PMID- 23904459
OWN - NLM
STAT- MEDLINE
DCOM- 20140514
LR  - 20220317
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 24
IP  - 10
DP  - 2013 Oct
TI  - Diagnostic value of a novel fully automated immunochemistry assay for detection 
      of ALK rearrangement in primary lung adenocarcinoma.
PG  - 2589-2593
LID - S0923-7534(19)37103-0 [pii]
LID - 10.1093/annonc/mdt295 [doi]
AB  - BACKGROUND: To evaluate the diagnostic value of a novel fully automated 
      immunohistochemistry (IHC) assay for detection of anaplastic lymphoma kinase 
      (ALK) fusion in a large number of ALK-positive lung adenocarcinoma (ADC) 
      patients. PATIENTS AND METHODS: We tested 196 lung ADCs for ALK rearrangement by 
      two IHC assays (Ventana pre-diluted ALK D5F3 antibody with the Optiview DAB IHC 
      detection kit and Optiview Amplification kit, D5F3 by Cell Signaling Technology 
      (CST) with Ultraview DAB detection kit by Ventana), fluorescence in situ 
      hybridization (FISH) and real-time reverse transcription-PCR (RT-PCR). CST ALK 
      IHC was scored using the scoring scheme of 0, no staining; 1+, faint; 2+, 
      moderate; and 3+, strong cytoplasmic reactivity in >/= 10% of tumor cells. As for 
      Ventana IHC, a binary scoring system (positive or negative for ALK status) was 
      adopted for evaluating the staining results. RESULTS: Among 196 cases tested, 63 
      (32%), 65 (33%), 70 (36%), and 69 (35%) cases were ALK positive by FISH, Ventana 
      IHC, CST IHC, and RT-PCR, respectively. The sensitivity and specificity of 
      Ventana IHC were 100% and 98%, respectively. Two Ventana IHC-positive cases, 
      which were also CST IHC score of 3+, showed FISH negative, but their ALK 
      rearrangement was confirmed by RT-PCR and direct sequencing. The sensitivity and 
      specificity of CST IHC with staining intensity score of 1+ or more were 100% and 
      95%, respectively. Five (25%, of 20) patients with CST IHC score of 1+ were both 
      FISH and RT-PCR negative. The sensitivity and specificity of RT-PCR for detection 
      of ALK fusion were 98% and 95%, respectively. The total accordance rate between 
      ALK RT-PCR and Ventana IHC was 97%. CONCLUSIONS: The novel fully automated IHC 
      assay is a reliable screening tool in routine pathologic laboratories for 
      identification of patients with ALK rearrangement for targeted therapy in lung 
      ADC.
FAU - Ying, J
AU  - Ying J
AD  - Department of Pathology, Cancer Institute and Hospital, Peking Union Medical 
      College and Chinese Academy of Medical Sciences, Beijing, China. Electronic 
      address: jmying@hotmail.com.
FAU - Guo, L
AU  - Guo L
AD  - Department of Pathology, Cancer Institute and Hospital, Peking Union Medical 
      College and Chinese Academy of Medical Sciences, Beijing, China.
FAU - Qiu, T
AU  - Qiu T
AD  - Department of Pathology, Cancer Institute and Hospital, Peking Union Medical 
      College and Chinese Academy of Medical Sciences, Beijing, China.
FAU - Shan, L
AU  - Shan L
AD  - Department of Pathology, Cancer Institute and Hospital, Peking Union Medical 
      College and Chinese Academy of Medical Sciences, Beijing, China.
FAU - Ling, Y
AU  - Ling Y
AD  - Department of Pathology, Cancer Institute and Hospital, Peking Union Medical 
      College and Chinese Academy of Medical Sciences, Beijing, China.
FAU - Liu, X
AU  - Liu X
AD  - Department of Pathology, Cancer Institute and Hospital, Peking Union Medical 
      College and Chinese Academy of Medical Sciences, Beijing, China.
FAU - Lu, N
AU  - Lu N
AD  - Department of Pathology, Cancer Institute and Hospital, Peking Union Medical 
      College and Chinese Academy of Medical Sciences, Beijing, China.
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20130731
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Recombinant Fusion Proteins)
RN  - EC 2.7.10.1 (ALK protein, human)
RN  - EC 2.7.10.1 (Anaplastic Lymphoma Kinase)
RN  - EC 2.7.10.1 (Receptor Protein-Tyrosine Kinases)
SB  - IM
MH  - Adenocarcinoma/*diagnosis/*genetics
MH  - Adenocarcinoma of Lung
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anaplastic Lymphoma Kinase
MH  - Carcinoma, Non-Small-Cell Lung/*diagnosis/*genetics
MH  - Female
MH  - Gene Rearrangement/genetics
MH  - Humans
MH  - Immunohistochemistry/methods
MH  - In Situ Hybridization, Fluorescence
MH  - Lung Neoplasms/*diagnosis/*genetics
MH  - Male
MH  - Middle Aged
MH  - Receptor Protein-Tyrosine Kinases/*genetics
MH  - Recombinant Fusion Proteins/genetics
MH  - Reverse Transcriptase Polymerase Chain Reaction
MH  - Sensitivity and Specificity
MH  - Sequence Analysis, DNA
MH  - Young Adult
OTO - NOTNLM
OT  - ALK
OT  - fluorescence in situ hybridization
OT  - immunohistochemistry
OT  - lung cancer
OT  - targeted therapy
EDAT- 2013/08/02 06:00
MHDA- 2014/05/16 06:00
CRDT- 2013/08/02 06:00
PHST- 2013/08/02 06:00 [entrez]
PHST- 2013/08/02 06:00 [pubmed]
PHST- 2014/05/16 06:00 [medline]
AID - S0923-7534(19)37103-0 [pii]
AID - 10.1093/annonc/mdt295 [doi]
PST - ppublish
SO  - Ann Oncol. 2013 Oct;24(10):2589-2593. doi: 10.1093/annonc/mdt295. Epub 2013 Jul 
      31.