The treatment of stomach cancer is enriched with a new therapeutic option. Aifa has in fact approved the reimbursement of trastuzumab deruxtecan as monotherapy for patients with Her2 positive tumors who have already received a previous trastuzumab-based treatment. This antibody-drug conjugate is therefore available as a second line of therapy in cases where the first line has not given the desired results, a category of patients for which until now the possible treatment options were still extremely limited.
The illness
Stomach cancer is a neoplasm that affects approximately 15 thousand people every year in our country. Early diagnosis is rare, and therefore in almost 80% of cases the tumor is detected at an advanced stage, when the prospects for cure are drastically reduced. Survival five years after diagnosis is therefore still low, equal to 35% in women and 30% in men. Approximately 20% of stomach tumors present an overexpression of the Her2 protein, a characteristic that allows the use of trastuzumab, a monoclonal antibody directed against this protein, alongside chemotherapy, as the first line of treatment. Until now, however, if this therapy was not effective, oncologists’ options were limited because no new anti-Her2 drugs for gastric cancer had been approved for over a decade.
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“Thanks to AIFA’s reimbursement, trastuzumab deruxtecan now becomes available in patients with HER2 positive advanced gastric cancer, who have already undergone previous anti-HER2 treatment – underlines Carmine PintoDirector of Medical Oncology of the Comprehensive Cancer Centre, AUSL-IRCCS of Reggio Emilia – This is an important change in the treatment strategy for the 20% of patients with gastric cancer who have overexpression of HER2”.
A new drug
Trastuzumab deruxtecan is an antibody-drug conjugate, that is, a therapy that combines a powerful chemotherapy with a monoclonal antibody capable of directing it precisely towards tumor cells, limiting its toxic effects on the body and increasing its effectiveness. The recent approval by Aifa arises from the results obtained in two clinical studies. The first, DESTINY-Gastric01, is a randomized phase 2 study conducted on 187 patients from Japan and South Korea, in which the group treated with trastuzumab deruxtecan achieved a median progression-free survival (the period in which half of treated patients showed no worsening) equal to 5.6 months, compared to 3.5 for those who received standard therapy, and a median overall survival (the period for which at least half of the patients on therapy survives) of 12.5 months , compared to 8.4 for the standard treatment.
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The results were then confirmed in the second clinical study, DESTINY-Gastric02, which involved 79 patients in North America and Europe. “The Veneto Oncology Institute of Padua is one of the centers that has enrolled the most patients – he underlines Sara Lonardi, Director of Oncology 3 of the Institute – The response to therapies is usually different in the eastern population compared to the western one; however, in the case of trastuzumab deruxtecan the results are similar. In the DESTINY-Gastric02 trial, all patients received trastuzumab deruxtecan, with an objective response of 42%, a progression-free survival of approximately 6 months, and a median overall survival of more than 12 months.”
How treatment changes
The availability of a new therapy against Her2 positive stomach tumors therefore now makes it even more essential to subject all patients with advanced carcinoma to the diagnostic test to evaluate the expression of Her2 from the beginning of the treatment process. As Pinto explains, positivity for Her2 determines a precise therapeutic process, with a first line of treatment entrusted to chemotherapy and trastuzumab, and a second line represented by trastuzumab deruxtecan. Without forgetting, obviously, the importance of paths dedicated to diagnosis, assistance and treatment of this specific category of patients.
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“The management of these patients, particularly with advanced cancer, requires a multidisciplinary approach that allows for global management, improving survival and quality of life – he recalls Claudia Santangelo, President of ‘Living without a stomach (it’s possible)’ – It is very important that patients receive a nutritional assessment right from the start and that they are followed from this point of view throughout the entire treatment process. In fact, people affected by stomach cancer risk malnutrition from the early stages of the disease. Greater attention to nutritional aspects improves the quality of life and the possibility of accessing multiple lines of therapy with a positive impact on survival.”