Circulating tumour DNA at baseline for individualised prognostication in patients with chemotherapy-naïve metastatic colorectal cancer. An AGEO prospective study

医学 内科学 危险系数 结直肠癌 肿瘤科 癌胚抗原 比例危险模型 置信区间 化疗 前瞻性队列研究 癌症 胃肠病学
作者
Jean–Baptiste Bachet,Pierre Laurent‐Puig,Aurélia Meurisse,Olivier Bouché,Léo Mas,Valérie Taly,Romain Cohen,Jean‐Marc Gornet,Pascal Artru,Samy Louafi,Anne Thirot‐Bidault,Isabelle Baumgaertner,Romain Coriat,David Tougeron,Thierry Lecomte,Florence Mary,Thomas Aparicio,Lysiane Marthey,Hélène Blons,Déwi Vernerey,Julien Taı̈eb
出处
期刊:European Journal of Cancer [Elsevier BV]
卷期号:189: 112934-112934 被引量:2
标识
DOI:10.1016/j.ejca.2023.05.022
摘要

Baseline circulating tumour DNA (ctDNA) is a potential prognostic marker in metastatic colorectal cancer (mCRC) patients. However, few studies have compared ctDNA with the usual prognostic factors, and no ctDNA cut-off has been proposed for daily use in clinical practice.Chemotherapy-naive patients with mCRC were prospectively included. Plasma samples were collected at diagnosis and analysed centrally by both NGS and methylation digital PCR. Baseline patient and disease characteristics, treatment regimens, and secondary surgeries were collected. The restricted cubic spline method was used to define the optimal cut-off of ctDNA mutated allelic frequency (MAF). Prognostic values were assessed on overall survival (OS) using Cox models.From July 2015 to December 2016, 412 patients were included. ctDNA was undetectable in 83 patients (20%). ctDNA was an independent prognostic marker for OS considering the whole study population. The optimal cut-off for ctDNA MAF was 20% with median OS of 16.0 and 35.8 months for patients with MAF ≥20% and<20%, respectively (hazard ratio = 0.40; 95% confidence intervals: 0.31-0.51; P < 0.0001). The independent prognostic value of ctDNA MAF at 20% was confirmed in subgroups defined by RAS/BRAF status or resectability of metastases. Combining ctDNA MAF and carcinoembryonic antigen levels allowed us to define three different prognostic groups with median OS of 14.2, 21.1, and 46.4 months (P < 0.0001).ctDNA with a MAF cut-off of 20% improves prognostication of chemotherapy-naïve mCRC patients and may be useful in the future for individualised therapeutic decisions and as a stratification factor in clinical trials.Clinicaltrials.gov, NCT02502656.
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