In Veneto, one thousand of the 4,900 women diagnosed with breast cancer every year – could benefit from genomic tests, analyzes that make it possible to establish, case by case, whether chemotherapy can be avoided or not. But today this test is reserved only for those who can pay for it out of their own pockets. Although they are recommended by the most important international guidelines and used in the main European countries, in fact, genomic tests are free only in Lombardy, Tuscany and in the Autonomous Province of Bolzano, which have approved their reimbursement. To ensure uniformity in all Regions in accessing molecular analyzes, the implementing decree is needed to release the 20 million euro fund allocated by the Budget Law for the free application of genomic tests for breast cancer throughout Italy. The Italian Association of Medical Oncology (Aiom) has been asking for it for some time, which, during the third stage of the virtual tour to raise awareness among oncologists on the role of genomic tests in breast cancer, carried out with the unconditional support of Exact Sciences, met with representatives of Venetian oncologists.
Who are genomic tests for?
“In early stage and ‘intermediate’ risk ‘luminal’ breast cancer there is significant therapeutic uncertainty, because in international and national guidelines there are no binding indications on when it is possible to omit chemotherapy or when it is necessary to administer it” he explains Giuseppe Azzarello, Coordinator Aiom Veneto and Director of Oncology Hematology Oncology Unit, AULSS 3 Serenissima: “Genomic tests can support the oncologist in the personalization of therapies in some types of patients with early stage breast cancer. The implementation decree by the Ministry of Health is necessary to release the 20 million euros of the Fund – he concludes – because immediately guaranteeing access to genomic tests in all Regions is a battle of civilization ”.
The experience of Padua
Genomic tests are a useful tool for the physician, because they allow to predict the risk of relapse and, therefore, to exclude chemotherapy in addition to hormone therapy, avoiding unnecessary toxicity with saving of resources, when they are used appropriately. And at the Veneto Oncology Institute (IOV) in Padua, a system was set up to ensure it free of charge to the women who can benefit most: “Pending the implementing decree to release the 20 million euro Fund, we decided at the IOV to use part of the funds obtained from the for-profit trials to offer the test to patients with early stage breast cancer (with hormone receptor positive, HER2 negative and lymph node negative, ed.) who do not belong to either the low-risk or high-risk group risk, ”he explains Pierfranco Conte, Director of the Medical Oncology 2 Division of the institute and Technical Scientific Coordinator of the Venetian Oncological Network. To select the patients, a team of 9 experts dedicated to breast disease was set up, called upon to express their opinion on intermediate-risk patients. If there is high agreement (i.e. at least 7 votes in favor of adjuvant hormone therapy alone or at least 7 in favor of chemotherapy in addition to hormone therapy), it is not performed in genomic testing. If there is no such agreement, then the test is performed. Of the 239 patients observed from September 2020 to March 2021, 123 were agreed to be defined as low-risk and then treated with hormone therapy without resorting to the test, 29 at high-risk and then referred to adjuvant chemotherapy in addition to hormone therapy without the test. , and 87 at intermediate risk. “The discordant evaluation concerned only 14 intermediate-risk patients – continues Conte – who were referred for the test: in 9 cases, the analysis confirmed the prevailing indication set by the 9 oncologists, in 3 the test changed the indication prevalent therapeutic from hormone therapy alone to the addition of chemotherapy and in 2 from chemotherapy to hormone therapy alone “.
Chemo, country you go …
The use of chemotherapy in patients with positive hormone receptors has historically been highly variable in different countries, even before the availability of genomic tests. For example, it is much larger in the United States than in Europe. And in the Old Continent, Spain and France resort to chemotherapy more frequently than in Germany and England. “In Italy – explains the expert – we are witnessing a considerable territorial variability, even within the same region, because the use of chemotherapy is more widespread in centers that promote studies on adjuvant chemotherapy than those focused on hormonal therapy. This is why it is essential to include scientific evidence within Italian clinical practice “
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Studies on the Oncotype DX test in Veneto
To understand the real impact of genomic testing in Veneto, two studies were conducted in the context of the ROV, both published in ‘The Oncologist’, using the Oncotype DX genomic test. In the first study, BREAST-DX Italy published in 2017 on 369 patients (with hormone-responsive tumor, HER2 negative and up to 3 positive lymph nodes), the genomic test led to a modification of the initial recommendations of clinicians in 16% of cases, with a net reduction of the use of chemotherapy by 8%. In the second study, ROXANE, recently published, in 30% of cases there was a change in the therapy initially chosen by the clinician, with a net reduction in the use of chemotherapy equal to 16%. Definitely different data when compared with those of other European countries which estimated a decrease of about 30% in the use of chemotherapy with the test. “The impact of genomic tests – concludes Conte – must therefore be contextualized in Italian clinical practice. And extreme care is needed in always applying the criterion of appropriateness “.
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