An international interpretation study using the ALK IHC antibody D5F3 and a sensitive detection kit demonstrates high concordance between ALK IHC and ALK FISH and between evaluators

Journal of Thoracic Oncology

Volumn 9, Issue 5, 2014, Pages 631-638

  Wynes, Murry W ^a   Sholl, Lynette M ^b   Dietel, Manfred ^c   Schuuring, Ed ^d   Tsao, Ming S ^e   Yatabe, Yasushi ^f   Tubbs, Raymond R ^g   Hirsch, Fred R ^a,h  

^a UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^d UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^e PRINCESS MARGARET HOSPITAL   (Canada)

^f AICHI CANCER CENTER HOSPITAL   (Japan)

^g LERNER RESEARCH INSTITUTE   (United States)

^h UNIVERSITY OF COLORADO CANCER CENTER   (United States)

Author keywords

Anaplastic lymphoma kinase; Biomarkers; Companion diagnostics; Crizotinib; Fluorescence in situ hybridization; Immunohistochemistry; Non small cell lung cancer

Indexed keywords

ANAPLASTIC LYMPHOMA KINASE; ANTIBODY; BIOLOGICAL MARKER; CRIZOTINIB; PROTEIN TYROSINE KINASE INHIBITOR; PROTEIN TYROSINE KINASE; TUMOR MARKER;

ARTICLE; ASSAY; CANCER DIAGNOSIS; DIAGNOSTIC ACCURACY; DIAGNOSTIC KIT; DIAGNOSTIC TEST; DIAGNOSTIC TEST ACCURACY STUDY; FLUORESCENCE IN SITU HYBRIDIZATION; HUMAN; HUMAN CELL; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; PATHOLOGIST; PERSONALIZED MEDICINE; PRIORITY JOURNAL; PROTEIN EXPRESSION; SENSITIVITY AND SPECIFICITY; TUMOR CELL; CHEMISTRY; COMPARATIVE STUDY; DIAGNOSTIC USE; EVALUATION STUDY; IMMUNOLOGY; LABORATORY DIAGNOSIS; LUNG TUMOR; NON SMALL CELL LUNG CANCER; OBSERVER VARIATION; PROCEDURES;

ANTIBODIES; CARCINOMA, NON-SMALL-CELL LUNG; FALSE NEGATIVE REACTIONS; FALSE POSITIVE REACTIONS; HUMANS; IMMUNOHISTOCHEMISTRY; IN SITU HYBRIDIZATION, FLUORESCENCE; INDIVIDUALIZED MEDICINE; LUNG NEOPLASMS; OBSERVER VARIATION; RECEPTOR PROTEIN-TYROSINE KINASES; SENSITIVITY AND SPECIFICITY; TUMOR MARKERS, BIOLOGICAL;

EID: 84899477450     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0000000000000115     Document Type: Article

References (34)

1. Jemal A Bray F Center MM Ferlay J Ward E Forman D. Global cancer statistics. CA Cancer J Clin 2011;61:69-90.
2. Howlader N Noone AM Krapcho M et al. SEER Cancer Statistics Review 1975-2010. National Cancer Institute. November 2012 SEER data submission posted to the SEER web site April 2013. Available at: http://seer.cancer.gov/csr/1975- 2010/. Accessed May 15 2013.
3. Kris MG Johnson BE Kwiatkowski DJ et al. Identification of driver mutations in tumor specimens from 1,000 patients with lung adenocarcinoma: the NCI's Lung Cancer Mutation Consortium (LCMC). ASCO Meeting Abstracts. 2011;29:CRA7506.
4. Maemondo M Inoue A Kobayashi K et al.; North-East Japan Study Group. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010;362:2380-2388.
5. Mitsudomi T Morita S Yatabe Y et al.; West Japan Oncology Group. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label randomised phase 3 trial. Lancet Oncol 2010;11:121-128.
6. Mok TS Wu YL Thongprasert S et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009;361:947-957.
7. Rosell R Carcereny E Gervais R et al.; Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancé rologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre open-label randomised phase 3 trial. Lancet Oncol 2012;13:239-246.
8. Zhou C Wu YL Chen G et al. Erlotinib versus chemotherapy as firstline treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL CTONG-0802): a multicentre open-label randomised phase 3 study. Lancet Oncol 2011;12:735-742.
9. Camidge DR Bang YJ Kwak EL et al. Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study. Lancet Oncol 2012;13:1011-1019.
10. 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.
11. 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.
12. 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.
13. Sasaki T Rodig SJ Chirieac LR Jänne PA. The biology and treatment of EML4-ALK non-small cell lung cancer. Eur J Cancer 2010;46:1773-1780.
14. 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.
15. Togashi Y Soda M Sakata S et al. KLC1-ALK: a novel fusion in lung cancer identified using a formalin-fixed paraffin-embedded tissue only. PLoS One 2012;7:e31323.
16. Palmer RH Vernersson E Grabbe C Hallberg B. Anaplastic lymphoma kinase: signalling in development and disease. Biochem J 2009;420:345-361.
17. Solomon B Varella-Garcia M Camidge DR. ALK gene rearrangements: a new therapeutic target in a molecularly defined subset of non-small cell lung cancer. J Thorac Oncol 2009;4:1450-1454.
18. Cui JJ Tran-Dubé M Shen H et al. Structure based drug design of crizotinib (PF-02341066) a potent and selective dual inhibitor of mesenchymal-epithelial transition factor (c-MET) kinase and anaplastic lymphoma kinase (ALK). J Med Chem 2011;54:6342-6363.
19. Kim D-W Ahn M-J Shi Y et al. Results of a global phase II study with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC). ASCO Meeting Abstracts. 2012;30:7533.
20. Shaw AT Kim DW Nakagawa K et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med 2013;368:2385-2394.
21. FDA Approves Xalkori with Companion Diagnostic for a Type of Late-Stage Lung Cancer. Silver Spring MD: United States Food and Drug Administration 2011. Available at: http://www.fda.gov/aboutfda/centersoffices/ officeofmedicalproductsandtobacco/cder/ucm270058.htm. Accessed February 2014.
22. Boland JM Erdogan S Vasmatzis G et al. Anaplastic lymphoma kinase immunoreactivity correlates with ALK gene rearrangement and transcriptional up-regulation in non-small cell lung carcinomas. Hum Pathol 2009;40:1152-1158.
23. Conklin CM Craddock KJ Have C Laskin J Couture C Ionescu DN. Immunohistochemistry is a reliable screening tool for identification of ALK rearrangement in non-small-cell lung carcinoma and is antibody dependent. J Thorac Oncol 2013;8:45-51.
24. 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.
25. 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.
26. To KF Tong JH Yeung KS et al. Detection of ALK rearrangement by immunohistochemistry in lung adenocarcinoma and the identification of a novel EML4-ALK variant. J Thorac Oncol 2013;8:883-891.
27. Minca EC Portier BP Wang Z et al. ALK status testing in non-small cell lung carcinoma: correlation between ultrasensitive IHC and FISH. J Mol Diagn 2013;15:341-346.
28. 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.
29. Peled N Palmer G Hirsch FR et al. Next-generation sequencing identifies and immunohistochemistry confirms a novel crizotinib-sensitive ALK rearrangement in a patient with metastatic non-small-cell lung cancer. J Thorac Oncol 2012;7:e14-e16.
30. 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.
31. Nitta H Tsuta K Yoshida A et al. 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. J Thorac Oncol 2013;8:1019-1031.
32. Ying J Guo L Qiu T et al. Diagnostic value of a novel fully automated immunochemistry assay for detection of ALK rearrangement in primary lung adenocarcinoma. Ann Oncol 2013;24:2589-2593.
33. Yi ES Boland JM Maleszewski JJ et al. Correlation of IHC and FISH for ALK gene rearrangement in non-small cell lung carcinoma: IHC score algorithm for FISH. J Thorac Oncol 2011;6:459-465.
34. Savic S Bode B Diebold J et al. Detection of ALK-positive non-small-cell lung cancers on cytological specimens: high accuracy of immunocytochemistry with the 5A4 clone. J Thorac Oncol 2013;8:1004-1011.