RAS mutation analysis in circulating tumor DNA from patients with metastatic colorectal cancer: the AGEO RASANC prospective multicenter study.

摘要: Abstract Background RAS mutations are currently sought for in tumor samples, which takes a median of almost 3weeks western European countries. This creates problems clinical situations that require urgent treatment and inclusion therapeutic trials need status randomization. Analysis circulating DNA might help to shorten the time required determine mutational before anti-epidermal growth factor receptor antibody therapy metastatic colorectal cancer. Here we compared plasma with tissue analysis large prospective multicenter cohort. Patients methods Plasma samples were collected prospectively from chemotherapy-naive patients analyzed centrally by next-generation sequencing (NGS) colon lung cancer V2 Ampliseq panel methylation digital PCR (WIF1 NPY genes). Tumoral was determined locally, parallel, according routine practice. For minimal κ coefficient 0.7, reflecting acceptable concordance (precision±0.07), an estimated 5% non-exploitable data, 425 subjects necessary. Results From July 2015 December 2016, enrolled. 412 available paired 0.71 [95% confidence interval (CI), 0.64–0.77] accuracy 85.2% (95% CI, 81.4% 88.5%). In 329 detectable ctDNA (at least one mutation or methylated biomarker), 0.89 0.84–0.94) 94.8% 91.9% 97.0%). The absence liver metastases main associated inconclusive results [odds ratio=0.11 0.06–0.21)]. metastases, 93.5% NGS alone 97% plus biomarkers. Conclusion trial demonstrates excellent between thus validating testing these patients. Clinical Trial registration Clinicaltrials.gov, NCT02502656.