2023-04-27 08:05:25
The drug fezolinetant is also effective in female breast cancer survivors on hormone withdrawal therapy, according to an international clinical trial
An international clinical trial in which the INCLIVA Health Research Institute of the Hospital ClÃnico de Valencia participates, has demonstrated the efficacy and safety of the drug fezolinetant against menopausal hot flashes and also in breast cancer survivors receiving hormone suppression treatment.
The finding of the SKYLIGHT 1 clinical trial, the results of which have been published in The Lancetis derived from international research on neurokinin 3 blockers to offer non-hormonal treatments for these vasomotor symptoms, according to a statement from the scientific institution.
Fezolinetat is a neurokinin 3 receptor blocker, a mediator that acts at the level of the hypothalamus to regulate the thermoregulatory center, which is affected by the loss of estrogen, with the consequent production of hot flashes.
At INCLIVA, the research is directed by Dr. Antonio Cano, coordinator of the Women’s Health Research Group at this institute and professor of Obstetrics and Gynecology at the University of Valencia (UV).
Menopause is associated with a symptom complex and increased susceptibility to diseases, such as osteoporosis, which also suffer from groups of women prior to menopause. Among them, the survivors of breast cancer stand out, who after overcoming the disease frequently receive hormone cancellation treatment for years.
Among these symptoms, the hot flushes constitute one of the most prevalent and with the greatest negative impact on work activity and on quality of life in general, according to the sources, which indicate that population studies have shown that they are perceived up to 80% women and, in around 25%, They are frequent and severe.
The INCLIVA Women’s Health Research Group has been investigating osteoporosis in women cancer survivors for several years, with the aim of improving their quality of life and health in the face of this pathology.
In this context, he is participating in international research on new neurokinin 3 receptor blocking products, which has now demonstrated the efficacy and safety of fezolinetant.
Neurokinin 3 is a small protein that acts as a stimulant for neurons, the cells of the central nervous system. At the brain level, in a region known as the hypothalamus, its production is regulated by estrogens, the female ovarian hormones.
Added suffering with breast cancer
When the ovary stops working, there is an overproduction of neurokinin 3, which excites the neurons responsible for maintaining temperature control. The result is the sudden sensation of heat, which can appear with more or less frequency or intensity, and which, in some women, interferes with sleep, work productivity and other activities of daily life.
In women where this problem is particularly acute, such as those subjected to intense ovarian deprivation due to diseases such as breast cancer, the series of hot flashes, frequent and intense in some cases, becomes a determinant of suffering added to that of the disease.
He The most effective treatment known to date is estrogen supplementation.but some women do not accept it, and, in cases such as breast cancer survivors, they cannot be given.
The Phase 3, randomized, double-blind, placebo-controlled trial lasted 12 weeks, with a 40-week active treatment extension, and took place at 97 facilities in the United States, Canada, the Czech Republic, Hungary, Poland, Spain and the United Kingdom.
Between July 11, 2019 and August 11, 2021, there had been initially recruited 2,205 women ages 40 to 65 with a diverse and representative profile of the potential target population for fezolinetant therapy.
Women with an average of seven or more moderate to severe hot flashes per day were randomly assigned to placebo, fezolinetant 30 mg, or fezolinetant 45 mg once daily, and the study results support clinical use of this drug as a nonhormonal treatment. for vasomotor symptoms associated with menopause.
The investigators believe that further characterization of fezolinetant’s benefit on quality of life, including mood symptoms and sexual well-being, requires further study.
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