% IMPORTANT: The following is UTF-8 encoded.  This means that in the presence
% of non-ASCII characters, it will not work with BibTeX 0.99 or older.
% Instead, you should use an up-to-date BibTeX implementation like “bibtex8” or
% “biber”.

@ARTICLE{Grosu:307436,
      author       = {A.-L. Grosu$^*$ and W. A. Weber and E. Graf and M. Mix and
                      U. Nestle and T. Schimek-Jasch and R. Wiehle and I. Mader
                      and U. Würtemberger and K.-J. Langen and M. Niyazi and F.
                      Paulsen and L. König and F. A. Giordano and I. Spehl and D.
                      Bernhardt and M. M. Schymalla and C. Pöttgen and S. Semrau
                      and T. Brunner and B. Hültenschmidt and B. J. Krause and I.
                      F. Ciernik and J. Beck and B. G. Baumert and P. T. Meyer$^*$
                      and H. Urbach and I. Popp},
      collaboration = {G. S. Group},
      othercontributors = {C. Belka and F. Eckert and M. J. Eble and E. Sperk and F.
                          Momm and S. E. Combs and B. Wiestler and R.
                          Engenhart-Cabillic and M. Stuschke and R. Fietkau and S.
                          Nadji and G. Hildebrandt and A. Chakravarti and S. C. Short
                          and C. Nieder and S. Schneider-Fuchs and M. Prinz},
      title        = {{O}-(2-[18{F}]fluoroethyl)-{L}-tyrosine-{PET}-guided versus
                      contrast-enhanced {T}1-weighted {MRI}-guided re-irradiation
                      in patients with recurrent glioblastoma ({GLIAA}/{NOA}-10
                      {ARO}2013-01): a multicentre, open-label, randomised trial.},
      journal      = {The lancet / Oncology},
      volume       = {nn},
      issn         = {1470-2045},
      address      = {London},
      publisher    = {The Lancet Publ. Group},
      reportid     = {DKFZ-2025-03035},
      pages        = {nn},
      year         = {2025},
      note         = {epub},
      abstract     = {O-(2-[18F]fluoroethyl)-L-tyrosine (FET)-PET has a higher
                      specificity than contrast-enhanced T1-weighted MRI
                      (CE-T1MRI) in diagnosing recurrent glioblastoma. We aimed to
                      evaluate whether a FET-PET-based target volume delineation,
                      compared with CE-T1MRI, improves outcomes in patients with
                      recurrent glioblastoma scheduled for re-irradiation.GLIAA
                      was a multicentre, open-label, parallel randomised study
                      done in 15 radiation oncology centres in Germany. Patients
                      aged 18 years or older with a Karnofsky performance score
                      greater than $60\%$ and a macroscopic WHO grade IV recurrent
                      glioblastoma (1-6 cm) were randomly assigned (1:1) to
                      receive either FET-PET-based or CE-T1MRI-based target volume
                      delineation followed by re-irradiation with 39 Gy in 13
                      fractions. Randomisation was performed centrally, using a
                      minimisation technique with a random element and a
                      computer-assisted randomisation tool, stratified by time
                      since first radiotherapy, previous chemotherapy, tumour
                      diameter, MGMT status, and planned chemotherapy. The primary
                      endpoint was progression-free survival from randomisation,
                      assessed in the per-protocol population (patients who
                      initiated treatment per their assigned group). Adverse
                      events were systematically assessed in all patients who
                      commenced therapy. The trial was registered with
                      ClinicalTrials.gov (NCT01252459), German Clinical Trials
                      Registry (DRKS00000634), and European Clinical Trials
                      Database (EudraCT 2012-001121-27), and is completed.Between
                      Nov 22, 2013, and Aug 18, 2021, 271 patients were recruited
                      and screened for eligibility, 200 of whom were randomly
                      assigned to re-irradiation based on FET-PET (n=100) or
                      CE-T1MRI (n=100). 85 $(43\%)$ participants were female and
                      115 $(58\%)$ were male. 98 patients in the FET-PET group and
                      97 in the CE-T1MRI group were treated per protocol. Median
                      follow-up for censored patients was 12·2 months (IQR
                      6·6-20·7). Median progression-free survival was 4·0
                      months $(95\%$ CI 3·7-5·2) in the FET-PET group and 4·9
                      months (3·7-6·0) in the CE-T1MRI group (one-sided
                      stratified log-rank p=0·98; adjusted hazard ratio 1·14
                      $[95\%$ CI 0·85-1·52]; p=0·39; median follow-up for six
                      censored patients 4·1 months [IQR 2·3-6·6]). The most
                      common grade 3-4 adverse event was radionecrosis (eight
                      $[8\%]$ of 99 in the FET-PET group vs seven $[7\%]$ of 99 in
                      the CE-T1MRI group). Acute and subacute serious adverse
                      events occurred in 15 $(15\%)$ of 99 patients in each group;
                      possibly re-irradiation-related late serious adverse events
                      occurred in ten $(10\%)$ of 97 patients in the FET-PET group
                      and 18 $(19\%)$ of 96 in the CE-T1MRI group. There were no
                      treatment-related deaths.FET-PET-based target volume
                      delineation for re-irradiation did not lead to a significant
                      clinical benefit compared with CE-T1MRI-based treatment in
                      patients with recurrent glioblastoma. Thus, CE-T1MRI remains
                      the preferred delineation method in this setting.Deutsche
                      Krebshilfe.},
      cin          = {FR01},
      ddc          = {610},
      cid          = {I:(DE-He78)FR01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:41429128},
      doi          = {10.1016/S1470-2045(25)00642-4},
      url          = {https://inrepo02.dkfz.de/record/307436},
}