ASCO Report Details "Insufficient Evidence" for Liquid Biopsies to Guide Cancer Treatment


Limited evidence exists that supports the use of most circulating tumor DNA assays in the diagnosis or management of early-stage or advanced solid tumors, according to an expert review published by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists.

"Like all new things in medicine, the use of circulating tumor DNA assays in routine cancer care requires evidence of clinical utility. At present, there is insufficient evidence of clinical validity and utility for the majority of circulating tumor DNA assays in advanced cancer, including those that interrogate a panel of genes," said Daniel F Hayes, MD, coauthor of the review, ASCO, in a press release (March 5, 2018).

An expert panel conducted a literature review on the use of circulating tumor DNA assays for solid tumors, including pre-analytical variables, analytical validity, interpretation and reporting, and clinical validity and utility. The review included 77 selected articles published from January 2007 through March 2017.

Although the expert panel agreed that some circulating tumor DNA assays showed clinical validity and utility for certain advanced cancers, there was “insufficient evidence” to justify using the assays outside of clinical trials. Similar “insufficient evidence” exists for the use of circulating tumor DNA assays in making treatment decisions in early-stage cancer, detecting residual disease, or screening for cancer, they added.

“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,” the panel wrote.


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“What is promising is that this area of research is rapidly evolving, so there should be enough evidence soon to formulate evidence-based guidance for a variety of clinical scenarios,” said Dr Hayes.—Zachary Bessette