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@ARTICLE{Hassel:278644,
      author       = {J. C. Hassel and C. Berking and A. Forschner and C.
                      Gebhardt and L. Heinzerling and F. Meier and S.
                      Ochsenreither and J. Siveke$^*$ and A. Hauschild and D.
                      Schadendorf$^*$},
      title        = {{P}ractical guidelines for the management of adverse events
                      of the {T} cell engager bispecific tebentafusp.},
      journal      = {European journal of cancer},
      volume       = {191},
      issn         = {0014-2964},
      address      = {Amsterdam [u.a.]},
      publisher    = {Elsevier},
      reportid     = {DKFZ-2023-01688},
      pages        = {112986},
      year         = {2023},
      abstract     = {Tebentafusp is a new T cell receptor bispecific fusion
                      protein and the first approved treatment option for human
                      leucocyte antigen-A*02:01 (HLA-A*02:01) metastatic uveal
                      melanoma, with a proven benefit in overall survival versus
                      the investigator's choice. As a first-in-class therapeutic
                      option, this Immune mobilising monoclonal T cell receptor
                      Against Cancer (ImmTAC) is associated with a new adverse
                      event (AE) profile. Based on clinical experience, a national
                      expert group discussed recommendations for tebentafusp
                      treatment, focusing on AE management. Further topics
                      included prerequisites for initiating tebentafusp treatment,
                      appropriate treatment setting, and patient selection
                      criteria. To provide guidance for treating physicians, the
                      resulting recommendations are summarised including a model
                      standard operating procedure for AE management. Patients in
                      good clinical condition and with a low tumour burden are
                      good candidates for tebentafusp treatment, particularly if
                      treated as early as possible after the diagnosis of
                      metastatic disease. The safety profile of tebentafusp is
                      manageable and includes two major pathologies: cytokine
                      release syndrome (CRS) and skin-related events. Postdose
                      monitoring should thus focus on pyrexia and hypotension as
                      the first symptoms of cytokine release. To minimise the risk
                      of hypotension associated with CRS, patients should receive
                      intravenous fluids before starting treatment. The monitoring
                      of liver values is crucial, as patients may experience an
                      increase in transaminases, which can even manifest as tumour
                      lysis syndrome.},
      keywords     = {Adverse event management (Other) / Bispecific (Other) /
                      Cytokine release syndrome (Other) / Expert opinion (Other) /
                      Immune mobilising monoclonal T cell receptor against cancer
                      (ImmTAC) (Other) / Skin toxicity (Other) / Tebentafusp
                      (Other) / Treatment recommendation (Other) / Uveal melanoma
                      (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:37595494},
      doi          = {10.1016/j.ejca.2023.112986},
      url          = {https://inrepo02.dkfz.de/record/278644},
}