Circulating Tumor DNA Analysis in Patients With Cancer: American Society of Clinical Oncology and College of American Pathologists Joint Review.
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Date
2018-06-01ICR Author
Author
Merker, JD
Oxnard, GR
Compton, C
Diehn, M
Hurley, P
Lazar, AJ
Lindeman, N
Lockwood, CM
Rai, AJ
Schilsky, RL
Tsimberidou, AM
Vasalos, P
Billman, BL
Oliver, TK
Bruinooge, SS
Hayes, DF
Turner, NC
Type
Journal Article
Metadata
Show full item recordAbstract
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.
Collections
Subject
Humans
Neoplasms
DNA, Neoplasm
Blood Specimen Collection
Societies, Medical
United States
Genotyping Techniques
Biomarkers, Tumor
Circulating Tumor DNA
Research team
Molecular Oncology
Language
eng
Date accepted
2018-05-16
License start date
2018-06
Citation
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2018, 36 (16), pp. 1631 - 1641
Publisher
LIPPINCOTT WILLIAMS & WILKINS