New data arrives from independent Italian research for patients with pleural mesothelioma, a particularly aggressive thoracic tumor: three years after diagnosis, 25% are alive thanks to immunotherapy. The data coming from the independent clinical study, IND.227, conducted by three cooperative groups and coordinated by the National Cancer Institute of Naples Irccs Fondazione Pascale, the Canadian Cancer Trials Group (CCTG) and the French Cooperative Thoracic Intergroup (IFCT), were published in the prestigious scientific journal “The Lancet” and presented in a plenary session at the XXV National Congress of the Italian Association of Medical Oncology (Aiom) in Rome.
The role of Italy in the study
Thanks to this study, Italy has defined a new therapeutic option in unresectable or metastatic pleural mesothelioma, a very difficult neoplasm to treat. “The standard of care for pleural mesothelioma for 20 years has been chemotherapy, with unsatisfactory results – he explains Francesco Perrone, president of Aiom. “This phase 3 study involved 440 patients from 51 centers in Italy, Canada and France and demonstrates the high value of independent research. It should also be highlighted that almost half of the patients, 212, were Italian, demonstrating the central role played by our country. The study design is the result of the work of Italian and Canadian researchers. International academic collaborations like this represent an important strategy to explore new strategies against cancer and also to define new treatments capable of improving patient prognosis, especially in the case of uncommon diseases such as pleural mesothelioma. The results of this research, in fact, are destined to have a tangible and significant impact on the lives of patients.”
In the work, immunotherapy with pembrolizumab in combination with platinum chemotherapy and first-line pemetrexed significantly improved overall survival, reducing the risk of death by 21%. At 3 years, 25% of patients treated with the combination were alive compared to 17% with chemotherapy alone. Progression-free survival was also significantly better. “Seventeen Italian centers participated in the IND.227 study – he states Marilina Piccirillo, medical director of the ‘Pascale’ Clinical Trials Complex Structure in Naples and scientific coordinator of the IND.227 study in Italy. The 8% improvement in 3-year survival is a significant result in a disease such as mesothelioma, which still has a poor prognosis. The same applies to progression-free survival and response. The latter, which is equivalent to a reduction in the size of the tumor, was achieved in 62% of patients treated with pembrolizumab in combination with chemotherapy compared to 38% of those treated with chemotherapy alone, therefore almost a doubling of the response rate. This is important, because patients with mesothelioma are often very symptomatic and reduction in tumor size generally corresponds to better control of respiratory symptoms and pain. We hope that this new therapeutic option will be made available in clinical practice as soon as possible.”
by Dario Rubino
Mesothelioma in Italy
Every year, in Italy, there are estimated to be around 2000 new cases of mesothelioma. The main risk factor is exposure to asbestos, recognized in 90% of diagnoses. Due to its nature as an occupational disease, a national surveillance system with mandatory reporting is active. This data flows into the National Mesothelioma Registry (ReNaM). The use of the mineral in our country ended in 1992, with the law that decreed a general ban on its extraction, import, export, marketing and production, but the quantities of asbestos still present in the territories remain significant, especially in different types of structures.
The role of asbestos and symptoms
Mesothelioma can occur decades after exposure to asbestos. In fact, it continues to be diagnosed even today, precisely due to the intense use of the mineral from the post-World War II period until the beginning of the nineties. “The sectors most involved – he underlines Federica Grosso, responsible for the Mesothelioma and Rare Tumors Departmental Simple Structure of the Santi Antonio e Biagio and Cesare Arrigo Hospital of Alessandria – are construction and heavy industry, from which 60% of the cases recorded in the National Registry archives derive. In some areas of our country, such as Casale Monferrato, Mestre, Savona and Ancona, mesothelioma is a frequent cancer, but in most of the area it is rare. The first symptoms, usually present for a few months after diagnosis, are chest pain, difficulty breathing and cough. The most frequent sign is the formation of pleural fluid in the thoracic locations. Recent studies have highlighted the role of immunotherapy in this neoplasm and IND.227 marks a further important progress in research”.
“The tragic story of professional and environmental exposure to asbestos in Italy, with the long trail of deaths from cancer, has allowed us to develop more experience and sensitivity on this issue compared to other countries – he concludes Saverio Cinieri, president of the Aiom Foundation. The latency times of the disease are very long. They can range from 20 to over 40 years from the start of exposure. The average age at diagnosis, in fact, is around 70 years and the social and judicial repercussions cannot be overlooked. Unfortunately, asbestos is still present in our area. It is a certain carcinogen, not only for pleural mesothelioma, but also for the lungs, larynx, ovary, peritoneum, pericardium, tunica vaginalis of the testicle, colorectal, esophagus, stomach and pharynx”.