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@ARTICLE{Fokas:292460,
      author       = {E. Fokas$^*$ and H. Williams and M. Diefenhardt$^*$ and S.
                      Lin and L.-X. Qin and P. Piso and H. Dapper and C.-T. Germer
                      and R. Grützmann and J. Tim Friede and J. Joshua Smith and
                      L. B. Saltz and A. J. Wu and M. R. Weiser and D. Omer and M.
                      Ghadimi and R.-D. Hofheinz and J. Garcia-Aguilar and C.
                      Rödel$^*$ and G. R. C. S. Group},
      collaboration = {t. O. Consortium},
      title        = {{C}hemoradiotherapy plus induction or consolidation
                      chemotherapy as total neoadjuvant therapy for locally
                      advanced rectal cancer: {P}ooled analysis of the
                      {CAO}/{ARO}/{AIO}-12 and the {OPRA} randomized phase 2
                      trials.},
      journal      = {European journal of cancer},
      volume       = {210},
      issn         = {0014-2964},
      address      = {Amsterdam [u.a.]},
      publisher    = {Elsevier},
      reportid     = {DKFZ-2024-01726},
      pages        = {114291},
      year         = {2024},
      abstract     = {Total neoadjuvant therapy (TNT) has been used for patients
                      with locally advanced rectal cancer. The optimal sequence of
                      chemoradiotherapy (CRT) and chemotherapy (CT) is a matter of
                      debate.We performed a pooled analysis of the CAO/ARO/AIO-12
                      and OPRA multicenter, randomized phase 2 trials to identify
                      patient subsets that could benefit from one TNT sequence
                      over the other regarding disease-free survival (DFS).
                      Patients with stage II/III rectal cancer were randomized to
                      CRT (50.4-54 Gy) with either induction (INCT-CRT) or
                      consolidation CT (CRT-CNCT) with fluorouracil, leucovorin,
                      oxaliplatin (CAO/ARO/AIO-12 and OPRA) or capecitabine and
                      oxaliplatin (OPRA) followed by mandatory total mesorectal
                      excision (TME) (CAO/ARO/AIO-12) or selective watch-and-wait
                      surveillance (OPRA). 311 and 324 patients were recruited
                      from June 15, 2015 to January 31, 2018; and from April 12,
                      2014 to March 30, 2020 in the two trials, respectively.
                      Pretreatment clinical and tumor characteristics included
                      were age, sex, ECOG, cT-category, cN-category, clinical UICC
                      stage, location from anal verge, and tumor grade.In total,
                      628 eligible patients were included in the pooled analysis
                      (CAO/ARO/AIO-12, n = 304; OPRA, n = 324). Of those, 313 were
                      randomly assigned to the INCT-CRT group, and 315 to the
                      CRT-CNCT group. Median follow-up was 43 months (IQR, 35-49)
                      months in the CAO/ARO/AIO-12 trial and 61,2 months (IQR,
                      42-68,4) in the OPRA trial. Pooled analysis of baseline
                      clinical and tumor characteristics did not identify any
                      subgroups of patients that would benefit by the one TNT
                      sequence over the other with regard to DFS.To our knowledge,
                      this is the first pooled analysis of two randomized trials
                      after direct head-to-head comparison of both TNT sequences.
                      Both trials reported higher rates of complete response with
                      CRT-CNCT, and this should be considered the preferred TNT
                      sequence if organ preservation is a priority.},
      keywords     = {Oncological guidelines (Other) / Pooled analysis (Other) /
                      Randomized trials (Other) / Rectal cancer (Other) / Sequence
                      (Other) / Total neoadjuvant treatment (Other)},
      cin          = {FM01},
      ddc          = {610},
      cid          = {I:(DE-He78)FM01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:39180940},
      doi          = {10.1016/j.ejca.2024.114291},
      url          = {https://inrepo02.dkfz.de/record/292460},
}