Universität zu Köln

Reguart, Noemi, Teixido, Cristina ORCID: 0000-0002-7226-6567, Gimenez-Capitan, Ana, Pare, Laia ORCID: 0000-0002-4904-558X, Galvan, Patricia, Viteri, Santiago, Rodriguez, Sonia, Peg, Vicente ORCID: 0000-0002-5203-6166, Aldeguer, Erika, Vinolas, Nuria, Remon, Jordi, Karachaliou, Niki, Conde, Esther, Lopez-Rios, Fernando, Nadal, Ernest ORCID: 0000-0002-9674-5554, Merkelbach-Bruse, Sabine, Buettner, Reinhard, Rosell, Rafael, Molina-Vila, Miguel A. and Prat, Aleix (2017). Identification of ALK, ROS1, and RET Fusions by a Multiplexed mRNA-Based Assay in Formalin-Fixed, Paraffin-Embedded Samples from Advanced Non-Small-Cell Lung Cancer Patients. Clin. Chem., 63 (3). S. 751 - 761. WASHINGTON: AMER ASSOC CLINICAL CHEMISTRY. ISSN 1530-8561

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Abstract

BACKGROUND: Anaplastic lymphoma receptor tyrosine kinase (ALK), ROS proto-oncogene 1, receptor tyrosine kinase (ROSA and ret proto-oncogene (RET) fusions are present in 5%-7% of patients with advanced non-small-cell lung cancer (NSCLC); their accurate identification is critical to guide targeted therapies. FISH and immunohistochemistry (IHC) are considered the gold standards to determine gene fusions, but they have limitations. The nCounter platform is a potentially useful genomic tool for multiplexed detection of gene fusions, but has not been validated in the clinical setting. METHODS: Formalin-fixed, paraffin embedded (FFPE) samples from 108 patients with advanced NSCLC were analyzed with an nCounter-based assay and the results compared with FISH, IHC, and reverse transcription PCR (RT-PCR). Data on response to fusion kinase inhibitors was retrospectively collected in a subset of 29 patients. RESULTS: Of 108 FFPE samples, 98 were successfully analyzed by nCounter (91%), which identified 55 fusion positive cases (32 ALK, 21 ROS1, and 2 RET). nCounter results were highly concordant with IHC for ALK (98.5%, CI = 91.8-99.7), while 11 discrepancies were found compared with FISH (87.5% concordance, CI = 79.0-92.9). For ROS1, nCounter showed similar agreement with IHC and FISH (87.2% and 85.9%), but a substantial number of samples were positive only by 1 or 2 techniques. Of the 25 patients deriving clinical benefit from fusion kinase inhibitors, 24 were positive by nCounter and 22 by FISH. CONCLUSIONS: nCounter compares favorably with IHC and FISH and can be used for identifying patients with advanced NSCLC positive for ALKIROS1/RET fusion genes. (C) 2016 American Association for Clinical Chemistry

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Reguart, Noemi UNSPECIFIED UNSPECIFIED UNSPECIFIED Teixido, Cristina UNSPECIFIED orcid.org/0000-0002-7226-6567 UNSPECIFIED Gimenez-Capitan, Ana UNSPECIFIED UNSPECIFIED UNSPECIFIED Pare, Laia UNSPECIFIED orcid.org/0000-0002-4904-558X UNSPECIFIED Galvan, Patricia UNSPECIFIED UNSPECIFIED UNSPECIFIED Viteri, Santiago UNSPECIFIED UNSPECIFIED UNSPECIFIED Rodriguez, Sonia UNSPECIFIED UNSPECIFIED UNSPECIFIED Peg, Vicente UNSPECIFIED orcid.org/0000-0002-5203-6166 UNSPECIFIED Aldeguer, Erika UNSPECIFIED UNSPECIFIED UNSPECIFIED Vinolas, Nuria UNSPECIFIED UNSPECIFIED UNSPECIFIED Remon, Jordi UNSPECIFIED UNSPECIFIED UNSPECIFIED Karachaliou, Niki UNSPECIFIED UNSPECIFIED UNSPECIFIED Conde, Esther UNSPECIFIED UNSPECIFIED UNSPECIFIED Lopez-Rios, Fernando UNSPECIFIED UNSPECIFIED UNSPECIFIED Nadal, Ernest UNSPECIFIED orcid.org/0000-0002-9674-5554 UNSPECIFIED Merkelbach-Bruse, Sabine UNSPECIFIED UNSPECIFIED UNSPECIFIED Buettner, Reinhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Rosell, Rafael UNSPECIFIED UNSPECIFIED UNSPECIFIED Molina-Vila, Miguel A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Prat, Aleix UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-238865
DOI:	10.1373/clinchem.2016.265314
Journal or Publication Title:	Clin. Chem.
Volume:	63
Number:	3
Page Range:	S. 751 - 761
Date:	2017
Publisher:	AMER ASSOC CLINICAL CHEMISTRY
Place of Publication:	WASHINGTON
ISSN:	1530-8561
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ANAPLASTIC LYMPHOMA KINASE; ADENOCARCINOMA; CRIZOTINIB; CHEMOTHERAPY; EXPRESSION; GENE; REARRANGEMENT; ERLOTINIB; KIF5B-RET; TISSUES Multiple languages Medical Laboratory Technology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/23886