Detection and Dynamic Changes of EGFR Mutations from Circulating Tumor DNA as a Predictor of Survival Outcomes in NSCLC Patients Treated with First-line Intercalated Erlotinib and Chemotherapy

摘要: Purpose: Blood-based circulating-free (cf) tumor DNA may be an alternative to tissue-based EGFR mutation testing in NSCLC. This exploratory analysis compares matched and blood samples from the FASTACT-2 study. Experimental Design: Patients were randomized receive six cycles of gemcitabine/platinum plus sequential erlotinib or placebo. was performed using cobas tissue test (in development). Blood at baseline, cycle 3, progression assessed for detection rate, sensitivity, specificity; concordance with ( n = 238), correlation progression-free survival (PFS) overall (OS). Results: Concordance between tests 88%, sensitivity 75% a specificity 96%. Median PFS 13.1 versus 6.0 months placebo, respectively, those baseline mut + cfDNA [HR, 0.22; 95% confidence intervals (CI), 0.14–0.33, P − subgroup (HR, 0.83; CI, 0.65–1.04, 0.1076). For patients median 7.2 12.0 3 patients, respectively 0.32; 0.21–0.48, 0.0066). Conclusions: is relatively sensitive highly specific. Dynamic changes status relative predict clinical outcomes. Clin Cancer Res; 21(14); 3196–203. ©2015 AACR .