Home » Breast cancer: “It is urgent to democratize access to genetic tests to avoid unnecessary chemotherapies”

Breast cancer: “It is urgent to democratize access to genetic tests to avoid unnecessary chemotherapies”

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Seventy international experts have expressed their ‘consensus’ on the fundamental role that genetic testing plays in avoiding chemotherapy when not needed for some women with breast cancer. A confirmation that comes from the St. Gallen International Breast Cancer Conference ‘which certifies every year the most relevant advances in the treatment of breast cancer. For this reason, once again the oncologists are launching an appeal asking that Italy also comply with the updated guidelines of the National Comprehensive Cancer Network.

The ‘consensus’ of the international experts of St. Gallen

Italy is at least a decade behind the practices adopted in other European countries, such as Germany, the United Kingdom, Spain and Greece, and the indications contained in the most important guidelines of scientific societies. In fact, the genomic tests that allow us to identify women for whom chemotherapy is useful are not yet available throughout our territory. Two recent international congresses have reiterated the essential role of genomic testing: “This year at the ‘St. Gallen International Breast Cancer Conference ‘the’ consensus’ of 70 international experts was placed on the fundamental role of genomic testing in avoiding chemotherapy in the majority of postmenopausal women with early stage breast cancer with positive lymph nodes “, explains Giuseppe Curigliano, professor of Medical Oncology at the University of Milan and director of the Development Division of New Drugs for Innovative Therapies at the European Institute of Oncology in Milan. “The impact on the quality of life is enormous, because unnecessary toxicity is spared. This is the addition of a further step in the definition of the most appropriate therapy, given that the group of experts of St. Gallen for ten years, in its guidelines, has been recommending these tests in hormone-sensitive early stage disease, without expression of the protein. HER2 and without involvement of the lymph nodes “.

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The ‘Sharing Progress in Cancer Care’ congress

The experts gathered in the international congress “Sharing Progress in Cancer Care”, which took place recently, also reached the same conclusions. “In Italy, in 2020, almost 55 thousand cases of breast cancer were estimated and 5-year survival reaches 87% – he says Francesco Cognetti, president of the Together Against Cancer Foundation and Director of Medical Oncology Regina Elena in Rome. “The goal of adjuvant treatment, that is, after surgery, is to offer every patient with early stage breast cancer the best possible cure. In these cases, after surgery, the therapy involves hormonal treatment, which can be associated with chemotherapy in cases deemed to be at greater risk of recurrence, for example in the presence of an involvement of the lymph nodes. About 25% of patients diagnosed with early-stage breast cancer, which expresses estrogen receptors but not the HER2 protein (ER + / HER2-), show involvement of the lymph nodes and two out of three women are postmenopausal. The great majority today are treated with chemotherapy, also due to an understandable prevalence of prudential attitudes on the part of clinicians ”.

The RxPonder study of postmenopausal women

The results of the international phase III RxPonder study provide an answer to doubts that cannot be resolved with traditional clinical pathological parameters. The study, conducted independently by the SWOG Cancer Research Network with support from the National Cancer Institute, involved 5,083 women with early stage (II-III) breast cancer, which expresses estrogen receptors but not the Her2 protein, involving axillary lymph nodes (one to three). About two-thirds were postmenopausal. “The patients were subjected to the genomic test of 21 Oncotype DX genes, able to establish, based on a specific score, how aggressive the tumor is and the response to chemotherapy – underlines Curigliano. Nearly 92% of postmenopausal women treated with hormone therapy alone were alive and free of invasive disease at 5 years, with no significant differences from patients who also received chemotherapy (91.6%) after surgery. These findings are changing clinical practice and show that the vast majority of postmenopausal women can avoid chemotherapy and be treated only with hormone therapy.

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The RxPonder study on premenopausal women

On the other hand, the conclusions for premenopausal women were different, in which a statistically significant benefit deriving from chemotherapy was observed, with a 3% improvement percentage in the 5-year distant relapse rate ”. “The scientific value of the RxPonder study – continues Curigliano – is such that the National Comprehensive Cancer Network (NCCN), an alliance of 21 centers of reference worldwide in the treatment of cancer, has updated the guidelines on breast cancer, recognizing Oncotype DX as the only predictive test capable of defining the benefit of chemotherapy in node-positive early stage breast cancer, even with micrometastases. In this way, the test is the only one classified as ‘preferred’ with high levels of evidence for both node-negative patients and postmenopausal women with node-positive ”.

Lo studio Tailorx

In 2018, the Tailorx study had already investigated the role of chemotherapy in patients without lymph node involvement. “With the RxPONDER and TAILORx studies, it is clear in a definitive and undeniable way who benefits from chemotherapy among patients with early stage breast cancer, with or without lymph node involvement – concludes Cognetti. Experience in numerous clinical trials and in some tens of thousands of patients shows that these tests help to define the most appropriate therapy and allow many women to avoid chemotherapy ”.

Where are we in Italy

The clinical value of genomic tests was also confirmed by trials conducted in Italy where women living after the diagnosis of breast cancer increased by 43% in ten years (from 581,373 in 2010 to 834,154 in 2020. The correct identification of women with breast cancer for which chemotherapy is appropriate remains a very important goal from a clinical, social and economic point of view. In fact, both the direct costs of chemotherapy and the indirect costs, linked to the lack of productivity resulting from debilitating treatments, must be considered. genomic tests are free only in Lombardy, Tuscany and in the Autonomous Province of Bolzano, which have approved reimbursement. The Budget Law 2021 has established a fund of 20 million euros for the purchase of genomic tests, which can standardize the access to these molecular tests throughout the national territory, but the implementing Decree of the Ministry of Health to unlock resources “.

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