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@ARTICLE{Dinkel:306673,
      author       = {H. Dinkel and L. Materna and R. Stelmach and S. Zschäbitz
                      and S. Neuberger and C. D. Aydogdu and J. Casuscelli and T.
                      Egenolf and M. Silberg and J. Steinestel and A. Strauss and
                      F. Kirchhoff and M. Ahrens and P. Paffenholz and R. Cathomas
                      and B. C. Özdemir and C. Gossler and P. Ivanyi and M.
                      Rehlinghaus and T. Hilser$^*$ and V. Grünwald$^*$ and K.
                      Schlack},
      title        = {{R}eal-world efficacy and toxicity of ipilimumab and
                      nivolumab as a first-line treatment for advanced renal cell
                      carcinoma according to {IMDC} risk criteria-{A} multi-center
                      retrospective analysis on behalf of the {GUARDIANS} group.},
      journal      = {International journal of cancer},
      volume       = {nn},
      issn         = {0020-7136},
      address      = {Bognor Regis},
      publisher    = {Wiley-Liss},
      reportid     = {DKFZ-2025-02666},
      pages        = {nn},
      year         = {2025},
      note         = {epub},
      abstract     = {Ipilimumab and nivolumab are recommended as first-line
                      therapy for patients with metastatic or advanced renal cell
                      carcinoma (aRCC) and International Metastatic RCC Database
                      Consortium (IMDC) intermediate or poor risk. We
                      retrospectively evaluated efficacy and safety in a
                      multi-center real-world cohort with 356 patients initiating
                      ipilimumab and nivolumab from 17 centers in Germany and
                      Switzerland. Median age was 64 years, most patients were
                      male $(69.1\%)$ and had clear cell histology $(74.1\%).$
                      IMDC risk was intermediate in $61.8\%$ and poor in $28.7\%.$
                      About $37.1\%$ of cases did not meet the inclusion criteria
                      for the CheckMate 214 pivotal study (e.g., poor Eastern
                      Cooperative Oncology Group [Performance Status Scale] [ECOG]
                      status, comorbidities, brain metastases, and impaired renal
                      function). After a median follow-up of 17.5 months, complete
                      response was seen in $8.7\%,$ partial response in $28.7\%$
                      of patients. Median progression-free survival (PFS) was 8
                      $(95\%$ confidence interval [CI] 5.4-10.6) and median
                      overall survival (OS) 39 months $(95\%$ CI 27.5-50.5).
                      Subgroup analysis of patients with non-clear cell histology
                      showed a shorter PFS and OS. Other negative predictors were
                      poor ECOG, fewer induction cycles, ineligibility to pivotal
                      study, and hepatic metastases. Adverse events occurred in
                      $76.4\%$ of patients $(35.4\%$ ≥ grade 3). High-dose
                      corticosteroids were applied in $27.3\%$ of cases.
                      Cabozantinib was most frequently administered $(63.4\%)$ as
                      subsequent therapy and showed superior OS and PFS compared
                      to other second-line options. Our data support ipilimumab
                      and nivolumab as a first-line treatment of aRCC with robust
                      efficacy and safety. Patient selection was less restrictive
                      in our clinical practice and may explain differences to
                      CheckMate 214 trial.},
      keywords     = {immunotherapy (Other) / ipilimumab (Other) / nivolumab
                      (Other) / real‐world (Other) / renal cell carcinoma
                      (Other)},
      cin          = {ED01},
      ddc          = {610},
      cid          = {I:(DE-He78)ED01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:41317031},
      doi          = {10.1002/ijc.70267},
      url          = {https://inrepo02.dkfz.de/record/306673},
}