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Lung cancer is a leading cause of cancer death worldwide. Patients with non-small cell lung cancer (NSCLC) often present with advanced disease and treatment benefit with standard chemotherapy is modest. The introduction of therapies that target the epidermal growth factor receptor (EGFR) pathway in NSCLC, such as the tyrosine kinase inhibitors erlotinib (Tarceva®), osimertinib (Tagrisso®) and gefitinib (Iressa®) has begun to improve outcomes in patients with advanced NSCLC. Especially those NSCLC cases harboring activating mutations in the EGFR gene show response to anti-EGFR tyrosin kinase inhibitors. The highest response rates have been shown for exon 19 deletions, G719A/C, L858R and L861Q. Therefore, it is important to identify EGFR mutations in NSCLC.
Treatment with first- or second-generation EGFR-tyrosine kinase inhibitors (TKIs) is effective for NSCLC patients harboring a sensitizing EGFR mutation. However, resistance is often acquired after 9–14 months. The most common mechanism of resistance to first- and second-generation EGFR-TKIs in the first-line setting is the EGFR T790M mutation, which accounts for approximately 60% of cases. Third-generation EGFR-TKIs targeting EGFR T790M mutation (e.g. osimertinib), are reported to be highly active against T790M-positive NSCLC. To detect the T790M mutation in patients progressing during EGFR-TKI treatment, tumor re-biopsy is necessary. As re-biopsies with invasive procedures (bronchoscopy or needle biopsy) are often infeasible in standard care of NSCLC patients, circulating tumor DNA (ctDNA) detected in plasma is recognized as a noninvasive biomarker for the molecular analysis of NSCLC. The cobas® EGFR Mutation Test (Roche Diagnostics K.K., Switzerland.) is a companion diagnostic test for the detection of EGFR mutations in plasma specimens and has been approved to identify such patients with NSCLC. T790M monitoring in plasma ctDNA of patients receiving EGFR-TKIs could yield valuable clinical information.
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Five to seven business days for plasma and slides and paraffin blocks, respectively.