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Updated: May 16, 2025

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PD-L1 in Lung Cytology: The Path for Standardization.

Mohammed S I Mansour1,2, Gennaro Acanfora3, Giancarlo Troncone3

  • 1Department of Pathology and Cytology, Halland Hospital Halmstad, Halmstad, Sweden.

Acta Cytologica
|May 14, 2025
PubMed
Summary

Assessing programmed death-ligand 1 (PD-L1) by immunohistochemistry (IHC) in cytology is complex. This review highlights challenges in validation, quality control, and interobserver variability for accurate lung cancer treatment decisions.

Keywords:
Cytohistological concordanceCytologyEQAInterobserver variabilityPD-L1

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Area of Science:

  • Oncology
  • Pathology
  • Immunohistochemistry

Background:

  • Programmed death-1 (PD-1)/PD-L1 inhibitors have transformed lung cancer therapy.
  • Accurate PD-L1 immunohistochemical (IHC) assessment is crucial for treatment selection.
  • PD-L1 testing on cytology samples presents significant challenges compared to histological specimens.

Purpose of the Study:

  • To review and address the complexities of PD-L1 IHC testing in cytological samples.
  • To focus on validation guidelines, quality assessment, cyto-histological correlation, and interobserver variability.
  • To synthesize current guidelines and research for reliable PD-L1 assessment in cytology.

Main Methods:

  • Review of current guidelines, particularly from the College of American Pathologists (CAP).
  • Analysis of 48 original articles on cyto-histological concordance for PD-L1 expression.
  • Discussion of challenges in quality assessment and interobserver variability in cytological samples.

Main Results:

  • Recent CAP guidelines emphasize rigorous validation for non-formalin-fixed specimens.
  • Cyto-histological concordance for PD-L1 expression shows significant variability (54-100% at 1% cutoff, 82-100% at 50% cutoff).
  • Interobserver variability is particularly notable in the 1-49% PD-L1 expression range.

Conclusions:

  • PD-L1 testing in cytology faces hurdles in validation, quality control, and interobserver agreement.
  • Standardized guidelines and thorough validation are essential for accurate PD-L1 assessment in cytological specimens.
  • Addressing these challenges is critical for optimizing immunotherapy in lung cancer patients.