Performance of standard procedures in detection of EGFR mutations in daily practice in advanced NSCLC patients selected according to the ESMO guideline: a large Caucasian cohort study

Abstract

BackgroundESMO consensus recommends EGFR mutation testing in never/former light smokers (<15 pack-years) or patients with non-squamous NSCLC. The aim of this work was to determine the frequency and clinical predictors of EGFR mutations, and the role of specimen sampling tests, in Caucasian standard practice setting.MethodsWe screened 297 patients according to this consensus. Mutational analysis of EGFR was performed using the Therascreen EGFR RGQ PCR mutation kit. Clinical and pathological correlative data were collected.ResultsAn EGFR activating mutation was found in 32 patients (11%), twelve exon 19 deletions, two exon 18 and eighteen exon 21 point mutations. Most were in females, but half were in smokers. Negative TTF-1 staining had a very strong negative predictive value (all except one patient had TTF-1 positive adenocarcinoma). Both biopsies as well as cytology specimens (mainly EBUS-TBNA) did well: 24 mutations in 213 biopsy samples (11.2%) and 8 in 84 cytology samples (9.5%), respectively. The Therascreen acted as a sensitive test in all types of samples: 7 activating mutations were found in samples rated to have <5% of tumour cells, and there were only 4 test failures in the whole series.ConclusionIn this Caucasian standard practice NSCLC cohort, tested according to the ESMO consensus, activating EGFR mutation occurred in 11% of the patients. Half of these were in former/current smokers. With our sampling technique and use of the Therascreen kit, EBUS-TBNA cell blocks performed as good as biopsies.

EGFR Mutation Status and First-Line Treatment in Patients with Stage III/IV Non–Small Cell Lung Cancer in Germany: An Observational Study

“…Although this EGFR mutation rate is similar to that reported in other studies of Caucasian populations (6,(15)(16)(17), other reports quote 5% to 23% (19,(24)(25)(26)(27)(28). This variability may arise from the design of the studies, which all included fewer patients than the REASON study.…”

“…In a recent retrospective analysis of specimens from the EURTAC study, 225 of 1,044 screened patients tested positive for EGFR exon 19 deletion or L858R mutations based on laboratorydeveloped tests (LDT), suggesting an EGFR mutation rate of 22% (33). This EGFR mutation rate is higher than that reported in REASON and other studies in Caucasian patients (15)(16)(17); however, the reasons for this discrepancy are not known and the authors do not discuss the EGFR mutation rate obtained from LDTs.…”

“…Real-world epidemiologic data on the prevalence of NSCLC EGFR mutations in Caucasian populations are limited. Recent studies in Caucasian populations have shown an EGFR mutation rate of 9% to 14%, associated with female gender and adenocarcinoma histology (15)(16)(17). However, these studies do not report outcomes such as treatment choices and healthcare resource use.…”

EGFR Mutations Status For Non-Small-Cell Lung Cancer Patients

“…Hatson I et al accomplished research results were different compared to our results -we have detected more mutations in female and male population (approximately 3 times more female and 4 times male population), however, identified mutations frequency was similar in both researches (the most common mutations were 19 exon deletion and 21 exon L861Q mutation) [8].…”

Real world utilization of EGFR TKIs and prognostic factors for survival in NSCLC during 2010–2016 in Sweden: A nationwide observational study

“…2 Most often NSCLC is diagnosed at advanced stage where treatment is focused on improved survival and quality of life often including systemic, targeted therapy based on actionable biomarkers. [3][4][5][6] A subgroup of patients with NSCLC (10-15% in Western countries 7 ) have somatic epidermal growth factor receptor (EGFR) mutations that predict sensitivity to EGFR targeting tyrosine kinase inhibitors (TKIs), such as gefitinib, erlotinib, afatinib and osimertinib. [8][9][10][11][12] Several phase III trials, have shown that first and second-generation EGFR TKIs are superior to chemotherapy in terms of progression-free survival (PFS) and objective response rates, albeit with no overall survival (OS) benefit potentially due to patient crossover from chemotherapy to EGFR TKI treatment.…”