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Worsening menopause-specific quality of life influences decision to end chemoprevention therapy
Negative changes in menopause-specific quality of life can influence a woman’s choice to end breast cancer chemoprevention therapy, according to study data published in the Journal of Clinical Oncology.
“In clinical trials, both selective estrogen-receptor modulators and aromatase inhibitors have been demonstrated to be efficacious chemoprevention agents for primary prevention in women at high risk for breast cancer,” Olivia Meggetto, MSc, senior research associate at Queen’s University in Ontario, Canada and colleagues wrote. “Nonetheless, chemoprevention is vastly underused in the clinical setting and many women who do begin chemoprevention are not fully adherent. Information on factors associated with aromatase-inhibitor nonadherence in the prevention setting is limited.”
The researchers performed a secondary analysis of the MAP.3 trial, a phase 3, international, randomized trial of 4,501 women receiving chemoprevention treatment. Meggetto and colleagues used multivariable log-binomial regression to evaluate the associations between patients’ baseline characteristics, negative changes to menopause-specific quality of life and discontinuation of treatment at 1 year.
The researchers randomly assigned patients to receive exemestane or placebo for five years.
Seventeen percent (n = 724) of women discontinued treatment within the first year (exemestane, 19% vs. placebo, 13%).
Within six months, 1,000 participants (24%) reported worsening menopause-specific quality of life: 35% saw worsening vasomotor quality of life, 19% had a decline in sexual quality of life, 28% had worsening physical quality of life and 27% had a decline in psychosocial quality of life.
Worsening menopause-specific quality of life was associated with early treatment discontinuation regardless of treatment group (RR = 1.79; 95% CI, 1.53-2.1). Other factors associated with early discontinuation were smoking history, assignment to exemestane and current employment.
Meggetto and colleagues acknowledged that the study was limited by its reliance on self-reported data.
“Although the efficacy of chemoprevention agents has been established, the benefits of chemoprevention as a primary prevention strategy in clinical practice for women at high risk for breast cancer will largely depend on the uptake of an adherence to these agents,” the researchers wrote. “This study addresses the extreme form of nonadherence, discontinuation, within the context of a clinical trial. Negative changes in menopause-specific quality of life influence a women’s decision to stop taking chemoprevention therapy. Attention to such symptoms may improve quality of life and potentially improve chemoprevention adherence.” – by Andy Polhamus
Disclosure: Meggetto reports no relevant financial disclosures. Please see the study for a full list of all other researchers’ relevant financial disclosures.
Perspective
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Making a decision to take a drug that may cause symptoms to reduce risk for a condition one is not certain to get is difficult. None of the standard drugs for breast cancer risk reduction have yet to show improved survival, which makes more difficult the decision to take a symptom-causing drug to reduce risk for a condition that is not certain.
Because all of the standard drugs for breast cancer risk reduction can precipitate or worsen menopausal symptoms, it is understandable that less than 5% of risk-eligible women agree to receive endocrine therapy, such as tamoxifen, or an aromatase inhibitor for primary prevention. However, women with a precancerous biopsy and at higher short-term risk have been reported to have much higher uptakes. Women who do not have menopausal symptoms would like to avoid them, and those who already have them, do not want to make them worse.
As was observed in the MAP.3 trial, if a medication is perceived to impact daily quality of life, it will frequently be discontinued — particularly if there is no objective evidence of benefit. Because menopause symptoms are common, the study drug a patient discontinues may be a placebo or endocrine therapy.
Greater efforts are needed to identify strategies for breast cancer risk reduction that do not result in symptoms of hormone deficiency. Adopting healthy behaviors — such as weight control, sufficient moderate- to vigorous-intensity physical activity, and alcohol avoidance — can reduce risk for breast cancer by 30% and probably should be the first line of defense in women at moderately increased risk. Efforts are underway to identify whether other commonly used prescription drugs, such as metformin, as well as anti-inflammatory over-the-counter medications, such as aspirin or natural product derivatives, are likely to reduce risk in previously unaffected individuals. We also need to identify and test affordable options that will relieve menopause symptoms, but will not increase risk for breast cancer, and might reduce it. Of interest is the combination of a selective estrogen receptor modulator with uterine antagonist effects and low-dose estrogen.