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Programmed Death Ligand-1 Testing in Triple-Negative Breast Cancer: National Practice and Interlaboratory Variation

Mirte Dekker1, Maaike Anna Hempenius1, Geertruida H de Bock2

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Programmed Death-Ligand 1 (PD-L1) testing in triple-negative breast cancer (TNBC) shows consistent use of the combined positive score (CPS). However, significant interlaboratory variation in PD-L1 positivity rates necessitates improved standardization for accurate immunotherapy selection.

Keywords:
combined positive scoreimmunohistochemistryimmunotherapyinterlaboratory variationprogrammed death ligand-1triple-negative breast cancer

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Area of Science:

  • Oncology
  • Pathology
  • Immunotherapy

Background:

  • Triple-negative breast cancer (TNBC) lacks targeted therapies, making PD-L1 expression a key biomarker for immunotherapy selection.
  • The introduction of PD-L1 testing in TNBC necessitates evaluation of its real-world performance and consistency.

Purpose of the Study:

  • To assess Programmed Death-Ligand 1 (PD-L1) test characteristics and results in TNBC during the initial two years post-implementation.
  • To analyze interlaboratory variability in PD-L1 positivity rates using the combined positive score (CPS) in the Netherlands.

Main Methods:

  • Retrieved pathology reports of TNBC patients with PD-L1 testing from the Dutch nationwide pathology database (Palga).
  • Evaluated PD-L1 test characteristics and results annually from August 2022 to August 2024.
  • Analyzed interlaboratory variation in PD-L1 positivity (CPS≥10) using funnel plots and adjusted for case-mix with multivariate logistic regression.

Main Results:

  • A total of 926 PD-L1 tests were performed, with CPS used in 94.5% of cases.
  • The national mean PD-L1 positivity rate was 46.7%.
  • Adjusted laboratory-specific positivity rates varied widely (21.3%–70.7%), with three of 19 laboratories showing significant deviations.

Conclusions:

  • PD-L1 testing for TNBC in the Netherlands generally adheres to guidelines, with consistent CPS application.
  • Significant interlaboratory variation in PD-L1 positivity rates indicates a need for enhanced standardization of testing methods.
  • Standardization is crucial for accurate patient selection for immunotherapy in TNBC.