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  3. Association of Circulating Tumor Cells and Tumor Molecular Profile With Clinical Outcomes in Patients With Previously Untreated Metastatic Colorectal Cancer: A Pooled Analysis of the Phase III VISNu-1 and Phase II VISNu-2 Randomized Trials

Association of Circulating Tumor Cells and Tumor Molecular Profile With Clinical Outcomes in Patients With Previously Untreated Metastatic Colorectal Cancer: A Pooled Analysis of the Phase III VISNu-1 and Phase II VISNu-2 Randomized Trials

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Autores de IDIVAL

Autores ajenos al IDIVAL

  • Jiménez-Fonseca P
  • Sastre J
  • García-Alfonso P
  • Gómez-España MA
  • Salud A
  • Gil S
  • Reina JJ
  • Quintero G
  • Valladares-Ayerbes M
  • Safont MJ
  • La Casta A
  • Robles-Díaz L
  • García-Paredes B
  • López López R
  • Guillot M
  • Gallego J
  • Alonso-Orduña V
  • Diaz-Rubio E
  • Aranda E
  • Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD)

Unidades

Abstract

Baseline circulating tumor cell (bCTC ) enumeration is an established biomarker in metastatic colorectal cancer (mCRC). A total of 589 untreated mCRC patients from 2 randomized clinical trials were included for evaluation of the prognostic/predictive role of the bCTC count ( >3 vs. < 3). Our results confirm the poor prognosis of patients with bCTC >3 but this is not associated with other adverse prognostic factors such as RAS/BRAF mutations. 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.

Copyright © 2023 Elsevier Inc. All rights reserved.

Datos de la publicación

ISSN/ISSNe:
1533-0028, 1938-0674

CLINICAL COLORECTAL CANCER  CIG MEDIA GROUP, LP

Tipo:
Article
Páginas:
222-230
PubMed:
36944559
Enlace a otro recurso:
www.sciencedirect.com

Citas Recibidas en Web of Science: 3

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Keywords

  • Metastatic colorectal cancer; Prognostic factors; Bevacizumab; BRAF; RAS

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