| Title | Concordance of immunohistochemistry and fluorescent in situ hybridization for anaplastic lymphoma kinase (ALK) rearrangement in non-small cell lung cancer: results from a multicenter study in China |
| Authors | Sun, Yu Yang, Fei Zhou, Xiao-Yan Zhou, Li-Xin Li, Xiang-Hong Lv, Ning Ying, Jian-Ming Du, Xiang |
| Affiliation | Peking Univ, Canc Hosp & Inst, Dept Pathol, Key Lab Carcinogenesis & Translat Res,Minist Educ, Beijing 100871, Peoples R China. Fudan Univ, Shanghai Canc Ctr, Dept Pathol, 270 Dongan Rd, Shanghai 200032, Peoples R China. Chinese Acad Med Sci, Canc Inst & Hosp, Dept Pathol, Beijing 100730, Peoples R China. Fudan Univ, Shanghai Med Coll, Dept Oncol, Shanghai 200433, Peoples R China. Fudan Univ, Inst Pathol, Shanghai 200433, Peoples R China. Fudan Univ, Inst Biomed Sci, Shanghai 200433, Peoples R China. |
| Keywords | Non-small cell lung cancer EML4-ALK gene fusion immunohistochemistry fluorescent in situ hybridization EML4-ALK FUSION TRANSCRIPTS GENE ADENOCARCINOMAS IDENTIFICATION INHIBITORS FISH |
| Issue Date | 2016 |
| Publisher | INTERNATIONAL JOURNAL OF CLINICAL AND EXPERIMENTAL MEDICINE |
| Citation | INTERNATIONAL JOURNAL OF CLINICAL AND EXPERIMENTAL MEDICINE.2016,9,(2),2642-2653. |
| Abstract | Crizotinib, a small molecular anaplastic lymphoma kinase (ALK) inhibitor, was approved by the Chinese Food and Drug Administration for ALK positive non-small cell lung cancer (NSCLC) patients in 2013. Although clinical trials have used the Vysis fluorescent in situ hybridization (FISH) ALK Break-Apart Assay to determine ALK status, the test is only available in limited laboratories and is technically challenging. A standardized and cost effective methodology is therefore in high demand. The aim of this study was to compare the diagnostic accuracy of Vysis FISH ALK Break-Apart Assay and VENTANA ALK (D5F3) immunohistochemistry (IHC) assay for detection of echinoderm microtubule associated protein like4-anaplastic lymphoma kinase (EML4-ALK) rearrangement in NSCLC. FISH and IHC analyses were performed on 1174 cases collected from three provincial cancer hospitals in China. The patient cohort included cases of NSCLC, small cell lung cancer (SCLC), normal lung specimens and other tumor types. We found that IHC assay is highly concordance with FISH assay, showing a positive percent agreement rate of 99.30%, negative percent agreement rate of 99.22%, and overall agreement rate of 99.23%. Our results thus suggest that the VENTANA ALK (D5F3) IHC assay is a valuable tool for the screening of patients with ALK rearrangement in clinical practice. |
| URI | http://hdl.handle.net/20.500.11897/438866 |
| ISSN | 1940-5901 |
| Indexed | SCI(E) |
| Appears in Collections: | 北京肿瘤医院 |
