Universität zu Köln

Hagmeyer, Lars, Schaefer, Stephan, Engels, Marianne, Pietzke-Calcagnile, Anja, Treml, Marcel, Herkenrath, Simon-Dominik, Heldwein, Matthias, Hekmat, Khosro, Matthes, Sandhya ORCID: 0000-0002-5227-0112, Scheel, Andreas, Wolf, Juergen, Buettner, Reinhard and Randerath, Winfried (2021). High sensitivity of PD-L1 analysis from pleural effusion in nonsmall cell lung cancer. ERJ Open Res., 7 (1). SHEFFIELD: EUROPEAN RESPIRATORY SOC JOURNALS LTD. ISSN 2312-0541

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Abstract

Background: Programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) immune checkpoint inhibitors have been approved for monotherapy of metastatic nonsmall cell lung cancer (mNSCLC) depending on tumour cells' PD-L1 expression. Pleural effusion is common in mNSCLC. The significance of immunocytochemistry PD-L1 analysis from pleural effusion samples is unclear. Aim: The aim of the study was to analyse the sensitivity regarding immunocytochemistry PD-L1 analysis of pleural effusion in NSCLC as compared to immunohistochemistry of pleural biopsies. Patients and Methods: Fifty consecutive subjects (17 female, median age 72.5 years, seven never-smokers) were enrolled in this prospective controlled two-centre study. Inclusion criteria were pleural effusion, suspected or known lung cancer, indication for pleural puncture and thoracoscopy, and written informed consent. Immunocytochemistry and immunohistochemistry PD-L1 analyses were performed with the Dako-PDL1-IHC-22C3pharmDx assay. Analysis for sensitivity, specificity, and positive and negative predictive value was performed for PD-L1 detection from pleural effusion. Results: 50 subjects underwent pleural puncture and thoracoscopy. Pathological diagnoses were lung cancer (48), lymphoma (1) and mesothelioma (1). Sensitivity, specificity, positive predictive value and negative predictive value of PD-L1-testing with expression.50% defined as positive were 100% (95% CI 46-100%), 63% (36-84%), 45% (18-75%) and 100% (66-100%), and with expression .1% defined as positive 86% (56-97%), 43% (12-80%), 75% (47-92%) and 60% (17-93%). Conclusion: PD-L1 analysis in tumour-positive pleural effusion samples shows a very high sensitivity and negative predictive value, especially regarding PD-L1 expression levels .50% (European Medicines Agency approval). Negative results are reliable and help in the decision against a first-line checkpoint inhibitor monotherapy. However, a 1% cut-off level (United States Food and Drug Administration approval) leads to a markedly lower negative predictive value, making other invasive procedures necessary (NCT02855281).

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Hagmeyer, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Schaefer, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Engels, Marianne UNSPECIFIED UNSPECIFIED UNSPECIFIED Pietzke-Calcagnile, Anja UNSPECIFIED UNSPECIFIED UNSPECIFIED Treml, Marcel UNSPECIFIED UNSPECIFIED UNSPECIFIED Herkenrath, Simon-Dominik UNSPECIFIED UNSPECIFIED UNSPECIFIED Heldwein, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Hekmat, Khosro UNSPECIFIED UNSPECIFIED UNSPECIFIED Matthes, Sandhya UNSPECIFIED orcid.org/0000-0002-5227-0112 UNSPECIFIED Scheel, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Wolf, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Buettner, Reinhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Randerath, Winfried UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-571052
DOI:	10.1183/23120541.00787-2020
Journal or Publication Title:	ERJ Open Res.
Volume:	7
Number:	1
Date:	2021
Publisher:	EUROPEAN RESPIRATORY SOC JOURNALS LTD
Place of Publication:	SHEFFIELD
ISSN:	2312-0541
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language EXPRESSION; IMMUNOHISTOCHEMISTRY Multiple languages Respiratory System Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/57105