A new targeted therapy for advanced HER2-positive breast cancer, a form considered aggressive, which accounts for 15-20% of all cases, has recently become available in our country. Out of an estimated 50,000 metastatic women in our country, therefore, between 7 and 10,000 have this form of breast cancer, which overexpresses the HER2 protein. To take stock of one of the new possibilities of treatment as a third line of treatment for these patients, with the drug tucatinib, are today two press conferences, which concerned in particular the data on the disease in Piedmont, Veneto and Friuli Venezia Giulia, where approximately 4,400, 5,000 and 1,300 new cases of the disease (in all stages and of all subtypes) are estimated each year, respectively.
Breast cancer, two new drugs to overcome resistance
by Tiziana Moriconi
“In most cases metastatic breast cancer cannot be cured, but it is a disease that can be kept under control for long periods”, explained Massimo Di Maio, National Secretary of the Italian Association of Medical Oncology (Aiom) and Director Oncology of the Mauriziano Hospital, University of Turin: “In particular, targeted therapies have changed the history of metastatic breast cancer, leading in many cases to 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”.
Breast cancer, new drug slows the disease and increases survival
by Tiziana Moriconi
The data on the new combination
Combining tucatinib with chemotherapy (capecitabine) has been shown to reduce the risk of death by 34%, improve overall survival, and at two years, 51% of patients are 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. In addition, 29% of patients treated with tucatinib were free from disease progression compared to 14% of the control group. These benefits are added to those already obtained with the first two lines of treatment. “Tucatinib is characterized by a different mechanism of action compared to other available therapies and shows a significant advantage not only in disease control but also in survival – explains Valentina Guarneri, Director of Oncology 2 of the Veneto-IRCCS Institute of Padua and Full Professor of Medical Oncology at the University of Padua -. More importantly, it shows significant and clinically relevant activity in patients with both stable and active brain metastases. Furthermore, the molecule is characterized by high tolerability, a fundamental aspect in the management of metastatic disease to guarantee patients a good quality of life”.
HER2 tumors and brain metastases
As anticipated, HER2-positive breast cancer tends to recur and be more aggressive: “Furthermore – adds Alessandra Gennari, Director of Oncology at the Maggiore University Hospital of Charity of Novara and Associate Professor of Oncology at the University of Piedmont Eastern – up to 50% of HER2 positive patients develop brain metastases. Tucatinib, a new generation tyrosine kinase inhibitor, is able to block the replication of tumor cells in a very effective way and has 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”.
Returning to work after breast cancer: 1 in 4 women has been demoted
by Barbara Orrico
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 in 612 patients with HER2 positive metastatic breast cancer with and without previously treated brain metastases. “This is the first prospective clinical trial to have enrolled 48% of patients with brain metastases, including active ones, the most difficult to treat”, says Mario Airoldi, Director of Medical Oncology 2 of the City of Health and Science of Turin – . This drug is in fact 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%).
Multidisciplinary paths and quality of life
In patients with metastatic disease, multidisciplinary management by breast centers is more important than ever, able to intercept and satisfy their need for global and long-term care, as underlined by Fabio Puglisi, Director of the Department of Medical Oncology at the IRCCS CRO of Aviano, Full Professor and Director of the School of Specialization in Medical Oncology at the University of Udine: “With a view to starting an increasingly long journey of coexistence with a disease such as metastatic breast cancer, it is essential to enhance the point of view of the patient to design the treatment process in a sartorial way. In fact, clinical trials are increasingly including among their goals the assessment of quality of life and patient-reported treatment outcomes, using validated tools.
Breast cancer, an award for doctors close to women
by Dario Rubino
The risk of metastasis
In the last 20 years, thanks to the identification of the different subtypes of breast cancer and the understanding of the biological heterogeneity of the disease, there has been an extraordinary evolution of therapies, increasingly targeted against specific targets and therefore less and less burdened by disabling toxicities. In Italy, 88% of patients affected by breast cancer are alive at 5 years. “Breast cancer, however, can recur in the form of metastases even many years after surgery and the end of postoperative therapies”, recalls Di Maio: “It is estimated that around 20% of women with initially non-metastatic cancer develop metastasis within 5 years of diagnosis. Furthermore, about 7% of patients already have metastatic disease at diagnosis. Research makes increasingly effective treatments available for these patients, such as tucatinib, which allow them to live longer”. “Tucatinib represents for us the commitment to develop drugs capable of changing the lives of people affected by cancer”, concludes Alfonso De Rosa, Medical Director of Seagen Italia -. At Seagen, we are constantly working to make innovative medicines available as soon as possible to all patients who can benefit from them”.