Huang, Richard S. P., Smith, Derek, Le, Catherine H., Liu, Wen-Wei, Ordinario, Ellen, Manohar, Chitra, Lee, Michael, Rajamani, Jaya, Truong, Huan, Li, Jing, Choi, Cindy, Li, Jingchuan, Pati, Amrita, Bubendorf, Lukas ORCID: 0000-0001-5970-1803, Buettner, Reinhard, Kerr, Keith M., Lopez-Rios, Fernando, Marchetti, Antonio, Marondel, Ivonne, Nicholson, Andrew G., Oz, Aysim Buge, Pauwels, Patrick, Penault-Llorca, Frederique, Rossi, Giulio, Thunnissen, Erik, Newell, Amy Hanlon, Pate, Greg and Menzl, Ina (2020). Correlation of ROS1 Immunohistochemistry With ROS1 Fusion Status Determined by Fluorescence In Situ Hybridization. Arch. Pathol. Lab. Med., 144 (6). S. 735 - 742. NORTHFIELD: COLL AMER PATHOLOGISTS. ISSN 1543-2165

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Abstract

Context.-The ability to determine ROS1 status has become mandatory for patients with lung adenocarcinoma, as many global authorities have approved crizotinib for patients with ROS1-positive lung adenocarcinoma. Objective.-To present analytical correlation of the VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody (ROS1 [SP384] antibody) with ROS1 fluorescence in situ hybridization (FISH). Design.-The immunohistochemistry (IHC) and FISH analytical comparison was assessed by using 122 non-small cell lung cancer samples that had both FISH (46 positive and 76 negative cases) and IHC staining results available. In addition, reverse transcription-polymerase chain reaction (RT-PCR) as well as DNA and RNA next-generation sequencing (NGS) were used to further examine the ROS1 status in cases that were discrepant between FISH and IHC, based on staining in the cytoplasm of 2+ or above in more than 30% of total tumor cells considered as IHC positive. Here, we define the consensus status as the most frequent result across the 5 different methods (IHC, FISH, RT-PCR, RNA NGS, and DNA NGS) we used to determine ROS1 status in these cases. Results.-Of the IHC scoring methods examined, staining in the cytoplasm of 2+ or above in more than 30% of total tumor cells considered as IHC positive had the highest correlation with a FISH-positive status, reaching a positive percentage agreement of 97.8% and negative percentage agreement of 89.5%. A positive percentage agreement (100%) and negative percentage agreement (92.0%) was reached by comparing ROS1 (SP384) using a cutoff for staining in the cytoplasm of 2+ or above in more than 30% of total tumor cells to the consensus status. Conclusions.-Herein, we present a standardized staining protocol for ROS1 (SP384) and data that support the high correlation between ROS1 status and ROS1 (SP384) antibody.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Huang, Richard S. P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Smith, DerekUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Le, Catherine H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Liu, Wen-WeiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ordinario, EllenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Manohar, ChitraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lee, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rajamani, JayaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Truong, HuanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Li, JingUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Choi, CindyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Li, JingchuanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pati, AmritaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bubendorf, LukasUNSPECIFIEDorcid.org/0000-0001-5970-1803UNSPECIFIED
Buettner, ReinhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kerr, Keith M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lopez-Rios, FernandoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Marchetti, AntonioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Marondel, IvonneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nicholson, Andrew G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oz, Aysim BugeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pauwels, PatrickUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Penault-Llorca, FrederiqueUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rossi, GiulioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thunnissen, ErikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Newell, Amy HanlonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pate, GregUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Menzl, InaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-332026
DOI: 10.5858/arpa.2019-0085-OA
Journal or Publication Title: Arch. Pathol. Lab. Med.
Volume: 144
Number: 6
Page Range: S. 735 - 742
Date: 2020
Publisher: COLL AMER PATHOLOGISTS
Place of Publication: NORTHFIELD
ISSN: 1543-2165
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
LUNG-CANCER; REARRANGEMENTS; CRIZOTINIBMultiple languages
Medical Laboratory Technology; Medicine, Research & Experimental; PathologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/33202

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