%0 Journal Article
%A Stintzing, Sebastian
%A Heinrich, Kathrin
%A Tougeron, David
%A Modest, Dominik Paul
%A Schwaner, Ingo
%A Eucker, Jan
%A Pihusch, Rudolf
%A Stauch, Martina
%A Kaiser, Florian
%A Kahl, Christoph
%A Karthaus, Meinolf
%A Müller, Christian
%A Burkart, Christof
%A Reinacher-Schick, Anke
%A Kasper-Virchow, Stefan
%A Fischer von Weikersthal, Ludwig
%A Krammer-Steiner, Beate
%A Prager, Gerald Wolfgang
%A Taieb, Julien
%A Heinemann, Volker
%T FOLFOXIRI Plus Cetuximab or Bevacizumab as First-Line Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer: The Randomized Phase II FIRE-4.5 (AIO KRK0116) Study.
%J Journal of clinical oncology
%V 41
%N 25
%@ 0732-183X
%C Alexandria, Va.
%I American Society of Clinical Oncology
%M DKFZ-2023-01266
%P 4143-4153
%D 2023
%Z 2023 Sep 1;41(25):4143-4153
%X BRAFV600E mutation is associated with a poor outcome in metastatic colorectal cancer (mCRC). This clinical trial investigated the efficacy of triplet chemotherapy (fluorouracil, folinic acid, oxaliplatin, and irinotecan) combined with either cetuximab or bevacizumab in patients with previously untreated BRAFV600E-mutant mCRC.In this controlled, randomized, open-label phase II trial, 109 patients were randomly assigned, 107 of whom were included into the full analysis set (FAS). Patients were randomly assigned in a 2:1 ratio to receive either FOLFOXIRI plus cetuximab in the experimental arm (n = 72) or FOLFOXIRI plus bevacizumab in the control arm (n = 35). The primary end point was objective response rate (ORR) according to RECIST 1.1., evaluated in patients treated according to protocol (ATP population). Progression-free survival (PFS), overall survival (OS), toxicity, and feasibility were analyzed as secondary end points.Eighteen patients discontinued study treatment before the first tumor assessment, thus resulting in the ATP population of 89 patients. In these patients, ORR was 51
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:37352476
%R 10.1200/JCO.22.01420
%U https://inrepo02.dkfz.de/record/277101