Detection of epidermal growth factor receptor mutations in non-small cell lung cancer by immunohistochemistry.
10.11817/j.issn.1672-7347.2021.200193
- Author:
Xuemei YU
1
;
Ruiqi MAO
2
;
Min LIU
3
;
Limei FU
2
;
Lifang SHI
2
;
Xinjun LI
4
Author Information
1. Department of Pathology, Binzhou People's Hospital, Binzhou Shandong 256610. yxm1977@126.com.
2. Department of Pathology, Binzhou People's Hospital, Binzhou Shandong 256610.
3. Department of Cardiovascular, Binzhou People's Hospital, Binzhou Shandong 256610, China.
4. Department of Pathology, Binzhou People's Hospital, Binzhou Shandong 256610. lixinjunhe@163.com.
- Publication Type:Journal Article
- Keywords:
epidermal growth factor receptor;
immunohistochemistry;
lung cancer;
sensitivity;
specificity
- MeSH:
Carcinoma, Non-Small-Cell Lung/genetics*;
ErbB Receptors/genetics*;
Humans;
Immunohistochemistry;
Lung Neoplasms/genetics*;
Mutation
- From:
Journal of Central South University(Medical Sciences)
2021;46(1):11-17
- CountryChina
- Language:English
-
Abstract:
OBJECTIVES:To evaluate the sensitivity and specificity of immunohistochemistry (IHC) for detecting common epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC) and to estimate the cost-effectiveness of IHC testing.
METHODS:A total of 208 NSCLC patients were included in the trial, and the EGFR mutation status in the patients were detected by PCR and IHC. Two mutation-specific antibodies against the most common exon 19 deletion (clone SP111) and exon 21 L858R mutation (clone SP125) were tested by using automated immunostainer. A cost-effectiveness analysis model was built for the analysis of optimal detection scheme.
RESULTS:With a cutoff value of IHC 1+, the overall sensitivity and specificity of the IHC-based method compared with the PCR-based method were 81.7% (95% CI 72.4% to 89.0%) and 94.7% (95% CI 92.6% to 99.5%), respectively. EGFR 19del mutation was detected by SP111 antibody with a sensitivity of 65.9% (95% CI 49.4% to 79.9%) and specificity of 98.8% (95% CI 95.7% to 99.9%). EGFR L858R mutation was detected by SP125 antibody with a sensitivity of 94.2% (95% CI 84.1% to 98.8%) and specificity of 99.4% (95% CI 96.5% to 100%). The IHC and PCR cost ratio needed to be 1-to-3 or more in our patients to economically justify before the use of IHC.
CONCLUSIONS:The study confirms an excellent specificity with fairly good sensitivity of IHC and mutation-specific antibodies for common EGFR mutations. It is cost-effective to use IHC method to detect EGFR mutation first when the IHC and PCR cost ratio is 1-to-3 or more in Chinese populations.
