Thanks to the innovation brought by precision oncology, it is now possible to postpone aggressive treatments such as chemotherapy in breast cancer. The identification of mutations in the gene responsible for the synthesis of the estrogen receptor (Esr-1), which determine its activity even without the link with estrogen, makes new targeted treatments possible for Er+ Her2- metastatic breast cancer. The new molecule elacestrant, the first orally active selective estrogen receptor degrader (Serd), reduces the risk of disease progression or death by 45% compared to ‘conventional’ endocrine therapy. The greatest benefits are for patients who present a mutation in the estrogen receptor gene (Esr1) and who have already received a first line of antihormonal therapy.
“A very interesting result for a group of patients who present a new therapeutic need, determined by the emergence of a new mechanism of resistance to antihormonal therapy. We hope that the therapy will soon become available in Italy to represent a further treatment option. It represents a great innovation since, at the moment, there are no alternative treatments able to delay or limit the use of chemotherapy in patients whose disease is progressing after treatment with cyclin-dependent kinase inhibitors and hormone therapy”. This was stated today by the president of the Foundation for Personalized Medicine (Fmp) Paolo Marchetti, in Rome during a press conference held thanks to the unconditional contribution of Menarini Stemline.
“Breast cancer is extremely complex and is classified into different histological subtypes, making a personalized approach necessary,” comments Marchetti. “In such a varied clinical-pathological picture, the neoplasia can present a highly variable clinical course. In particular, due to the introduction of new active treatments, we are observing the appearance of resistance mechanisms that were not previously evident. Chemotherapy, although often an essential treatment after cyclins, nevertheless presents side effects that patients suffer greatly. In this context, elacestrant comes into play, which has demonstrated superior efficacy compared to the current standard of care in patients who are not only hormone-resistant, but also cyclin-resistant.”
“The peculiarities of the therapy are also represented by the high tolerability and ease of administration – adds Giuseppe Curigliano, director of the New Drug Development Division at the European Institute of Oncology in Milan and professor of Medical Oncology at the University of Milan – Elacestrant is, in fact, the first oral selective degrader of the alpha estrogen receptor (Er-a) and carries out an activity against mutations of the Esr1 gene. These represent a fairly common resistance mechanism after prolonged treatments with conventional antihormonal therapies in Er-positive breast tumors and the acquisition of mutations has a strongly unfavorable impact in terms of both progression-free and overall survival. The fewer side effects and the daily oral intake of elacestrant are two elements that favor therapeutic adherence and contribute to maintaining quality of life”.
“There are more than 2,200 women in Italy alone who could benefit from the new treatment with elacestrant every year – says Saverio Cinieri, president of the Aiom Foundation – Italian Association of Medical Oncology – It is possible that there is a tendency to increase this already significant number. In fact, Esr1 mutations, which represent the molecular target of the molecule, can reach 40% of cases of Er+, Her2- breast cancer. To identify potential patients, for some years now, specialists have had at their disposal not only tissue biopsy, but, as an important innovation, also liquid biopsy. This is a blood test that evaluates circulating tumor DNA and is a useful test for both diagnostic and prognostic purposes. Furthermore, it can also provide information on the possible response to further oncological treatments with molecular-targeted therapies”.
The test “has great advantages and important potential not only for the entire national health system, but also for the individual patient – underlines Antonella Iadanza, Patient Advocate of Fondazione IncontraDonna – In particular, the low invasiveness of the test and the precision in improving the selection of therapies by specialists are appreciated. It is therefore essential that everyone, including institutions, understand the importance of ensuring that all patients have access to the best therapy, in terms of efficacy, but also quality of life. IncontraDonna, which has always been very active in the field of metastatic breast cancer, therefore confirms its commitment to equity of care and the right to health. The test is used not only for breast cancer, but also for colorectal cancer, melanoma and lung cancer. For these reasons, the use of liquid biopsy must be encouraged and supported in all healthcare facilities on our Peninsula”.
Elacestrant has already been approved by the US FDA and European regulatory bodies, the EMA, a note reports. “It is the only therapeutic solution recommended in the subgroup of patients resistant to cyclins with ESR1 mutations – highlights Marchetti – In particular, in those in whom progression is observed with previous therapies, but who do not obtain optimal results from the administration of currently available drugs. The treatment is innovative because in the luminal Her2-negative population that has the greatest therapeutic need due to ESR1 mutations, it is the first oral Serd that has demonstrated efficacy in cyclin-resistant patients, the first that can be prescribed on a liquid biopsy test and not on the more invasive tissue biopsies”.
“Elacestrant – concludes the Fmp president – responds to a therapeutic need that was not known before the introduction of treatments with antihormonal agents associated with cyclin-dependent kinase inhibitors and presents an added therapeutic value compared to therapies already available. We therefore trust that the Italian Medicines Agency will also recognize these innovations and that the therapy will be made reimbursable in our country as soon as possible”.
#Breast #Cancer #Chemotherapy #Precision #Oncology
