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ctDNA Determination of EGFR Mutation Status in European and Japanese Patients with Advanced NSCLC: The ASSESS Study.

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dc.contributor.author Reck, Martin
dc.contributor.author Hagiwara, Koichi
dc.contributor.author Han, Baohui
dc.contributor.author Tjulandin, Sergei
dc.contributor.author Grohé, Christian
dc.contributor.author Yokoi, Takashi
dc.contributor.author Morabito, Alessandro
dc.contributor.author Novello, Silvia
dc.contributor.author Arriola Aperribay, Edurne
dc.contributor.author Molinier, Olivier
dc.contributor.author McCormack, Rose
dc.contributor.author Ratcliffe, Marianne
dc.contributor.author Normanno, Nicola
dc.date.accessioned 2017-01-12T09:58:48Z
dc.date.available 2017-01-12T09:58:48Z
dc.date.issued 2006
dc.identifier.citation Reck M, Hagiwara K, Han B, Tjulandin S, Grohé C, Yokoi T. et al. ctDNA Determination of EGFR Mutation Status in European and Japanese Patients with Advanced NSCLC: The ASSESS Study. J Thorac Oncol. 2016 Oct;11(10):1682-9. doi: 10.1016/j.jtho.2016.05.036
dc.identifier.issn 1556-0864
dc.identifier.uri http://hdl.handle.net/10230/27872
dc.description.abstract INTRODUCTION: To offer patients with EGFR mutation-positive advanced NSCLC appropriate EGFR tyrosine kinase inhibitor treatment, mutation testing of tumor samples is required. However, tissue/cytologic samples are not always available or evaluable. The large, noninterventional diagnostic ASSESS study (NCT01785888) evaluated the utility of circulating free tumor-derived DNA (ctDNA) from plasma for EGFR mutation testing. METHODS: ASSESS was conducted in 56 centers (in Europe and Japan). Eligible patients (with newly diagnosed locally advanced/metastatic treatment-naive advanced NSCLC) provided diagnostic tissue/cytologic and plasma samples. DNA extracted from tissue/cytologic samples was subjected to EGFR mutation testing using local practices; designated laboratories performed DNA extraction/mutation testing of blood samples. The primary end point was level of concordance of EGFR mutation status between matched tissue/cytologic and plasma samples. RESULTS: Of 1311 patients enrolled, 1288 were eligible. Concordance of mutation status in 1162 matched samples was 89% (sensitivity 46%, specificity 97%, positive predictive value 78%, and negative predictive value 90%). A group of 25 patients with apparent false-positive plasma results was overrepresented for cytologic samples, use of less sensitive tissue testing methodologies, and smoking habits associated with high EGFR mutation frequency, indicative of false-negative tumor results. In cases in which plasma and tumor samples were tested with identical highly sensitive methods, positive predictive value/sensitivity were generally improved. CONCLUSIONS: These real-world data suggest that ctDNA is a feasible sample for EGFR mutation analysis. It is important to conduct mutation testing of both tumor and plasma samples in specialized laboratories, using robust/sensitive methods to ensure that patients receive appropriate treatments that target the molecular features of their disease.
dc.description.sponsorship This work was supported by AstraZeneca and coordinated by Worldwide Clinical Trials, which also managed the database and performed the primary analyses.
dc.format.mimetype application/pdf
dc.language.iso eng
dc.publisher Elsevier
dc.rights This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
dc.rights.uri https://creativecommons.org/licenses/by/4.0/
dc.subject.other Plasma
dc.subject.other Tumors
dc.title ctDNA Determination of EGFR Mutation Status in European and Japanese Patients with Advanced NSCLC: The ASSESS Study.
dc.type info:eu-repo/semantics/article
dc.identifier.doi http://dx.doi.org/10.1016/j.jtho.2016.05.036
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.type.version info:eu-repo/semantics/publishedVersion

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