Use of Liquid Biopsies in Clinical Oncology

Purpose: There is growing interest in using circulating tumor DNA (ctDNA) testing in patients with cancer. Experimental Design: 168 patients with diverse cancers were analyzed. Patients had digital next-generation sequencing (54 cancer-related gene panel including amplifications in ERBB2, EGFR, and MET) performed on their plasma. Type of genomic alterations, potential actionability, concordance with tissue testing, and patient outcome were examined. Results: Fifty-eight percent of patients (98/168) had {greater than or equal to}1 ctDNA alteration(s). Of the 98 patients with alterations, 71.4% had {greater than or equal to} 1 alteration potentially actionable by an FDA-approved drug. The median time interval between the tissue biopsy and the blood draw was 2.7 months for patients with {greater than or equal to} 1 alteration in common compared to 14.4 months (P=0.006) for the patients in whom no common alterations were identified in the tissue and plasma. Overall concordance rates for tissue and ctDNA were 70.3% for TP53 and EGFR, 88.1% for PIK3CA, and 93.1% for ERBB2 alterations. There was a significant correlation between the cases with {greater than or equal to} 1 alteration with ctDNA {greater than or equal to} 5% and shorter survival (median = 4.03 months versus not reached at median follow up of 6.1 months; P<0.001). Finally, five of the twelve evaluable patients (42%) matched to a treatment targeting an alteration(s) detected in their ctDNA test achieved stable disease {greater than or equal to} 6 months/partial remission compared to two of 28 patients (7.1%) for the unmatched patients, P=0.02. Conclusions: Our initial study demonstrates that ctDNA tests provide information complementary to that in tissue biopsies and may be useful in determining prognosis and treatment.

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