title: Immunohistochemistry with a novel mutation-specific monoclonal antibody as a screening tool for the EGFR L858R mutational status in primary lung adenocarcinoma.
abstract: Epidermal growth factor receptor (EGFR) mutation status is the best predictor of patient response to treatments with tyrosine kinase inhibitors in primary lung adenocarcinoma and is typically analyzed by DNA-based techniques, such as direct DNA sequencing and allele-specific PCR. Recently, however, two mutation-specific antibodies against delE746-A750 in exon 19 and L858R in exon 21 have opened the door for a more convenient and more efficient strategy to determine EGFR mutation status. To evaluate the clinical application of a new mutation-specific mouse monoclonal antibody for EGFR (L858R), we performed immunohistochemistry (IHC) studies with tumor samples from primary lung adenocarcinoma in retrospective and validation settings. A total of 215 cases of primary lung adenocarcinoma were examined and compared using a combination of DNA-based techniques (direct DNA sequencing and/or allele-specific PCR) and protein-based IHC. IHC staining was assessed on a 0 to 3+ score scale, and a cutoff value of 2+ was used as positive by IHC. In the retrospective setting, statistical analyses of the data showed that the sensitivity of IHC was 90.9% and the specificity was 96.8%. Findings from the validation study demonstrated that the sensitivity and specificity of IHC were 88.2% and 100%, respectively. IHC with the novel mutation-specific antibody could be used as a screening method to assess the EGFR L858R mutation status in primary lung adenocarcinoma.
authors.affiliation: Department of Thoracic Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jie Fang Avenue, Wuhan, Hubei, 430030, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Ping
authors.forename: Chunjiao
authors.initials: C
authors.lastname: Xia
authors.forename: Shengling
authors.initials: S
authors.lastname: Fu
authors.forename: Yixin
authors.initials: Y
authors.lastname: Cai
authors.forename: Yu
authors.initials: Y
authors.lastname: Deng
authors.forename: Wei
authors.initials: W
authors.lastname: Sun
authors.forename: Cuiping
authors.initials: C
authors.lastname: Dong
authors.forename: Xiangning
authors.initials: X
authors.lastname: Fu
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis / Q000235:genetics* / Q000473:pathology; D000077192:Adenocarcinoma of Lung; D000328:Adult; D000368:Aged; D000818:Animals; D000911:Antibodies, Monoclonal / Q000276:immunology; D055088:Early Detection of Cancer; D066246:ErbB Receptors / Q000096:biosynthesis* / Q000235:genetics; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D008175:Lung Neoplasms / Q000175:diagnosis / Q000235:genetics* / Q000473:pathology; D008297:Male; D051379:Mice; D008875:Middle Aged; D009154:Mutation; D012189:Retrospective Studies
chemical_list: D000911:Antibodies, Monoclonal; C512478:EGFR protein, human; D066246:ErbB Receptors