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Validation of ALK/ROS1 Dual Break Apart FISH Probe probe in non-small-cell lung cancer

Authors
 Sun Min Lim  ;  Hyun Chang  ;  Yoon Jin Cha  ;  Shile Liang  ;  Yan Chin Tai  ;  Gu Li  ;  Ekaterina Pestova  ;  Frank Policht  ;  Thomas Perez  ;  Ross A. Soo  ;  Won Young Park  ;  Hye Ryun Kim  ;  Hyo Sup Shim  ;  Byoung Chul Cho 
Citation
 Lung Cancer, Vol.111 : 79-83, 2017 
Journal Title
 Lung Cancer 
ISSN
 0169-5002 
Issue Date
2017
MeSH
Adult ; Aged ; Biomarkers, Tumor ; Carcinoma, Non-Small-Cell Lung/diagnosis ; Carcinoma, Non-Small-Cell Lung/genetics ; DNA Probes ; Female ; Gene Rearrangement ; Genotype ; Humans ; In Situ Hybridization, Fluorescence*/methods ; Lung Neoplasms/diagnosis ; Lung Neoplasms/genetics ; Male ; Middle Aged ; Mutation ; Neoplasm Staging ; Oncogene Proteins, Fusion/genetics ; Protein-Tyrosine Kinases/genetics ; Proto-Oncogene Proteins/genetics ; Reagent Kits, Diagnostic ; Receptor Protein-Tyrosine Kinases/genetics ; Reproducibility of Results
Keywords
ALK ; Fluorescent in situ hybridization ; Non-small-cell lung cancer ; ROS1
Abstract
BACKGROUND: ALK and ROS1 gene rearrangements are distinct molecular subsets of non-small-cell lung cancer (NSCLC), and they are strong predictive biomarkers of response to ALK/ROS1 inhibitors, such as crizotinib. Thus, it is clinically important to develop an effective screening strategy to detect patients who will benefit from such treatment. In this study, we aimed to validate analytical performance of Vysis ALK/ROS1 Dual Break Apart Probe Kit (RUO) in NSCLC. METHODS: Study population composed of three patient cohorts with histologically confirmed lung adenocarcinoma (patients with ALK rearrangement, patients with ROS1 rearrangement and patients with wild-type ALK and ROS1). Specimens consisted of 12 ALK-positive, 8 ROS1-positive and 21 ALK/ROS1-wild type formalin-fixed paraffin-embedded samples obtained from surgical resection or excisional biopsy. ALK rearrangement was previously assessed by Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Abbot Park, IL, USA) and ROS1 rearrangement was previously assessed by ZytoLight® SPEC ROS1 Break Apart Probe (ZytoVision, GmbH). All specimens were re-evaluated by Vysis ALK/ROS1 Dual Break Apart Probe Kit. FISH images were scanned on BioView AllegroPlus system and interpreted via BioView SoloWeb remotely. RESULTS: For a total of 41 patient samples, the concordance of the results by Vysis ALK/ROS1 Dual Break Apart Probe Kit was evaluated and compared to the known ALK and ROS1 rearrangement status of the specimen. Of the 12 ALK-positive cases, hybridization with Vysis ALK/ROS1 Dual Break Apart Probe Kit was successful in 10 cases (success rate 10/12, 83%) and of these 10 cases, all showed ALK rearrangement (100% concordance with the results of Vysis ALK Break Apart FISH Probe Kit). Two of the ALK+ cases were excluded due to weak ROS1 signals that could not be enumerated. Of the 8 ROS1-positive cases, 6 cases were successfully evaluated using Vysis ALK/ROS1 Dual Break Apart Probe Kit. The success rate was 75% (6/8), and of these 6 cases, all showed ROS1 rearrangement, giving a 100% concordance with ZytoLight® SPEC ROS1 Break Apart Probe. Two of the cases were excluded due to weak ROS1 gold signal or high background. In the cohort of 21 wild-type cases, the success rate using Vysis ALK/ROS1 Dual Break Apart FISH Probe Kit was 85% (18/21) and the concordance with ALK and ROS1 probe kit was 100% (18/18). CONCLUSION: Vysis ALK/ROS1 Dual Break Apart Probe Kit (RUO) can detect ALK and ROS1 rearrangement simultaneously in NSCLC.
Full Text
https://www.sciencedirect.com/science/article/pii/S0169500217303951
DOI
10.1016/j.lungcan.2017.07.016
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hye Ryun(김혜련) ORCID logo https://orcid.org/0000-0002-1842-9070
Shim, Hyo Sup(심효섭) ORCID logo https://orcid.org/0000-0002-5718-3624
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
Cha, Yoon Jin(차윤진) ORCID logo https://orcid.org/0000-0002-5967-4064
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/160848
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