Today in Italy there are more than 40,000 people with metastatic breast cancer, a figure that is constantly increasing thanks to new therapies which, in many cases, make the disease chronic. 30% of these patients (the neoplasm can affect even a small percentage of men) are alive today 5 years after diagnosis. A very important result, achieved both thanks to new therapies and thanks to the multidisciplinary approach and the diagnostic-therapeutic care pathways within the Breast Units. A result, however, which can be further improved precisely by overcoming the obstacles still present in assistance and guaranteeing access to the most effective treatments in a short time. We talked about it with Antonio Russo (National Treasurer of the Italian Association of Medical Oncology, Full Professor of Medical Oncology, DICHIRONS Department – University of Palermo and President of COMU, College of University Medical Oncologists) and Vincenzo Adamo (Scientific Director Oncology AO Papardo di Messina and Coordinator of the Sicilian Oncological Network, Re.OS).
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Prof. Russo, what are the characteristics of metastatic breast cancer and what are the clinical needs of the patients?
“The scenario of metastatic disease has changed in recent years thanks to the availability of drugs that are able to control it over time. Innovative therapies are able to prolong survival, stabilize metastatic disease, decrease or delay the onset of symptoms, ensuring a good quality of life. And, in its course, the tumor can go through phases of growth, but also of remission, allowing you to lead an almost normal life. Targeted therapies have changed the story of metastatic breast cancer, resulting in many cases in a long life expectancy, much higher than in the past. However, there remains a strong clinical need for even more effective weapons for patients with HER2 positive metastatic breast cancer already treated with standard therapeutic options”.
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Prof. Adamo, in which types of breast cancer are targeted therapies used?
“In HER2 positive tumors, the growth of tumor cells is due to the stimulation of the HER2 receptor (human epidermal growth factor type 2), which also has the function of stimulating their growth and proliferation in healthy cells. In HER2 positive tumors this receptor is overexpressed, i.e. present in excess, thus causing rapid and uncontrolled growth of the diseased cells. This tumor biology accounts for approximately 20% of all breast cancers. From a biological point of view, it is one of the most aggressive forms and, in the past, as there were no drugs available, these patients had the worst prognosis. Today however, thanks to the presence of targeted therapies that specifically interfere by blocking the HER2 receptor and which are used both in the initial non-metastatic and in the metastatic forms, the clinical course has radically changed. In metastatic forms, anti-HER2 drugs, associated with chemotherapy or hormone therapy (the latter obviously only in cases in which hormone receptors are also present, ed.), determine an average survival of patients much longer than in the past . And there is continuous progress.”
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Prof. Russo, the Italian Medicines Agency (AIFA) has recently approved the reimbursement of a new targeted therapy, tucatinib, for patients with HER2+ metastatic breast cancer in the third line of treatment. How is clinical practice changing for these patients?
“Today, research marks an important step forward in prolonging the survival of these patients. The HER2CLIMB study, published in the New England Journal of Medicine, which led to the approval of the molecule in Europe in February 2021, evaluated the addition of tucatinib to trastuzumab and chemotherapy (capecitabine) in 612 patients with HER2 positive metastatic breast cancer with and without brain metastases, previously treated. The combination with tucatinib reduced the risk of death by 34%, improved overall survival, and at two years, 51% of patients were alive compared with 40% of those treated with trastuzumab and capecitabine. Median overall survival at 2 years was 24.7 months with the tucatinib-based regimen compared with 19.2 months with the control group. HER2CLIMB is the first prospective clinical trial to have enrolled 48% of patients with brain metastases, including active ones, the most difficult to cure. Tucatinib is small enough to cross the blood brain barrier and reach the brain, directly blocking the proliferation stimulus of the HER2 protein. At 24 months, tucatinib demonstrated nearly doubled overall survival in patients with brain metastases (48.5%) compared to the comparator arm (25.1%).
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Prof. Adamo, what is the role of the oncological networks and, in particular, of the Sicilian Oncological Network in the management of the disease?
“Every year there are about 3,460 new cases of breast cancer in Sicily, the most frequent in the entire population of the island. In metastatic disease we are able to obtain prolonged remissions, so for many women we can speak of chronicity with a good quality of life. It is not uncommon to find patients alive even more than 10 years after diagnosis. However, it is essential that the evaluation of metastatic neoplasia takes place by multidisciplinary groups, i.e. the Breast Units. The wealth of multi-voiced discussion and the complementarity of knowledge is also useful in this phase and can favor inclusion in clinical studies. The Sicilian Oncological Network has led to the monitoring of the Breast Units. There are 7 breast centers on the island, which have already been monitored twice with data sent to the Ministry of Health. About 95% of Sicilian women with breast cancer, in the last 2 and a half years, have followed the PDTA, i.e. the diagnostic therapeutic assistance path, within the Breast Units. This is a very important result that we are also transferring to other neoplasms. In fact, PDTAs have been approved for lung, colorectal, ovarian and prostate cancers. And specialist centers for the treatment of these diseases have been identified. By 23 July 2023, the healthcare companies and general hospitals will have to organize the GOMs, i.e. the Multidisciplinary Oncological Groups, dedicated to these PDTAs and communicate them to the Regional Health Department, because the DRGs, i.e. the remuneration of healthcare services, also for these pathologies they will be provided only within the identified structures. Our next goals are the computerized platform and structural governance of the Internet”.