Quality of life in MAP.3 (Mammary Prevention 3): A randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer

Elizabeth Maunsell, Paul E. Goss, Rowan T. Chlebowski, James N. Ingle, José E. Alés-Martínez, Gloria E. Sarto, Carol J. Fabian, Pascal Pujol, Amparao Ruiz, Andrew L. Cooke, Susan Hendrix, Debra W. Thayer, Kendrith M. Rowland, Pierre Dubé, Silvana Spadafora, Sandhya Pruthi, Lavina Lickley, Susan L. Ellard, Angela M. Cheung, Jean Wactawski-WendeKaren A. Gelmon, Dianne Johnston, Andrea Hiltz, Michael Brundage, Joseph L. Pater, Dongsheng Tu, Harriet Richardson

Research output: Contribution to journalArticle

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Abstract

Purpose: Exemestane, a steroidal aromatase inhibitor, reduced invasive breast cancer incidence by 65% among 4,560 postmenopausal women randomly assigned to exemestane (25 mg per day) compared with placebo in the National Cancer Institute of Canada (NCIC) Clinical Trials Group MAP.3 (Mammary Prevention 3) trial, but effects on quality of life (QOL) were not fully described. Patients and Methods: Menopause-specific and health-related QOL were assessed by using the four Menopause-Specific Quality of Life Questionnaire (MENQOL) domains and the eight Medical Outcomes Study Short Form Health Survey (SF-36) scales at baseline, 6 months, and yearly thereafter. MENQOL questionnaire completion was high (88% to 98%) in both groups at each follow-up visit. Change scores for each MENQOL and SF-36 scale, calculated at each assessment time relative to baseline, were compared by using the Wilcoxon rank-sum test. Clinically important worsened QOL was defined as a MENQOL change score increase of more than 0.5 (of 8) points and an SF-36 change score decrease of more than 5 (of 100) points from baseline. Results: Exemestane had small negative effects on women's self-reported vasomotor symptoms, sexual symptoms, and pain, which occurred mainly in the first 6 months to 2 years after random assignment. However, these changes represented only a small excess number of women being given exemestane with clinically important worsening of QOL at one time or another; specifically, 8% more in the vasomotor domain and 4% more each in the sexual domain and for pain. No other between-group differences were observed. Overall, slightly more women in the exemestane arm (32%) than in the placebo arm (28%) discontinued assigned treatment. Conclusion: Exemestane given for prevention has limited negative impact on menopause-specific and health-related QOL in healthy postmenopausal women at risk for breast cancer.

Original languageEnglish (US)
Pages (from-to)1427-1436
Number of pages10
JournalJournal of Clinical Oncology
Volume32
Issue number14
DOIs
StatePublished - May 10 2014

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exemestane
Breast
Randomized Controlled Trials
Placebos
Quality of Life
Breast Neoplasms
Menopause
Nonparametric Statistics
Pain
Aromatase Inhibitors
National Cancer Institute (U.S.)

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Maunsell, E., Goss, P. E., Chlebowski, R. T., Ingle, J. N., Alés-Martínez, J. E., Sarto, G. E., ... Richardson, H. (2014). Quality of life in MAP.3 (Mammary Prevention 3): A randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer. Journal of Clinical Oncology, 32(14), 1427-1436. https://doi.org/10.1200/JCO.2013.51.2483

Quality of life in MAP.3 (Mammary Prevention 3) : A randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer. / Maunsell, Elizabeth; Goss, Paul E.; Chlebowski, Rowan T.; Ingle, James N.; Alés-Martínez, José E.; Sarto, Gloria E.; Fabian, Carol J.; Pujol, Pascal; Ruiz, Amparao; Cooke, Andrew L.; Hendrix, Susan; Thayer, Debra W.; Rowland, Kendrith M.; Dubé, Pierre; Spadafora, Silvana; Pruthi, Sandhya; Lickley, Lavina; Ellard, Susan L.; Cheung, Angela M.; Wactawski-Wende, Jean; Gelmon, Karen A.; Johnston, Dianne; Hiltz, Andrea; Brundage, Michael; Pater, Joseph L.; Tu, Dongsheng; Richardson, Harriet.

In: Journal of Clinical Oncology, Vol. 32, No. 14, 10.05.2014, p. 1427-1436.

Research output: Contribution to journalArticle

Maunsell, E, Goss, PE, Chlebowski, RT, Ingle, JN, Alés-Martínez, JE, Sarto, GE, Fabian, CJ, Pujol, P, Ruiz, A, Cooke, AL, Hendrix, S, Thayer, DW, Rowland, KM, Dubé, P, Spadafora, S, Pruthi, S, Lickley, L, Ellard, SL, Cheung, AM, Wactawski-Wende, J, Gelmon, KA, Johnston, D, Hiltz, A, Brundage, M, Pater, JL, Tu, D & Richardson, H 2014, 'Quality of life in MAP.3 (Mammary Prevention 3): A randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer', Journal of Clinical Oncology, vol. 32, no. 14, pp. 1427-1436. https://doi.org/10.1200/JCO.2013.51.2483
Maunsell, Elizabeth ; Goss, Paul E. ; Chlebowski, Rowan T. ; Ingle, James N. ; Alés-Martínez, José E. ; Sarto, Gloria E. ; Fabian, Carol J. ; Pujol, Pascal ; Ruiz, Amparao ; Cooke, Andrew L. ; Hendrix, Susan ; Thayer, Debra W. ; Rowland, Kendrith M. ; Dubé, Pierre ; Spadafora, Silvana ; Pruthi, Sandhya ; Lickley, Lavina ; Ellard, Susan L. ; Cheung, Angela M. ; Wactawski-Wende, Jean ; Gelmon, Karen A. ; Johnston, Dianne ; Hiltz, Andrea ; Brundage, Michael ; Pater, Joseph L. ; Tu, Dongsheng ; Richardson, Harriet. / Quality of life in MAP.3 (Mammary Prevention 3) : A randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer. In: Journal of Clinical Oncology. 2014 ; Vol. 32, No. 14. pp. 1427-1436.
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title = "Quality of life in MAP.3 (Mammary Prevention 3): A randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer",
abstract = "Purpose: Exemestane, a steroidal aromatase inhibitor, reduced invasive breast cancer incidence by 65{\%} among 4,560 postmenopausal women randomly assigned to exemestane (25 mg per day) compared with placebo in the National Cancer Institute of Canada (NCIC) Clinical Trials Group MAP.3 (Mammary Prevention 3) trial, but effects on quality of life (QOL) were not fully described. Patients and Methods: Menopause-specific and health-related QOL were assessed by using the four Menopause-Specific Quality of Life Questionnaire (MENQOL) domains and the eight Medical Outcomes Study Short Form Health Survey (SF-36) scales at baseline, 6 months, and yearly thereafter. MENQOL questionnaire completion was high (88{\%} to 98{\%}) in both groups at each follow-up visit. Change scores for each MENQOL and SF-36 scale, calculated at each assessment time relative to baseline, were compared by using the Wilcoxon rank-sum test. Clinically important worsened QOL was defined as a MENQOL change score increase of more than 0.5 (of 8) points and an SF-36 change score decrease of more than 5 (of 100) points from baseline. Results: Exemestane had small negative effects on women's self-reported vasomotor symptoms, sexual symptoms, and pain, which occurred mainly in the first 6 months to 2 years after random assignment. However, these changes represented only a small excess number of women being given exemestane with clinically important worsening of QOL at one time or another; specifically, 8{\%} more in the vasomotor domain and 4{\%} more each in the sexual domain and for pain. No other between-group differences were observed. Overall, slightly more women in the exemestane arm (32{\%}) than in the placebo arm (28{\%}) discontinued assigned treatment. Conclusion: Exemestane given for prevention has limited negative impact on menopause-specific and health-related QOL in healthy postmenopausal women at risk for breast cancer.",
author = "Elizabeth Maunsell and Goss, {Paul E.} and Chlebowski, {Rowan T.} and Ingle, {James N.} and Al{\'e}s-Mart{\'i}nez, {Jos{\'e} E.} and Sarto, {Gloria E.} and Fabian, {Carol J.} and Pascal Pujol and Amparao Ruiz and Cooke, {Andrew L.} and Susan Hendrix and Thayer, {Debra W.} and Rowland, {Kendrith M.} and Pierre Dub{\'e} and Silvana Spadafora and Sandhya Pruthi and Lavina Lickley and Ellard, {Susan L.} and Cheung, {Angela M.} and Jean Wactawski-Wende and Gelmon, {Karen A.} and Dianne Johnston and Andrea Hiltz and Michael Brundage and Pater, {Joseph L.} and Dongsheng Tu and Harriet Richardson",
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T1 - Quality of life in MAP.3 (Mammary Prevention 3)

T2 - A randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer

AU - Maunsell, Elizabeth

AU - Goss, Paul E.

AU - Chlebowski, Rowan T.

AU - Ingle, James N.

AU - Alés-Martínez, José E.

AU - Sarto, Gloria E.

AU - Fabian, Carol J.

AU - Pujol, Pascal

AU - Ruiz, Amparao

AU - Cooke, Andrew L.

AU - Hendrix, Susan

AU - Thayer, Debra W.

AU - Rowland, Kendrith M.

AU - Dubé, Pierre

AU - Spadafora, Silvana

AU - Pruthi, Sandhya

AU - Lickley, Lavina

AU - Ellard, Susan L.

AU - Cheung, Angela M.

AU - Wactawski-Wende, Jean

AU - Gelmon, Karen A.

AU - Johnston, Dianne

AU - Hiltz, Andrea

AU - Brundage, Michael

AU - Pater, Joseph L.

AU - Tu, Dongsheng

AU - Richardson, Harriet

PY - 2014/5/10

Y1 - 2014/5/10

N2 - Purpose: Exemestane, a steroidal aromatase inhibitor, reduced invasive breast cancer incidence by 65% among 4,560 postmenopausal women randomly assigned to exemestane (25 mg per day) compared with placebo in the National Cancer Institute of Canada (NCIC) Clinical Trials Group MAP.3 (Mammary Prevention 3) trial, but effects on quality of life (QOL) were not fully described. Patients and Methods: Menopause-specific and health-related QOL were assessed by using the four Menopause-Specific Quality of Life Questionnaire (MENQOL) domains and the eight Medical Outcomes Study Short Form Health Survey (SF-36) scales at baseline, 6 months, and yearly thereafter. MENQOL questionnaire completion was high (88% to 98%) in both groups at each follow-up visit. Change scores for each MENQOL and SF-36 scale, calculated at each assessment time relative to baseline, were compared by using the Wilcoxon rank-sum test. Clinically important worsened QOL was defined as a MENQOL change score increase of more than 0.5 (of 8) points and an SF-36 change score decrease of more than 5 (of 100) points from baseline. Results: Exemestane had small negative effects on women's self-reported vasomotor symptoms, sexual symptoms, and pain, which occurred mainly in the first 6 months to 2 years after random assignment. However, these changes represented only a small excess number of women being given exemestane with clinically important worsening of QOL at one time or another; specifically, 8% more in the vasomotor domain and 4% more each in the sexual domain and for pain. No other between-group differences were observed. Overall, slightly more women in the exemestane arm (32%) than in the placebo arm (28%) discontinued assigned treatment. Conclusion: Exemestane given for prevention has limited negative impact on menopause-specific and health-related QOL in healthy postmenopausal women at risk for breast cancer.

AB - Purpose: Exemestane, a steroidal aromatase inhibitor, reduced invasive breast cancer incidence by 65% among 4,560 postmenopausal women randomly assigned to exemestane (25 mg per day) compared with placebo in the National Cancer Institute of Canada (NCIC) Clinical Trials Group MAP.3 (Mammary Prevention 3) trial, but effects on quality of life (QOL) were not fully described. Patients and Methods: Menopause-specific and health-related QOL were assessed by using the four Menopause-Specific Quality of Life Questionnaire (MENQOL) domains and the eight Medical Outcomes Study Short Form Health Survey (SF-36) scales at baseline, 6 months, and yearly thereafter. MENQOL questionnaire completion was high (88% to 98%) in both groups at each follow-up visit. Change scores for each MENQOL and SF-36 scale, calculated at each assessment time relative to baseline, were compared by using the Wilcoxon rank-sum test. Clinically important worsened QOL was defined as a MENQOL change score increase of more than 0.5 (of 8) points and an SF-36 change score decrease of more than 5 (of 100) points from baseline. Results: Exemestane had small negative effects on women's self-reported vasomotor symptoms, sexual symptoms, and pain, which occurred mainly in the first 6 months to 2 years after random assignment. However, these changes represented only a small excess number of women being given exemestane with clinically important worsening of QOL at one time or another; specifically, 8% more in the vasomotor domain and 4% more each in the sexual domain and for pain. No other between-group differences were observed. Overall, slightly more women in the exemestane arm (32%) than in the placebo arm (28%) discontinued assigned treatment. Conclusion: Exemestane given for prevention has limited negative impact on menopause-specific and health-related QOL in healthy postmenopausal women at risk for breast cancer.

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