Durvalumab Plus Gemcitabine and Cisplatin in Patients with Advanced Biliary Tract Cancer: An Exploratory Analysis of Real-World Data.

Autor:	Olkus A; Department of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.; Liver Cancer Center Heidelberg, Heidelberg, Germany., Tomczak A; Liver Cancer Center Heidelberg, Heidelberg, Germany.; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Berger AK; Department of Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany.; National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, Heidelberg, Germany., Rauber C; Department of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.; Liver Cancer Center Heidelberg, Heidelberg, Germany., Puchas P; Department of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany., Wehling C; Department of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.; Liver Cancer Center Heidelberg, Heidelberg, Germany., Longerich T; Liver Cancer Center Heidelberg, Heidelberg, Germany.; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Mehrabi A; Liver Cancer Center Heidelberg, Heidelberg, Germany.; Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany., Chang DH; Liver Cancer Center Heidelberg, Heidelberg, Germany.; Department of Diagnostic and Interventional Radiology, Heidelberg University Hospital, Heidelberg, Germany., Liermann J; Liver Cancer Center Heidelberg, Heidelberg, Germany.; Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany., Schäfer S; Liver Cancer Center Heidelberg, Heidelberg, Germany.; Department of Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany.; National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, Heidelberg, Germany.; Clinical Cancer Registry, Heidelberg University Hospital, Heidelberg, Germany., Pfeiffenberger J; Department of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.; Liver Cancer Center Heidelberg, Heidelberg, Germany., Jäger D; Liver Cancer Center Heidelberg, Heidelberg, Germany.; Department of Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany.; National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, Heidelberg, Germany., Michl P; Department of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.; Liver Cancer Center Heidelberg, Heidelberg, Germany., Springfeld C; Liver Cancer Center Heidelberg, Heidelberg, Germany.; Department of Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany.; National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, Heidelberg, Germany., Dill MT; Department of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany. michael.dill@med.uni-heidelberg.de.; Liver Cancer Center Heidelberg, Heidelberg, Germany. michael.dill@med.uni-heidelberg.de.; National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and Heidelberg University Hospital, Heidelberg, Germany. michael.dill@med.uni-heidelberg.de.; German Cancer Research Center (DKFZ) Heidelberg, Research Group Experimental Hepatology, Inflammation and Cancer, Heidelberg, Germany. michael.dill@med.uni-heidelberg.de.
Jazyk:	angličtina
Zdroj:	Targeted oncology [Target Oncol] 2024 Mar; Vol. 19 (2), pp. 213-221. Date of Electronic Publication: 2024 Feb 28.
DOI:	10.1007/s11523-024-01044-1
Abstrakt:	Background: The combination of gemcitabine and cisplatin (gem/cis) with the anti-PD-L1-antibody durvalumab was recently approved as first line therapy for biliary tract cancer (BTC) based on the results of the TOPAZ-1 trial. Objective: We aim to analyse the feasibility and efficacy of the triple combination therapy in patients with BTC in a real-world setting and in correspondence with the genetic alterations of the cancer. Methods: In this single-centre retrospective analysis, all patients with BTC and treated with durvalumab plus gem/cis from April 2022 to September 2023 were included. Survival and treatment response were investigated, within the context of the inclusion and exclusion criteria of TOPAZ-1 and in correspondence with genetic alterations of the cancer. Results: In total, 35 patients, of which 51% met the inclusion criteria of the TOPAZ-1 trial, were analysed. Patients treated within TOPAZ-1 criteria did not have a significantly different median overall survival and progression free survival than the rest of the patients (10.3 versus 9.7 months and 5.3 versus 5 months, respectively). The disease control rate of patients within the TOPAZ-1 criteria was 61.1%, in comparison to 58.8% in the rest of patients. A total of 51 grade 3 and 4 adverse events were observed without significant differences in the subgroups. No specific correlating patterns of genetic alterations with survival and response were observed. Conclusions: The treatment of advanced patients with BTC with durvalumab and gem/cis, even beyond the inclusion criteria of the TOPAZ-1 trial, shows promising safety. (© 2024. The Author(s).)
Databáze:	MEDLINE
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