Over a year ago, the Minister of Health Roberto Speranza signed the implementing decree that released 20 million euros to reimburse genomic tests for women with early stage breast cancer, so that patients could access them for free. Yet, even today the situation in Italy appears patchy. Because? “The Regions have issued specific resolutions to make the Ministerial Implementation Decree operational, but not all of them are using the available resources, pending the conclusion of the calls for tenders and the unused funds will be lost”, replies Saverio Cinieri, Aiom National President (Italian Association of Medical Oncology), who spoke at the opening of the AIOM Youth National Congress, taking place today and tomorrow in San Martino in Campo (Perugia). A two-day event dedicated to multidisciplinarity and new challenges, where the importance of genomic tests is also discussed and where the first Aiom Giovani social campaign is launched, aimed precisely at making this new precision medicine tool known.
Cancer: personalized prevention and a new mutational model
by Irma D’Aria
What are genomic tests
Genomic tests are molecular analyzes that, in some types of patients, allow us to predict the risk of relapse and, therefore, to better evaluate the use of chemotherapy in addition to hormone therapy after surgery. In this way it is possible to avoid unnecessary toxicity in those who do not need chemotherapy and, at the same time, to save resources of the health system. “The goal of adjuvant treatment, that is, after surgery, is to offer every patient with early stage breast cancer the best chance of treatment, limiting the risk of relapse”, explains Massimo Di Maio, Aiom National Secretary: “The majority of cases of breast cancer is of the luminal type, that is, it expresses estrogen receptors and not the HER2 protein. After surgery, the systemic treatment of this tumor involves the use of hormone therapy in cases considered to be at low risk and the addition of chemotherapy in the presence of a high risk “. What to do, however, in ‘intermediate’ risk luminal breast cancer? “In this case – continues Di Maio – there is a significant therapeutic uncertainty, hence the importance of genomic profiling tests, which allow us to identify more precisely the patients who can benefit from chemotherapy after surgery”.
Aiom Giovani’s social campaign
In Italy, in six years (between 2015 and 2021), mortality from breast cancer decreased by almost 7% (6.8%). The numbers are very encouraging even if you look at how many patients live after the disease today: from 581,373 in 2010 to 834,154 in 2020, with an increase of 43% in ten years. And the 5-year survival reaches 88%. “However, too many patients with an early stage diagnosis are receiving chemotherapy without real need”, underlines Lorena Incorvaia, Coordinator of the AIOM Young Working Group. This is why the new social campaign, created with the unconditional support of Exact Sciences, will include live broadcasts, online surveys and educational videos to ‘make culture’ on genomic tests through social profiles. “For over 10 years, genomic tests have been part of the daily clinical practice of other European countries, such as Germany, the United Kingdom, Spain and Greece”, continues Incorvaia: “We must make up for lost time and our scientific society, with this project, we want engage at the forefront in the training of specialists under 40 “.
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Tests indicated for one in 5 patients
The most important guidelines of scientific societies recommend these molecular analyzes, which must be used in specific cases to be really effective. It is estimated that they can be prescribed to one in five patients: more than 10 thousand women in Italy, therefore, every year could benefit from relatively inexpensive and easy to perform tests, specifies the oncologist. “The exam with the highest level of scientific validation is the 21-gene genomic test Oncotype DX”, Cinieri resumes: “The ‘National Comprehensive Cancer Network’, an alliance of 21 centers of reference worldwide in the treatment of cancer , updated breast cancer guidelines, recognizing Oncotype DX as the only predictive test that can define the benefit of chemotherapy in node-positive early-stage breast cancer, even with micrometastases. This test is the only one classified as ‘preferred’, with high levels of evidence for both node-negative patients and postmenopausal women with node-positive. The recent update of the Guidelines of the American Society of Clinical Oncology goes in the same direction ”. The latest recommendations of the American Society of Clinical Oncology (ASCO) in fact provide that the Oncotype DX test, already indicated for patients with negative lymph nodes, is also used in postmenopausal women with up to three positive lymph nodes.
Breast cancer: the usefulness of genomic tests confirmed. Still little used in Italy
by Dario Rubino
“The clinical studies on Oncotype DX have definitively clarified who benefits from chemotherapy among patients with early stage breast cancer, with or without lymph node involvement,” says President Aiom: “The correct identification of these women 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 loss of productivity caused by debilitating treatments must be considered. Not administering unnecessary chemotherapy – concludes Cinieri – in addition to reducing patient anxieties and treatment disparities, it allows to eliminate suffering and inconvenience for thousands of women ”.