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

Journal

Targeted oncology
ISSN: 1776-260X
Titre abrégé: Target Oncol
Pays: France
ID NLM: 101270595

Informations de publication

Date de publication:
28 Feb 2024
Historique:
accepted: 05 02 2024
medline: 28 2 2024
pubmed: 28 2 2024
entrez: 28 2 2024
Statut: aheadofprint

Résumé

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. 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. 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. 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. 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.

Sections du résumé

BACKGROUND 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 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 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 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 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.

Identifiants

DOI: 10.1007/s11523-024-01044-1 PMID: 38416377
pubmed: 38416377
doi: 10.1007/s11523-024-01044-1
pii: 10.1007/s11523-024-01044-1
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : Deutsche Krebshilfe
ID : 70113858
Organisme : German Ministry of Research and Education
ID : 01ZZ1802
Organisme : German Ministry of Research and Education
ID : 01ZZ3222E

Informations de copyright

© 2024. The Author(s).

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Auteurs

Alexander 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.

Aurelie Tomczak (A)

Liver Cancer Center Heidelberg, Heidelberg, Germany.
Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.

Anne Katrin 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.

Conrad 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.

Philip Puchas (P)

Department of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.

Cyrill 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.

Thomas Longerich (T)

Liver Cancer Center Heidelberg, Heidelberg, Germany.
Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.

Arianeb Mehrabi (A)

Liver Cancer Center Heidelberg, Heidelberg, Germany.
Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.

De-Hua Chang (DH)

Liver Cancer Center Heidelberg, Heidelberg, Germany.
Department of Diagnostic and Interventional Radiology, Heidelberg University Hospital, Heidelberg, Germany.

Jakob Liermann (J)

Liver Cancer Center Heidelberg, Heidelberg, Germany.
Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.

Sophia 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.

Jan 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.

Dirk 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.

Patrick 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.

Christoph 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.

Michael T 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.
ORCID: 0000-0002-1926-4204

Classifications MeSH