{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T17:50:45Z","timestamp":1792000245843,"version":"4.4.0"},"reference-count":27,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,9,20]],"date-time":"2024-09-20T00:00:00Z","timestamp":1726790400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["UEG Journal"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Combined Immuno\u2010chemotherapy consisting of gemcitabine, cisplatin and the programmed death\u2010ligand one inhibitor durvalumab (GCD) is the new standard of care for patients with biliary tract cancers (BTC) based on positive results of the TOPAZ\u20101 study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>We here evaluated the efficacy and safety of GCD for BTC in a German multicenter real\u2010world patient cohort.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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\u2013Meier analyses and Cox regression models.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 165 patients treated with GCD between 2021 and 2024 were included in the study. Median OS and median progression\u2010free survival were 14 months (95% CI 10.3\u201317.7) and 8\u00a0months (95% CI 6.8\u20139.2), 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\u2010CA) with 9\u00a0months (95% CI 5.5\u201312.4; <jats:italic>p<\/jats:italic>\u00a0=\u00a00.02). In univariate analyses age \u226570\u00a0years, Eastern Cooperative Oncology Group (ECOG) performance status (PS) \u22651, status post cholecystectomy, GB\u2010CA and high baseline CRP values were significantly associated with OS. ECOG PS\u00a0\u2265\u00a01 and GB\u2010CA remained independent prognostic factors for OS in multivariable cox regression analysis. AEs have been reported in 130 patients (78.8%), including 149 grade 3\u20134 AEs (25.5%). One patient died of severe infectious pneumonia. Immune\u2010related (ir)AEs occurred in 17 patients (10.3%), including 9 grade 3\u20134 irAEs (2.2%), which led to treatment interruption in 4 patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Immuno\u2010chemotherapy in patients with BTC was feasible, effective and safe in a real\u2010life scenario. Our results were comparable to the phase 3 clinical trial results (TOPAZ\u20101). Reduced efficacy was noted in patients with GB\u2010CA and\/or a reduced performance status that warrants further investigation.<\/jats:p><\/jats:sec>","DOI":"10.1002\/ueg2.12656","type":"journal-article","created":{"date-parts":[[2024,9,20]],"date-time":"2024-09-20T09:21:21Z","timestamp":1726824081000},"page":"1230-1242","source":"Crossref","is-referenced-by-count":19,"title":["Efficacy, safety and differential outcomes of immune\u2010chemotherapy with gemcitabine, cisplatin and durvalumab in patients with biliary tract cancers: A multicenter real world cohort"],"prefix":"10.1002","volume":"12","author":[{"given":"Katharina","family":"Mitzlaff","sequence":"first","affiliation":[{"name":"Department of Medicine I University Medical Center\u2014Campus L\u00fcbeck  L\u00fcbeck Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martha M.","family":"Kirstein","sequence":"additional","affiliation":[{"name":"Department of Medicine I University Medical Center\u2014Campus L\u00fcbeck  L\u00fcbeck Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"M\u00fcller","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Infectious Diseases Otto von Guericke University Hospital  Magdeburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8581-0974","authenticated-orcid":false,"given":"Marino","family":"Venerito","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Infectious Diseases Otto von Guericke University Hospital  Magdeburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Olkus","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology, Infectious Diseases and Intoxication Heidelberg University Hospital  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael T.","family":"Dill","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology, Infectious Diseases and Intoxication Heidelberg University Hospital  Heidelberg Germany"},{"name":"National Center for Tumor Diseases (NCT) NCT Heidelberg, a Partnership Between DKFZ and Heidelberg University Hospital  Heidelberg Germany"},{"name":"German Cancer Research Center (DKFZ) Heidelberg Research Group Experimental Hepatology Inflammation and Cancer  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arndt","family":"Weinmann","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine University Medical Center of the Johannes Gutenberg University Mainz  Mainz Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0036-2234","authenticated-orcid":false,"given":"Lorenz","family":"Kocheise","sequence":"additional","affiliation":[{"name":"I. Department for Medicine University Medical Center Hamburg\u2010Eppendorf  Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alina","family":"Busch","sequence":"additional","affiliation":[{"name":"Department of Oncology, Hematology and BMT with Section of Pneumology University Medical Center Hamburg\u2010Eppendorf  Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kornelius","family":"Schulze","sequence":"additional","affiliation":[{"name":"I. Department for Medicine University Medical Center Hamburg\u2010Eppendorf  Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7568-7431","authenticated-orcid":false,"given":"Gabriel","family":"Allo","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Faculty of Medicine and University Hospital Cologne University of Cologne  Cologne Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk\u2010Thomas","family":"Waldschmidt","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Faculty of Medicine and University Hospital Cologne University of Cologne  Cologne Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3983-8276","authenticated-orcid":false,"given":"Maryam","family":"Barsch","sequence":"additional","affiliation":[{"name":"Department of Medicine II, Gastroenterology, Hepatology, Endocrinology, and Infectious Disease University Medical Center  Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bertram","family":"Bengsch","sequence":"additional","affiliation":[{"name":"Department of Medicine II, Gastroenterology, Hepatology, Endocrinology, and Infectious Disease University Medical Center  Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Quante","sequence":"additional","affiliation":[{"name":"Department of Medicine II, Gastroenterology, Hepatology, Endocrinology, and Infectious Disease University Medical Center  Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria A.","family":"Gonzalez\u2010Carmona","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I University Hospital Bonn  Bonn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vera","family":"Himmelsbach","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Endocrinology University Hospital Frankfurt  Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8559-9910","authenticated-orcid":false,"given":"Fabian","family":"Finkelmeier","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology and Endocrinology University Hospital Frankfurt  Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roman","family":"Kloeckner","sequence":"additional","affiliation":[{"name":"Department for Interventional Radiology University Medical Center\u2014Campus L\u00fcbeck  L\u00fcbeck Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Schirmacher","sequence":"additional","affiliation":[{"name":"Institute of Pathology Heidelberg University Hospital  Heidelberg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8314-2682","authenticated-orcid":false,"given":"Jens U.","family":"Marquardt","sequence":"additional","affiliation":[{"name":"Department of Medicine I University Medical Center\u2014Campus L\u00fcbeck  L\u00fcbeck Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8451-8015","authenticated-orcid":false,"given":"Carolin","family":"Zimpel","sequence":"additional","affiliation":[{"name":"Department of Medicine I University Medical Center\u2014Campus L\u00fcbeck  L\u00fcbeck Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,9,20]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bpg.2015.02.003"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2019.03.013"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1055\/a\u20101589\u20107585"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa0908721"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2023.41.4_suppl.lba490"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.21.00679"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/evidoa2200015"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/liv.15641"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11523\u2010024\u201001044\u20101"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2007.11.008"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2023.10.001"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140\u20106736(23)00727\u20104"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa2206834"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/s1470\u20102045(20)30157\u20101"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/s1470\u20102045(20)30109\u20101"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers13143507"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers12113370"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm10132803"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/HEP.0000000000000688"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.xcrm.2023.101052"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1136\/jitc\u20102021\u2010003214"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11523\u2010024\u201001032\u20105"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2024.114148"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41698\u2010023\u201000380\u20101"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40425\u2010019\u20100805\u20108"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2023.1141148"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2023.41.16_suppl.4004"}],"container-title":["United European Gastroenterology Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ueg2.12656","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,21]],"date-time":"2024-11-21T04:57:18Z","timestamp":1732165038000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/ueg2.12656"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,20]]},"references-count":27,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2024,11]]}},"alternative-id":["10.1002\/ueg2.12656"],"URL":"https:\/\/doi.org\/10.1002\/ueg2.12656","archive":["Portico"],"relation":{},"ISSN":["2050-6406","2050-6414"],"issn-type":[{"value":"2050-6406","type":"print"},{"value":"2050-6414","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,20]]}}}