PMID- 29199679
OWN - NLM
STAT- MEDLINE
DCOM- 20180712
LR  - 20190221
IS  - 1998-4774 (Electronic)
IS  - 0019-509X (Linking)
VI  - 54
IP  - 1
DP  - 2017 Jan-Mar
TI  - A comparative analysis of immunohistochemistry and fluorescent in situ 
      hybridization assay to detect anaplastic lymphoma kinase status in lung 
      adenocarcinoma cases: A search for a testing algorithm.
PG  - 148-154
LID - 10.4103/ijc.IJC_202_17 [doi]
AB  - INTRODUCTION: Testing for echinoderm microtubule-associated protein-like 4 (EML4) 
      anaplastic lymphoma kinase (ALK) translocation by fluorescence in situ 
      hybridization (FISH) is well established whereas the Food and Drug Administration 
      (FDA) ALK immunohistochemical (IHC) test is relatively new. AIMS AND OBJECTIVE: 
      The aim of this study is to compare FDA-approved ALK IHC test (D5F3 clone) with 
      the standard ALK FISH test. MATERIALS AND METHODS: A validation and a test arm 
      with 100 and 200 cases of Formalin-Fixed, Paraffin-embedded blocks of lung 
      adenocarcinoma, respectively, comprised the material. All cases had ALK IHC test 
      on automated Ventana Benchmark XT IHC slide stainer using anti-ALK D5F3 rabbit 
      monoclonal primary antibody; when positive tumor cells (any percentage) showed 
      strong granular cytoplasmic staining. For the FISH test, Vysis ALK Dual Color 
      Break Apart Rearrangement Probe (Abbott Molecular Inc.,) was used to detect ALK 
      gene 2p23 rearrangements; when positive the red and green signals were split two 
      signal diameter apart and/or isolated 3'red signal were detected in more than 15% 
      tumor cells. The ALK FISH results were available in all 100 validation cases and 
      64-test arm cases which formed the basis of this analysis. RESULTS: The ALK IHC 
      test was positive in 16% cases; four discordant cases were ALK IHC positive but 
      ALK FISH negative, but no case was ALK IHC negative and ALK FISH positive. There 
      was 100% sensitivity, 90.5% specificity, and 93.75% accuracy. CONCLUSION: A 
      negative ALK IHC result obviates the need for a FISH test barring those with a 
      strong clinical profile, and a positive ALK IHC result is sufficient basis for 
      the initiation of treatment.
FAU - Wagle, P B
AU  - Wagle PB
AD  - Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
FAU - Jambhekar, N A
AU  - Jambhekar NA
AD  - Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
FAU - Kumar, R
AU  - Kumar R
AD  - Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
FAU - Prabhash, K
AU  - Prabhash K
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, 
      India.
FAU - Pramesh, C S
AU  - Pramesh CS
AD  - Department of Surgical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, 
      India.
FAU - Desai, S B
AU  - Desai SB
AD  - Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
FAU - Noronha, V
AU  - Noronha V
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, 
      India.
FAU - Karimundackal, G
AU  - Karimundackal G
AD  - Department of Surgical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, 
      India.
FAU - Shah, A
AU  - Shah A
AD  - Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
FAU - Joshi, A
AU  - Joshi A
AD  - Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, 
      India.
FAU - Laskar, S G
AU  - Laskar SG
AD  - Department of Radiation Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, 
      India.
FAU - Jiwnani, S
AU  - Jiwnani S
AD  - Department of Surgical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, 
      India.
FAU - Pai, T
AU  - Pai T
AD  - Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
FAU - Agarwal, J P
AU  - Agarwal JP
AD  - Department of Radiation Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, 
      India.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PL  - India
TA  - Indian J Cancer
JT  - Indian journal of cancer
JID - 0112040
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/*genetics/pathology
MH  - Adenocarcinoma of Lung
MH  - Algorithms
MH  - Anaplastic Lymphoma Kinase
MH  - Female
MH  - Gene Rearrangement
MH  - Humans
MH  - *Immunohistochemistry
MH  - *In Situ Hybridization, Fluorescence
MH  - Lung Neoplasms/*genetics/pathology
MH  - Male
MH  - Receptor Protein-Tyrosine Kinases/*genetics
EDAT- 2017/12/05 06:00
MHDA- 2018/07/13 06:00
CRDT- 2017/12/05 06:00
PHST- 2017/12/05 06:00 [entrez]
PHST- 2017/12/05 06:00 [pubmed]
PHST- 2018/07/13 06:00 [medline]
AID - IndianJournalofCancer_2017_54_1_148_219565 [pii]
AID - 10.4103/ijc.IJC_202_17 [doi]
PST - ppublish
SO  - Indian J Cancer. 2017 Jan-Mar;54(1):148-154. doi: 10.4103/ijc.IJC_202_17.