2024-01-10 10:54:00
by Vera Martinella
An innovative conjugated antibody is also reimbursable in Italy for HER2-low type tumors, which until now were treated only with chemotherapy
The goal is to become chronic. If healing from metastatic breast cancer is no longer possible, one can try to make the disease chronic and, therefore, live with it for as long as possible and as well as possible. Making patients gain good quality time is the objective achieved by trastuzumab deruxtecan, a new medicine, recently approved by the Italian Medicines Agency (Aifa), which reduces the risk of disease progression or death by 50%. This the drug had received the green light from Aifa in July 2023 for a certain subtype of breast cancer (HER2 positive), even with brain metastases in patients who have already had a first line of treatment – recalls Giampaolo Bianchini, associate professor and head of the Group breast of the IRCSS San Raffaele Hospital, Vita-Salute San Raffaele University of Milan –. Now the Italian reimbursement is added for another subtype (the so-called HER2 low), for which we only had chemotherapy available with which we obtained unsatisfactory results.
The results of the study
Specifically, AIFA has approved the reimbursement of trastuzumab deruxtecan as monotherapy for the treatment of adult patients (female and male) with unresectable or metastatic HER2 low breast cancer, who have received previous chemotherapy for metastatic disease or who have developed recurrence of the disease. disease during or within six months of completing adjuvant chemotherapy (i.e. after surgery). The approval for this new indication came in the light of the important results achieved by the DESTINY-Breast04 study, also presented with great prominence during the American oncology congress in 2022. The trial compared 557 patients with an inoperable HER2-low type carcinoma or metastatic chemotherapy with the trastuzumab deruxtecan conjugated antibody, specifically engineered to be directed against the HER2 receptor – explains Bianchini –. And its results have changed the current standard chemotherapy because they have demonstrated that by using trastuzumab deruxtecan it is possible to keep the tumor under control for a longer time: it doubles the time free from disease progression (the time during which the tumor remains stable, going from 5 to 10 months), survival also improves (from 17 months to over 23), the risk of death is reduced by 50% and the quality of life improves, given that fewer side effects are recorded.
A precise diagnosis is needed
In 2023, in Italy, an estimated 55,900 new cases of breast cancer were estimated and approximately 37 thousand people are living with metastatic disease, a number that is constantly increasing. One in 8 women will get sick during their lifetime (males can also develop it, although it is a very rare event): thanks to the successes in early diagnosis and new therapies, today 87% of patients live 5 years after diagnosis, but especially against the more aggressive forms and in those in the metastatic stage, innovative strategies are needed.
Today we know that there are many different types of breast cancer and it is essential to know which histological and molecular subtype you are dealing with in order to be able to choose, among the many available therapies, the most effective one based on the individual case – underlines Michelino De Laurentiis, director of the Department of Senological and Thoraco-Pulmonary Oncology, National Cancer Institute IRCCS Pascale Foundation of Naples –. HER2-low tumors represent all tumors that do not have high expression or amplification of the HER2 receptor: in practice over half of the 55 thousand new cases diagnosed in our country per year, but having a precise diagnosis, today more than ever, is a decisive step.
So many different types of breast cancer
Breast cancer is classified into three main subtypes, which are fundamental for defining the prognosis and the therapeutic approach. These include the human epidermal growth factor receptor 2 positive (HER2+) tumor subtype, the hormone receptor (HR) positive (estrogen or progesterone positive) and simultaneously HER2 negative (HR+/HER2-) luminal tumor subtype, and the triple-negative subtype (negative for all three receptors).
HER2 expression defined as positive or negative. It is determined using an immunohistochemistry test, which measures the levels of HER2 protein in a tumor cell (IHC test results are reported as 0, 1+, 2+, or 3+4) and a fluorescent in situ hybridization test (FISH ), which counts the copies of the HER2 gene in tumor cells (the latter is only done if a 2+ score is obtained from IHC testing). Up to 55% of all breast cancers express low levels of HER2 and, therefore, can be classified as HER2 low – specifies De Laurentiis –. Until now, these tumors were simply classified as HER2 negative and therefore fell among luminal tumors or triple-negative tumors, depending on the presence or absence of hormone receptors. Today, however, given that HER2 low tumors (HER2 1+ or 2+) can benefit from trastuzumab deruxtecan, it becomes essential to identify them precisely by performing a common immunohistochemistry test. For this reason, the role of the multidisciplinary team in the evaluation of patients is more necessary than ever and, in particular, a close collaboration between the oncologist and the pathologist who carries out the diagnostic tests.
Drug-conjugated antibodies
Trastuzumab deruxtecan belongs to the category of drug-conjugated antibodies, which are basically composed of two parts: a monoclonal antibody designed to specifically recognize and bind to a very specific target, present only on cancerous cells and not on healthy ones, which brings with it a powerful chemotherapy. On the one hand, this allows for great therapeutic effectiveness, because the chemotherapy transported and “released” on the target to be hit has great destructive power; on the other hand, however, the toxicity for normal cells (and therefore for the patient’s organism) is very reduced given that the treatment is targeted – says Alessandra Fabi, head of Precision Medicine in Senology at the Fondazione Policlinico Universitario Gemelli IRCCS in Rome –. Trastuzumab deruxtecan is the first anti-HER2 therapy approved for patients with HER2 low breast cancer. If until now chemotherapy was the only option available for patients with advanced or metastatic breast cancer with low HER2 expression, now (after having received at least one line of chemo) it will be possible to proceed with this innovative treatment, which allows respond to hitherto unmet clinical needs.
Step forward
A step forward also seen with satisfaction by patient associations: The news that Aifa has approved the reimbursement of the molecule even in HER2-low cases makes us very happy because it represents a new possibility of treatment and offers a chance to those who didn’t have it before – concludes Rosanna D’Antona, president of Europa Donna Italia – . Innovative therapeutic strategies, together with management within breast units and the joint work of the multidisciplinary team, will not only increase the survival of these women, but also their quality of life. For women with metastatic breast cancer, facilitated access to clinical trials and innovative treatments is crucial, as indicated in our “Manifesto on Metastatic Breast Cancer”.
Corriere della Sera also on Whatsapp. sufficient click here to subscribe to the channel and always be updated.
January 10, 2024 (changed January 10, 2024 | 08:40)
© ALL RIGHTS RESERVED
#extends #improves #patients #lives #time.news