Every year in Italy about 10 thousand women affected by early stage breast cancer can benefit from genomic testing. These tests make it possible to establish in which cases chemotherapy in addition to hormone therapy is really necessary after surgery and in which, on the other hand, hormone therapy is sufficient, thus avoiding unnecessary toxicity. The gratuitousness of genomic tests throughout the territory is the very important result of a battle for which the Italian Association of Medical Oncology (AIOM) and patient associations have spent in recent months and which ended with the recent signing of the implementing decree by the Minister of Health Roberto Speranza, which released the Fund of 20 million euros for these molecular analyzes. Now it is necessary that the Regions immediately issue the measures required for the disbursement of the loan. A webinar aimed at patients and organized by the scientific society, with the support of Exact Sciences, is dedicated today to the perspectives opened by the provision.
“The signing of the implementing decree in a few months is truly an excellent result, achieved thanks to teamwork – he explains Giordano Beretta, President of AIOM -. The introduction of genomic tests in the clinical pathway of breast cancer patients represents a virtuous example of synergy between institutions, patients and the scientific community. These tests are recommended by the AIOM guidelines and by the most important international guidelines for women with early stage breast cancer that express estrogen receptors but not the HER2 protein. The objective of our scientific society is to continue to collaborate with the institutions and with all the actors involved in the exclusive interest of patients “.
“In 2020, almost 55,000 new cases of breast cancer were estimated in Italy – he says Saverio Cinieri, President-elect AIOM -. The incidence is growing, also due to the spread of mammography screening which allows to identify the disease at an early stage when the chances of recovery are very high. In our country, in fact, the 5-year survival rate, equal to 87%, is among the highest in Europe. In some women, the benefit of adding adjuvant, i.e. post-surgery, chemotherapy to hormone therapy may be controversial. Genomic tests, which are part of precision oncology, represent an important tool for the clinician to personalize the therapy according to the needs of each patient “.
Until now, in Italy, the free of charge genomic tests was established only in Lombardy, Tuscany and in the Autonomous Province of Bolzano. “The signing of the implementing decree by the Minister guarantees the reimbursement of the tests throughout the territory and allows to remedy a delay of at least a decade compared to the practices adopted in other European countries, such as Germany, United Kingdom, Spain and Greece – underlines Francesco Cognetti, President of the Together Against Cancer Foundation and of FOCE (ConFederation of Oncologists, Cardiologists, Hematologists) -. About 20% of women affected by breast cancer, equal to more than 10 thousand patients every year in Italy, can be subjected to genomic tests because they have luminal disease, that is, it expresses estrogen receptors but not the HER2 protein, and is considered at intermediate risk of relapse. Up to now, in these cases, an understandable prevalence of prudential attitudes in which chemotherapy was generally recommended has prevailed on the part of clinicians. In particular, a 21-gene genomic test can identify patients who are more or less likely to benefit from adjuvant chemotherapy or hormone therapy alone. In the PONDx study, carried out by Regina Elena of Rome on 1,738 patients, more than a third avoided chemotherapy which, without this test, would have been practiced ”.
“To teamwork, to take up the words of Doctor Beretta, who made it possible to obtain this decree, our Movement has contributed with an intense awareness campaign, conducted on our web and social channels, which has collected over 15 thousand signatures of patients, caregivers, clinicians and ordinary citizens – he says Rosanna D’Antona, President of Europa Donna Italia -. The issue of free access to genomic tests to avoid unnecessary chemotherapy patients has been busy for years, and we are aware that it cannot stop now. In fact, we are ready to continue, together with the 170 Associations that are part of our network, our monitoring action and remind the Regions so that, in turn, they immediately issue the measures required by the Ministry for the disbursement of the loan. ” In fact, the deadline for the transmission to the Ministry of Health of the regional resolutions is 60 days and expires on 7 September, which will have to report the methods of prescription, execution and use, monitoring, verifications and controls of the tests. In the following 60 days, the Coordination Committee assesses the compliance of the Resolutions with the implementing Decree. And November 7 is the deadline for the disbursement to the Regions of 50% of the funding for 2021. The remaining 50% will be disbursed by March 31, 2022, after the evaluation by the Ministry of Final Regional Relations which must contain the number , the type and costs of the tests carried out in 2021.
“Experience in numerous clinical trials and in several tens of thousands of patients shows that genomic tests help define the appropriate therapy and allow many women to avoid chemotherapy – conclude Adriana Bonifacino, President of IncontraDonna onlus -. The clinical value of these tests was also confirmed by experiments conducted in Italy. The sharp decrease in the misuse of chemotherapy can translate, on the one hand, into a clinical benefit for patients who are no longer exposed to over-treatment and the related risk of immediate and late toxicity, and on the other hand in a favorable impact. on health expenditure, which represents a fundamental element for the sustainability of the system. In fact, the exam costs 2 thousand euros, a course of chemotherapy ranges from 7 to 8 thousand euros “.