Long-term therapeutic response in gallbladder cancer — the potential of chemoimmunotherapy

Malignant biliary tract tumors, including gallbladder cancer and cholangiocarcinoma, are associated with particularly poor prognoses. For many years, chemotherapy with cisplatin and gemcitabine was the only available treatment option for patients with the advanced disease. A breakthrough in the management of this patient group came with the introduction of immunotherapy, especially in com­bination with chemotherapy. The TOPAZ-1 clinical trial demonstrated that the use of the programmed death-ligand 1 (PD-L1) checkpoint inhibitor durvalumab, in combination with cisplatin and gemcitabine, improves treatment efficacy, significantly prolonging both overall survival (OS) and progression-free survival (PFS). Using available research, the case reports of patients with unresectable advanced biliary tract adenocarcinoma who were treated with chemotherapy combined with durvalumab are presented herein. The treatment was initiated within an Expanded Access Program (EAP) and subsequently continued within the Polish National Health Fund’s Drug Program ( Program Lekowy Ministerstwa Zdrowia ). In selected patients, disease stabili­zation was observed and a long-term therapeutic response with maintenance of very good performance status (Eastern Cooperative Oncology Group 0) over many months of treatment — significantly exceeded the outcomes reported in the registration trial. In one case, the patient had been receiving treatment for over 30 months and remains in good clinical condition (as of July 2025). Treatment was well tolerated in both cases and led to substantial prolongation of progression-free survival. These findings illustrate the high efficacy and acceptable safety profile of durvalumab combined with che­motherapy in patients with advanced biliary tract cancers. Long-term treatment response in this population gives hope for better prognosis and improved quality of life in selected cases.