The Pascale Cancer Institute in Naples has launched a promising study called Citation to offer new hope to patients suffering from cholangiocarcinoma, a form of cancer of the biliary tract. Currently, the causes of this disease are unknown and chemotherapy, the only recognized therapy so far, has not always been effective. The strategy adopted in the Citation study is “neoadjuvant” therapy based on immunotherapy. Patients receive a combination of two immunotherapy drugs (Durvalumab and Tremelimumab) along with conventional chemotherapy before surgery.
The European Commission had already approved the use of durvalumab, an immunotherapy drug, as a first-line treatment for advanced biliary tract cancer. The Phase III TOPAZ-1 study demonstrated that durvalumab combined with chemotherapy was able to reduce the risk of death by 24% compared with chemotherapy alone. This approval had therefore opened a window and represented a change in the standard of care for advanced biliary tract cancer. The biliary tract cancer is a group of rare, aggressive cancers that affect the bile ducts or gallbladder. TOCurrently, the prognosis for patients with advanced cancer is poor, with 5-year survival ranging from 5% to 15%. Therefore, the combination of durvalumab and chemotherapy had been shown to improve survival, reduce the risk of progression and increase the response rate, without compromising quality of life. Unfortunately, there are no screening tests or routine diagnostic tests to detect early-stage biliary tract cancer, therefore the diagnosis often occurs when the disease is already advanced. Therefore, the approval of durvalumab as first-line therapy represented an important advance in the treatment of this disease and an additional treatment option.
The new therapy, which would stimulate the immune system to fight cancer cells and enhance the anti-tumor efficacy of chemotherapy, would offer numerous advantages, such as the reduction in tumor size to allow for more effective surgical removal and the early control of micrometastases. To this end, the goal of the study by the Neapolitan institute is to open up new therapeutic perspectives for patients affected by this insidious disease. In addition to the Cancer Institute of Naples, five Italian groups, including universities and hospitals, will participate in this project: theUniversity of Naples Federico II, l’Cardarelli hospital,l’ San Camillo Forlanini/Spallanzani hospital,l’ Mauritian hospital, l’Umberto I°, l’University of Verona, the Borgoroma hospital. Great satisfaction of the general manager of Pascale, Attilio Bianchi“I am pleased – says the manager – that our Institute once again offers this opportunity to patients suffering from tumors of the biliary tract“, highlighting the importance of research and innovation in combating this complex disease.
