The International Association for the Study of Lung Cancer Global Survey on Programmed Death-Ligand 1 Testing for NSCLC

Mari Mino-Kenudson*, Nolwenn le Stang, Jillian B. Daigneault, Andrew G. Nicholson, Wendy A. Cooper, Anja C. Roden, Andre L. Moreira, Erik Thunnissen, Mauro Papotti, Giuseppe Pelosi, Noriko Motoi, Claudia Poleri, Elisabeth Brambilla, Mary Redman, Deepali Jain, Sanja Dacic, Yasushi Yatabe, Ming Sound Tsao, Fernando Lopez-Rios, Johan BotlingGang Chen, Teh-Ying Chou, Fred R. Hirsch, Mary Beth Beasley, Alain Borczuk, Lukas Bubendorf, Jin-Haeng Chung, David Hwang, Dongmei Lin, John Longshore, Masayuki Noguchi, Natasha Rekhtman, Lynette Sholl, William Travis, Akihiko Yoshida, Murry W. Wynes, Ignacio I. Wistuba, Keith M. Kerr, Sylvie Lantuejoul

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Introduction: Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) is required to determine the eligibility for pembrolizumab monotherapy in advanced NSCLC worldwide and for several other indications depending on the country. Four assays have been approved/ Communauté Européene–In vitro Diagnostic (CV-IVD)–marked, but PD-L1 IHC seems diversely implemented across regions and laboratories with the application of laboratory-developed tests (LDTs). Method: To assess the practice of PD-L1 IHC and identify issues and disparities, the International Association for the Study of Lung Cancer Pathology Committee conducted a global survey for pathologists from January to May 2019, comprising multiple questions on preanalytical, analytical, and postanalytical conditions. Result: A total of 344 pathologists from 64 countries participated with 41% from Europe, 24% from North America, and 18% from Asia. Besides biopsies and resections, cellblocks were used by 75% of the participants and smears by 11%. The clone 22C3 was most often used (69%) followed by SP263 (51%). They were applied as an LDT by 40% and 30% of the users, respectively, and 76% of the participants developed at least one LDT. Half of the participants reported a turnaround time of less than or equal to 2 days, whereas 13% reported that of greater than or equal to 5 days. In addition, quality assurance (QA), formal training for scoring, and standardized reporting were not implemented by 18%, 16%, and 14% of the participants, respectively. Conclusions: Heterogeneity in PD-L1 testing is marked across regions and laboratories in terms of antibody clones, IHC assays, samples, turnaround times, and QA measures. The lack of QA, formal training, and standardized reporting stated by a considerable minority identifies a need for additional QA measures and training opportunities.
Original languageEnglish
Pages (from-to)686-696
Number of pages11
JournalJournal of Thoracic Oncology
Volume16
Issue number4
DOIs
Publication statusPublished - 1 Apr 2021

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