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@ARTICLE{vandenBent:303036,
      author       = {M. J. van den Bent and T. F. Cloughesy and B. M. Ellingson
                      and J. E. Allen and S. C. Blackman and M. W. Kieran and J.
                      C. Tonn$^*$ and P. Karschnia and M. Wijnenga and J. Pallud
                      and R. J. Young and R. Y. Huang and I. K. Mellinghoff and J.
                      de Groot and A. van der Hoorn and G. Youssef and S. L.
                      Hervey-Jumper and M. A. Vogelbaum and S. M. Chang and P. Y.
                      Wen},
      title        = {{T}he {U}se of {M}inor {R}esponse, {V}olumetric
                      {A}ssessment and {G}rowth {R}ate {K}inetics as {E}ndpoints
                      in {G}rade 1-3 {G}lioma {C}linical {T}rials: a {RANO}
                      perspective.},
      journal      = {Neuro-Oncology},
      volume       = {nn},
      issn         = {1522-8517},
      address      = {Oxford},
      publisher    = {Oxford Univ. Press},
      reportid     = {DKFZ-2025-01483},
      pages        = {nn},
      year         = {2025},
      note         = {epub},
      abstract     = {The RANO criteria for response to treatment in glioma make
                      a distinction between enhancing and unenhancing tumors,
                      which reflects assessment of a different biological process
                      underlying the MRI findings in enhancing and non-enhancing
                      tumors. The recent regulatory approval of tovorafenib has
                      also considered the patients with minor responses $(25\%$ -
                      $50\%$ decrease) based on the 2D measurement on T2/FLAIR MR
                      imaging, while incorporating other measures of patient
                      benefit. The INDIGO placebo controlled trial led to the
                      regulatory approval of vorasidenib based on the increase in
                      PFS in the active treatment arm, as measured by blinded
                      independent radiology review using the 2D RANO criteria.
                      With that, more insight in the regulatory requirements for
                      approval in low grade tumors has been obtained, but other
                      issues in assessing outcome in studies on low grade
                      enhancing tumors remain. These include the added value of
                      volumetric assessment instead of 2D assessments, and
                      assessment of tumor growth rate as an early marker of
                      outcome. This manuscript gives an overview of the current
                      perspective on and challenges of assessing outcome in trials
                      on unenhancing glioma, with both regulatory and clinical
                      perspectives.},
      keywords     = {Minor Response (Other) / RANO (Other) / Tumor Growth rate
                      (Other) / unenhancing tumors (Other) / volumetric (3D)
                      assessment (Other)},
      cin          = {MU01},
      ddc          = {610},
      cid          = {I:(DE-He78)MU01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:40692474},
      doi          = {10.1093/neuonc/noaf173},
      url          = {https://inrepo02.dkfz.de/record/303036},
}