TY  - JOUR
AU  - Stintzing, Sebastian
AU  - Heinrich, Kathrin
AU  - Tougeron, David
AU  - Modest, Dominik Paul
AU  - Schwaner, Ingo
AU  - Eucker, Jan
AU  - Pihusch, Rudolf
AU  - Stauch, Martina
AU  - Kaiser, Florian
AU  - Kahl, Christoph
AU  - Karthaus, Meinolf
AU  - Müller, Christian
AU  - Burkart, Christof
AU  - Reinacher-Schick, Anke
AU  - Kasper-Virchow, Stefan
AU  - Fischer von Weikersthal, Ludwig
AU  - Krammer-Steiner, Beate
AU  - Prager, Gerald Wolfgang
AU  - Taieb, Julien
AU  - Heinemann, Volker
TI  - 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.
JO  - Journal of clinical oncology
VL  - 41
IS  - 25
SN  - 0732-183X
CY  - Alexandria, Va.
PB  - American Society of Clinical Oncology
M1  - DKFZ-2023-01266
SP  - 4143-4153
PY  - 2023
N1  - 2023 Sep 1;41(25):4143-4153
AB  - 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
LB  - PUB:(DE-HGF)16
C6  - pmid:37352476
DO  - DOI:10.1200/JCO.22.01420
UR  - https://inrepo02.dkfz.de/record/277101
ER  -