In order not to waste time, it is important to guarantee the simultaneous availability of innovative molecules and analyzes in Italy to identify the molecular alterations necessary to understand in whom the treatment is useful or not.
Know the DNA mutations present in a patient’s cancer, the molecular characteristics of the single tumor, fundamental today to guide therapeutic choices: the target therapy, in fact, they can only be used if the presence of cancer cells (or, in some cases, in the blood or other biological samples taken from the patient) specific markers. And it is estimated that about 25% of patients can receive targeted therapy thanks to genomic analyzes that discover molecular alterations. There are some critical issues in Italy to overcome. If, in fact, the national network of high-tech laboratories capable of identifying the characteristics that can affect the choice of the best therapy in the individual patient is now a consolidated reality (albeit with few centers in the South), a bureaucratic question remains to be resolved that causes important delays for the sick: approval of a new drug and corresponding test (which investigates the mutation against which the medicine is directed and therefore essential to understand whether or not to prescribe it to a certain patient).
To approve the new drug and its test together
Biomarkers are the set of genetic-molecular characteristics of tumors, necessary to define personalized therapy – he explains Saverio Cinieri, director of the Medical Oncology and Breast Unit of the Perrino Hospital in Brindisi and elected president of the Italian Association of Medical Oncology (Aiom) -. National and international guidelines suggest that, in tumors for which molecularly targeted drugs are available, the determination of biomarkers should be performed simultaneously with the histological evaluation of the disease, to provide the clinician with all the information necessary for choosing the best therapy. Unlike what happens in the United States, where the regulatory body (FDA) simultaneously approves the molecularly targeted drugs and the tests necessary to identify the corresponding biomarker, the European regulatory agency (Ema) responsible only for the approval of drugs. At both European and national level, drug / test approval by biomarker is disjoint, creating a potential paradoxical situation in which, the availability of the drug, does not correspond to the simultaneous approval of the biomarker, consequently limiting access to new therapies. It is also important to guarantee the simultaneous availability of drugs and tests for cancer patients in Italy; without ever abandoning the principle of appropriateness. in this context, the AZFastNet diagnostic platform was created (by the pharmaceutical company AstraZeneca), with the aim of making access to molecular diagnosis tests easier and more widespread and promoting a multidisciplinary approach to cancer prevention and treatment. Through this application, cancer centers can come into contact with highly qualified diagnostic laboratories to request in a simple and direct way the tests to determine the mutational status of the BRCA1 / BRCA2 genes (for breast and ovarian cancer) and EGFR (for lung cancer).
The example of breast cancer
With about 55 thousand new diagnoses in Italy in 2020 Breast cancer is the most frequent in the female population. Today 87% of women affected by this neoplasm live at 5 years, a very important result obtained also thanks to research, even if, for some subgroups, there is still a strong clinical need – says Cinieri -. The mutation of the BRCA genes determines the choice of therapy. Olaparib, progenitor of the class of PARP inhibitors, acts by inducing further damage to the DNA that cannot be repaired, due to the mutation, to enhance the effectiveness of the treatments. approved in Italy in the first-line maintenance treatment of ovarian cancer and in the treatment of triple negative metastatic breast cancer with the genetic mutation. As in lung cancer, also in breast cancer anticipating therapy increases the chances of recovery. Innovative weapons are emerging such as trastuzumab deruxtecan, a new conjugated antibody, that is, a molecule that arises from the union of a monoclonal antibody (trastuzumab) with chemotherapy (deruxtecan) – continues the expert -. It is about a very powerful molecular target therapy, which is able to carry 8 chemotherapy molecules for each antibody, acting not only on the tumor cell that constitutes the target, but also on the neighboring ones. In a study recently presented at the European Congress of Medical Oncology (ESMO), trastuzumab deruxtecan reduced the risk of disease progression by 72% in previously treated HER2 positive metastatic cancer with a disease control rate of 97% – a never-seen-before benefit. first in this patient population.
Targeted therapies for chronic lymphocytic leukemia
Another example of the usefulness of precision medicine chronic lymphocytic leukemia. Every year this blood cancer causes about 3,400 new diagnoses to be registered in Italy – he says Paolo Ghia, director of the strategic research program on chronic lymphatic leukemia at the IRCCS San Raffaele Hospital in Milan and full professor of medical oncology at the Vita-Salute San Raffaele University -. Enlarged lymph nodes, anemia, thrombocytopenia with fever and feeling of fatigue are manifestations of the disease. One of the major obstacles to treating these patients, who are typically diagnosed after age 70 and often have one or more comorbidities, find effective and tolerated treatment options for long-term disease management, without having to interrupt the therapeutic path. Acalabrutinib, a BTK inhibitor, showed a significant benefit in terms of efficacy and long-term tolerability, both in first-line treatment and in relapsed or refractory disease.
October 27, 2021 (change October 27, 2021 | 19:22)
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