Fassunke, Jana, Ihle, Michaela Angelika, Lenze, Dido, Lehmann, Annika, Hummel, Michael, Vollbrecht, Claudia, Penzel, Roland, Volckmar, Anna-Lena, Stenzinger, Albrecht, Endris, Volker, Jung, Andreas, Lehmann, Ulrich, Zeugner, Silke, Baretton, Gustavo, Kreipe, Hans, Schirmacher, Peter, Kirchner, Thomas, Dietel, Manfred, Buettner, Reinhard and Merkelbach-Bruse, Sabine (2017). EGFR T790M mutation testing of non-small cell lung cancer tissue and blood samples artificially spiked with circulating cell-free tumor DNA: results of a round robin trial. Virchows Arch., 471 (4). S. 509 - 521. NEW YORK: SPRINGER. ISSN 1432-2307

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Abstract

The European Commision (EC) recently approved osimertinib for the treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring EGFR T790M mutations. Besides tissue-based testing, blood samples containing cell-free circulating tumor DNA (ctDNA) can be used to interrogate T790M status. Herein, we describe the conditions and results of a round robin trial (RRT) for T790M mutation testing in NSCLC tissue specimens and peripheral blood samples spiked with cell line DNA mimicking tumor-derived ctDNA. The underlying objectives of this two-staged external quality assessment (EQA) approach were (a) to evaluate the accuracy of T790M mutations testing across multiple centers and (b) to investigate if a liquid biopsy-based testing for T790M mutations in spiked blood samples is feasible in routine diagnostic. Based on a successfully completed internal phase I RRT, an open RRT for EGFR T790M mutation testing in tumor tissue and blood samples was initiated. In total, 48 pathology centers participated in the EQA. Of these, 47 (97.9%) centers submitted their analyses within the pre-defined time frame and 44 (tissue), respectively, 40 (plasma) successfully passed the test. The overall success rates in the RRT phase II were 91.7% (tissue) and 83.3% (blood), respectively. Thirty-eight out of 48 participants (79.2%) successfully passed both parts of the RRT. The RRT for blood-based EGFR testing initiated in Germany is, to the best of our knowledge, the first of his kind in Europe. In summary, our results demonstrate that blood-based genotyping for EGFR resistance mutations can be successfully integrated in routine molecular diagnostics complementing the array of molecular methods already available at pathology centers in Germany.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Fassunke, JanaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ihle, Michaela AngelikaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lenze, DidoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lehmann, AnnikaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hummel, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vollbrecht, ClaudiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Penzel, RolandUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Volckmar, Anna-LenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stenzinger, AlbrechtUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Endris, VolkerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jung, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lehmann, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zeugner, SilkeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baretton, GustavoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreipe, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schirmacher, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kirchner, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dietel, ManfredUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Buettner, ReinhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Merkelbach-Bruse, SabineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-216338
DOI: 10.1007/s00428-017-2226-8
Journal or Publication Title: Virchows Arch.
Volume: 471
Number: 4
Page Range: S. 509 - 521
Date: 2017
Publisher: SPRINGER
Place of Publication: NEW YORK
ISSN: 1432-2307
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
GROWTH-FACTOR RECEPTOR; ACQUIRED-RESISTANCE; 1ST-LINE TREATMENT; KINASE INHIBITORS; LIQUID BIOPSY; OPEN-LABEL; GEFITINIB; THERAPY; TKI; ERLOTINIBMultiple languages
PathologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/21633

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