Table 2 ctDNA plasma detection of EGFR mutation
Reference | Method of detection | Study type/ Sample size | Sensitivity/ PPA | Specificity/NPA | Concordance/ OPA between tissue and liquid biopsy |
|---|---|---|---|---|---|
Douillard J et al. [65] | QUIAGEN therascreen® EGFR RGQ PCR Kit | Prospective, single-arm phase IV study (IFUM study); N = 652 | 65.7% | 99.8% | 94.3% |
Reck M et al. [54] | QUIAGEN therascreen® EGFR RGQ PCR Kit; Cobas® EGFR mutations test version 2; Cycleave®; PNA-LNA PCR Clamp; other | Multicenter (ASSESS study); N = 1162 | 46% | 97% | 89% |
Han B et al. [55] | Cobas® EGFR mutations test version 2 | Multicenter (IGNITE study); N = 2561 | 46.9% | 95.6% | 80.5% |
Wu YL et al. [148] | QUIAGEN therascreen® EGFR RGQ PCR Kit | Phase III, Prospective (Lux-Lung 3 and 6 studies); N = 334 (plasma); N = 287 (serum) | 60.5% (plasma) 28.6% (serum) | n.r | n.r |
Jenkins et al. [74] | Cobas® EGFR Mutation Test v2 | AURA extension and AURA2 phase II studies; N = 210 | T790M: 61% L858R: 76% Del19: 91% | T790M: 79% L858R: 98% Del19: 98% | T790M: 65% L858R: 85% Del19: 90% |
Oxnard et al. [76] | BEAMing (Sysmex®) | Retrospective (AURA phase I) N = 216 | T790M: 70% L858R: 86% Del19: 82% | T790M: 69% L858R: 97% Del19: 98% | n.r |
Karlovich et al. [73] | Cobas® EGFR mutations test; BEAMing (Symex® Inostics GmbH) | Prospective, multicentre, observational and phase-1 TIGER-X; N = 153 | (Cobas/BEAMING) Activating mutations: 73%/82% T790M: 64%/73% | (Cobas/BEAMING) Activating mutations: 100% T790M: 98%/50% | (Cobas/BEAMING) Activating mutations: 80% T790M: 86%/67% |
Sacher et al. [56] | Droplet digital PCR (ddPCR) | Prospective; N = 180 (120 newly diagnosed + 60 acquired resistance) | Del19: 82% L858R: 74% T790M: 77% | Del19:100% L858R: 100% T790M: 63% | Del19: 91% L858R: 80% T790M: 40% |
Zheng D et al. [57] | Droplet digital PCR (ddPCR) | N = 117 | T790M: 81% | T790M: 100% | 88% |