PMID- 30999109
OWN - NLM
STAT- MEDLINE
DCOM- 20200625
LR  - 20200625
IS  - 1556-1380 (Electronic)
IS  - 1556-0864 (Linking)
VI  - 14
IP  - 7
DP  - 2019 Jul
TI  - Multicenter Evaluation of a Novel ROS1 Immunohistochemistry Assay (SP384) for 
      Detection of ROS1 Rearrangements in a Large Cohort of Lung Adenocarcinoma 
      Patients.
PG  - 1204-1212
LID - S1556-0864(19)30283-7 [pii]
LID - 10.1016/j.jtho.2019.03.024 [doi]
AB  - INTRODUCTION: The detection of a ROS1 rearrangement in advanced and metastatic 
      lung adenocarcinoma (LUAD) led to a targeted treatment with tyrosine kinase 
      inhibitors with favorable progression-free survival and overall survival of the 
      patients. Thus, it is mandatory to screen for the ROS1 rearrangement in all these 
      patients. ROS1 rearrangements can be detected using break-apart fluorescence in 
      situ hybridization (FISH), which is the gold standard; however, ROS1 
      immunohistochemistry (IHC) can be used as a screening test because it is widely 
      available, easy and rapid to perform, and cost-effective. METHODS: We evaluated 
      the diagnostic accuracy and interpathologist agreement of two anti-ROS1 IHC 
      clones, SP384 (Ventana, Tucson, Arizona) and D4D6 (Cell Signaling, Danvers, 
      Massachusetts), in a training cohort of 51 positive ROS1 FISH LUAD cases, and 
      then in a large validation cohort of 714 consecutive cases of LUAD from six 
      routine molecular pathology platforms. RESULTS: In the two cohorts, the SP384 and 
      D4D6 clones show variable sensitivity and specificity rates on the basis of two 
      cutoff points greater than or equal to 1+ (all % tumor cells) and greater than or 
      equal to 2+ (>30% stained tumor cells). In the validation cohort, the D4D6 
      yielded the best accuracy for the presence of a ROS1 rearrangement by FISH. 
      Interpathologist agreement was moderate to good (interclass correlation 
      0.722-0.874) for the D4D6 clone and good to excellent (interclass correlation: 
      0.830-0.956) for the SP384 clone. CONCLUSIONS: ROS1 IHC is an effective screening 
      tool for the presence of ROS1 rearrangements. However, users must be acutely 
      aware of the variable diagnostic performance of different anti-ROS1 antibodies 
      before implementation into routine clinical practice.
CI  - Copyright (c) 2019 International Association for the Study of Lung Cancer. 
      Published by Elsevier Inc. All rights reserved.
FAU - Hofman, Veronique
AU  - Hofman V
AD  - Universite Cote d'Azur, University Hospital Federation OncoAge, Laboratory of 
      Clinical and Experimental Pathology, Pasteur Hospital, Nice, France; Universite 
      Cote d'Azur, CNRS, INSERM, Institute of Research on Cancer and Ageing of Nice 
      (IRCAN), University Hospital Federation OncoAge, Nice, France; Universite Cote 
      d'Azur, University Hospital Federation OncoAge, Hospital-Related Biobank 
      (BB-0033-00025), Pasteur Hospital, Nice, France.
FAU - Rouquette, Isabelle
AU  - Rouquette I
AD  - CHU Toulouse, Department of Pathology, Toulouse, France.
FAU - Long-Mira, Elodie
AU  - Long-Mira E
AD  - Universite Cote d'Azur, University Hospital Federation OncoAge, Laboratory of 
      Clinical and Experimental Pathology, Pasteur Hospital, Nice, France; Universite 
      Cote d'Azur, CNRS, INSERM, Institute of Research on Cancer and Ageing of Nice 
      (IRCAN), University Hospital Federation OncoAge, Nice, France; Universite Cote 
      d'Azur, University Hospital Federation OncoAge, Hospital-Related Biobank 
      (BB-0033-00025), Pasteur Hospital, Nice, France.
FAU - Piton, Nicolas
AU  - Piton N
AD  - Charles Nicolle Hospital, Department of Pathology, Rouen, France.
FAU - Chamorey, Emmanuel
AU  - Chamorey E
AD  - Antoine Lacassagne Comprehensive Cancer Center, Biostatistics Unit, Nice, France.
FAU - Heeke, Simon
AU  - Heeke S
AD  - Universite Cote d'Azur, CNRS, INSERM, Institute of Research on Cancer and Ageing 
      of Nice (IRCAN), University Hospital Federation OncoAge, Nice, France.
FAU - Vignaud, Jean Michel
AU  - Vignaud JM
AD  - CHU Nancy, Department of Pathology and Biobank (BB-0033-00035), Nancy, France.
FAU - Yguel, Clemence
AU  - Yguel C
AD  - CHU Nancy, Department of Pathology and Biobank (BB-0033-00035), Nancy, France.
FAU - Mazieres, Julien
AU  - Mazieres J
AD  - CHU Toulouse, Larrey Hospital, Universite Paul Sabatier, Toulouse, France.
FAU - Lepage, Anne-Laure
AU  - Lepage AL
AD  - Normandie Universite, Department of Pathology, Caen, France.
FAU - Bibeau, Frederic
AU  - Bibeau F
AD  - Normandie Universite, Department of Pathology, Caen, France.
FAU - Begueret, Hugues
AU  - Begueret H
AD  - CHU Bordeaux, Department of Pathology, Pessac, France.
FAU - Lassalle, Sandra
AU  - Lassalle S
AD  - Universite Cote d'Azur, University Hospital Federation OncoAge, Laboratory of 
      Clinical and Experimental Pathology, Pasteur Hospital, Nice, France; Universite 
      Cote d'Azur, CNRS, INSERM, Institute of Research on Cancer and Ageing of Nice 
      (IRCAN), University Hospital Federation OncoAge, Nice, France.
FAU - Lalvee, Salome
AU  - Lalvee S
AD  - Universite Cote d'Azur, University Hospital Federation OncoAge, Laboratory of 
      Clinical and Experimental Pathology, Pasteur Hospital, Nice, France.
FAU - Zahaf, Katia
AU  - Zahaf K
AD  - Universite Cote d'Azur, University Hospital Federation OncoAge, Laboratory of 
      Clinical and Experimental Pathology, Pasteur Hospital, Nice, France.
FAU - Benzaquen, Jonathan
AU  - Benzaquen J
AD  - Universite Cote d'Azur, CNRS, INSERM, Institute of Research on Cancer and Ageing 
      of Nice (IRCAN), University Hospital Federation OncoAge, Nice, France; Universite 
      Cote d'Azur, University Hospital Federation OncoAge, Department of Pulmonary 
      Medicine and Thoracic Oncology, Nice, France.
FAU - Poudenx, Michel
AU  - Poudenx M
AD  - Universite Cote d'Azur, University Hospital Federation OncoAge, Department of 
      Pulmonary Medicine and Thoracic Oncology, Nice, France.
FAU - Marquette, Charles-Hugo
AU  - Marquette CH
AD  - Universite Cote d'Azur, University Hospital Federation OncoAge, Department of 
      Pulmonary Medicine and Thoracic Oncology, Nice, France.
FAU - Sabourin, Jean-Christophe
AU  - Sabourin JC
AD  - Charles Nicolle Hospital, Department of Pathology, Rouen, France.
FAU - Ilie, Marius
AU  - Ilie M
AD  - Universite Cote d'Azur, University Hospital Federation OncoAge, Laboratory of 
      Clinical and Experimental Pathology, Pasteur Hospital, Nice, France; Universite 
      Cote d'Azur, CNRS, INSERM, Institute of Research on Cancer and Ageing of Nice 
      (IRCAN), University Hospital Federation OncoAge, Nice, France; Universite Cote 
      d'Azur, University Hospital Federation OncoAge, Hospital-Related Biobank 
      (BB-0033-00025), Pasteur Hospital, Nice, France.
FAU - Hofman, Paul
AU  - Hofman P
AD  - Universite Cote d'Azur, University Hospital Federation OncoAge, Laboratory of 
      Clinical and Experimental Pathology, Pasteur Hospital, Nice, France; Universite 
      Cote d'Azur, CNRS, INSERM, Institute of Research on Cancer and Ageing of Nice 
      (IRCAN), University Hospital Federation OncoAge, Nice, France; Universite Cote 
      d'Azur, University Hospital Federation OncoAge, Hospital-Related Biobank 
      (BB-0033-00025), Pasteur Hospital, Nice, France. Electronic address: 
      hofman.p@chu-nice.fr.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190415
PL  - United States
TA  - J Thorac Oncol
JT  - Journal of thoracic oncology : official publication of the International 
      Association for the Study of Lung Cancer
JID - 101274235
RN  - 0 (Biomarkers, Tumor)
RN  - 0 (Proto-Oncogene Proteins)
RN  - EC 2.7.10.1 (Protein-Tyrosine Kinases)
RN  - EC 2.7.10.1 (ROS1 protein, human)
SB  - IM
MH  - Adenocarcinoma of Lung/*diagnosis/genetics/metabolism
MH  - Biomarkers, Tumor/*analysis
MH  - Follow-Up Studies
MH  - *Gene Rearrangement
MH  - Humans
MH  - Immunohistochemistry/*methods
MH  - In Situ Hybridization, Fluorescence
MH  - Lung Neoplasms/*diagnosis/genetics/metabolism
MH  - Prognosis
MH  - Protein-Tyrosine Kinases/*genetics/*metabolism
MH  - Proto-Oncogene Proteins/*genetics/*metabolism
MH  - Retrospective Studies
OTO - NOTNLM
OT  - D4D6
OT  - Fluorescence in situ hybridization
OT  - Immunohistochemistry
OT  - Lung adenocarcinoma
OT  - ROS1
OT  - SP384
EDAT- 2019/04/19 06:00
MHDA- 2020/06/26 06:00
CRDT- 2019/04/19 06:00
PHST- 2019/01/28 00:00 [received]
PHST- 2019/03/06 00:00 [revised]
PHST- 2019/03/19 00:00 [accepted]
PHST- 2019/04/19 06:00 [pubmed]
PHST- 2020/06/26 06:00 [medline]
PHST- 2019/04/19 06:00 [entrez]
AID - S1556-0864(19)30283-7 [pii]
AID - 10.1016/j.jtho.2019.03.024 [doi]
PST - ppublish
SO  - J Thorac Oncol. 2019 Jul;14(7):1204-1212. doi: 10.1016/j.jtho.2019.03.024. Epub 
      2019 Apr 15.