TY - JOUR
T1 - The International Association for the Study of Lung Cancer Global Survey on programmed death-ligand 1 testing for NSCLC
AU - Mino-Kenudson, Mari
AU - Le Stang, Nolwenn
AU - Daigneault, Jillian B.
AU - Nicholson, Andrew G.
AU - Cooper, Wendy A.
AU - Roden, Anja C.
AU - Moreira, Andre L.
AU - Thunnissen, Erik
AU - Papotti, Mauro
AU - Pelosi, Giuseppe
AU - Motoi, Noriko
AU - Poleri, Claudia
AU - Brambilla, Elisabeth
AU - Redman, Mary
AU - Jain, Deepali
AU - Dacic, Sanja
AU - Yatabe, Yasushi
AU - Tsao, Ming Sound
AU - Lopez-Rios, Fernando
AU - Botling, Johan
AU - Chen, Gang
AU - Chou, Teh-Ying
AU - Hirsch, Fred R.
AU - Beasley, Mary Beth
AU - Borczuk, Alain
AU - Bubendorf, Lukas
AU - Chung, Jin-Haeng
AU - Hwang, David
AU - Lin, Dongmei
AU - Longshore, John
AU - Noguchi, Masayuki
AU - Rekhtman, Natasha
AU - Sholl, Lynette
AU - Travis, William
AU - Yoshida, Akihiko
AU - Wynes, Murry W.
AU - Wistuba, Ignacio I.
AU - Kerr, Keith M.
AU - Lantuejoul, Sylvie
PY - 2021
Y1 - 2021
N2 - 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/Communaute Europeene-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.
AB - 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/Communaute Europeene-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.
UR - https://hdl.handle.net/1959.7/uws:65071
U2 - 10.1016/j.jtho.2020.12.026
DO - 10.1016/j.jtho.2020.12.026
M3 - Article
SN - 1556-0864
VL - 16
SP - 686
EP - 696
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 4
ER -
