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Comprehensive cross-platform comparison of methods for non-invasive EGFR mutation testing : results of the RING observational trial
- Source :
- Molecular Oncology, r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA, instname, MOLECULAR ONCOLOGY, r-FISABIO. Repositorio Institucional de Producción Científica, r-CIPF: Repositorio Institucional Producción Científica del Centro de Investigación Principe Felipe (CIPF), Centro de Investigación Principe Felipe (CIPF), BASE-Bielefeld Academic Search Engine, Romero Alfonso, Atocha Jantus Lewintre, Eloisa García-Peláez, Beatriz Royuela, Ana Insa Mollá, Amelia Cruz, Patricia Collazo, Ana Pérez Altozano, Javier Juan Vidal, Óscar José Diz Taín, Pilar Cobo, Manuel Hernández Marín, Berta Vázquez Estévez, Sergio Benítez, Gretel Guirado, Maria Majem, Margarita Bernabé, Reyes Ortega, Ana Laura Blasco Cordellat, Ana Bosch Barrera, Joaquim Jurado, José María García González, Jorge Viteri, Santiago García Girón, Carlos Massuti Sureda, Bartomeu López Martín, Ana Rodríguez Festa, Alejandro Calabuig-Fariñas, S. Molina Vila, Miguel Ángel Provencio Pulla, Mariano 2021 Comprehensive cross-platform comparison of methods for non-invasive EGFR mutation testing : results of the RING observational trial. Molecular Oncology 15 1 43 56, RODERIC. Repositorio Institucional de la Universitat de Valéncia, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, Fundacion Sancho el Sabio Fundazioa (FSS), r-FISABIO: Repositorio Institucional de Producción Científica, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO), Molecular Oncology, Vol 15, Iss 1, Pp 43-56 (2021), r-CIPF. Repositorio Institucional Producción Científica del Centro de Investigación Principe Felipe (CIPF), r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante, RODERIC: Repositorio Institucional de la Universitat de Valéncia, r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe
- Publication Year :
- 2021
-
Abstract
- Plasma samples from 72 EGFR‐mutant advanced NSCLC patients, collected upon progression to first‐line TKI, were analyzed by seven methodologies (two NGS‐based methods, three high‐sensitivity PCR‐based platforms, and two FDA‐approved methods). Our study demonstrates a good to excellent agreement between methodologies and supports the use of liquid biopsies for therapy decision‐making.<br />Several platforms for noninvasive EGFR testing are currently used in the clinical setting with sensitivities ranging from 30% to 100%. Prospective studies evaluating agreement and sources for discordant results remain lacking. Herein, seven methodologies including two next‐generation sequencing (NGS)‐based methods, three high‐sensitivity PCR‐based platforms, and two FDA‐approved methods were compared using 72 plasma samples, from EGFR‐mutant non‐small‐cell lung cancer (NSCLC) patients progressing on a first‐line tyrosine kinase inhibitor (TKI). NGS platforms as well as high‐sensitivity PCR‐based methodologies showed excellent agreement for EGFR‐sensitizing mutations (K = 0.80–0.89) and substantial agreement for T790M testing (K = 0.77 and 0.68, respectively). Mutant allele frequencies (MAFs) obtained by different quantitative methods showed an excellent reproducibility (intraclass correlation coefficients 0.86–0.98). Among other technical factors, discordant calls mostly occurred at mutant allele frequencies (MAFs) ≤ 0.5%. Agreement significantly improved when discarding samples with MAF ≤ 0.5%. EGFR mutations were detected at significantly lower MAFs in patients with brain metastases, suggesting that these patients risk for a false‐positive result. Our results support the use of liquid biopsies for noninvasive EGFR testing and highlight the need to systematically report MAFs.
- Subjects :
- 0301 basic medicine
Oncology
Male
Cancer Research
cell lung cancer
Intraclass correlation
Biopsy
DNA Mutational Analysis
non-small cell lung cancer (NSCLC)
Tyrosine kinase inhibitor
Tyrosine-kinase inhibitor
Cohort Studies
circulating free DNA
T790M
0302 clinical medicine
tyrosine kinase inhibitor
Gene Frequency
Osimertinib
Prospective cohort study
Càncer
non‐small‐cell lung cancer
Circulating free DNA
RC254-282
Research Articles
Sequence Deletion
Aged, 80 and over
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
High-Throughput Nucleotide Sequencing
non‐
General Medicine
DNA, Neoplasm
Exons
Middle Aged
ErbB Receptors
Epidermal growth factor receptor (EGFR), NGS, Non-small cell lung cancer (NSCLC), PCR, Tyrosine Kinase Inhibitor (TKI), circulating free DNA (cfDNA), osimertinib
030220 oncology & carcinogenesis
osimertinib
NGS
Molecular Medicine
small‐
Female
Research Article
Adult
medicine.medical_specialty
medicine.drug_class
Sensitivity and Specificity
03 medical and health sciences
Predictive Value of Tests
Internal medicine
Genetics
medicine
Humans
Aged
non-small-cell lung cancer
business.industry
Epidermal growth factor receptor
Non invasive
epidermal growth factor receptor
medicine.disease
respiratory tract diseases
030104 developmental biology
Egfr mutation
Pulmons
Mutation
business
Non-small-cell lung cancer
Subjects
Details
- Language :
- English
- ISSN :
- 18780261 and 15747891
- Database :
- OpenAIRE
- Journal :
- Molecular Oncology, r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA, instname, MOLECULAR ONCOLOGY, r-FISABIO. Repositorio Institucional de Producción Científica, r-CIPF: Repositorio Institucional Producción Científica del Centro de Investigación Principe Felipe (CIPF), Centro de Investigación Principe Felipe (CIPF), BASE-Bielefeld Academic Search Engine, Romero Alfonso, Atocha Jantus Lewintre, Eloisa García-Peláez, Beatriz Royuela, Ana Insa Mollá, Amelia Cruz, Patricia Collazo, Ana Pérez Altozano, Javier Juan Vidal, Óscar José Diz Taín, Pilar Cobo, Manuel Hernández Marín, Berta Vázquez Estévez, Sergio Benítez, Gretel Guirado, Maria Majem, Margarita Bernabé, Reyes Ortega, Ana Laura Blasco Cordellat, Ana Bosch Barrera, Joaquim Jurado, José María García González, Jorge Viteri, Santiago García Girón, Carlos Massuti Sureda, Bartomeu López Martín, Ana Rodríguez Festa, Alejandro Calabuig-Fariñas, S. Molina Vila, Miguel Ángel Provencio Pulla, Mariano 2021 Comprehensive cross-platform comparison of methods for non-invasive EGFR mutation testing : results of the RING observational trial. Molecular Oncology 15 1 43 56, RODERIC. Repositorio Institucional de la Universitat de Valéncia, r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau, Fundacion Sancho el Sabio Fundazioa (FSS), r-FISABIO: Repositorio Institucional de Producción Científica, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO), Molecular Oncology, Vol 15, Iss 1, Pp 43-56 (2021), r-CIPF. Repositorio Institucional Producción Científica del Centro de Investigación Principe Felipe (CIPF), r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante, RODERIC: Repositorio Institucional de la Universitat de Valéncia, r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe
- Accession number :
- edsair.doi.dedup.....46f513258b8efbde604e958cfd3c12be