Universität zu Köln

Buttner, Reinhard, Gosney, John R., Skov, Birgit Guldhammer, Adam, Julien, Motoi, Noriko ORCID: 0000-0001-7098-3311, Bloom, Kenneth J., Dietel, Manfred, Longshore, John W., Lopez-Rios, Fernando, Penault-Llorca, Frederique, Viale, Giuseppe, Wotherspoon, Andrew C., Kerr, Keith M. and Tsao, Ming-Sound (2017). Programmed Death-Ligand 1 Immunohistochemistry Testing: A Review of Analytical Assays and Clinical Implementation in Non-Small-Cell Lung Cancer. J. Clin. Oncol., 35 (34). S. 3867 - 3878. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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Abstract

Purpose Three programmed death-1/programmed death-ligand 1 (PD-L1) inhibitors are currently approved for treatment of non-small-cell lung cancer (NSCLC). Treatment with pembrolizumab in NSCLC requires PD-L1 immunohistochemistry (IHC) testing. Nivolumab and atezolizumab are approved without PD-L1 testing, though US Food and Drug Administration-cleared complementary PD-L1 tests are available for both. PD-L1 IHC assays used to assess PD-L1 expression in patients treated with programmed death-1/PD-L1 inhibitors in clinical trials include PD-L1 IHC 28-8 pharmDx (28-8), PD-L1 IHC 22C3 pharmDx (22C3), Ventana PD-L1 SP142 (SP142), and Ventana PD-L1 SP263 (SP263). Differences in antibodies and IHC platforms have raised questions about comparability among these assays and their diagnostic use. This review provides practical information to help physicians and pathologists understand analytical features and comparability of various PD-L1 IHC assays and their diagnostic use. Methods We reviewed and summarized published or otherwise reported studies (January 2016 to January 2017) on clinical trial and laboratory-developed PD-L1 IHC assays (LDAs). Studies assessing the effect of diagnostic methods on PD-L1 expression levels were analyzed to address practical issues related to tissue samples used for testing. Results High concordance and interobserver reproducibility were observed with the 28-8, 22C3, and SP263 clinical trial assays for PD-L1 expression on tumor cell membranes, whereas lower PD-L1 expression was detected with SP142. Immune-cell PD-L1 expression was variable and interobserver concordance was poor. Inter-and intratumoral heterogeneity had variable effects on PD-L1 expression. Concordance among LDAs was variable. Conclusion High concordance among 28-8, 22C3, and SP263 when assessing PD-L1 expression on tumor cell membranes suggests possible interchangeability of their clinical use for NSCLC but not for assessment of PD-L1 expression on immune cells. Development of LDAs requires stringent standardization before their recommendation for routine clinical use. (C) 2017 by American Society of Clinical Oncology

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Buttner, Reinhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Gosney, John R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Skov, Birgit Guldhammer UNSPECIFIED UNSPECIFIED UNSPECIFIED Adam, Julien UNSPECIFIED UNSPECIFIED UNSPECIFIED Motoi, Noriko UNSPECIFIED orcid.org/0000-0001-7098-3311 UNSPECIFIED Bloom, Kenneth J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dietel, Manfred UNSPECIFIED UNSPECIFIED UNSPECIFIED Longshore, John W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lopez-Rios, Fernando UNSPECIFIED UNSPECIFIED UNSPECIFIED Penault-Llorca, Frederique UNSPECIFIED UNSPECIFIED UNSPECIFIED Viale, Giuseppe UNSPECIFIED UNSPECIFIED UNSPECIFIED Wotherspoon, Andrew C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kerr, Keith M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Tsao, Ming-Sound UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-210217
DOI:	10.1200/JCO.2017.74.7642
Journal or Publication Title:	J. Clin. Oncol.
Volume:	35
Number:	34
Page Range:	S. 3867 - 3878
Date:	2017
Publisher:	AMER SOC CLINICAL ONCOLOGY
Place of Publication:	ALEXANDRIA
ISSN:	1527-7755
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language RANDOMIZED CONTROLLED-TRIAL; PULMONARY SQUAMOUS-CELL; PD-L1 EXPRESSION; OPEN-LABEL; ADVANCED NSCLC; DOCETAXEL; MULTICENTER; HARMONIZATION; ATEZOLIZUMAB; SENSITIVITY Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/21021