New methods for ALK status diagnosis in non-small-cell lung cancer: An improved ALK immunohistochemical assay and a new, brightfield, dual ALK IHC-in situ hybridization assay

Journal of Thoracic Oncology

Volumn 8, Issue 8, 2013, Pages 1019-1031

  Nitta, Hiroaki ^a   Tsuta, Koji ^b   Yoshida, Akihiko ^b   Ho, Steffan N ^c   Kelly, Brian D ^a   Murata, Lauren B ^a   Kosmeder, Jerry ^a   White, Katie ^a   Ehser, Sandra ^d   Towne, Penny ^a   Schemp, Crystal ^a   McElhinny, Abigail ^a   Ranger Moore, Jim ^a   Bieniarz, Chris ^a   Singh, Shalini ^a   Tsuda, Hitoshi ^b   Grogan, Thomas M ^a  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

^b NATIONAL CANCER CENTER HOSPITAL   (Japan)

^c PFIZER INC   (United States)

^d 42 Life Sciences GmbH and Co   (Germany)

Author keywords

ALK; Brightfield; Immunohistochemistry; In situ hybridization; Non?small cell lung cancer

Indexed keywords

ANAPLASTIC LYMPHOMA KINASE; HAPTEN; HORSERADISH PEROXIDASE; ISOPROPAMIDE IODIDE;

ARTICLE; CONTROLLED STUDY; FLUORESCENCE IN SITU HYBRIDIZATION; GENE REARRANGEMENT; HUMAN; HUMAN TISSUE; IN SITU HYBRIDIZATION; LUNG NON SMALL CELL CANCER; PRIORITY JOURNAL; PROTEIN ANALYSIS; PROTEIN EXPRESSION;

CARCINOMA, NON-SMALL-CELL LUNG; CELL LINE, TUMOR; HAPTENS; HUMANS; IMMUNOHISTOCHEMISTRY; IN SITU HYBRIDIZATION, FLUORESCENCE; LUNG NEOPLASMS; RECEPTOR PROTEIN-TYROSINE KINASES;

EID: 84880921918     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e31829ebb4d     Document Type: Article

References (31)

1. Ong FS, Das K, Wang J, et al. Personalized medicine and pharmacogenetic biomarkers: progress in molecular oncology testing. Expert Rev Mol Diagn 2012;12:593-602.
2. Hechtman JF, Polydorides AD. HER2/neu gene amplification and protein overexpression in gastric and gastroesophageal junction adenocarcinoma: a review of histopathology, diagnostic testing, and clinical implications. Arch Pathol Lab Med 2012;136:691-697.
3. Soda M, Choi YL, Enomoto M, et al. Identification of the transforming EML4- ALK fusion gene in non-small-cell lung cancer. Nature 2007;448:561-566.
4. Cabezón-Gutiérrez L, Khosravi-Shahi P, Diaz-Muńoz- de-la-Espada VM, et al. ALK-mutated non-small-cell lung cancer: a new strategy for cancer treatment. Lung 2012;190:381-388.
5. Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010;363:1693-1703.
6. Thunnissen E, Bubendorf L, Dietel M, et al. EML4-ALK testing in non-small cell carcinomas of the lung: a review with recommendations. Virchows Arch 2012;461:245-257.
7. Wallander ML, Geiersbach KB, Tripp SR, et al. Comparison of reverse transcription-polymerase chain reaction, immunohistochemistry, and fluorescence in situ hybridization methodologies for detection of echinoderm microtubule-associated proteinlike 4-anaplastic lymphoma kinase fusion-positive non-small cell lung carcinoma. Arch Pathol Lab Med 2012;136:796-803.
8. Sun JM, Choi YL, Won JK, et al. A dramatic response to crizotinib in a non-small-cell lung cancer patient with IHC-positive and FISH-negative ALK. J Thorac Oncol 2012;7:e36-e38.
9. Takeuchi K, Choi YL, Soda M, et al. Multiplex reverse transcription- PCR screening for EML4-ALK fusion transcripts. Clin Cancer Res 2008;14:6618-6624.
10. Soda M, Isobe K, Inoue A, et al. A prospective PCR-based screening for the EML4-ALK oncogene in non-small cell lung cancer. Clin Cancer Res 2012;18:5682-5689.
11. Murakami Y, Mitsudomi T, Yatabe Y. A screening method for the ALK fusion gene in NSCLC. Front Oncol 2012;2:24.
12. Nitta H, Zhang W, Kelly BD, et al. Automated brightfield break-apart in situ hybridization (ba-ISH) application: ALK and MALT1 genes as models. Methods 2010;52:352-358.
13. Kim H, Yoo SB, Choe JY, et al. Detection of ALK gene rearrangement in non-small cell lung cancer: a comparison of fluorescence in situ hybridization and chromogenic in situ hybridization with correlation of ALK protein expression. J Thorac Oncol 2011;6:1359-1366.
14. Yoshida A, Tsuta K, Nitta H, et al. Bright-field dual-color chromogenic in situ hybridization for diagnosing echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase-positive lung adenocarcinomas. J Thorac Oncol 2011;6:1677-1686.
15. Hatanaka Y, Hashizume K, Nitta K, et al. Cytometrical image analysis for immunohistochemical hormone receptor status in breast carcinomas. Pathol Int 2003;53:693-699.
16. Kim SH, Jung KC, Shin YK, et al. The enhanced reactivity of endogenous biotin-like molecules by antigen retrieval procedures and signal amplification with tyramine. Histochem J 2002;34:97-103.
17. Klopfleisch R, Weiss AT, Gruber AD. Excavation of a buried treasure- DNA, mRNA, miRNA and protein analysis in formalin fixed, paraffin embedded tissues. Histol Histopathol 2011;26:797-810.
18. Shi SR, Shi Y, Taylor CR. Antigen retrieval immunohistochemistry: review and future prospects in research and diagnosis over two decades. J Histochem Cytochem 2011;59:13-32.
19. Choi YL, Takeuchi K, Soda M, et al. Identification of novel isoforms of the EML4-ALK transforming gene in non-small cell lung cancer. Cancer Res 2008;68:4971-4976.
20. Takeuchi K, Choi YL, Togashi Y, et al. KIF5B-ALK, a novel fusion oncokinase identified by an immunohistochemistry-based diagnostic system for ALK-positive lung cancer. Clin Cancer Res 2009;15:3143-3149.
21. Mino-Kenudson M, Chirieac LR, Law K, et al. A novel, highly sensitive antibody allows for the routine detection of ALK-rearranged lung adenocarcinomas by standard immunohistochemistry. Clin Cancer Res 2010;16:1561-1571.
22. Paik JH, Choe G, Kim H, et al. Screening of anaplastic lymphoma kinase rearrangement by immunohistochemistry in non-small cell lung cancer: correlation with fluorescence in situ hybridization. J Thorac Oncol 2011;6:466-472.
23. McLeer-Florin A, Moro-Sibilot D, Melis A, et al. Dual IHC and FISH testing for ALK gene rearrangement in lung adenocarcinomas in a routine practice: a French study. J Thorac Oncol 2012;7:348-354.
24. Park HS, Lee JK, Kim DW, et al. Immunohistochemical screening for anaplastic lymphoma kinase (ALK) rearrangement in advanced nonsmall cell lung cancer patients. Lung Cancer 2012;77:288-292.
25. Paik JH, Choi CM, Kim H, et al. Clinicopathologic implication of ALK rearrangement in surgically resected lung cancer: a proposal of diagnostic algorithm for ALK-rearranged adenocarcinoma. Lung Cancer 2012;76:403-409.
26. Conklin CMJ, Craddock KJ, Have C, et al. Immunohistochemistry is a reliable screening tool for identification of ALK rearrangement in nonsmall- cell lung carcinoma and is antibody dependent. J Thorac Oncol 2013;8:45-51.
27. Ignatiadis M, Sotiriou C. Breast cancer: should we assess HER2 status by Oncotype DX? Nat Rev Clin Oncol 2012;9:12-14.
28. Dabbs DJ, Klein ME, Mohsin SK, et al. High false-negative rate of HER2 quantitative reverse transcription polymerase chain reaction of the Oncotype DX test: an independent quality assurance study. J Clin Oncol 2011;29:4279-4285.
29. Werner M, Chott A, Fabiano, A. et al. Effect of formalin tissue fixation and processing on immunohistochemistry. Am J Surg Pathol 2000;24:1016-1029.
30. Heuckmann JM, Balke-Want H, Malchers F, et al. Differential protein stability and ALK inhibitor sensitivity of EML4-ALK fusion variants. Clin Cancer Res 2012;18:4682-4690.
31. Nitta H, Kelly BD, Padilla M, et al. A gene-protein assay for human epidermal growth factor receptor 2 (HER2): brightfield tricolor visualization of HER2 protein, the HER2 gene, and chromosome 17 centromere (CEN17) in formalin-fixed, paraffin-embedded breast cancer tissue sections. Diagn Pathol 2012;7:60.