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

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 u...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Hauptverfasser: Fassunke, Jana (VerfasserIn) , Penzel, Roland (VerfasserIn) , Volckmar, Anna-Lena (VerfasserIn) , Stenzinger, Albrecht (VerfasserIn) , Endris, Volker (VerfasserIn) , Schirmacher, Peter (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 8 September 2017
In: Virchows Archiv
Year: 2017, Jahrgang: 471, Heft: 4, Pages: 509-520
ISSN:1432-2307
DOI:10.1007/s00428-017-2226-8
Online-Zugang:Verlag, Volltext: http://dx.doi.org/10.1007/s00428-017-2226-8
Verlag, Volltext: https://doi.org/10.1007/s00428-017-2226-8
Volltext
Verfasserangaben:Jana Fassunke, Michaela Angelika Ihle, Dido Lenze, Annika Lehmann, Michael Hummel, Claudia Vollbrecht, Roland Penzel, Anna-Lena Volckmar, Albrecht Stenzinger, Volker Endris, Andreas Jung, Ulrich Lehmann, Silke Zeugner, Gustavo Baretton, Hans Kreipe, Peter Schirmacher, Thomas Kirchner, Manfred Dietel, Reinhard Büttner, Sabine Merkelbach-Bruse

MARC

LEADER 00000caa a2200000 c 4500
001 1581650574
003 DE-627
005 20220815024950.0
007 cr uuu---uuuuu
008 181008s2017 xx |||||o 00| ||eng c
024 7 |a 10.1007/s00428-017-2226-8  |2 doi 
035 |a (DE-627)1581650574 
035 |a (DE-576)511650574 
035 |a (DE-599)BSZ511650574 
035 |a (OCoLC)1341019701 
040 |a DE-627  |b ger  |c DE-627  |e rda 
041 |a eng 
084 |a 33  |2 sdnb 
100 1 |a Fassunke, Jana  |d 1976-  |e VerfasserIn  |0 (DE-588)135915473  |0 (DE-627)574408649  |0 (DE-576)30071775X  |4 aut 
245 1 0 |a EGFR T790M mutation testing of non-small cell lung cancer tissue and blood samples artificially spiked with circulating cell-free tumor DNA  |b results of a round robin trial  |c Jana Fassunke, Michaela Angelika Ihle, Dido Lenze, Annika Lehmann, Michael Hummel, Claudia Vollbrecht, Roland Penzel, Anna-Lena Volckmar, Albrecht Stenzinger, Volker Endris, Andreas Jung, Ulrich Lehmann, Silke Zeugner, Gustavo Baretton, Hans Kreipe, Peter Schirmacher, Thomas Kirchner, Manfred Dietel, Reinhard Büttner, Sabine Merkelbach-Bruse 
264 1 |c 8 September 2017 
300 |a 12 
336 |a Text  |b txt  |2 rdacontent 
337 |a Computermedien  |b c  |2 rdamedia 
338 |a Online-Ressource  |b cr  |2 rdacarrier 
500 |a Gesehen am 08.10.2018 
500 |a Im Titel ist "EGFR" kursiv geschrieben 
520 |a 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. 
650 4 |a Blood and plasma samples 
650 4 |a DNA sequencing 
650 4 |a EGFR 
650 4 |a FFPE 
650 4 |a Liquid biopsy 
650 4 |a NSCLC 
650 4 |a Osimertinib 
650 4 |a T790M mutation 
650 4 |a Tumor tissue 
700 1 |a Penzel, Roland  |e VerfasserIn  |0 (DE-588)102044021X  |0 (DE-627)691221316  |0 (DE-576)360421083  |4 aut 
700 1 |a Volckmar, Anna-Lena  |d 1984-  |e VerfasserIn  |0 (DE-588)173874916  |0 (DE-627)698776666  |0 (DE-576)134713478  |4 aut 
700 1 |a Stenzinger, Albrecht  |e VerfasserIn  |0 (DE-588)139606106  |0 (DE-627)703395238  |0 (DE-576)312432755  |4 aut 
700 1 |a Endris, Volker  |e VerfasserIn  |0 (DE-588)1063753686  |0 (DE-627)812590961  |0 (DE-576)422898198  |4 aut 
700 1 |a Schirmacher, Peter  |d 1961-  |e VerfasserIn  |0 (DE-588)1020440112  |0 (DE-627)691221197  |0 (DE-576)360427448  |4 aut 
773 0 8 |i Enthalten in  |t Virchows Archiv  |d Berlin : Springer, 1847  |g 471(2017), 4, Seite 509-520  |h Online-Ressource  |w (DE-627)254910645  |w (DE-600)1463276-7  |w (DE-576)074754416  |x 1432-2307  |7 nnas  |a 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 
773 1 8 |g volume:471  |g year:2017  |g number:4  |g pages:509-520  |g extent:12  |a 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 
856 4 0 |u http://dx.doi.org/10.1007/s00428-017-2226-8  |x Verlag  |x Resolving-System  |3 Volltext 
856 4 0 |u https://doi.org/10.1007/s00428-017-2226-8  |x Verlag  |3 Volltext 
951 |a AR 
992 |a 20181008 
993 |a Article 
994 |a 2017 
998 |g 1020440112  |a Schirmacher, Peter  |m 1020440112:Schirmacher, Peter  |d 910000  |d 912000  |d 700000  |d 718000  |e 910000PS1020440112  |e 912000PS1020440112  |e 700000PS1020440112  |e 718000PS1020440112  |k 0/910000/  |k 1/910000/912000/  |k 0/700000/  |k 1/700000/718000/  |p 16 
998 |g 1063753686  |a Endris, Volker  |m 1063753686:Endris, Volker  |d 910000  |d 912000  |e 910000PE1063753686  |e 912000PE1063753686  |k 0/910000/  |k 1/910000/912000/  |p 10 
998 |g 139606106  |a Stenzinger, Albrecht  |m 139606106:Stenzinger, Albrecht  |d 910000  |d 912000  |e 910000PS139606106  |e 912000PS139606106  |k 0/910000/  |k 1/910000/912000/  |p 9 
998 |g 173874916  |a Volckmar, Anna-Lena  |m 173874916:Volckmar, Anna-Lena  |d 910000  |d 912000  |e 910000PV173874916  |e 912000PV173874916  |k 0/910000/  |k 1/910000/912000/ 
998 |g 102044021X  |a Penzel, Roland  |m 102044021X:Penzel, Roland  |d 910000  |d 912000  |e 910000PP102044021X  |e 912000PP102044021X  |k 0/910000/  |k 1/910000/912000/  |p 7 
999 |a KXP-PPN1581650574  |e 3028186942 
BIB |a Y 
SER |a journal 
JSO |a {"type":{"media":"Online-Ressource","bibl":"article-journal"},"title":[{"title":"EGFR T790M mutation testing of non-small cell lung cancer tissue and blood samples artificially spiked with circulating cell-free tumor DNA","subtitle":"results of a round robin trial","title_sort":"EGFR T790M mutation testing of non-small cell lung cancer tissue and blood samples artificially spiked with circulating cell-free tumor DNA"}],"id":{"doi":["10.1007/s00428-017-2226-8"],"eki":["1581650574"]},"physDesc":[{"extent":"12 S."}],"relHost":[{"title":[{"title_sort":"Virchows Archiv","subtitle":"official journal of the European Society of Pathology","title":"Virchows Archiv"}],"physDesc":[{"extent":"Online-Ressource"}],"id":{"zdb":["1463276-7"],"issn":["1432-2307"],"eki":["254910645"]},"origin":[{"publisherPlace":"Berlin ; Heidelberg","dateIssuedKey":"1847","dateIssuedDisp":"1847-","publisher":"Springer"}],"recId":"254910645","disp":"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 trialVirchows Archiv","type":{"bibl":"periodical","media":"Online-Ressource"},"corporate":[{"role":"isb","display":"European Society of Pathology"}],"titleAlt":[{"title":"Archiv für pathologische Anatomie und Physiologie und für klinische Medicin"},{"title":"Virchows Archiv für pathologische Anatomie und Physiologie und für klinische Medizin"},{"title":"Virchows Archiv / A"}],"language":["eng"],"part":{"extent":"12","pages":"509-520","issue":"4","text":"471(2017), 4, Seite 509-520","year":"2017","volume":"471"},"note":["Gesehen am 06.12.05"],"pubHistory":["1.1847 -"]}],"origin":[{"dateIssuedKey":"2017","dateIssuedDisp":"8 September 2017"}],"language":["eng"],"name":{"displayForm":["Jana Fassunke, Michaela Angelika Ihle, Dido Lenze, Annika Lehmann, Michael Hummel, Claudia Vollbrecht, Roland Penzel, Anna-Lena Volckmar, Albrecht Stenzinger, Volker Endris, Andreas Jung, Ulrich Lehmann, Silke Zeugner, Gustavo Baretton, Hans Kreipe, Peter Schirmacher, Thomas Kirchner, Manfred Dietel, Reinhard Büttner, Sabine Merkelbach-Bruse"]},"recId":"1581650574","person":[{"family":"Fassunke","role":"aut","given":"Jana","display":"Fassunke, Jana"},{"family":"Penzel","role":"aut","given":"Roland","display":"Penzel, Roland"},{"display":"Volckmar, Anna-Lena","given":"Anna-Lena","role":"aut","family":"Volckmar"},{"role":"aut","family":"Stenzinger","given":"Albrecht","display":"Stenzinger, Albrecht"},{"display":"Endris, Volker","given":"Volker","family":"Endris","role":"aut"},{"role":"aut","family":"Schirmacher","display":"Schirmacher, Peter","given":"Peter"}],"note":["Gesehen am 08.10.2018","Im Titel ist \"EGFR\" kursiv geschrieben"]} 
SRT |a FASSUNKEJAEGFRT790MM8201