Abstract
BackgroundAdjuvant 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.MethodsThe 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.ResultsOut 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.ConclusionsOur data illustrate the need for further standardized studies in order to find the most reliable prognostic/predictive biomarker in early-stage colon cancer.Trial registrationThis trial was prospectively registered at Jules Bordet institute (NCT00994864) on the October 14, 2009.
Highlights
Adjuvant therapy improves the prognosis of stage II & III colon cancer patients
In stage III colon cancer, FOLFOX adjuvant chemotherapy is associated with a statistically significant improvement in disease-free survival (DFS) and overall survival (OS) by more than 20% compared to surgery alone [3]
Out of 58 patients registered in the PePiTA trial at the time of the evaluation of the circulating tumor cell (CTC) companion study, blood samples for CTC analysis were obtained from 36 (62%) patients enrolled in 11 recruiting clinical sites
Summary
Adjuvant therapy improves the prognosis of stage II & III colon cancer patients. most patients do not benefit from this treatment. Changes in CTC count between baseline and the second anti-cancer treatment course in advanced breast cancer [6,7,8] have been associated with an adverse prognostic and predictive value on the patient’s outcome, with a reported good “negative predictive value of CTCs” This finding has been reiterated in other metastatic cancer types, such as colorectal [9,10,11,12,13,14,15,16,17], prostate [18,19,20], melanoma [21, 22], gastric [23], ovarian [24] and lung cancer [25, 26]
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