Exemestane for breast-cancer prevention in postmenopausal women

AU - Goss, Paul E.

AU - Ingle, James N.

AU - Alés-Martínez, José E.

AU - Cheung, Angela M.

AU - Chlebowski, Rowan T.

AU - Wactawski-Wende, Jean

AU - McTiernan, Anne

AU - Robbins, John

AU - Johnson, Karen

AU - Martin, Lisa W.

AU - Winquist, Eric

AU - Sarto, Gloria E.

AU - Garber, Judy E.

AU - Fabian, Carol J.

AU - Pujol, Pascal

AU - Maunsell, Elizabeth

AU - Farmer, Patricia

AU - Gelmon, Karen A.

AU - Tu, Dongsheng

AU - Richardson, Harriet

PY - 2011/6/23

Y1 - 2011/6/23

N2 - 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.)

AB - 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.)

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