Tuberc Respir Dis.  2020 Jan;83(1):51-60. 10.4046/trd.2019.0026.

Correlation of PD-L1 Expression Tested by 22C3 and SP263 in Non-Small Cell Lung Cancer and Its Prognostic Effect on EGFR Mutation–Positive Lung Adenocarcinoma

• Kim T
• Cha YJ
• Chang YS

• KMID: 2466620
• DOI: http://doi.org/10.4046/trd.2019.0026

Abstract

BACKGROUND
Programmed death-ligand 1 (PD-L1) expression is tested by immunohistochemistry (IHC)"”22C3, SP263, and SP142. The aim of this study is to evaluate the correlation among the three methods of PD-L1 IHC in non-small cell lung cancer (NSCLC) and clinical significance of PD-L1 expression in lung adenocarcinoma with an epidermal growth factor receptor (EGFR)-tyrosine kinase domain mutation.
METHODS
The results of 230 patients who were pathologically confirmed as having NSCLC; tested using PD-L1 IHC 22C3, SP263, and SP142 methods; and evaluated via the peptide nucleic acid clamping method to confirm EGFR mutation, were analyzed in this study.
RESULTS
164 patients underwent both the SP263 and 22C3 tests. There was a significant positive correlation between the outcomes of the two tests (Spearman correlation coefficient=0.912, p<0.001), with a derived regression equation as follows: 22C3=15.2+0.884×SP263 (R2=0.792, p<0.001). There was no relationship between the expression of PD-L1 and clinical parameters, including EGFR-tyrosine kinase inhibitor (TKI) mutation. The PD-L1 expression in patients treated with EGFR-TKI yielded a 2-month-shorter progression period than that in the PD-L1-negative group. However, this did not reach statistical significance (PD-L1<1% vs. PD-L1≥1%, 10 months vs. 8 months).
CONCLUSION
The results of the 22C3 and those of SP263 methods were in good correlation with one another. Since the PD-L1 expression is not influenced by the EGFR mutation, it is necessary to perform a PD-L1 test to set the treatment direction in the patients with EGFR-mutant NSCLC.

Keyword

Non-Small Cell Lung Cancer; PD-L1; Companion Diagnotics; EGFR

MeSH Terms

Adenocarcinoma*
Carcinoma, Non-Small-Cell Lung*
Constriction
Humans
Immunohistochemistry
Lung*
Methods
Phosphotransferases
Receptor, Epidermal Growth Factor
Phosphotransferases
Receptor, Epidermal Growth Factor

Figure

• 

  Figure 1 Prevalence and correlation of programmed death-ligand 1 (PD-L1) expression using the 22C3 pharmDx, SP263, and SP142 assays. (A) The rate of PD-L1 expression with cutoff tumor proportion score of 1% using the 22C3 pharmDx assay, SP263 assay, and SP142 assay. (B) Scatter diagrams illustrating the correlation between expression levels according to 22C3 pharmDx and SP263 assays, 22C3 pharmDx and SP142 assays (C), and SP263 and SP142 assays (D). (E) PD-L1 expression by 22C3 assay according to epidermal growth factor receptor (EGFR) mutation. IHC: immunohistochemistry; TKI: tyrosine kinase inhibitor.

• 

  Figure 2 Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC) staining using the PD-L1 IHC 22C3 pharmDx assay (tumor proportion score [TPS] 80%) (A), the PD-L1 IHC SP263 assay (TPS 90%) (B), and the PD-L1 IHC SP142 assay (TC2, 40%; IC0, 0%) (C) (A–C, ×200).

• 

  Figure 3 Kaplan-Meier curves of progression-free survival (PFS) and overall survival (OS) according to programmed death-ligand 1 (PD-L1) expression status in non-small cell lung cancer patients. The p-value for the difference between the two curves was determined using the log-rank test. (A) PFS for overall population. (B) OS for overall population. (C) PFS for patients treated with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). (D) OS for patients treated with EGFR-TKI.

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