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@ARTICLE{Stintzing:298573,
author = {S. Stintzing$^*$ and S. Klein-Scory and L. Fischer von
Weikersthal and M. Fuchs and F. Kaiser and K. Heinrich and
D. P. Modest and R.-D. Hofheinz and T. Decker and A. Gerger
and S. Angermeier and H. Rumpold and A. Dickhut and L.
Öhler and B. Gruenberger and D. Niedersuess-Beke and M.
Sandmann and T. Winder and J. Trojan and G. Prager and S.
Held and J. Kumbrink$^*$ and W. Schmiegel and A. Baraniskin
and V. Heinemann$^*$},
title = {{B}aseline {L}iquid {B}iopsy in {R}elation to
{T}issue-{B}ased {P}arameters in {M}etastatic {C}olorectal
{C}ancer: {R}esults {F}rom the {R}andomized {FIRE}-4
({AIO}-{KRK}-0114) {S}tudy.},
journal = {Journal of clinical oncology},
volume = {43},
number = {12},
issn = {0732-183X},
address = {Alexandria, Va.},
publisher = {American Society of Clinical Oncology},
reportid = {DKFZ-2025-00290},
pages = {1463-1473},
year = {2025},
note = {2025 Apr 20;43(12):1463-1473},
abstract = {The FIRE-4 study randomly assigned patients with first-line
RAS wild-type (RASwt) metastatic colorectal cancer to either
flourouracil (FU), folinic acid, and irinotecan (FOLFIRI)
plus cetuximab until progression or intolerable toxicity
(standard arm) or to FOLFIRI plus cetuximab followed by a
switch maintenance treatment using FU plus bevacizumab
(experimental arm). Here, we investigate the relevance of
liquid biopsy (LB) RAS and BRAF testing compared with
tissue-based analyses.LBs were taken at baseline and during
treatment and were analyzed for RAS and BRAFV600E mutations
using the in vitro diagnostics-certified ONCOBEAM RAS
procedure (Sysmex Inostics) and digital-droplet polymerase
chain reaction technology.Six hundred seventy-two RASwt
patients were randomly assigned. LBs of 540 patients were
evaluable at baseline. Of those, 70 $(13\%)$ were RAS mutant
(RASmut) and 38 $(7\%)$ BRAFV600E mutant. RASmut patients
had significantly shorter survival compared with RASwt
patients (progression-free survival [PFS], 9.0 months v 11.5
months; P < .001; hazard ratio [HR], 1.66; overall survival
[OS], 22.1 months v 33.6 months; P < .001; HR, 1.85). RASmut
patients had a numerically greater benefit from early switch
maintenance compared with continuation of FOLFIRI/cetuximab
(PFS, 10.1 months v 6.4 months; HR, 0.82; OS, 24.9 months v
16.3 months; HR, 0.57). Patients with a BRAFV600E mutation
in LB showed poor outcome (PFS, 5.4 months; OS, 12.0
months). On the basis of serial LB analyses, the conversion
rate from RASwt to RASmut at disease progression was
significantly higher in the arm with continuous cetuximab
administration than in the switch maintenance arm.LB allows
the detection of RAS and BRAF mutations in patients deemed
RASwt on the basis of tissue analyses. These patients show
outcome characteristics expected for RAS- and BRAF-mutant
patients in tissue. The study thus confirms the high
clinical relevance of LB performed at baseline before the
start of therapy.},
cin = {BE01 / MU01},
ddc = {610},
cid = {I:(DE-He78)BE01-20160331 / I:(DE-He78)MU01-20160331},
pnm = {899 - ohne Topic (POF4-899)},
pid = {G:(DE-HGF)POF4-899},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:39903881},
doi = {10.1200/JCO.24.01174},
url = {https://inrepo02.dkfz.de/record/298573},
}