期刊
CLINICAL LUNG CANCER
卷 21, 期 1, 页码 56-+出版社
CIG MEDIA GROUP, LP
DOI: 10.1016/j.cllc.2019.07.010
关键词
Afatinib; Erlotinib; Gefitinib; Non-invasive assay; Osimertinib
类别
资金
- Canceropole Provence-Alpes-Cote d'Azur
- Conseil Departemental des Alpes Maritimes
- Ligue Departementale 06 contre le Cancer
- GIRCI 2017
- French government (National Research Agency, ANR) through the Investments for the Future LABEX SIGNALIFE [ANR-11-LABX-0028-01]
We assessed EGFR mutations using liquid biopsies (LB) in 345 patients with lung cancer to analyze if this approach is reliable and sufficiently robust to guide rapid treatment decisions in daily practice. LB for the assessment of EGFR mutations can guide treatment decisions, but some limitations must be carefully communicated to the physicians to avoid unnecessary testing. Background: The introduction of liquid biopsy using PCR-based assays into routine practice has had a strong impact on the treatment of EGFR-mutated lung adenocarcinoma and is now commonly used for routine testing of EGFR mutations in certain clinical settings. To assess whether the claimed benefits of PCR-based assays hold true in daily practice at a multicenter clinical institution, we assessed how treatment decisions are affected by PCR-based assays for the analysis of EGFR mutations from plasma samples in a centralized laboratory (LPCE, Nice, France). Patients and Methods: A total of 345 samples were analyzed using the US Food and Drug Administration-approved Cobas EGFR Mutation Test v2 and 103 using the Therascreen EGFR Plasma RGQ PCR Kit over 3 years (395 samples from 324 patients). Eleven plasma samples were validated independently using Cobas at 3 institutions, and 130 samples were analyzed using Stilla digital PCR. Clinical data were collected for 175 (54%) of 324 patients. Results: Cobas was superior to the Therascreen assay and demonstrated 100% reproducibility. Digital PCR showed only 48%, 83%, and 58% concordance with Cobas for exon 19 deletions, L858R mutations, and T790M mutations, respectively. Liquid biopsies helped inform and change treatment when resistance occurred and enabled the detection of EGFR mutations in patients when biopsy tissue results were unavailable. Conclusion: PCR-based assays are a fast and convenient test, allowing the detection of primary and secondary EGFR mutations from plasma. Cobas proved to be a reliable test, whereas digital PCR produced too many inconclusive results to be currently recommended as a principal testing device. (C) 2019 Elsevier Inc. All rights reserved.
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