Senchukova MA, Saidler NV, Zubareva EY, Prokofiev AB, Tagabilev DG. Concordance of programmed death-ligand 1 expression assessments determined via two immunohistochemical tests and the polymerase chain reaction method. World J Exp Med 2025; 15(3): 108984 [DOI: 10.5493/wjem.v15.i3.108984]
Corresponding Author of This Article
Marina A Senchukova, MD, PhD, Professor, Scientific and Clinical Center No. 3, Petrovsky National Research Centre of Surgery, Oktyabrsky Prospekt 3, Moscow 108840, Troitsk, Russia. masenchukova@yandex.com
Research Domain of This Article
Oncology
Article-Type of This Article
Observational Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Exp Med. Sep 20, 2025; 15(3): 108984 Published online Sep 20, 2025. doi: 10.5493/wjem.v15.i3.108984
Concordance of programmed death-ligand 1 expression assessments determined via two immunohistochemical tests and the polymerase chain reaction method
Marina A Senchukova, Natalia V Saidler, Evgeniya Yu Zubareva, Alexander B Prokofiev, Dmitry G Tagabilev
Marina A Senchukova, Dmitry G Tagabilev, Scientific and Clinical Center No. 3, Petrovsky National Research Centre of Surgery, Moscow 108840, Troitsk, Russia
Natalia V Saidler, Department of Pathology, Orenburg Regional Cancer Clinic, Orenburg 460021, Orenburgskaya Oblast’, Russia
Evgeniya Yu Zubareva, Department of Oncology, Orenburg State Medical University, Orenburg 460021, Orenburgskaya Oblast’, Russia
Alexander B Prokofiev, Molecular Genetics Laboratory, Orenburg State Medical University, Orenburg 460000, Orenburgskaya Oblast’, Russia
Author contributions: Senchukova MA formulated the idea and aims of the study, wrote the first version of the manuscript and performed the analysis of the results and statistical processing of the results; Saidler NV made a significant contribution to the development of the study methodology, participated in the discussion of the obtained results, and revised and approved the final version; Zubareva EYu collected and analyzed the data and made a significant contribution to the concept and design of the study, participated in the preparation of tables and figures; Prokofiev AB made a significant contribution to the development of the methodology of the molecular genetic study and participated in the discussion of the obtained results; Tagabilev DG made a significant contribution to the selection and analysis of data and their discussion, as well as to the interpretation of the obtained results; All the authors wrote and approved the final version of the manuscript.
Supported by Russian Science Foundation, No. 23-25-00183.
Institutional review board statement: This study was reviewed and approved by Ethics Committee of Orenburg State Medical University (Russia, Orenburg).
Informed consent statement: This article presents data from a clinical study involving 148 patients with breast cancer. The patient has signed the informed consent form.
Conflict-of-interest statement: The authors have no conflicts of interest to declare.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Data sharing statement: Data from patients included in the study in Statistica10 table or Excel table formats can be provided upon request to the corresponding author at masenchukova@yandex.com.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Marina A Senchukova, MD, PhD, Professor, Scientific and Clinical Center No. 3, Petrovsky National Research Centre of Surgery, Oktyabrsky Prospekt 3, Moscow 108840, Troitsk, Russia. masenchukova@yandex.com
Received: April 27, 2025 Revised: May 21, 2025 Accepted: July 29, 2025 Published online: September 20, 2025 Processing time: 107 Days and 16.1 Hours
Abstract
BACKGROUND
We previously demonstrated that the antibody against programmed cell death protein 1 ligand 1 (PDCD1 LG1) is a promising new marker of programmed death-ligand 1 (PD-L1) expression that correlates with both breast cancer (BC) clinicopathological characteristics and tumor sensitivity to chemotherapy. However, the concordance of PDCD1 LG1 expression scoring with immunohistochemical (IHC) tests approved for clinical use and with the polymerase chain reaction (PCR) method has not been previously studied.
AIM
To evaluate the concordance of methods for assessing PD-L1 expression, IHC tests with anti-PD-L1 (PDCD1 LG1) and anti-PD-L1 (SP142) antibodies and PCR.
METHODS
This prospective single-center observational cohort study included 148 patients with BC. PD-L1 expression in immune cells was assessed by the IHC method with anti-PD-L1 (PDCD1 LG1) and anti-PD-L1 (SP142) antibodies and by PCR. The concordance of PD-L1 scores between tests was assessed with positive percentage agreement (PPA) and negative percentage agreement (NPA). The strength of the agreement between the methods was calculated via the Cohen kappa index. P < 0.05 was considered statistically significant.
RESULTS
Regardless of the method used to assess marker expression, PD-L1 expression was significantly more often detected in patients with negative estrogen receptor status, human epidermal growth factor receptor-2-positive (HER2+) status, luminal B HER+ BC, nonluminal HER+ BC and triple-negative BC. PPA and NPA were 38.3% and 70.4%, respectively, for PD-L1 (PDCD1 LG1) and PD-L1 (SP142); 26.3% and 63.3%, respectively, for PD-L1 (PDCD1 LG1) and PD-L1 (PCR); and 36.5% and 74.4%, respectively, for PD-L1 (SP142) and PD-L1 (PCR). Cohen's kappa index for PD-L1 (PDCD1 LG1) and PD-L1 (SP142) was 0.385 (95%CI: 0.304–0.466), that for PD-L1 (PDCD1 LG1) and PD-L1 (PCR) was 0.207 (95%CI: 0.127–0.287), and that for PD-L1 (SP142) and PD-L1 (PCR) was 0.389 (95%CI: 0.309–0.469).
CONCLUSION
Thus, all three markers of PD-L1 expression are associated with the characteristics of aggressive BC, demonstrating moderate concordance between the tests.
Core Tip: We determined the expression of programmed cell death ligand 1 in immune cells using immunohistochemistry with antibodies against programmed cell death protein 1 ligand 1 (PDCD1 LG1) and SP142 and polymerase chain reaction (PCR) and then examined the agreement between the results of three assays in patients with breast cancer (BC). All three tests were positively correlated with estrogen receptor-negative status, human epidermal growth factor receptor-2-positive (HER2+) status, and luminal B HER+, nonluminal HER+, and triple-negative BCs. Cohen's kappa index was 0.385 for PDCD1 LG1 and SP142 and 0.389 for SP142 and programmed death-ligand 1 (PCR), which is considered moderate agreement between the markers.
