PMID- 28884371
OWN - NLM
STAT- MEDLINE
DCOM- 20171205
LR  - 20210325
IS  - 1432-2307 (Electronic)
IS  - 0945-6317 (Linking)
VI  - 471
IP  - 4
DP  - 2017 Oct
TI  - 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.
PG  - 509-520
LID - 10.1007/s00428-017-2226-8 [doi]
AB  - 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.
FAU - Fassunke, Jana
AU  - Fassunke J
AUID- ORCID: 0000-0002-8391-5577
AD  - Institue of Pathology, University Hospital Cologne, Kerpener Strasse 62, 50924, 
      Cologne, Germany. jana.fassunke@uk-koeln.de.
FAU - Ihle, Michaela Angelika
AU  - Ihle MA
AD  - Institue of Pathology, University Hospital Cologne, Kerpener Strasse 62, 50924, 
      Cologne, Germany.
FAU - Lenze, Dido
AU  - Lenze D
AD  - Institute of Pathology, Charite-University Hospital Berlin, Campus Mitte, 
      Virchowweg 15, 10117, Berlin, Germany.
FAU - Lehmann, Annika
AU  - Lehmann A
AD  - Institute of Pathology, Charite-University Hospital Berlin, Campus Mitte, 
      Virchowweg 15, 10117, Berlin, Germany.
FAU - Hummel, Michael
AU  - Hummel M
AD  - Institute of Pathology, Charite-University Hospital Berlin, Campus Mitte, 
      Virchowweg 15, 10117, Berlin, Germany.
FAU - Vollbrecht, Claudia
AU  - Vollbrecht C
AD  - Institute of Pathology, Charite-University Hospital Berlin, Campus Mitte, 
      Virchowweg 15, 10117, Berlin, Germany.
FAU - Penzel, Roland
AU  - Penzel R
AD  - Institute of Pathology, University Hospital Heidelberg, Im Neuenheimer Feld 224, 
      Heidelberg, Germany.
FAU - Volckmar, Anna-Lena
AU  - Volckmar AL
AD  - Institute of Pathology, University Hospital Heidelberg, Im Neuenheimer Feld 224, 
      Heidelberg, Germany.
FAU - Stenzinger, Albrecht
AU  - Stenzinger A
AD  - Institute of Pathology, University Hospital Heidelberg, Im Neuenheimer Feld 224, 
      Heidelberg, Germany.
FAU - Endris, Volker
AU  - Endris V
AD  - Institute of Pathology, University Hospital Heidelberg, Im Neuenheimer Feld 224, 
      Heidelberg, Germany.
FAU - Jung, Andreas
AU  - Jung A
AD  - Pathologisches Institut of the Ludwig-Maximilinas-Universitat Munchen, 
      Thalkirchnerstrasse 36, 80336, Munich, Germany.
FAU - Lehmann, Ulrich
AU  - Lehmann U
AD  - Institute of Pathology, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625, 
      Hannover, Germany.
FAU - Zeugner, Silke
AU  - Zeugner S
AD  - Institute of Pathology, University Hospital Dresden Carl Gustav Carus, 
      Fetscherstrasse 74, 01307, Dresden, Germany.
FAU - Baretton, Gustavo
AU  - Baretton G
AD  - Institute of Pathology, University Hospital Dresden Carl Gustav Carus, 
      Fetscherstrasse 74, 01307, Dresden, Germany.
FAU - Kreipe, Hans
AU  - Kreipe H
AD  - Institute of Pathology, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625, 
      Hannover, Germany.
FAU - Schirmacher, Peter
AU  - Schirmacher P
AD  - Institute of Pathology, University Hospital Heidelberg, Im Neuenheimer Feld 224, 
      Heidelberg, Germany.
FAU - Kirchner, Thomas
AU  - Kirchner T
AD  - Pathologisches Institut of the Ludwig-Maximilinas-Universitat Munchen, 
      Thalkirchnerstrasse 36, 80336, Munich, Germany.
FAU - Dietel, Manfred
AU  - Dietel M
AD  - Institute of Pathology, Charite-University Hospital Berlin, Campus Mitte, 
      Virchowweg 15, 10117, Berlin, Germany.
FAU - Buttner, Reinhard
AU  - Buttner R
AD  - Institue of Pathology, University Hospital Cologne, Kerpener Strasse 62, 50924, 
      Cologne, Germany.
FAU - Merkelbach-Bruse, Sabine
AU  - Merkelbach-Bruse S
AD  - Institue of Pathology, University Hospital Cologne, Kerpener Strasse 62, 50924, 
      Cologne, Germany.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
DEP - 20170908
PL  - Germany
TA  - Virchows Arch
JT  - Virchows Archiv : an international journal of pathology
JID - 9423843
RN  - 0 (Circulating Tumor DNA)
RN  - EC 2.7.10.1 (EGFR protein, human)
RN  - EC 2.7.10.1 (ErbB Receptors)
SB  - IM
MH  - Carcinoma, Non-Small-Cell Lung/blood/genetics
MH  - Circulating Tumor DNA/*analysis
MH  - DNA Mutational Analysis/*standards
MH  - ErbB Receptors/*analysis/genetics
MH  - Genotyping Techniques/*standards
MH  - Germany
MH  - Humans
MH  - Lung Neoplasms/blood/genetics
MH  - *Quality Assurance, Health Care
OTO - NOTNLM
OT  - Blood and plasma samples
OT  - DNA sequencing
OT  - EGFR
OT  - FFPE
OT  - Liquid biopsy
OT  - NSCLC
OT  - Osimertinib
OT  - T790M mutation
OT  - Tumor tissue
EDAT- 2017/09/09 06:00
MHDA- 2017/12/06 06:00
CRDT- 2017/09/09 06:00
PHST- 2017/03/07 00:00 [received]
PHST- 2017/08/22 00:00 [accepted]
PHST- 2017/07/22 00:00 [revised]
PHST- 2017/09/09 06:00 [pubmed]
PHST- 2017/12/06 06:00 [medline]
PHST- 2017/09/09 06:00 [entrez]
AID - 10.1007/s00428-017-2226-8 [pii]
AID - 10.1007/s00428-017-2226-8 [doi]
PST - ppublish
SO  - Virchows Arch. 2017 Oct;471(4):509-520. doi: 10.1007/s00428-017-2226-8. Epub 2017 
      Sep 8.