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PD-L1 in lung cytology: the path for standardization

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Bibliographic Details
Title: PD-L1 in lung cytology: the path for standardization
Authors: Mohammed S. I. Mansour, Gennaro Acanfora, Giancarlo Troncone, Hans Brunnström, Elena Vigliar
Source: Acta Cytologica. :1-19
Publisher Information: S. Karger AG, 2025.
Publication Year: 2025
Subject Terms: Cytohistological concordance, PD-L1, EQA, Cytology, Interobserver variability
Description: Background: The advent of PD-1/PD-L1 inhibitors has revolutionized lung cancer treatment, necessitating accurate PD-L1 immunohistochemical (IHC) assessment. While standardized for formalin-fixed paraffin-embedded (FFPE) histological samples, PD-L1 testing on cytology remains challenging. This review aims to address the complexities of PD-L1 IHC in cytology, focusing on validation guidelines, quality assessment, cyto-histological correlation, and interobserver variability. Summary: This review synthesizes current guidelines and research on PD-L1 IHC in cytology; in particular, recent College of American Pathologists (CAP) guidelines emphasize the necessity for rigorous validation, particularly for non-formalin-fixed specimens. As far as cyto-histological concordance studies is concerned, the review of 48 original articles reveal significant variability in PD-L1 expression, with concordance rates ranging from 54-100% at the 1% cutoff and 82-100% at the 50% cutoff. Finally, interobserver variability, particularly in the 1-49% PD-L1 expression range, further complicates accurate assessment. The review also discusses the challenges associated with quality assessment in cytology, including the lack of standardized control materials and external quality assessment (EQA) programs specifically tailored for cytological samples. Conclusion: PD-L1 testing on cytology presents significant challenges, including validation complexities, quality control limitations, and interobserver variability. Standardized guidelines and rigorous validation are essential to ensure accurate and reliable PD-L1 assessment in cytological specimens.
Document Type: Article
Language: English
ISSN: 1938-2650
0001-5547
DOI: 10.1159/000546275
Access URL: https://pubmed.ncbi.nlm.nih.gov/40367930
https://hdl.handle.net/11588/1011343
Rights: URL: https://karger.com/pages/terms-and-conditions
Accession Number: edsair.doi.dedup.....f3fc7dae5f77debc605fc32201ffe211
Database: OpenAIRE
Description
Abstract:Background: The advent of PD-1/PD-L1 inhibitors has revolutionized lung cancer treatment, necessitating accurate PD-L1 immunohistochemical (IHC) assessment. While standardized for formalin-fixed paraffin-embedded (FFPE) histological samples, PD-L1 testing on cytology remains challenging. This review aims to address the complexities of PD-L1 IHC in cytology, focusing on validation guidelines, quality assessment, cyto-histological correlation, and interobserver variability. Summary: This review synthesizes current guidelines and research on PD-L1 IHC in cytology; in particular, recent College of American Pathologists (CAP) guidelines emphasize the necessity for rigorous validation, particularly for non-formalin-fixed specimens. As far as cyto-histological concordance studies is concerned, the review of 48 original articles reveal significant variability in PD-L1 expression, with concordance rates ranging from 54-100% at the 1% cutoff and 82-100% at the 50% cutoff. Finally, interobserver variability, particularly in the 1-49% PD-L1 expression range, further complicates accurate assessment. The review also discusses the challenges associated with quality assessment in cytology, including the lack of standardized control materials and external quality assessment (EQA) programs specifically tailored for cytological samples. Conclusion: PD-L1 testing on cytology presents significant challenges, including validation complexities, quality control limitations, and interobserver variability. Standardized guidelines and rigorous validation are essential to ensure accurate and reliable PD-L1 assessment in cytological specimens.
ISSN:19382650
00015547
DOI:10.1159/000546275