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Detection of epidermal growth factor receptor mutations in plasma by mutant-enriched PCR assay for prediction of the response to gefitinib in patients with non-small-cell lung cancer
International Journal of Cancer, 08/17/09

He C et al. – Study validated that the plasma-based, mutant-enriched PCR assay is a reproducible, highly sensitive and specific method for detection of the two activating mutations of epidermal growth factor receptor (EGFR) in non-small-cell lung cancer (NSCLC) patients. This new strategy may allow genotyping the NSCLC noninvasively, particularly in pts with advanced NSCLC, and may provide clinicians reliable evidence to select patients who most likely benefit from tyrosine kinase inhibitors (TKIs).

Methods

Aim was to establish a blood-based approach for the assessment of EGFR mutations in NSCLC pts using a mutant-enriched PCR assay, and to test its clinical application
To validate the sensitivity of this assay, direct sequencing of plasma samples was performed
In a subset of pts, mutation detection in paired specimens of plasma and tumor tissue were compared
In addition, correlation between EGFR mutations detected by this assay and response to gefitinib or docataxel as the second-line therapy for the NSCLC was examined

Results

Detection rate of the EGFR exon19 deletions and exon21 L858R was 49.3% (66/134) by the blood-based, mutant-enriched PCR
In paired tumor and plasma samples, the detected mutant types of each pair respectively by direct sequencing and mutant-enriched PCR were concordant in 17 of 18 (94.4%)
In pts treated with gefitinib as a second-line therapy, those with plasma EGFR mutation had a prolonged median PFS vs those with EGFR wild type
Median PFS was longer for pts treated with gefitinib than those with docetaxel in those harboring plasma EGFR mutation
These results suggest that the blood-based EGFR mutations test has the ability to provide a reliable guidance for clinical decision making for the treatment of the advanced NSCLC pts

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