Breast cancer: “genomic tests are guaranteed to everyone”

Genomic tests that identify women with breast cancer who can avoid chemotherapy after surgery should be included in the list of services that the national health service is required to provide to all citizens, the so-called Lea. “The provision would represent a way to encourage its use and personalized medicine in the treatment of the most frequent neoplasm in Italy. Every year more than 55,000 women fall ill with breast cancer and 10,000 of these are entitled to reimbursement of the test”, underlined Saverio Cinieri, president of the Italian Medical Oncology Association, from Chicago where the congress of the American Society of Clinical Oncology.

Almost two years after the implementing decree of the 20 million euro Fund for the purchase of genomic tests for breast cancer, specialists are now asking for a qualitative leap: really spreading the tests in all Regions and increasing the number of patients candidates to reduce the use of chemotherapy whenever possible. “To quantify the patient setting we were based on experiences prior to 2020 – continues Cinieri -. After almost three years of work, across the peninsula, we can believe that the potential number of women to be tested is higher. It should not be forgotten that Italy has arrived decidedly late in the regular use of genomic tests. The latter then also allow important economic benefits to the health sector. They allow savings for not purchasing chemotherapy drugs and for hospitalizations avoided. For all these reasons, we ask for inclusion in the LEA as soon as possible”.

Studies presented in Chicago

Nine-year data on 10,000 patients with invasive lobular breast cancer and 65,000 with invasive ductal carcinoma tested with Oncotype DX are presented at the Chicago Congress. The study confirmed the potential of the test designed to predict the likelihood of recurrence and the benefit of chemotherapy in patients with early stage disease. The analysis carried out shows that high “recurrence score” results correspond to high rates of use of chemotherapy and to the risk of specific mortality due to breast cancer. “These correlations were then found to be independent of whether or not lymph nodes were involved. According to the previous RxPONDER study, this applies to women after menopause, while for the younger ones, in the majority of cases, the indication for chemotherapy remains”, explains Francesco Cognetti, president of the Confederation of Oncologists, Cardiologists and Haematologists (FOCE). “Our goal is always to avoid the administration of useless chemotherapy drugs with savings for the individual patient and the entire national health system”.

The new frontiers in the molecular diagnosis of early breast cancer are then represented by the role of molecular markers related to hormonal transcription and the tumor microenvironment which favors the processes of metastatic dissemination. Another field of great perspective is the role of molecular biomarkers found in blood: circulating tumor cells and circulating DNA (or ctDNA). The prognostic role of these two elements is consolidated but there is not yet a clinical utility that allows us to guide imaging and therapeutic decisions.
“A growing number of women can benefit from the use of genomic tests – concludes Cinieri -. At the same time, Italian clinicians now have a new and effective tool that can assist them in making the most appropriate therapeutic choice. Predicting the risk of tumor recurrence through the analysis of certain genes within tumor cells is a reality demonstrated by numerous scientific studies conducted all over the world”.