PD-L1 assessment in urothelial carcinoma: a practical approach

Eckstein M, Cimadamore A, Hartmann A, Lopez-Beltran A, Cheng L, Scarpelli M, Montironi R, Gevaert T (2019)

Publication Type: Journal article, Review article

Publication year: 2019


Book Volume: 7

Journal Issue: 22

DOI: 10.21037/atm.2019.10.24


Five programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors are currently approved for treatment of locally advanced or metastatic urothelial carcinoma of the bladder and the upper urinary tract. Due to restrictions by the FDA and EMA first-line treatment with Atezolizumab and Pembrolizumab in platinum-ineligible patients requires immunohistochemical PD-L1 testing. In the second-line setting all drugs are approved without PD-L1 testing. Used PD-L1 assays in clinical trials include the 28-8 pharmDx (Nivolumab), the 22C3 pharmDx (Pembrolizumab), Ventana SP142 (Atezolizumab), and the Ventana PD-L1 SP263 assays (Durvalumab). Differences in antibodies, needed platforms and testing algorithms have raised questions about interchangeability and comparability among these assays and their diagnostic use. We provide a practical review about the current recommendations, used assays and algorithms of PD-L1 testing in urothelial carcinoma to help oncologists, urologists and pathologists to understand analytical features, differences in antibody assays, differences in scoring algorithms and comparability of various PD-L1 assays. We reviewed and summarized published studies from the last four years (2016-2019) on PD-L1 testing in bladder cancer and present a condensed practical guideline including pre-analytical, analytical and test-specific issues.

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Eckstein, M., Cimadamore, A., Hartmann, A., Lopez-Beltran, A., Cheng, L., Scarpelli, M.,... Gevaert, T. (2019). PD-L1 assessment in urothelial carcinoma: a practical approach. Annals of Translational Medicine, 7(22). https://doi.org/10.21037/atm.2019.10.24


Eckstein, Markus, et al. "PD-L1 assessment in urothelial carcinoma: a practical approach." Annals of Translational Medicine 7.22 (2019).

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