PMID- 27338643 OWN - NLM STAT- MEDLINE DCOM- 20170405 LR - 20181202 IS - 1724-6008 (Electronic) IS - 0393-6155 (Linking) VI - 31 IP - 4 DP - 2016 Dec 23 TI - ALK immunohistochemistry for ALK gene rearrangement screening in non-small cell lung cancer: a systematic review and meta-analysis. PG - e413-e421 LID - EC854003-9EE4-4E48-80DC-D4FC188AD206 [pii] LID - 10.5301/jbm.5000218 [doi] AB - INTRODUCTION: The aim of this study was to investigate the diagnostic accuracy of anaplastic lymphoma kinase (ALK) immunohistochemistry (IHC) for ALK gene rearrangement in non-small cell lung cancer (NSCLC) through systematic review, meta-analysis and diagnostic test accuracy review. METHODS: The current study included 11,806 NSCLC cases in 42 eligible studies. We performed concordance analyses between ALK IHC and fluorescence in situ hybridization (FISH). The diagnostic accuracy of ALK IHC was analyzed based on ALK IHC criteria and antibodies. RESULTS: The overall ALK IHC results were positive in 13.2%. The overall concordance rate between ALK IHC and FISH was 0.950 (95% confidence interval [CI], 0.927-0.966). In the ALK IHC-positive and negative groups, the concordance rates were 0.805 (95% CI 0.733-0.861) and 0.985 (95% CI 0.978-0.990), respectively. The ALK FISH-positive rates were 0.009 (95% CI 0.004-0.023), 0.378 (95% CI 0.217-0.572), 0.628 (95% CI 0.420-0.796) and 0.900 (95% CI 0.840-0.939) in the ALK IHC 0, 1+, 2+ and 3+ groups, respectively. In diagnostic test accuracy review for ALK IHC, the pooled sensitivity and specificity were 0.92 (95% CI 0.89-0.94) and 0.91 (95% CI 0.90-0.91), respectively. The diagnostic odds ratio and the area under the curve on the summary receiver operating characteristic curve were 266.56 (95% CI 110.83-641.14) and 0.983, respectively. CONCLUSIONS: Our results suggested that ALK IHC equivocal (score 1+ and 2+) cases should not be considered as IHC-negative in screening for ALK gene rearrangement. Additional detailed criteria for ALK IHC equivocal cases are necessary to determine how to best apply this approach in daily practice. FAU - Pyo, Jung-Soo AU - Pyo JS AD - Department of Pathology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul - Republic of Korea. AD - Department of Pathology, Eulji University Hospital, Daejeon, Republic of Korea. FAU - Kang, Guhyun AU - Kang G AD - Department of Pathology, Inje University Sanggye Paik Hospital, Seoul - Republic of Korea. FAU - Sohn, Jin Hee AU - Sohn JH AD - Department of Pathology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul - Republic of Korea. LA - eng PT - Journal Article PT - Meta-Analysis PT - Review PT - Systematic Review DEP - 20161223 PL - United States TA - Int J Biol Markers JT - The International journal of biological markers JID - 8712411 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 - Anaplastic Lymphoma Kinase MH - Carcinoma, Non-Small-Cell Lung/*enzymology/*genetics/pathology MH - Early Detection of Cancer MH - Gene Rearrangement MH - Humans MH - Immunohistochemistry MH - Lung Neoplasms/*enzymology/*genetics/pathology MH - Receptor Protein-Tyrosine Kinases/*genetics EDAT- 2016/10/30 06:00 MHDA- 2017/04/06 06:00 CRDT- 2016/06/25 06:00 PHST- 2016/05/27 00:00 [accepted] PHST- 2016/10/30 06:00 [pubmed] PHST- 2017/04/06 06:00 [medline] PHST- 2016/06/25 06:00 [entrez] AID - EC854003-9EE4-4E48-80DC-D4FC188AD206 [pii] AID - 10.5301/jbm.5000218 [doi] PST - epublish SO - Int J Biol Markers. 2016 Dec 23;31(4):e413-e421. doi: 10.5301/jbm.5000218.