A Multicenter Blinded Study Evaluating EGFR and KRAS Mutation Testing Methods in the Clinical Non–Small Cell Lung Cancer Setting—IFCT/ERMETIC2 Project Part 1: Comparison of Testing Methods in 20 French Molecular Genetic National Cancer Institute Platforms

摘要: Epidermal growth factor receptor (EGFR)–tyrosine kinase inhibitors have limited use as first-line treatment for mutated EGFR metastatic non–small cell lung cancer. The French National Cancer Institute has installed molecular genetics platforms implementing and KRAS testing. However, there is considerable uncertainty to which detection methods should be applied routine diagnosis. This study aimed compare the genotyping developed by IFCT/ERMETIC2 network in two blind panels: 25 samples of serial dilutions line DNA (20 centers) 74 FFPE tumor (10 centers). best threshold mutation on lines was obtained using allele-specific amplification-based technologies. Nonamplifiable tissue were significantly less common when alternative testing versus direct sequencing [15%; 95% confidence interval (CI), 14%–16% 40%; CI, 39%–42%; P