92% of women at high risk of relapse live 5 years after diagnosis. Most patients can only be treated with hormone therapy after surgery
With over 55 thousand new cases estimated in 2021 in our country, breast cancer is the most frequent cancer not only in women, but in absolute terms. Genomic tests are used to choose the most appropriate treatment for the individual case: they are an extremely important tool in the life of all cancer patients and, in particular, also for about 10 thousand women with breast cancer who every year undergo unnecessary chemotherapy. To demonstrate again the usefulness of these tests a new study published in The New England Journal of Medicine and presented at the San Antonio Breast Cancer Symposium, the main international congress dedicated to this neoplasm. In Italy, to date, these exams have not yet been reimbursed uniformly throughout the national territory, despite the fact that a year has now passed since the establishment of the special national fund of 20 million euros, created precisely to give access to tests to all women who need it.
The results of the study
In some types of breast cancer patients, those postmenopausal with early stage cancer and positive lymph nodes at high risk of relapse, genomic tests allow to predict the risk of relapse and, therefore, to exclude chemotherapy in addition to hormone therapy after surgery, avoiding unnecessary toxicity. According to estimates, these tests can be prescribed to more or less one in five patients, for a total of over 10 thousand women who in our country alone could benefit each year from tests that are easy to perform and which, for the NHS, would be relatively inexpensive (if patients pay the cost of about 2 thousand euros out of their own pockets) and would save (for each non-prescribed chemotherapy) about 7 thousand euros. 92% of postmenopausal women treated, after surgery, with hormone therapy alone at 5 years, alive and free from invasive disease, with no significant differences compared to patients who also received chemotherapy (91.3%) after surgery . And that, with longer follow-up (on average after just over 6 years), postmenopausal women still do not benefit from chemotherapy after surgery.
Useful in women with early stage cancer
The study was independently conducted by the SWOG Cancer Research Network with support from the National Cancer Institute and involved 5,083 women with early stage (II-III) breast cancer, which expresses estrogen receptors but not the HER2 protein (ER + / HER2-), with involvement of axillary lymph nodes (one to three). RxPONDER’s goal was to better understand when to use adjuvant chemotherapy, that is, after surgery, to allow personalized treatment – explains Francesco Cognetti, president of the Together Against Cancer Foundation -. Patients underwent the Oncotype DX genomic test. The results of the study may change clinical practice and show conclusively that postmenopausal women with this common form of breast cancer and a Recurrence Score result, i.e. a genomic test score of 25 or less, can avoid chemotherapy and be treated only with hormone therapy, saving tens of thousands of patients worldwide from the side effects associated with chemotherapy. We must then consider both the savings for the health system and the indirect costs, linked to the lack of productivity resulting from debilitating treatments, and the infertility induced by chemotherapy in younger women.
Know better when to use chemotherapy
The clinical value of genomic tests was also confirmed by experiments conducted in Italy. In the PONDx study, carried out by Regina Elena of Rome on 1,738 patients with the participation of numerous Italian centers, in about 50% of cases the test made clinicians change the choice of adjuvant treatment, avoiding chemotherapy. with early stage hormone receptor positive, HER2-negative breast cancer, she has a disease that has spread to the lymph nodes and two out of three are in menopause – explains Saverio Cinieri, president of the Italian Association of Medical Oncology and director of Oncology Medica and Breast Unit of the Perrino Hospital in Brindisi -. Most today are treated with adjuvant chemotherapy, with an understandable prevalence of prudential attitudes. The results of RxPONDER can change this trend and mark a further step in favor of the 21-gene molecular test as a tool able to support the clinician in the personalization of therapy. In 2018, the TAILORx study had already analyzed the role of chemotherapy in patients without lymph node involvement, showing that, thanks to this genomic test, it is possible to identify the small number of women, about 20%, who benefit substantially from chemotherapy. , saving the vast majority, about 80%, from the toxicity and side effects associated with chemotherapy regimens.
Differences between pre and post menopause
With the RxPONDER and TAILORx studies, it is clear in a definitive and undeniable way who gets a benefit from chemotherapy among patients with early stage breast cancer, with or without lymph node involvement – underlines 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 -. RxPONDER showed that the vast majority of postmenopausal women can avoid chemotherapy and be treated only with hormone therapy. Conversely, the study showed that premenopausal breast cancer patients with the same characteristics should be treated with adjuvant chemotherapy. The invasive disease-free survival rate in premenopausal women improved by nearly 5%, from 89% with hormone therapy alone to 93.9% with the addition of chemotherapy. Genomic testing is recommended by leading guidelines. international, such as those of the European Society of Medical Oncology (Esmo) and the American Society of Clinical Oncology (Asco). Based on the results of the RxPONDER study – adds Curigliano, Chair of the ESMO Guideline Committee -, the National Comprehensive Cancer Network, an alliance of 21 centers of reference worldwide in cancer care, has updated the guidelines for breast cancer. and recognized the Oncotype DX test as the only one that can be used to predict the benefit of chemotherapy in patients with early breast cancer with positive axillary lymph nodes (1 to 3), including micrometastases. And the only one classified as “preferred” with the highest level of evidence for postmenopausal patients with negative lymph nodes and positive (1 to 3) lymph nodes.
Relapses up to 20 years after diagnosis
Additionally, the National Comprehensive Cancer Network recommends testing to determine the prognosis of node-positive premenopausal patients who are candidates for chemotherapy. In women with breast cancer, survival at 5 years from diagnosis reaches 87%, but it must be considered that recurrence for this type of neoplasm can occur up to more than 20 years from the initial diagnosis, especially in women with hormone receptor positive carcinoma : for this reason it is essential to be able to understand who is most in danger and to be able to better calibrate the treatment. In December 2020, the Budget Law established a Fund of 20 million euros for the free application of genomic tests throughout the territory – concludes Rosanna D ‘Antona, President of Europa Donna Italia -. In July 2021, the Minister of Health Roberto Speranza signed the implementing decree that released the 20 million euros included in the Fund. The regions have implemented the government decree, but only a few hospitals have begun to order the tests. Between regional tenders to be launched and further bureaucratic and administrative delays, there is a real risk of having to wait other months. It is no longer acceptable to further prolong the wait of patients. Together with the 170 Associations that are part of our network, we continue the monitoring and reminder action so that all women can count on therapeutic choices increasingly based on the evidence of personalized medicine, of which genomic tests represent a fundamental element.
December 20, 2021 (change December 20, 2021 | 16:10)
© REPRODUCTION RESERVED
#Breast #cancer #genomic #testing #avoids #unnecessary #chemotherapy