title: Factors Associated With Early Discontinuation of Study Treatment in the Mammary Prevention.3 Breast Cancer Chemoprevention Trial.
abstract: Purpose Aromatase inhibitors are established breast cancer chemoprevention interventions. However, nonadherence remains a significant challenge. We investigated the association between worsening menopause-specific quality of life, baseline participant characteristics, and early treatment discontinuation within the Mammary Prevention.3 (MAP.3) breast cancer prevention trial. Methods In the MAP.3 randomized, placebo-controlled trial evaluating exemestane, participants completed the Menopause-Specific Quality of Life Questionnaire (MENQOL) at entry and at 6 months. Multivariable log-binomial regression was used to assess the associations of baseline participant characteristics and clinically meaningful worsening in menopause-specific quality of life (QOL) with treatment discontinuation at 1 year. Results Of the 4,501 participants eligible for this analysis, 724 (17%) discontinued assigned treatment within the first year of random assignment of treatment (19% of the exemestane group and 13% of the placebo group). Between 19% and 35% of women experienced a clinically meaningful worsening in the vasomotor, sexual, physical, and psychosocial domains of the MENQOL within 6 months of treatment initiation. Regardless of receiving exemestane or not, experiencing a worsening in any MENQOL domain or, especially, overall menopause-specific QOL, was associated with early treatment discontinuation (relative risk, 1.79; 95% CI, 1.53 to 2.10 for overall worsening). Assignment to exemestane, having a smoking history, and current employment also were significantly associated with early discontinuation. Conclusion Negative changes in menopause-specific QOL influence a woman's decision to stop chemoprevention therapy. Attention to such symptoms may improve QOL and potentially improve chemoprevention adherence.
authors.affiliation: Olivia Meggetto, Dongsheng Tu, and Harriet Richardson, Queen's University; Dongsheng Tu and Harriet Richardson, Canadian Cancer Trials Group, Kingston, Ontario; Elizabeth Maunsell, Centre de Recherche du Centre Hospitalier Universitaire de Québec, Québec City, Québec, Canada; Rowan Chlebowski, Harbor-University of California, Los Angeles, Medical Center, Torrance, CA; Paul Goss, Massachusetts General Hospital, Boston, MA.
authors.forename: Olivia
authors.initials: O
authors.lastname: Meggetto
authors.affiliation: Olivia Meggetto, Dongsheng Tu, and Harriet Richardson, Queen's University; Dongsheng Tu and Harriet Richardson, Canadian Cancer Trials Group, Kingston, Ontario; Elizabeth Maunsell, Centre de Recherche du Centre Hospitalier Universitaire de Québec, Québec City, Québec, Canada; Rowan Chlebowski, Harbor-University of California, Los Angeles, Medical Center, Torrance, CA; Paul Goss, Massachusetts General Hospital, Boston, MA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Maunsell
authors.affiliation: Olivia Meggetto, Dongsheng Tu, and Harriet Richardson, Queen's University; Dongsheng Tu and Harriet Richardson, Canadian Cancer Trials Group, Kingston, Ontario; Elizabeth Maunsell, Centre de Recherche du Centre Hospitalier Universitaire de Québec, Québec City, Québec, Canada; Rowan Chlebowski, Harbor-University of California, Los Angeles, Medical Center, Torrance, CA; Paul Goss, Massachusetts General Hospital, Boston, MA.
authors.forename: Rowan
authors.initials: R
authors.lastname: Chlebowski
authors.affiliation: Olivia Meggetto, Dongsheng Tu, and Harriet Richardson, Queen's University; Dongsheng Tu and Harriet Richardson, Canadian Cancer Trials Group, Kingston, Ontario; Elizabeth Maunsell, Centre de Recherche du Centre Hospitalier Universitaire de Québec, Québec City, Québec, Canada; Rowan Chlebowski, Harbor-University of California, Los Angeles, Medical Center, Torrance, CA; Paul Goss, Massachusetts General Hospital, Boston, MA.
authors.forename: Paul
authors.initials: P
authors.lastname: Goss
authors.affiliation: Olivia Meggetto, Dongsheng Tu, and Harriet Richardson, Queen's University; Dongsheng Tu and Harriet Richardson, Canadian Cancer Trials Group, Kingston, Ontario; Elizabeth Maunsell, Centre de Recherche du Centre Hospitalier Universitaire de Québec, Québec City, Québec, Canada; Rowan Chlebowski, Harbor-University of California, Los Angeles, Medical Center, Torrance, CA; Paul Goss, Massachusetts General Hospital, Boston, MA.
authors.forename: Dongsheng
authors.initials: D
authors.lastname: Tu
authors.affiliation: Olivia Meggetto, Dongsheng Tu, and Harriet Richardson, Queen's University; Dongsheng Tu and Harriet Richardson, Canadian Cancer Trials Group, Kingston, Ontario; Elizabeth Maunsell, Centre de Recherche du Centre Hospitalier Universitaire de Québec, Québec City, Québec, Canada; Rowan Chlebowski, Harbor-University of California, Los Angeles, Medical Center, Torrance, CA; Paul Goss, Massachusetts General Hospital, Boston, MA.
authors.forename: Harriet
authors.initials: H
authors.lastname: Richardson
mesh_terms: D000730:Androstadienes / Q000008:administration & dosage; D047072:Aromatase Inhibitors / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000517:prevention & control*; D018890:Chemoprevention / Q000379:methods; D005260:Female; D006801:Humans; D008593:Menopause / Q000502:physiology / Q000523:psychology; D008875:Middle Aged; D010349:Patient Compliance; D010352:Patient Dropouts; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D000730:Androstadienes; D047072:Aromatase Inhibitors; C056516:exemestane