Almost 92% of postmenopausal women treated with hormone therapy alone after surgery are alive and free from invasive disease at 5 years, with no significant differences compared to patients who also received chemotherapy (91.3%) after surgery. This is the good news that comes from the “San Antonio Breast Cancer Symposium”, the most important international congress dedicated to this neoplasm, which closes today. The data are those of the RxPONDER study, published a few days ago in the prestigious scientific journal “The New England Journal of Medicine” and which demonstrate how the 21-gene molecular test allows to avoid unnecessary chemotherapy in postmenopausal women with early stage breast cancer and positive lymph nodes at high risk of recurrence.
Breast cancer and genomic testing: associations urge regions
I study
Updated data from RxPONDER, presented in San Antonio, demonstrate that postmenopausal women continue to not benefit from chemotherapy after surgery at longer follow-up (median of 6.1 years). The study was conducted independently by the SWOG Cancer Research Network with support from the National Cancer Institute (NCI) and involved 5,083 women with early stage (II-III) breast cancer, which expresses estrogen receptors but not the protein. HER2 (ER + / HER2-), with involvement of axillary lymph nodes (one to three).
Breast cancer, Emilia-Romagna makes genomic tests available
Results that change the quality of life
“The goal of RxPONDER was to better understand when to use adjuvant chemotherapy, ie after surgery, to allow for personalized treatment – he says. Francesco Cognetti, president of the Together Against Cancer Foundation. Patients underwent the Oncotype DX genomic test. These results can 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 with hormone therapy alone, saving tens of thousands of patients worldwide from the side effects associated with chemotherapy. The impact on the quality of life is enormous, because unnecessary toxicities are avoided ”.
Random 2021
Breast cancer, genomic tests: in 5 regions the patients forced to pay for themselves
by Irma D’Aria
The role of genomic tests
In 2020, about 55,000 new cases of breast cancer were estimated in Italy and 834,200 people live after diagnosis. “Genomic tests – he explains Saverio Cinieri, president of Aiom (Italian Association of Medical Oncology) and director of the Medical Oncology and Breast Unit of the ‘Perrino’ Hospital in Brindisi – represent a tool that adds to the therapeutic weapons available to oncologists, to decide whether a patient should adjuvant chemotherapy may or may not be administered in addition to standard hormone therapy “.
Genomic tests, the example of Emilia-Romagna: hospitals buy them first and then the region reimburses them
by Irma D’Aria
Towards the personalization of therapy
About one-third of patients with hormone receptor-positive, HER2-negative early stage breast cancer have disease that has spread to the lymph nodes, and two out of three are in menopause. “Most – continues Cinieri – 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, demonstrating 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%, the toxicity and side effects associated with chemotherapy regimens “.
Who needs adjuvant chemotherapy and who can do without it
In short, the RxPONDER and TAILORx studies clarify who benefits from chemotherapy among patients with early stage breast cancer, with or without lymph node involvement. “RxPONDER – 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 – showed that the vast majority of postmenopausal women can avoid chemotherapy and be treated only with therapy hormonal. 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 has improved by nearly 5%, going from 89% with hormone therapy alone to 93.9% by adding chemotherapy “.
New data on the relapse-free interval
Moreover, the data of a new analysis relating to the interval free from distant recurrence were presented at the San Antonio Congress. “The analysis – explains Curigliano – showed that premenopausal women, with a genomic test score equal to or less than 13, obtain a moderate absolute benefit, equal to 2.3%, from chemotherapy at 5 years. For premenopausal women with a genomic test score between 14 and 25, the benefit is 2.8% “.
What the Guidelines say
Genomic tests are recommended by the most important international guidelines, 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 – explains 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. The Oncotype DX test is the only one classified as ‘preferred’ with the highest level of evidence for node-negative and node-positive (1 to 3) postmenopausal patients. In addition, the National Comprehensive Cancer Network recommends the test to determine the prognosis of premenopausal patients with positive lymph nodes, candidates for chemotherapy ”.
The waiting of the patients
Is this genomic test so precious for the life of patients available for free in Italy? In December 2020, the Budget Law established a Fund of 20 million euros for the free application of genomic tests throughout the territory. Unfortunately, it was only in July 2021 that the Minister of Health Roberto Speranza signed the implementing decree that released the 20 million euros included in the Fund. Then the matter passed to the Regions that have implemented the government decree, but only a few hospitals have begun to order the tests. “Between regional tenders to start and further bureaucratic and administrative delays – he says Rosanna D’Antona, president of Europa Donna Italia – 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 “. But how many regions are there today in which these tests are already available? “Unfortunately they can be counted on the fingers of one hand”, denounces D’Antona who adds: “They are Lombardy, Veneto, Val d’Aosta, the province of Bolzano and Tuscany but only in some Breast Units. Not only: in Italy out of 180 Breast Units only 45% have access to funds and therefore to genomic tests but they are always concentrated in the areas of Northern Italy. What is absurd is that this delay is not due to lack of funds but only to bureaucracy and is unacceptable. “.
The direct and indirect economic benefits
How many women could benefit from these tests? “It is estimated that they can be prescribed to one in five patients”, replies Cognetti. “There are over 10 thousand women in our country who are candidates for these exams. The savings must also be considered, given that this exam costs about 2 thousand euros and a course of chemotherapy ranges from 7 to 8 thousand euros. Without forgetting the indirect costs, linked to the lack of productivity resulting from debilitating treatments, and the infertility induced by chemotherapy in younger women. 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 “.
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