Mari Mino-Kenudson1, Nolwenn Le Stang2, Jillian B Daigneault3, Andrew G Nicholson4, Wendy A Cooper5, Anja C Roden6, Andre L Moreira7, Erik Thunnissen8, Mauro Papotti9, Giuseppe Pelosi10, Noriko Motoi11, Claudia Poleri12, Elisabeth Brambilla13, Mary Redman14, Deepali Jain15, Sanja Dacic16, Yasushi Yatabe11, Ming Sound Tsao17, Fernando Lopez-Rios18, Johan Botling19, Gang Chen20, Teh-Ying Chou21, Fred R Hirsch22, Mary Beth Beasley23, Alain Borczuk24, Lukas Bubendorf25, Jin-Haeng Chung26, David Hwang27, Dongmei Lin28, John Longshore29, Masayuki Noguchi30, Natasha Rekhtman31, Lynette Sholl32, William Travis31, Akihiko Yoshida11, Murry W Wynes3, Ignacio I Wistuba33, Keith M Kerr34, Sylvie Lantuejoul2. 1. Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: mminokenudson@partners.org. 2. Centre Léon Bérard Unicancer, Lyon, France. 3. International Association for the Study of Lung Cancer, Denver, Colorado. 4. Royal Brompton and Harefield National Health Service (NHS) Foundation Trust, London, United Kingdom; National Heart and Lung Institute, Imperial College London, London, United Kingdom. 5. Royal Prince Alfred Hospital, New South Wales (NSW) Health Pathology and University of Sydney, Camperdown, Australia. 6. Department of Pathology, Mayo Clinic, Rochester, Minnesota. 7. Department of Pathology, New York University Langone Health, New York, New York. 8. Department of Pathology, VU Medical Center, Amsterdam, The Netherlands. 9. Anatomic Pathology, University of Turin, Turin, Italy. 10. Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) MultiMedica, Milan, Italy. 11. Diagnostic Pathology, National Cancer Center Hospital, Tokyo, Japan. 12. Office of Pathology Consultants, Buenos Aires, Argentina. 13. Université Grenoble Alpes, Grenoble, France. 14. Fred Hutchinson Cancer Research Center, Seattle, Washington. 15. All India Institute of Medical Sciences, New Delhi, India. 16. Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 17. Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada. 18. Pathology-Laboratorio de Dianas Terapeuticas, HM Hospitales, Madrid, Spain. 19. Department of Immunology Genetics and Pathology, Science for Life Laboratory, Uppsala University Hospital, Uppsala, Sweden. 20. Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China. 21. Taipei Veterans General Hospital, Taipei, Republic of China. 22. Center for Thoracic Oncology, The Tisch Cancer Institute, New York, New York; Ichan School of Medicine, Mount Sinai Health System, New York, New York. 23. Ichan School of Medicine, Mount Sinai Health System, New York, New York. 24. Department of Pathology, Weill Cornell Medicine, New York, New York. 25. Institute of Pathology, University of Basel, Basel, Switzerland. 26. Seoul National University Bundang Hospital, Seoul, South Korea. 27. Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. 28. Department of Pathology, Peking University Cancer Hospital and Institute, Beijing, People's Republic of China. 29. Carolinas Pathology Group, Charlotte, North Carolina. 30. University of Tsukuba, Tsukuba, Japan. 31. Memorial Sloan Kettering Cancer Center, New York, New York. 32. Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. 33. The University of Texas MD Anderson Cancer Center, Houston, Texas. 34. Department of Pathology, Aberdeen Royal Infirmary, Aberdeen, United Kingdom.
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.
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.
Authors: Matthew P Smeltzer; Murry W Wynes; Sylvie Lantuejoul; Ross Soo; Suresh S Ramalingam; Marileila Varella-Garcia; Meghan Meadows Taylor; Kristin Richeimer; Kelsey Wood; Kristen E Howell; Mercedes Lilana Dalurzo; Enriqueta Felip; Gina Hollenbeck; Keith Kerr; Edward S Kim; Clarissa Mathias; Jose Pacheco; Pieter Postmus; Charles Powell; Masahiro Tsuboi; Ignacio I Wistuba; Heather A Wakelee; Chandra P Belani; Giorgio V Scagliotti; Fred R Hirsch Journal: J Thorac Oncol Date: 2020-05-20 Impact factor: 15.609
Authors: Edward B Garon; Naiyer A Rizvi; Rina Hui; Natasha Leighl; Ani S Balmanoukian; Joseph Paul Eder; Amita Patnaik; Charu Aggarwal; Matthew Gubens; Leora Horn; Enric Carcereny; Myung-Ju Ahn; Enriqueta Felip; Jong-Seok Lee; Matthew D Hellmann; Omid Hamid; Jonathan W Goldman; Jean-Charles Soria; Marisa Dolled-Filhart; Ruth Z Rutledge; Jin Zhang; Jared K Lunceford; Reshma Rangwala; Gregory M Lubiniecki; Charlotte Roach; Kenneth Emancipator; Leena Gandhi Journal: N Engl J Med Date: 2015-04-19 Impact factor: 91.245
Authors: Angels Barberà; Ruth Marginet Flinch; Montserrat Martin; Jose L Mate; Albert Oriol; Fina Martínez-Soler; Tomas Santalucia; Pedro L Fernández Journal: Appl Immunohistochem Mol Morphol Date: 2021-01
Authors: Scott J Antonia; Augusto Villegas; Davey Daniel; David Vicente; Shuji Murakami; Rina Hui; Takashi Yokoi; Alberto Chiappori; Ki H Lee; Maike de Wit; Byoung C Cho; Maryam Bourhaba; Xavier Quantin; Takaaki Tokito; Tarek Mekhail; David Planchard; Young-Chul Kim; Christos S Karapetis; Sandrine Hiret; Gyula Ostoros; Kaoru Kubota; Jhanelle E Gray; Luis Paz-Ares; Javier de Castro Carpeño; Catherine Wadsworth; Giovanni Melillo; Haiyi Jiang; Yifan Huang; Phillip A Dennis; Mustafa Özgüroğlu Journal: N Engl J Med Date: 2017-09-08 Impact factor: 91.245
Authors: Jamaal A Rehman; Gang Han; Daniel E Carvajal-Hausdorf; Brad E Wasserman; Vasiliki Pelekanou; Nikita L Mani; Joseph McLaughlin; Kurt A Schalper; David L Rimm Journal: Mod Pathol Date: 2016-11-11 Impact factor: 7.842
Authors: Nicola L Lawson; Carly I Dix; Paul W Scorer; Christopher J Stubbs; Edmond Wong; Liam Hutchinson; Eileen J McCall; Marianne Schimpl; Emma DeVries; Jill Walker; Gareth H Williams; James Hunt; Craig Barker Journal: Mod Pathol Date: 2019-09-26 Impact factor: 7.842