Circulating Tumor DNA Analysis in Patients With Cancer: American Society of Clinical Oncology and College of American Pathologists Joint Review.
By J. Merker, G. Oxnard, C. Compton, M. Diehn, P. Hurley, A. Lazar, N. Lindeman, C. Lockwood, A. Rai, R. Schilsky and 7 more. Journal of Clinical Oncology, 2018
899 citations recorded by the source corpus.
Purpose Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from ASCO and the College of American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research. Methods An Expert Panel conducted a literature review on the use of ctDNA assays for solid tumors, including pre-analytical variables, analytical validity, interpretation and reporting, and clinical validity and utility. Results The literature search identified 1,338 references. Of those, 390, plus 31 references supplied by the Expert Panel, were selected for full-text review. There were 77 articles selected for inclusion. Conclusion The evidence indicates that testing for ctDNA is optimally performed on plasma collected in cell stabilization or EDTA tubes, with EDTA tubes processed within 6 hours of collection. Some ctDNA assays have demonstrated clinical validity and utility with certain types of advanced cancer; however, there is insufficient evidence of clinical validity and utility for the majority of ctDNA assays in advanced cancer. Evidence shows discordance between the results of ctDNA assays and genotyping tumor specimens and supports tumor tissue genotyping to confirm undetected results from ctDNA tests. There is no evidence of clinical utility and little evidence of clinical validity of ctDNA assays in early-stage cancer, treatment monitoring, or residual disease detection. There is no evidence of clinical validity and clinical utility to suggest that ctDNA assays are useful for cancer screening, outside of a clinical trial. Given the rapid pace of research, re-evaluation of the literature will shortly be required, along with the development of tools and guidance for clinical practice.
Subfields: Cancer Research, Molecular Biology, Pulmonary and Respiratory Medicine
View Paper: https://www.semanticscholar.org/paper/682a6fd5a40b59709a6bbd2318debd802330e5ef
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Citations in the corpus
- 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) (2020, background): “There is insufficient evidence of clinical validity and utility for themajority of circulating tumour DNA (ctDNA) assays in advanced cancer.(82) Thus, ctDNA assessment is not recommended for demonstration of disease progression in ABC.”
- Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA (2020, neutral): “11 Annals of Oncology indels) that focus on key alterations associated with speci fi c tumor types or treatment options 12 may be hampered by confounding signals from white blood cells (WBCs) or other tissue.”