TY - JOUR
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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U2 - 10.1200/JCO.2013.51.2483
DO - 10.1200/JCO.2013.51.2483
M3 - Article
C2 - 24711552
AN - SCOPUS:84902976096
SN - 0732-183X
VL - 32
SP - 1427
EP - 1436
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 14
ER -