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


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.


CONCLUSIONS
Exemestane given for prevention has limited negative impact on menopause-specific and health-related QOL in healthy postmenopausal women at risk for breast cancer.
Elizabeth Maunsell, Centre de recherche du Centre hospitalier universitaire (CHU) de Québec, (Axe Oncologie), Québec; Pierre Dubé, Hôpital Maisonneuve-Rosemont, Montreal, QC; Andrew L. Cooke, CancerCare Manitoba, Winnipeg, MB; Silvana Spadafora, Algoma District Cancer Program, Sault Ste. Marie, ON; Lavina Lickley, Women's College Hospital; Angela M. Cheung, University Health Network, University of Toronto, Toronto; Dianne Johnston, Andrea Hiltz, Michael Brundage, Dongsheng Tu, and Harriet Richardson, National Cancer Institute of Canada Clinical Trials Group; Joseph Pater, Queens University, Kingston, ON; Susan L. Ellard, British Columbia Cancer Agency-Southern Interior, Kelowna; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, BC, Canada; Paul E. Goss, Massachusetts General Hospital, Boston, MA; Rowan T. Chlebowski, University of California at Los Angeles Medical Centre, Torrance, CA; James N. Ingle and Sandhya Pruthi, Mayo Clinic, Rochester, MN; José E. Alés Martínez, Hospital N. S. Sonsoles, Ávila; Amparao Ruiz, Instituto Valenciano de Oncologia, Valencia, Spain; Gloria E. Sarto, Center for Women's Health & Health Research, University of Wisconsin, Madison, WI; Carol J. Fabian, University of Kansas Medical Center, Kansas City, KS; Pascal Pujol, CHU-Hôpital Arnaud de Villeneuve, Montpellier, France; Susan Hendrix, Hutzel Women's Health Specialists, Detroit, MI; Debra W. Thayer, MedStar Health Research Institute, Hyattsville, MD; Kendrith M. Rowland, Carle Cancer Centre/Mills Breast Cancer Institute, Urbana, IL; and Jean Wactawski-Wende, State University of New York at Buffalo, Buffalo, NY.
Elizabeth
E
Maunsell
Paul E
PE
Goss
Rowan T
RT
Chlebowski
James N
JN
Ingle
José E
JE
Alés-Martínez
Gloria E
GE
Sarto
Carol J
CJ
Fabian
Pascal
P
Pujol
Amparao
A
Ruiz
Andrew L
AL
Cooke
Susan
S
Hendrix
Debra W
DW
Thayer
Kendrith M
KM
Rowland
Pierre
P
Dubé
Silvana
S
Spadafora
Sandhya
S
Pruthi
Lavina
L
Lickley
Susan L
SL
Ellard
Angela M
AM
Cheung
Jean
J
Wactawski-Wende
Karen A
KA
Gelmon
Dianne
D
Johnston
Andrea
A
Hiltz
Michael
M
Brundage
Joseph L
JL
Pater
Dongsheng
D
Tu
Harriet
H
Richardson
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000627:therapeutic use*; D047072:Aromatase Inhibitors / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D011788:Quality of Life; D011795:Surveys and Questionnaires
D000730:Androstadienes; D047072:Aromatase Inhibitors; C056516:exemestane