Cited by 448Lung Cancer Treatments and MutationsCancer Genomics and DiagnosticsLung Cancer Diagnosis and Treatment

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Gefitinib Treatment in EGFR Mutated Caucasian NSCLC: Circulating-Free Tumor DNA as a Surrogate for Determination of EGFR Status

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Douillard, Jean-Yves, Ostoros, Gyula, Cobo, Manuel, Ciuleanu, Tudor, Cole, Rebecca, McWalter, Gael, Walker, Jill, Dearden, Simon, Webster, Alan, Milenkova, Tsveta, McCormack, Rose·2014·Journal of Thoracic Oncology

DOI 10.1097/jto.0000000000000263PMC PMC4224589

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Abstract

INTRODUCTION: In the phase IV, open-label, single-arm study NCT01203917, first-line gefitinib 250 mg/d was effective and well tolerated in Caucasian patients with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (previously published). Here, we report EGFR mutation analyses of plasma-derived, circulating-free tumor DNA. METHODS: Mandatory tumor and duplicate plasma (1 and 2) baseline samples were collected (all screened patients; n = 1060). Preplanned, exploratory analyses included EGFR mutation (and subtype) status of tumor versus plasma and between plasma samples. Post hoc, exploratory analyses included efficacy by tumor and plasma EGFR mutation (and subtype) status. RESULTS: Available baseline tumor samples were 1033 of 1060 (118 positive of 859 mutation status known; mutation frequency, 13.7%). Available plasma 1 samples were 803 of 1060 (82 positive of 784 mutation status known; mutation frequency, 10.5%). Mutation status concordance between 652 matched tumor and plasma 1 samples was 94.3% (95% confidence interval [CI], 92.3-96.0) (comparable for mutation subtypes); test sensitivity was 65.7% (95% CI, 55.8-74.7); and test specificity was 99.8% (95% CI, 99.0-100.0). Twelve patients of unknown tumor mutation status were subsequently identified as plasma mutation-positive. Available plasma 2 samples were 803 of 1060 (65 positive of 224 mutation status-evaluable and -known). Mutation status concordance between 224 matched duplicate plasma 1 and 2 samples was 96.9% (95% CI, 93.7-98.7). Objective response rates are as follows: mutation-positive tumor, 70% (95% CI, 60.5-77.7); mutation-positive tumor and plasma 1, 76.9% (95% CI, 65.4-85.5); and mutation-positive tumor and mutation-negative plasma 1, 59.5% (95% CI, 43.5-73.7). Median progression-free survival (months) was 9.7 (95% CI, 8.5-11.0; 61 events) for mutation-positive tumor and 10.2 (95% CI, 8.5-12.5; 36 events) for mutation-positive tumor and plasma 1. CONCLUSION: The high concordance, specificity, and sensitivity demonstrate that EGFR mutation status can be accurately assessed using circulating-free tumor DNA. Although encouraging and suggesting that plasma is a suitable substitute for mutation analysis, tumor tissue should remain the preferred sample type when available.

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Authors: Douillard, J.-Y., Ostoros, G., Cobo, M., Ciuleanu, T., Cole, R., McWalter, G., Walker, J., Dearden, S., Webster, A., Milenkova, T., & McCormack, R.
Affiliations: Iuliu Hațieganu University of Medicine and Pharmacy (RO)
Országos Korányi Tbc és Pulmonológiai Intézet (HU)
Hospital Regional Universitario de Málaga (ES)
AstraZeneca (United Kingdom) (GB)
Corresponding author: Douillard, Jean-Yves
ORCID: Douillard, Jean-Yves
Ostoros, Gyula
Cobo, Manuel
Ciuleanu, Tudor
Cole, Rebecca
Walker, Jill
Dearden, Simon
Milenkova, Tsveta
Venue: Journal of Thoracic Oncology
Publisher: Elsevier BV
Published: 2014-09
Volume: 9
Issue: 9
Pages: 1345-1353
ISSN: 1556-0864 (ISSN-L)
DOI: 10.1097/jto.0000000000000263
PMC: PMC4224589
OpenAlex: W1978285367
Cited by: 448
References: 28
Citations by year: 2026: 2 · 2025: 7 · 2024: 8 · 2023: 16 · 2022: 20 · 2021: 37 · 2020: 44 · 2019: 69 · 2018: 70 · 2017: 72 · 2016: 63 · 2015: 38 · 2014: 2
FWCI: 46.71
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
creativecommons.org/licenses/by-nc-nd/4.0/ (vor, 438 d)
Locations: Journal of Thoracic Oncology (publishedVersion, cc-by-nc-nd)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: AstraZeneca
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: gefitinib, EGFR mutation, non-small cell lung cancer, circulating tumor DNA, liquid biopsy, plasma DNA, tumor mutation status, treatment response, sensitivity and specificity, first-line therapy, Caucasian patients, EGFR tyrosine kinase inhibitors, objective response rate, progression-free survival, overall survival
MeSH terms: Gefitinib, Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung, DNA Mutational Analysis, DNA, Neoplasm, Female, Follow-Up Studies, Humans, Lung Neoplasms, Male, Middle Aged, Mutation, Prospective Studies, Quinazolines, Single-Blind Method, Treatment Outcome, Disease-Free Survival, Protein Kinase Inhibitors, ErbB Receptors

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Gefitinib Treatment in EGFR Mutated Caucasian NSCLC: Circulating-Free Tumor DNA as a Surrogate for Determination of EGFR Status

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