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
,
2
,
3
;
Ruiqi MAO
1
;
Min LIU
4
;
Limei FU
1
;
Lifang SHI
1
;
Xinjun LI
1
,
3
,
5
Author Information
1. Department of Pathology, Binzhou People's Hospital, Binzhou Shandong
2. yxm1977@
3. com.
4. Department of Cardiovascular, Binzhou People's Hospital, Binzhou Shandong 256610, China.
5. lixinjunhe@
- 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.
