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Multicenter Validation Study to Implement Plasma Epidermal Growth Factor Receptor T790M Testing in Clinical

Natasha B Leighl1, Suzanne Kamel-Reid1, Parneet K Cheema2

  • 1University Health Network, Toronto, Ontario, Canada.

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Plasma testing for EGFR T790M mutations offers a more effective way to identify lung cancer patients who can benefit from targeted therapy compared to biopsy alone. This method improves detection rates and supports treatment decisions.

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Area of Science:

  • Oncology
  • Molecular Diagnostics
  • Genetics

Background:

  • Acquired resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) is a significant challenge in advanced non-small cell lung cancer (NSCLC).
  • The T790M mutation in EGFR is a key mechanism of acquired resistance to first and second-generation EGFR TKIs.
  • Plasma-based detection of EGFR mutations is emerging as a less invasive alternative to tumor rebiopsy for identifying T790M mutations.

Purpose of the Study:

  • To validate the analytical sensitivity and clinical utility of plasma EGFR T790M mutation detection.
  • To compare the diagnostic yield of plasma testing versus tumor biopsy for T790M mutations in patients with advanced EGFR-mutant lung cancer.
  • To assess the concordance of plasma T790M results with tumor biopsy results and among different laboratories.

Main Methods:

  • A multicenter study involving 63 patients with advanced EGFR-mutant lung cancer screened for the ASTRIS trial.
  • Plasma T790M mutation detection was performed using droplet digital PCR, Cobas, or next-generation sequencing across 4 laboratories.
  • Concordance analysis was conducted between plasma and tumor samples, and inter-laboratory agreement was assessed.

Main Results:

  • Plasma testing yielded T790M results in 97% of patients, with 62% testing positive, significantly increasing the detection rate compared to tumor biopsy (49% success rate).
  • In patients with negative or indeterminate tumor biopsy results, plasma testing identified T790M mutations in 55%, raising the overall T790M-positive rate to 73%.
  • Plasma T790M testing demonstrated a sensitivity of 75% and an overall concordance of 64% with tissue testing, while inter-laboratory concordance was high at 90.3%.

Conclusions:

  • Plasma EGFR T790M testing is a valuable tool that significantly increases the identification of patients eligible for targeted therapy compared to biopsy alone.
  • The findings support the clinical utility of plasma T790M testing for guiding treatment decisions in EGFR-mutant lung cancer.
  • Further validation is warranted for routine implementation in clinical diagnostic laboratories.