CTCs as a prognostic and predictive biomarker for stage II/III Colon Cancer: a companion study to the PePiTA trial.
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Colonic Neoplasms
/ drug therapy
Female
Fluorouracil
/ therapeutic use
Humans
Leucovorin
/ therapeutic use
Male
Middle Aged
Neoadjuvant Therapy
Neoplasm Staging
Neoplastic Cells, Circulating
/ drug effects
Organoplatinum Compounds
/ therapeutic use
Predictive Value of Tests
Prognosis
Prospective Studies
Sample Size
Treatment Outcome
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
03 Apr 2019
03 Apr 2019
Historique:
received:
29
06
2018
accepted:
27
03
2019
entrez:
5
4
2019
pubmed:
5
4
2019
medline:
30
7
2019
Statut:
epublish
Résumé
Adjuvant therapy improves the prognosis of stage II & III colon cancer patients. Unfortunately, most patients do not benefit from this treatment. PePITA (NCT00994864) is a prospective, multicenter, non-randomized study whose primary objective is to predict the outcome of adjuvant therapy in colon cancer. The primary objective was to determine the prognostic and predictive value of circulating tumor cell (CTC) detection before therapy and after one course of preoperative FOLFOX. Out of the 58 first patients accrued in PePiTA trial, 36 patients participated in the CTC companion study, of whom 32 had at least one evaluable sample. Only 5 patients (14, 95% CI = 5-30%) had ≥1 CTC/22.5 ml blood in at least one of the two timepoints with 2 patients having ≥1 CTC/22.5 ml at baseline (6, 95% CI: 1-19%). The detection rate of patients with CTCs at baseline being lower than expected, the inclusion of patients in the PePiTA CTC substudy was stopped. The limited sample size did not allow us to investigate the prognostic and predictive value of CTCs in locally advanced colon cancer. Our data illustrate the need for further standardized studies in order to find the most reliable prognostic/predictive biomarker in early-stage colon cancer. This trial was prospectively registered at Jules Bordet institute ( NCT00994864 ) on the October 14, 2009.
Sections du résumé
BACKGROUND
BACKGROUND
Adjuvant therapy improves the prognosis of stage II & III colon cancer patients. Unfortunately, most patients do not benefit from this treatment. PePITA (NCT00994864) is a prospective, multicenter, non-randomized study whose primary objective is to predict the outcome of adjuvant therapy in colon cancer.
METHODS
METHODS
The primary objective was to determine the prognostic and predictive value of circulating tumor cell (CTC) detection before therapy and after one course of preoperative FOLFOX.
RESULTS
RESULTS
Out of the 58 first patients accrued in PePiTA trial, 36 patients participated in the CTC companion study, of whom 32 had at least one evaluable sample. Only 5 patients (14, 95% CI = 5-30%) had ≥1 CTC/22.5 ml blood in at least one of the two timepoints with 2 patients having ≥1 CTC/22.5 ml at baseline (6, 95% CI: 1-19%). The detection rate of patients with CTCs at baseline being lower than expected, the inclusion of patients in the PePiTA CTC substudy was stopped. The limited sample size did not allow us to investigate the prognostic and predictive value of CTCs in locally advanced colon cancer.
CONCLUSIONS
CONCLUSIONS
Our data illustrate the need for further standardized studies in order to find the most reliable prognostic/predictive biomarker in early-stage colon cancer.
TRIAL REGISTRATION
BACKGROUND
This trial was prospectively registered at Jules Bordet institute ( NCT00994864 ) on the October 14, 2009.
Identifiants
pubmed: 30943928
doi: 10.1186/s12885-019-5528-1
pii: 10.1186/s12885-019-5528-1
pmc: PMC6446374
doi:
Substances chimiques
Organoplatinum Compounds
0
Leucovorin
Q573I9DVLP
Fluorouracil
U3P01618RT
Types de publication
Clinical Study
Journal Article
Multicenter Study
Langues
eng
Pagination
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