EGFR mutation diagnostic program for NSCLC patients in Poland between 2011-2014

Targeted therapy of non-small cell lung cancer necessitates fast and reliable molecular evaluation of tissue/cytologic samples within the routine diagnostic process. Here we present the dynamic development of the EGFR mutation screening program for NSCLC patients in Poland within the previous 4 years. In total, 177 samples were analysed for EGFR mutations in 2011 (11,3% positive), 915 (8,7%) in 2012, 1843 (9,9%, 1,2% unsuitable for diagnostics) in 2013, 3405 (10,6%, 1,7% unsuitable for diagnostics) in 2014. Most were adenocarcinomas (82,1% in 2012, 93,2% in 2014), number of NOS materials fell continuously (12,5% down to 4,9%). 73,7% of samples contained u003e50% of cancer cells, 13% - 20-50% of cancer cells, 4,7% - 10-20%, 8,6% below 10%. Between 2011 – 2014, 578 activating EGFR mutations were identified, 4,5% in exon 18, 59,3% in exon19, 36,5% in exon 21, and 63 resistance mutations in exon 20 (9,8%). Currently, all laboratories employ CE-IVD real-time PCR tests as diagnostic method of choice. Additionally, 3 labs use alternative diagnostic methods as well. Results are available within 48hrs (1 lab), 3-5 days (3 labs), 6-7 days (1), u003e8 days (1). All centres participate in the external quality schemes. Conclusion: The diagnostic program provides fast and reliable diagnostics of EGFR mutation for NSCLC patients in Poland.