The Italian Medicines Agency (Aifa) has given the green light to immunotherapy on the front line in the treatment of hepatocellular carcinoma and biliary tract cancer. In advanced or unresectable hepatocellular carcinoma, 25% of patients treated with a single initial dose of tremelimumab with durvalumab followed by durvalumab monotherapy are alive at four years. In unresectable or metastatic biliary tract cancer, the combination of durvalumab plus chemotherapy reduced the risk of death by 24% compared to chemotherapy alone, with the estimated number of patients still alive at two years more than doubling. AIFA has approved the reimbursement of a single initial dose of tremelimumab with durvalumab followed by durvalumab monotherapy for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma.
In 2023, in Italy, an estimated 12,200 new diagnoses of liver cancer were estimated, of which 79% were represented by hepatocellular carcinoma. “It is one of the main causes of death from cancer, particularly in men between 60 and 70 years old – explains Fabio Piscaglia, Full Professor of Internal Medicine at the University of Bologna and Director of Internal Medicine, Hepatobiliary and Immunoallergological Diseases of the Irccs – Aou of Bologna -. In the large majority of cases, the tumor develops in patients suffering from chronic liver disease, often already at the cirrhosis stage. Among the causes of chronic liver disease we remember hepatitis B and C virus infections, alcohol abuse, genetic and autoimmune diseases, but also the rapidly growing numerical condition called metabolic syndrome, generally linked to overweight and diabetes”.
“The treatment is complex, because the tumor must be treated without underestimating the fact that the patient very often suffers from chronic liver disease”, adds Mario Scartozzi, Full Professor of Medical Oncology, Director of Medical Oncology, University of Cagliari, University Hospital of Cagliari. “For patients with advanced disease, not eligible for surgery and locoregional therapies, it is essential to have access to effective tools such as immunotherapy – explains Massimiliano Conforti, Vice President of EpaC -. It is also important to raise awareness among family doctors, to activate programs surveillance of people at risk”. “The approval of the reimbursement of durvalumab by Aifa for the treatment of biliary tract tumors is very important news – states Paolo Leonardi, President of the Association of Italian Cholangiocarcinoma Patients (Apic) -, because it prolongs life by controlling the development of the tumor “. “The approval of the reimbursement of durvalumab in liver and biliary tract tumors is a decisive result for the scientific community and for patients. In particular, we are faced with the first approval of a front-line immunotherapy regimen in cholangiocarcinoma”, he concludes Paola Morosini, Medical Affairs Head Oncology AstraZeneca.
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