by Vera Martinella
Reimbursed by the National Health System for a drug that has proven capable of extending the survival of advanced and HER2-positive patients (taking the diagnostic test is essential)
Another small, important step forward that extends the survival of patients with metastatic stomach cancer: a new drug is also available in Italy, reimbursed by the National Health System, which has proven capable of saving months of precious time for those who have an inoperable neoplasm and did not derive the hoped-for benefits from a first cycle of treatment. Relevant news also by virtue of the numbers: gastric cancer is, in fact, diagnosed in around 15 thousand Italians every year, but less than 20% of cases are identified in the initial phase.
The symptoms and who is most at risk
So, unfortunately, five-year survival still remains low: Only a third of patients are alive five years after diagnosis – says Carmine Pinto, director of Medical Oncology at the Comprehensive Cancer Center of the AUSL-IRCCS of Reggio Emilia -. He blames it above all on the fact that it is an aggressive neoplasm that is mostly discovered late, when it is already in an advanced stage, because only then does it begin to show the first symptoms. Persistent abdominal pain, weight loss without obvious cause, nausea, lack of appetite, a general sense of weakness and tiredness, blood in the stool or diarrhea are the signs that should not be ignored, which are confused by many people with those of other less serious problems. Above all, those who are most at risk of getting ill must not underestimate these alarm bells, that is, those who suffer from atrophic gastritis (an inflammation of the stomach) or chronic Helicobacter pylori infection (responsible for ulcers and gastritis) – explains Sara Lonardi , acting director of Oncology 3 at the Veneto Oncology Institute IRCCS in Padua -. Also increasing the danger are overweight and obesity, a sedentary lifestyle, smoking, a diet poor in fruit and vegetables, excessive consumption of red meat, foods preserved with salt, nitrates and smoked foods. And then there are the hereditary-familial forms, which despite constituting 1% of all stomach tumors diagnosed in a year, are extremely relevant because they are due to gene mutations, very rare but extremely powerful, which can be inherited from blood relatives. of patients and in some cases guide therapies. These are aggressive tumors, the most common hereditary form is related to mutations in the CDH1 gene.
For whom the new treatment is indicated
Although cases of gastric cancer are increasing in Italy, thanks to the progress made by scientific research, mortality has started to decrease in recent years and new drugs have arrived which have contributed to extending the average survival of patients with advanced stage cancer or metastatic. Also included in this panorama is the green light from the Italian Medicines Agency (Aifa) of the drug-conjugated monoclonal antibody trastuzumab deruxtecan as monotherapy for the treatment of adult patients with advanced, HER2-positive adenocarcinoma of the stomach or gastroesophageal junction, who have received previous trastuzumab-based treatment. Trastuzumab deruxtecan has proven to be very effective in a complex clinical condition, i.e. in patients with HER2-positive gastric cancer (20% of cases have over-expression of the HER2 protein) not amenable to surgery, after failure of the first line of therapy standard medical treatment, consisting of chemotherapy plus trastuzumab – continues Lonardi -. In these cases, until now, the possibilities of cure were limited and with this new strategy we are able to improve both the objective response and overall survival. The new medicine is a monoclonal antibody drug conjugate: that is, it combines a monoclonal antibody, trastuzumab, with a chemotherapy drug, deruxtecan.
Get tested for HER2
The approval of the new therapy is based on the results of the studio DESTINY-Gastric01, pubblicato sul New England Journal of Medicine in 2020, also confirmed in the study DESTINY-Gastric02, published in The Lancet Oncology in 2023. The first (phase two) trial was conducted on 187 patients from Japan and South Korea, with important advantages – explains Lonardi -: an objective response rate of 51% was observed in patients treated with trastuzumab deruxtecan compared to 14% with standard therapy. The median progression-free survival was 5.6 months versus 3.5 months. Median overall survival reached 12.5 months versus 8.4 months. These results were then validated by DESTINY-Gastric02, which involved 79 patients in North America and Europe with an objective response of 42%, a progression-free survival of approximately six months and a median overall survival of over 12 months. Since gastric cancer is an often aggressive neoplasm, it often presents with relapses even in those patients who have undergone surgery with radical intent. In light of the news, it is important that all patients with advanced gastric cancer undergo the diagnostic test to evaluate the expression of HER2 from the beginning of the treatment process, with the awareness that this fundamental step is not only for the first line of therapy, but also for the next one – underlines Pinto -. Based on the results of the test, a decision is made on how to proceed, given that important advances have also recently been achieved in the treatment of HER2 negative disease, combining chemotherapy with immunotherapy in patients positive for PD-L1.
Reference hospitals
No less crucial is that people with stomach cancer are treated in specialized centres, where the various doctors consult with each other in order to choose the most suitable therapies in the individual case, because this increases the chances of surviving and living better. The diffusion of these centers is still very limited on the national territory. Gastric cancer is a pathology of high clinical complexity and requires dedicated paths for diagnosis, treatment and assistance – underlines Claudia Santangelo, president of the Vivere senza stomach (si pu) association -. The management of these patients, particularly with advanced cancer, requires a multidisciplinary approach that allows global management, improving survival and quality of life. It is very important that patients receive a nutritional assessment from the beginning and that they are followed from this point of view throughout the entire treatment process because they 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.
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January 23, 2024 (changed January 23, 2024 | 08:15)
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