In the Journals

Exemestane had limited negative effect on QOL for postmenopausal women at risk for breast cancer

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May 13, 2014

Exemestane was associated with small negative effects on menopause-specific and health-related quality of life in otherwise healthy postmenopausal women at high risk for breast cancer, but these effects did not affect overall health or social activities, study results showed.

Previous results of the randomized Mammary Prevention 3 trial, which included 4,560 postmenopausal women, suggested exemestane reduced invasive breast cancer incidence by 65% compared with placebo. However, the agent’s effect on quality of life was not well understood.

Elizabeth Maunsell, PhD, of the Hopital du Saint-Sacrement Research Centre in Quebec, and colleagues assessed menopause-specific and health-related quality of life. They performed the analysis using the four Menopause-Specific Quality of Life Questionnaire (MENQOL) domains and eight Medical Outcomes Study Short Form Health Survey (SF-36) scales at baseline, 6 months and each year thereafter.

Treatment with exemestane resulted in small negative effects on women’s self-reported vasomotor symptoms, sexual symptoms and pain — primarily in the first 6 months to 2 years after randomization — in women aged younger than 60 years.

A higher percentage of women assigned exemestane than placebo reported worsened vasomotor symptoms (55% vs. 47%; RR=1.17; P<.001), negative impacts on sexual domain (39% vs. 35%; RR=1.15; P=.04), and worsened pain (66% vs. 62%; RR=1.07; P=.01).

“Differences seen on other dimensions of menopause-specific or general health-related quality of life, including mental health, were smaller than those prospectively defined as being clinically meaningful,” Maunsell and colleagues wrote. “Thus, overall health-related quality of life, including women’s perceptions of their health and their usual work or social activities, even when these symptoms were present, was not negatively affected by exemestane use.”

A slightly higher percentage of women assigned exemestane (32% vs. 28%) discontinued treatment.

“Despite a small excess of early discontinuation in women receiving exemestane, the overall proportion of women who remained in the trial up until the final analysis — 68% taking exemestane and 72% taking placebo — indicates that our findings represent those from a majority of participants and supports good tolerance for exemestane use in a prevention setting,” the researchers wrote.

Disclosure:The researchers report consultant or advisory roles with Novartis and Pfizer; stock ownership in Pfizer; honoraria from Novartis, Pfizer and Sanofi-Aventis; and research funding from Pfizer.

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