Feasibility of Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Lung Cancer

Detection rate of druggable genetic alteration is defined as the number of true positive druggable genetic alterations detected by Next Generation Sequencing, divided by the total number of attempts. Druggable mutations were defined the presence of following genetic alterations: 1) EGFR mutation, 2) KRAS G12C mutation, 3) ALK rearrangement, 4) ROS1 rearrangement, 5) BRAF V600E mutation, 6) NTRK1/2/3 gene fusion, 7) METex14 skipping mutation, 8) RET rearrangement and 9) ERBB2 (HER2) mutation. The full patient set included all enrolled subjects.

The concordance rate of druggable genetic alterations detected in bronchial washing fluid by Next Generation Sequencing is compared with that in plasma and tissue in the analysis intent group. Druggable mutations were defined the presence of following genetic alterations: 1) EGFR mutation, 2) KRAS G12C mutation, 3) ALK rearrangement, 4) ROS1 rearrangement, 5) BRAF V600E mutation, 6) NTRK1/2/3 gene fusion, 7) METex14 skipping mutation, 8) RET rearrangement and 9) ERBB2 (HER2) mutation. The analysis intent group consisted of the subset of subjects for whom Next Generation Sequencing testing was successfully performed with tissue samples.

Detection rate of co-occuring genetic alteration is defined as the number of true positive co-occurring genetic alterations detected by Next Generation Sequencing, divided by the total number of attempts. Co-occurring genetic alterations were defined as the presence of following GAs: 1) ATM mutation, 2) CDKN2A mutation, 3) CTNNB1 mutation, 4) FGFR1 mutation, 5) KEAP1 mutation, 6) MDM2 amplification, 7) MET amplification, 8) MYC amplification, 9) PIK3CA mutation 10) RB1 mutation, 11) STK11 mutation and 12) TP53 mutation. The full patient set included all enrolled subjects.

The frequency and severity of adverse events resulting from bronchial washing procedures