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PD-L1 assessment in urothelial carcinoma: a practical approach

	author = {Markus Eckstein and Alessia Cimadamore and Arndt Hartmann and Antonio Lopez-Beltran and Liang Cheng and Marina Scarpelli and Rodolfo Montironi and Thomas Gevaert},
	title = {PD-L1 assessment in urothelial carcinoma: a practical approach},
	journal = {Annals of Translational Medicine},
	volume = {7},
	number = {22},
	year = {2019},
	keywords = {},
	abstract = {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.},
	issn = {2305-5847},	url = {}