There is a new drug for advanced breast cancer: a therapy targeted against the HER2 protein and particularly effective against brain metastases. The Italian Medicines Agency has in fact approved the reimbursement of tucatinib as a third line of treatment, i.e. for those with disease progression after two previous therapies. The novelty affects about 15% of patients.
Thanks to new mammograms, screening numbers exceed pre-pandemic levels
by Valentina Guglielmo
Patients with metastatic cancer
“According to the latest estimates, over 50,000 people live in Italy, mainly women, with metastatic breast cancer,” he says. Lucia DelMastro, Professor of the University of Genoa and Clinical Director of Medical Oncology of the IRCCS San Martino Policlinico Hospital. “Of these, about 15% have the form of breast cancer called HER2 positive, which is particularly aggressive but against which, since the year 2000, we have various targeted therapeutic weapons”. In most cases – continues the oncologist – metastatic breast cancer cannot be cured yet, but it is possible to keep it under control for long periods, thanks to these therapies. “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. This type of tumor, in fact, tends to recur and up to 50% of patients develop brain metastases”.
Metastatic breast cancer, the numbers of Italian cases
by Tiziana Moriconi
The new drug
Tucatinib is a new generation tyrosine kinase inhibitor that acts by blocking the replication of tumor cells with a different mechanism of action compared to other available therapies, and shows an important advantage not only in disease control, but also in survival, especially in patients with both stable and active brain metastases. It was approved in combination with the monoclonal antibody trastuzumab and chemotherapy (capecitabine): in the HER2CLIMB study, which led to its approval, the median two-year overall survival was 24.7 months with the tucatinib-based regimen compared to 19.2 months of the control group; after this period, 51% of patients were alive vs. 40%. Furthermore, 29% of patients treated with tucatinib had no disease progression compared to 14% of the control group (and these benefits are in addition to those already obtained with the first two lines of treatment). Last but not least, the combination has shown a high tolerability, maintaining or improving the quality of life.
Metastatic breast cancer, a targeted therapy for the most aggressive cases
by Tiziana Moriconi
“Tucatinib made it possible to reduce the risk of death by 34% in the entire population studied and, even, by 52% in patients with brain metastases”, underlines Michelino De Laurentiis, Director of the Department of Breast and Thoraco-Pulmonary Oncology, National Cancer Institute IRCCS Fondazione ‘G. Pascale’ of Naples – It is in fact a small molecule capable of overcoming the blood-brain barrier and reaching the brain, to directly block the proliferation stimulus of the HER2 protein”.
Between Breast Unit and territory
The European approval of the combination with tucatinib took place in February 2021 and Italy was quite quick in establishing reimbursement, arriving before Spain and France. However, in order for patients to receive the most appropriate therapies, not only from a pharmacological point of view, it is essential that they are taken care of within the Breast Units and that collaboration is activated with the general practitioner and the local health facilities. “Patients with metastatic disease must be taken care of by a multidisciplinary team, i.e. by breast care centers capable of intercepting and satisfying their need for global and long-term care – underlines Joseph 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 -. With a view to starting a path of coexistence with a chronic disease such as metastatic breast cancer – concludes Curigliano – it is essential to enhance the patient’s point of view to design the treatment process in a tailor-made way. In fact, clinical trials are increasingly including the assessment of quality of life and patient-reported treatment outcomes among their goals.