There are 8250 new cases of this very aggressive type every year in Italy. Molecular analysis allows to estimate the chances of survival and those of having a relapse, avoiding inappropriate treatments
HER2 positive breast cancer affects approximately every year 8 thousand Italians and represents 15-20 per cent of new diagnoses overall (more or less 55 thousand) of breast cancer in Italy. Positive HER2 protein is not good newsbecause it is a receptor that stimulates cell growth and division and that therefore makes the tumor more aggressive: in the past, as there were no weapons available, these patients had the worst prognosis. Today, however, thanks to targeted therapies that block the HER2 receptor, the clinical course has radically changed. Now also available a genomic test that allows to define the best treatment in patients with this type of neoplasm.
The benefits for patients
The test is called HER2DX and allows, on the basis of a specific score, to establish both the chances of survival (prognostic value) and, in women undergoing therapy before surgery (neoadjuvant), the probabilities of reaching the complete pathological response (predictive value), that is the complete disappearance of any cancer cell in the breast and lymph node. The potential benefits for patients are important, because the risk of over-administering treatments and the consequent toxicity or overly mild therapies, if the disease is aggressive, is excluded. On the other hand, savings for the health system are also evident by avoiding inappropriate treatment. The test was developed and patented jointly by the Universities of Padua and Barcelona and was studied on over a thousand people, as demonstrated by two studies published in The Lancet Oncology
e The Lancet eBioMedicine
which bear the signature of, among others Pierfranco Contepresident of the Periplo Foundation and professor of medical oncology at the University of Padua and of Valentina Guarneridirector of Oncology 2 at the Venetian Oncology Institute of Padua and full professor of Oncology at the University of Padua.
Many effective cures
In HER2 positive tumors the growth of tumor cells due to the stimulation of this receptor, which is present in overabundance, thus causing rapid and uncontrolled growth of diseased cells – explains Conte -. From the biological point of view one of the most aggressive forms, but today we have several effective treatments. The first anti-HER2 monoclonal antibody, which revolutionized the history of the disease, was trastuzumab, which were followed by numerous other therapies, for example monoclonal antibodies carrying very powerful cytotoxic drugs such as trastuzumab emtansine, or tyrosine inhibitors or chemotherapy drugs associated with anti HER2 molecules. The presence of numerous therapeutic alternatives it requires new tools to support clinicians in choosing the most effective therapy, avoiding over or under treatments.
Define the benefit of therapies
The traditional parameters used by oncologists to choose a cure are the size of the tumor, the state of the axillary lymph nodes and hormone receptors. These are very useful criteria, but they do not allow us to identify with sufficient precision some patients who risk receiving treatments that are higher or lower than necessary – says Conte -. The HER2DX genomic test therefore responds to a clinical need that is still unmet because, to date, there are no tools for define, in the HER2 positive forms, the benefit of targeted therapies and the risk of relapse. The test evaluates the activation status of 27 genes that regulate four metabolic pathways, fundamental for neoplastic growth: the expression of HER2, the endocrine stimulation pathway (role of hormones), that of cell proliferation (the genes that control the speed with which cancer cells divide) and the immunological pathway (the reaction of our immune system towards cancer cells). By analyzing this group of genes we have shown that thanks to the genomic test, in addition to the traditional parameters, it is possible to define not only the prognosis, that is the odds of survival without the presence of disease years after surgery, but also the probability that women undergoing preoperative medical therapy, ie neoadjuvant, will obtain the complete pathological response continues the expert.
Difficult cases to interpret
The test result can direct the clinician, for example, towards an extension of the adjuvant therapy, using more anti HER2 drugs after surgery. Or it can lead to a decrease in the intensity of care, with clear benefits in terms of toxicity avoided for patients and savings in resources for the system. And in patients for whom neoadjuvant therapy is indicated (especially recommended in HER2 positive tumors above 2 centimeters measured by mammography or ultrasound, or smaller in size but with palpable axillary lymph nodes in more advanced stages), the type of treatment systemic preoperative and possibly subsequent to surgery determined by the test result in terms of complete pathological response. Women who get it usually present a better prognosis, even if the risk of a recurrence of illness is not entirely excluded – concludes Conte -. Hence the importance of the prognostic value of the test which works in synergy with the predictive one and allows you to choose the best treatment even in these cases of difficult interpretation.
February 9, 2022 (change February 11, 2022 | 13:10)
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