Abstract
Background
The bCTC count is a well-established prognostic biomarker in mCRC, as well as in other
tumor types. The aim of this analysis was to evaluate the prognostic/predictive role
of the bCTC count (≥3 vs. <3) in previously untreated mCRC.
Patients and Methods
The study involved 589 untreated mCRC patients included in the intention-to-treat
population of 2 randomized clinical trials (phase III VISNU-1 [NCT01640405] and phase
II VISNU-2 [NCT01640444] studies).
Results
Of the 589 patients, 349 (59.2%) had bCTC≥3 and 240 (40.7%) had bCTC<3. Multivariate
analysis showed that the bCTC count is an independent prognostic factor for overall
survival (OS) (HR 0.59, 95% CI 0.48-0.72; P = 0.000) and potential for progression-free survival (PFS) (P = 0.0549). Median OS was 32.9 and 19.5 months in patients with bCTC<3 and bCTC≥3
(P <0.001), respectively. This effect was also observed comparing OS in RASwt patients
from both studies. Other prognostic factors were: ECOG-PS, primary tumor site, number
of metastatic sites and surgery of the primary tumor. Median OS was lower for patients
treated with anti-VEGF versus anti-EGFR (22.3 vs. 33.3 months, P <0.0001) while there were no significant differences in PFS according to the targeted
treatment received.
Conclusion
This post-hoc analysis of 2 randomized studies confirms the poor prognosis of patients
with bCTC≥3 but this is not associated with other adverse independent prognostic factors
such as RAS/BRAF mutations.
Keywords
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Article info
Publication history
Published online: February 20, 2023
Accepted:
February 10,
2023
Received in revised form:
January 30,
2023
Received:
April 6,
2022
Publication stage
In Press Journal Pre-ProofIdentification
Copyright
© 2023 Elsevier Inc. All rights reserved.
