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@ARTICLE{Mitzlaff:293582,
      author       = {K. Mitzlaff and M. M. Kirstein and C. Müller and M.
                      Venerito and A. Olkus and M. T. Dill$^*$ and A. Weinmann and
                      L. Kocheise and A. Busch and K. Schulze and G. Allo and
                      D.-T. Waldschmidt and M. Barsch and B. Bengsch and M. Quante
                      and M. A. Gonzalez-Carmona and V. Himmelsbach and F.
                      Finkelmeier and R. Kloeckner and P. Schirmacher and J. U.
                      Marquardt and C. Zimpel},
      title        = {{E}fficacy, safety and differential outcomes of
                      immune-chemotherapy with gemcitabine, cisplatin and
                      durvalumab in patients with biliary tract cancers: {A}
                      multicenter real world cohort.},
      journal      = {United european gastroenterology journal},
      volume       = {12},
      number       = {9},
      issn         = {2050-6406},
      address      = {Hoboken, NJ},
      publisher    = {Wiley},
      reportid     = {DKFZ-2024-01905},
      pages        = {1230-1242},
      year         = {2024},
      note         = {2024 Nov;12(9):1230-1242},
      abstract     = {Combined 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.},
      keywords     = {biliary tract cancers (Other) / check‐point inhibition
                      (Other) / cholangiocarcinoma (Other) / cisplatin (Other) /
                      durvalumab (Other) / gemcitabine (Other) /
                      immuno‐chemotherapy (Other) / programmed death‐ligand 1
                      inhibitor (Other)},
      cin          = {D500},
      ddc          = {610},
      cid          = {I:(DE-He78)D500-20160331},
      pnm          = {314 - Immunologie und Krebs (POF4-314)},
      pid          = {G:(DE-HGF)POF4-314},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:39301763},
      doi          = {10.1002/ueg2.12656},
      url          = {https://inrepo02.dkfz.de/record/293582},
}