Background: Previous studies have shown that there are different methods used to detect the epidermal growth factor receptor () mutation status in plasma cell-free DNA (cfDNA) for advanced lung adenocarcinoma patients including the ADx-Amplification Refractory Mutation System (ADx-ARMS). We explored the performance of the ADx-ARMS in detecting the mutations in cfDNA.
Methods: This prospective cohort study enrolled patients who presented with advanced (stage IIIb/IV) lung adenocarcinoma. mutations in plasma cfDNA and tumor tissues by ADx-ARMS were detected. Next-generation sequencing (NGS) in plasma was performed in patients with inconsistent gene region mutations in the plasma and matched tissue samples. We calculated the clinical parameters of the ADx-ARMS for mutation status in the plasma of cfDNA, using the tumor tissues as the standard for measurement. The objective response rate (ORR) and progression-free survival (PFS) were also calculated for patients receiving first-generation EGFR-tyrosine kinase inhibitors (TKIs) therapy.
Results: In total, 203 patients were included in the final analysis. Mutations were discovered in 58.6% (119/203) of the tumor tissues and 31.0% (63/203) were detected mutations in both tumor tissues and matched plasma. The sensitivity and the specificity setting for detecting the mutations in the plasma using the ADx-ARMS were configured to 52.9% and 98.8%. An ORR of 64.8% was observed among the 71 patients who were identified as being -positive in their tumor tissues, who had received treatments using Gefitinib or Icotinib. Next, the ORR was observed to be 69.0% among the 42 patients with an mutation in their plasma. The median PFS of the patients with an mutation in tumor tissues and plasma were 10.0 11.0 months (P=0.175). The median PFS of the patients with an wild-type in the plasma was 8.7 months, which was significantly shorter than the mutant-type in plasma (P=0.001).
Conclusions: Using ADx-ARMS as an approach with high specificity but moderate sensitivity to detect the mutations in plasma cfDNA and mutation status in plasma cfDNA using the ADx-ARMS can predict the tumor response for EGFR-TKIs.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6504650 | PMC |
| http://dx.doi.org/10.21037/tlcr.2019.03.10 | DOI Listing |
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