Elizabeth Maunsell1, 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-Wende, Karen A Gelmon, Dianne Johnston, Andrea Hiltz, Michael Brundage, Joseph L Pater, Dongsheng Tu, Harriet Richardson. 1. 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.
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 placeboin 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.
RCT Entities:
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.
Authors: Paul E Goss; James N Ingle; José E Alés-Martínez; Angela M Cheung; Rowan T Chlebowski; Jean Wactawski-Wende; Anne McTiernan; John Robbins; Karen C 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 Journal: N Engl J Med Date: 2011-06-04 Impact factor: 91.245
Authors: Angela M Cheung; Lianne Tile; Savannah Cardew; Sandhya Pruthi; John Robbins; George Tomlinson; Moira K Kapral; Sundeep Khosla; Sharmila Majumdar; Marta Erlandson; Judy Scher; Hanxian Hu; Alice Demaras; Lavina Lickley; Louise Bordeleau; Christine Elser; James Ingle; Harriet Richardson; Paul E Goss Journal: Lancet Oncol Date: 2012-02-07 Impact factor: 41.316
Authors: Erika A Waters; Timothy S McNeel; Worta McCaskill Stevens; Andrew N Freedman Journal: Breast Cancer Res Treat Date: 2012-05-24 Impact factor: 4.872
Authors: J R Hilditch; J Lewis; A Peter; B van Maris; A Ross; E Franssen; G H Guyatt; P G Norton; E Dunn Journal: Maturitas Date: 1996-07 Impact factor: 4.342
Authors: Kala Visvanathan; Rowan T Chlebowski; Patricia Hurley; Nananda F Col; Mary Ropka; Deborah Collyar; Monica Morrow; Carolyn Runowicz; Kathleen I Pritchard; Karen Hagerty; Banu Arun; Judy Garber; Victor G Vogel; James L Wade; Powel Brown; Jack Cuzick; Barnett S Kramer; Scott M Lippman Journal: J Clin Oncol Date: 2009-05-26 Impact factor: 44.544
Authors: Vikki Ho; Romain Pasquet; Shaman Luo; Gang Chen; Paul Goss; Dongsheng Tu; Philip Lazarus; Harriet Richardson Journal: Breast Cancer Res Treat Date: 2020-08-01 Impact factor: 4.872
Authors: Jürg Bernhard; Weixiu Luo; Karin Ribi; Marco Colleoni; Harold J Burstein; Carlo Tondini; Graziella Pinotti; Simon Spazzapan; Thomas Ruhstaller; Fabio Puglisi; Lorenzo Pavesi; Vani Parmar; Meredith M Regan; Olivia Pagani; Gini F Fleming; Prudence A Francis; Karen N Price; Alan S Coates; Richard D Gelber; Aron Goldhirsch; Barbara A Walley Journal: Lancet Oncol Date: 2015-06-16 Impact factor: 41.316
Authors: Julie Lemieux; Michael D Brundage; Wendy R Parulekar; Paul E Goss; James N Ingle; Kathleen I Pritchard; Paul Celano; Hyman Muss; Julie Gralow; Kathrin Strasser-Weippl; Kate Whelan; Dongsheng Tu; Timothy J Whelan Journal: J Clin Oncol Date: 2018-01-12 Impact factor: 44.544
Authors: Karin Ribi; Weixiu Luo; Jürg Bernhard; Prudence A Francis; Harold J Burstein; Eva Ciruelos; Meritxell Bellet; Lorenzo Pavesi; Ana Lluch; Marilena Visini; Vani Parmar; Carlo Tondini; Pierre Kerbrat; Antonia Perelló; Patrick Neven; Roberto Torres; Davide Lombardi; Fabio Puglisi; Per Karlsson; Thomas Ruhstaller; Marco Colleoni; Alan S Coates; Aron Goldhirsch; Karen N Price; Richard D Gelber; Meredith M Regan; Gini F Fleming Journal: J Clin Oncol Date: 2016-03-28 Impact factor: 44.544
Authors: Ana Maria López; Sandhya Pruthi; Judy C Boughey; Marjorie Perloff; Chiu-Hsieh Hsu; Julie E Lang; Michele Ley; Denise Frank; Josephine A Taverna; H-H Sherry Chow Journal: Cancer Prev Res (Phila) Date: 2015-12-14
Authors: J E Alés-Martínez; A Ruiz; J I Chacón; A Lluch Hernández; M Ramos; O Córdoba; E Aguirre; A Barnadas; C Jara; S González; A Plazaola; J Florián; R Andrés; P Sánchez Rovira; A Frau Journal: Clin Transl Oncol Date: 2014-12-02 Impact factor: 3.405