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000293582 0247_ $$2ISSN$$a2050-6414
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000293582 041__ $$aEnglish
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000293582 1001_ $$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$$c2024
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000293582 500__ $$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.
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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
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