000293582 001__ 293582 000293582 005__ 20250523121347.0 000293582 0247_ $$2doi$$a10.1002/ueg2.12656 000293582 0247_ $$2pmid$$apmid:39301763 000293582 0247_ $$2ISSN$$a2050-6406 000293582 0247_ $$2ISSN$$a2050-6414 000293582 037__ $$aDKFZ-2024-01905 000293582 041__ $$aEnglish 000293582 082__ $$a610 000293582 1001_ $$aMitzlaff, Katharina$$b0 000293582 245__ $$aEfficacy, safety and differential outcomes of immune-chemotherapy with gemcitabine, cisplatin and durvalumab in patients with biliary tract cancers: A multicenter real world cohort. 000293582 260__ $$aHoboken, NJ$$bWiley$$c2024 000293582 3367_ $$2DRIVER$$aarticle 000293582 3367_ $$2DataCite$$aOutput Types/Journal article 000293582 3367_ $$0PUB:(DE-HGF)16$$2PUB:(DE-HGF)$$aJournal Article$$bjournal$$mjournal$$s1732282726_4248 000293582 3367_ $$2BibTeX$$aARTICLE 000293582 3367_ $$2ORCID$$aJOURNAL_ARTICLE 000293582 3367_ $$00$$2EndNote$$aJournal Article 000293582 500__ $$a2024 Nov;12(9):1230-1242 000293582 520__ $$aCombined Immuno-chemotherapy consisting of gemcitabine, cisplatin and the programmed death-ligand one inhibitor durvalumab (GCD) is the new standard of care for patients with biliary tract cancers (BTC) based on positive results of the TOPAZ-1 study.We here evaluated the efficacy and safety of GCD for BTC in a German multicenter real-world patient cohort.Patients with BTC treated with GCD from 9 German centers were included. Clinicopathological baseline parameters, overall survival (OS), response rate and adverse events (AEs) were retrospectively analyzed. The prognostic impact was determined by Kaplan-Meier analyses and Cox regression models.A total of 165 patients treated with GCD between 2021 and 2024 were included in the study. Median OS and median progression-free survival were 14 months (95% CI 10.3-17.7) and 8 months (95% CI 6.8-9.2), respectively. The best overall response rate was 28.5% and disease control rate was 65.5%. While extrahepatic and intrahepatic BTC showed similar outcomes, mOS was significantly shorter in patients with gall bladder cancer (GB-CA) with 9 months (95% CI 5.5-12.4; p = 0.02). In univariate analyses age ≥70 years, Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥1, status post cholecystectomy, GB-CA and high baseline CRP values were significantly associated with OS. ECOG PS ≥ 1 and GB-CA remained independent prognostic factors for OS in multivariable cox regression analysis. AEs have been reported in 130 patients (78.8%), including 149 grade 3-4 AEs (25.5%). One patient died of severe infectious pneumonia. Immune-related (ir)AEs occurred in 17 patients (10.3%), including 9 grade 3-4 irAEs (2.2%), which led to treatment interruption in 4 patients.Immuno-chemotherapy in patients with BTC was feasible, effective and safe in a real-life scenario. Our results were comparable to the phase 3 clinical trial results (TOPAZ-1). Reduced efficacy was noted in patients with GB-CA and/or a reduced performance status that warrants further investigation. 000293582 536__ $$0G:(DE-HGF)POF4-314$$a314 - Immunologie und Krebs (POF4-314)$$cPOF4-314$$fPOF IV$$x0 000293582 588__ $$aDataset connected to CrossRef, PubMed, , Journals: inrepo02.dkfz.de 000293582 650_7 $$2Other$$abiliary tract cancers 000293582 650_7 $$2Other$$acheck‐point inhibition 000293582 650_7 $$2Other$$acholangiocarcinoma 000293582 650_7 $$2Other$$acisplatin 000293582 650_7 $$2Other$$adurvalumab 000293582 650_7 $$2Other$$agemcitabine 000293582 650_7 $$2Other$$aimmuno‐chemotherapy 000293582 650_7 $$2Other$$aprogrammed death‐ligand 1 inhibitor 000293582 7001_ $$aKirstein, Martha M$$b1 000293582 7001_ $$aMüller, Christian$$b2 000293582 7001_ $$00000-0001-8581-0974$$aVenerito, Marino$$b3 000293582 7001_ $$aOlkus, Alexander$$b4 000293582 7001_ $$0P:(DE-He78)54a6641a6c26ddc49cc754740e90b438$$aDill, Michael T$$b5$$udkfz 000293582 7001_ $$aWeinmann, Arndt$$b6 000293582 7001_ $$00000-0002-0036-2234$$aKocheise, Lorenz$$b7 000293582 7001_ $$aBusch, Alina$$b8 000293582 7001_ $$aSchulze, Kornelius$$b9 000293582 7001_ $$00000-0001-7568-7431$$aAllo, Gabriel$$b10 000293582 7001_ $$aWaldschmidt, Dirk-Thomas$$b11 000293582 7001_ $$00000-0003-3983-8276$$aBarsch, Maryam$$b12 000293582 7001_ $$aBengsch, Bertram$$b13 000293582 7001_ $$aQuante, Michael$$b14 000293582 7001_ $$aGonzalez-Carmona, Maria A$$b15 000293582 7001_ $$aHimmelsbach, Vera$$b16 000293582 7001_ $$aFinkelmeier, Fabian$$b17 000293582 7001_ $$aKloeckner, Roman$$b18 000293582 7001_ $$aSchirmacher, Peter$$b19 000293582 7001_ $$00000-0002-8314-2682$$aMarquardt, Jens U$$b20 000293582 7001_ $$00000-0001-8451-8015$$aZimpel, Carolin$$b21 000293582 773__ $$0PERI:(DE-600)2728585-6$$a10.1002/ueg2.12656$$gp. ueg2.12656$$n9$$p1230-1242$$tUnited european gastroenterology journal$$v12$$x2050-6406$$y2024 000293582 8564_ $$uhttps://inrepo02.dkfz.de/record/293582/files/UEG%20Journal%20-%202024%20-%20Mitzlaff%20-%20Efficacy%20safety%20and%20differential%20outcomes%20of%20immune%E2%80%90chemotherapy%20with%20gemcitabine%20.pdf 000293582 8564_ $$uhttps://inrepo02.dkfz.de/record/293582/files/UEG%20Journal%20-%202024%20-%20Mitzlaff%20-%20Efficacy%20safety%20and%20differential%20outcomes%20of%20immune%E2%80%90chemotherapy%20with%20gemcitabine%20.pdf?subformat=pdfa$$xpdfa 000293582 909CO $$ooai:inrepo02.dkfz.de:293582$$pVDB 000293582 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)54a6641a6c26ddc49cc754740e90b438$$aDeutsches Krebsforschungszentrum$$b5$$kDKFZ 000293582 9131_ $$0G:(DE-HGF)POF4-314$$1G:(DE-HGF)POF4-310$$2G:(DE-HGF)POF4-300$$3G:(DE-HGF)POF4$$4G:(DE-HGF)POF$$aDE-HGF$$bGesundheit$$lKrebsforschung$$vImmunologie und Krebs$$x0 000293582 9141_ $$y2024 000293582 915__ $$0StatID:(DE-HGF)0420$$2StatID$$aNationallizenz$$d2023-10-26$$wger 000293582 915__ $$0StatID:(DE-HGF)0200$$2StatID$$aDBCoverage$$bSCOPUS$$d2023-10-26 000293582 915__ $$0StatID:(DE-HGF)0300$$2StatID$$aDBCoverage$$bMedline$$d2023-10-26 000293582 915__ $$0StatID:(DE-HGF)0320$$2StatID$$aDBCoverage$$bPubMed Central$$d2023-10-26 000293582 915__ $$0StatID:(DE-HGF)0199$$2StatID$$aDBCoverage$$bClarivate Analytics Master Journal List$$d2023-10-26 000293582 915__ $$0StatID:(DE-HGF)0113$$2StatID$$aWoS$$bScience Citation Index Expanded$$d2023-10-26 000293582 915__ $$0StatID:(DE-HGF)0150$$2StatID$$aDBCoverage$$bWeb of Science Core Collection$$d2023-10-26 000293582 915__ $$0StatID:(DE-HGF)0160$$2StatID$$aDBCoverage$$bEssential Science Indicators$$d2023-10-26 000293582 915__ $$0StatID:(DE-HGF)0100$$2StatID$$aJCR$$bUNITED EUR GASTROENT : 2022$$d2023-10-26 000293582 915__ $$0StatID:(DE-HGF)9905$$2StatID$$aIF >= 5$$bUNITED EUR GASTROENT : 2022$$d2023-10-26 000293582 9201_ $$0I:(DE-He78)D500-20160331$$kD500$$lNWG Experimentelle Hepatologie, Entzündung und Krebs$$x0 000293582 980__ $$ajournal 000293582 980__ $$aVDB 000293582 980__ $$aI:(DE-He78)D500-20160331 000293582 980__ $$aUNRESTRICTED