Can I read FOLFOXIRI Plus Cetuximab or Bevacizumab as First-Line Treatment of BRAF ^V600E^-Mutant Metastatic Colorectal Cancer: The Randomized Phase II FIRE-4.5 (AIO KRK0116) Study on EtoBox?

FOLFOXIRI Plus Cetuximab or Bevacizumab as First-Line Treatment of BRAF ^V600E^-Mutant Metastatic Colorectal Cancer: The Randomized Phase II FIRE-4.5 (AIO KRK0116) Study by Sebastian Stintzing; Kathrin Heinrich; David Tougeron; Dominik Paul Modest; Ingo Schwaner; Jan Eucker; Rudolf Pihusch; Martina Stauch; Florian Kaiser; Christoph Kahl; Meinolf Karthaus; Christian Müller; Christof Burkart; Anke Reinacher-Schick; Stefan Kasper-Virchow; Ludwig Fischer von Weikersthal; Beate Krammer-Steiner; Gerald Wolfgang Prager; Julien Taieb; Volker Heinemann is a Medicine article available to read on EtoBox.

What is FOLFOXIRI Plus Cetuximab or Bevacizumab as First-Line Treatment of BRAF ^V600E^-Mutant Metastatic Colorectal Cancer: The Randomized Phase II FIRE-4.5 (AIO KRK0116) Study about?

## PURPOSE BRAF^V600E^ 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 BRAF^V600E^-mutant mCRC. ## PATIENTS AND METHODS 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. ## RESULTS 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% (30/59) in the cetuximab-based experimental a

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Author

Sebastian Stintzing; Kathrin Heinrich; David Tougeron; Dominik Paul Modest; Ingo Schwaner; Jan Eucker; Rudolf Pihusch; Martina Stauch; Florian Kaiser; Christoph Kahl; Meinolf Karthaus; Christian Müller; Christof Burkart; Anke Reinacher-Schick; Stefan Kasper-Virchow; Ludwig Fischer von Weikersthal; Beate Krammer-Steiner; Gerald Wolfgang Prager; Julien Taieb; Volker Heinemann

Publisher

American Society of Clinical Oncology (ASCO)

Published

2023

Language

EN

Field

Medicine (Health Sciences)