1. Exemestane given for prevention of breast cancer in post-menopausal women has limited negative effects on menopause-specific and health-related quality of life.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Exemestane, a steroidal aromatase inhibitor, was shown in the Mammary Prevention 3 (MAP.3) trial to reduce the risk of breast cancer among post-menopausal women when given prophylactically. The purpose of this follow-up study was to examine the effects of this regimen on quality of life among the patients during this trial. After collecting survey responses on both menopause-specific and overall quality of life measures from patients in both the exemestane and placebo arms, the authors found that differences were minimal. There were small negative effects on vasomotor and sexual symptoms and pain among women treated with exemestane. However, most of this difference was attributed to a small number of women in the treatment arm with clinically important declines in quality of life. Treatment discontinuation rates were also similar between the exemestane and placebo groups. It should be noted that, while these results are supported by high survey response rates and the randomized, controlled design of the original trial, these surveys were a secondary outcome.
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In-Depth [prospective randomized controlled trial]: The MAP.3 study was a randomized, placebo-controlled trial that enrolled a total of 4560 post-menopausal women assigned to either exemestane or placebo. In order to evaluate effects on quality of life, the study authorsused the four Menopause-Specific Quality of Life Questionnaire (MENQOL) domains and the eight Medical Outcomes Study Short Form Health Survey (SF-36). Responses were collected at baseline, then at 6 months, then annually. MENQOL response rates were high in both groups, ranging from 88% to 98%. At the conclusion of the trial, the authors found only small negative effects on self-reported vasomotor or sexual symptoms or pain. Most of these effects were attributed to a small number of patients in the exemestane arm with clinically important decline in quality of life. No other significant differences were found between the treatment and placebo arms. Overall, 32% of women in the exemestane arm and 28% of women in the placebo arm discontinued treatment.
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