Clinical value of genotyping cfDNA demonstrated in advanced NSCLC setting
medwireNews: The NILE study has shown the noninferiority of cell-free (cf)DNA analysis, so-called liquid biopsy, to the standard of care for identifying targetable biomarkers in individuals with treatment-naïve metastatic non-small-cell lung cancer (NSCLC).
Addressing delegates at the AACR Annual Meeting 2019 in Atlanta, Georgia, USA, presenting author Vassiliki Papadimitrakopoulou (The University of Texas MD Anderson Cancer Center, Houston, USA) said: “This prospective study demonstrated that utilization of a validated, comprehensive, and sensitive cfDNA test in newly diagnosed [metastatic] NSCLC patients successfully identifies guideline recommended biomarkers at a rate similar to physician discretion standard of care tissue testing.”
Among 282 participants who underwent both liquid and tissue biopsy, cfDNA analysis using the Guardant360 test (Guardant Health, Redwood City, California, USA) identified guideline-recommended biomarkers in 27.3% of patients, while tissue genotyping classified 21.3% as being biomarker-positive, thereby demonstrating the noninferiority of cfDNA analysis.
Papadimitrakopoulou reported that the number of biomarker-positive patients rose from 60 with tissue testing alone to 89 when both tissue and cfDNA testing were used. And the research team estimated that using cfDNA analysis as the first genomic testing approach would have identified 87% of the 89 biomarker-positive participants, compared with a rate of 67% using tissue testing first, a significant difference.
Moreover, results of cfDNA testing were returned significantly quicker than tissue genotyping results, at a median of 9 and 15 days, respectively.
The biomarkers evaluated in the NILE (Noninvasive versus Invasive Lung Evaluation) study were EGFR and HER2 mutations, ALK, ROS1, and RET fusions, MET amplification and exon 14 skipping variants, and the BRAF V600E mutation.
For alterations in EGFR, ALK, and BRAF, cfDNA analysis had a positive predictive value of 100% compared with tissue testing and the negative predictive values ranged from 98% to 100%.
“These results suggest that initial biomarker assessment using cfDNA rather than tissue (‘blood first’), improves biomarker discovery rate [and] turn-around time,” concluded Papadimitrakopoulou.
She added in a press release: “Our results show that a highly sensitive and specific liquid biopsy should be part of the standard of care for these patients.”
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