Evidence map›Paper›PMID 38416377›Full record

ArticleTargeted oncology2024

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

Alexander Olkus, Aurelie Tomczak, Anne Katrin Berger, Conrad Rauber, Philip Puchas, Cyrill Wehling, Thomas Longerich, Arianeb Mehrabi, De-Hua Chang, Jakob Liermann and 6 more

Open access · hybridAbstract read
In one paragraph

Article in Targeted oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
12.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 21 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 2 institutions in 1 country.

Alexander OlkusDepartment of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
Aurelie TomczakLiver Cancer Center Heidelberg, Heidelberg, Germany.
Anne Katrin BergerDepartment of Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Conrad RauberDepartment of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
Philip PuchasDepartment of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
Cyrill WehlingDepartment of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
Thomas LongerichLiver Cancer Center Heidelberg, Heidelberg, Germany.
Arianeb MehrabiLiver Cancer Center Heidelberg, Heidelberg, Germany.
De-Hua ChangLiver Cancer Center Heidelberg, Heidelberg, Germany.
Jakob LiermannLiver Cancer Center Heidelberg, Heidelberg, Germany.
Sophia SchäferLiver Cancer Center Heidelberg, Heidelberg, Germany.
Jan PfeiffenbergerDepartment of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
Dirk JägerLiver Cancer Center Heidelberg, Heidelberg, Germany.
Patrick MichlDepartment of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
Christoph SpringfeldLiver Cancer Center Heidelberg, Heidelberg, Germany.
Michael T DillDepartment of Gastroenterology, Infectious Diseases and Intoxication, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany. michael.dill@med.uni-heidelberg.de.ORCID 0000-0002-1926-4204
Heidelberg University · DEGerman Cancer Research Center · DE

Funding

Deutsche Krebshilfe 70113858German Ministry of Research and Education 01ZZ1802German Ministry of Research and Education 01ZZ3222E
6 · The paper itself

Abstract

backgroundThe 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.

objectiveWe 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.

methodsIn 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.

resultsIn 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.

conclusionsThe treatment of advanced patients with BTC with durvalumab and gem/cis, even beyond the inclusion criteria of the TOPAZ-1 trial, shows promising safety.

Indexed as

Antibodies, MonoclonalBile Duct NeoplasmsBiliary Tract NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCisplatinDeoxycytidineGemcitabineHumansRetrospective StudiesAntibodies, MonoclonalCisplatinDeoxycytidinedurvalumabGemcitabine

Identifiers

PMID38416377
PMCPMC10963573
OpenAlexW4392231852

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.