Advancing the PD-L1 CPS test in metastatic TNBC: Insights from pathologists and findings from a nationwide survey.

Autor: Fusco N; Division of Pathology, IEO, European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy. Electronic address: nicola.fusco@ieo.it., Ivanova M; Division of Pathology, IEO, European Institute of Oncology IRCCS, Milan, Italy., Frascarelli C; Division of Pathology, IEO, European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy., Criscitiello C; Division of Pathology, IEO, European Institute of Oncology IRCCS, Milan, Italy; Division of New Drugs and Early Drug Development for Innovative Therapies, IEO, European Institute of Oncology IRCCS, Milan, Italy., Cerbelli B; Department of Medical-Surgical Sciences and Biotechnologies Sapienza University of Rome, Rome, Italy., Pignataro MG; Department of Medical-Surgical Sciences and Biotechnologies Sapienza University of Rome, Rome, Italy., Pernazza A; Department of Medical-Surgical Sciences and Biotechnologies Sapienza University of Rome, Rome, Italy., Sajjadi E; Division of Pathology, IEO, European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy., Venetis K; Division of Pathology, IEO, European Institute of Oncology IRCCS, Milan, Italy., Cursano G; Division of Pathology, IEO, European Institute of Oncology IRCCS, Milan, Italy., Pagni F; Department of Medicine and Surgery, University Milan Bicocca, Monza (MB), Italy; Department of Pathology, IRCCS San Gerardo Hospital, Monza (MB), Italy., Di Bella C; Department of Pathology, IRCCS San Gerardo Hospital, Monza (MB), Italy., Accardo M; Pathology Unit, Department of Mental and Physical Health and Preventive Medicine, Università degli Studi della Campania 'L. Vanvitelli', Naples, Italy., Amato M; Department of Pathology, San Giovanni-Addolorata Hospital, Rome Italy., Amico P; Department of Pathology, Ospedale Maria Paternò Arezzo, Ragusa, Italy., Bartoli C; Morphological Diagnostic and Biomolecular Characterization Area, Complex Unit of Pathological Anatomy Empoli-Prato, Oncological Department Azienda USL Toscana Centro, Italy., Bogina G; Pathology Unit, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar di Valpolicella, Italy., Bortesi L; Pathology Unit, IRCCS Ospedale Sacro Cuore Don Calabria, Negrar di Valpolicella, Italy., Boldorini R; Pathology Unit, University of Eastern Piedmont, Novara, Italy., Bruno S; Division of Pathology, ASL2 Savona, Liguria, Italy., Cabibi D; Department of Sciences for the Promotion of Health and Mother and Child Care, Anatomic Pathology, University of Palermo, Palermo, Italy., Caruana P; Pathology Unit, Department of Medicine and Surgery, University Hospital of Parma, Parma, Italy., Dainese E; Surgical Pathology Division, Department of Oncology, ASST Lecco, 'A. Manzoni' Hospital, Lecco, Italy., De Camilli E; Division of Pathology, IEO, European Institute of Oncology IRCCS, Milan, Italy., Dell'Anna V; Department of Laboratory Diagnostics, Ospedale Vito Fazzi, Lecce, Italy., Duda L; Department of Clinical and Experimental Medicine, Pathology Unit, University of Foggia, Foggia, Italy., Emmanuele C; Division of Pathology, Umberto I Hospital Presidium, Enna Provincial Health Department (ASP), Enna, Italy., Fanelli GN; Division of Pathology, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy., Fernandes B; Humanitas Cllinical and Research Center IRCCS, Rozzano, Milan, Italy., Ferrara G; Department of Anatomic Pathology and Cytopathology, G. Pascale National Cancer Institute Foundation (IRCCS) Naples, Italy., Gnetti L; Division of Pathology, Umberto I Hospital Presidium, Enna Provincial Health Department (ASP), Enna, Italy., Gurrera A; Department of Pathology, University of Catania, Italy., Leone G; Division of Pathology, Clinical Institute Humanitas Catania Cubba, Misterbianco (Catania), Italy., Lucci R; Pathology Unit, Monaldi Hospital, A.O. dei Colli of Naples, Naples, Italy., Mancini C; Division of Pathology, Umberto I Hospital Presidium, Enna Provincial Health Department (ASP), Enna, Italy., Marangi G; Anatomic Pathology Unit, SS. Annunziata Hospital, Taranto, Italy., Mastropasqua MG; Department of Precision and Regenerative Medicine and Jonian Area, School of Medicine, University of Bari 'Aldo Moro', Bari, Italy., Nibid L; Research Unit of Anatomical Pathology, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Rome, Italy; Anatomical Pathology Operative Research Unit, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, Rome, Italy., Orrù S; Businco Oncologic Hospital, ARNAS Brotzu, Cagliari, Italy., Pastena M; IRCCS Istituto Tumori 'Giovanni Paolo II', Bari, Italy., Peresi M; Pathology and Cytopathology Diagnostic Unit, Ospedale Villa Scassi di Genova, Genoa, Italy., Perracchio L; Department of Pathology, IRCCS Regina Elena National Cancer Institute, Rome, Italy., Santoro A; General Pathology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy., Vezzosi V; Histopathology and Molecular Diagnostics Unit, Careggi Hospital, Firenze, Italy., Zambelli C; Pathology Unit, ASST Spedali Civili, Brescia, Italy., Zuccalà V; Pathology Unit, Pugliese-Ciaccio Hospital Catanzaro, Catanzaro, Italy., Rizzo A; Division of Pathology, Clinical Institute Humanitas Catania Cubba, Misterbianco (Catania), Italy., Costarelli L; Department of Pathology, San Giovanni-Addolorata Hospital, Rome Italy., Pietribiasi F; Division of Pathology, Santa Croce Hospital, Moncalieri, Turin, Italy., Santinelli A; Anatomic Pathology, Azienda Sanitaria Territoriale di Pesaro-Urbino, Pesaro, Italy., Scatena C; Division of Pathology, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy., Curigliano G; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; Division of New Drugs and Early Drug Development for Innovative Therapies, IEO, European Institute of Oncology IRCCS, Milan, Italy., Guerini-Rocco E; Division of Pathology, IEO, European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy., Martini M; Department of Human and Developmental Pathology, University of Messina, Messina, Italy., Graziano P; Pathology Unit, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo (FG), Italy., Castellano I; Department of Medical Science, University of Turin, Turin, Italy., d'Amati G; Department of Medical-Surgical Sciences and Biotechnologies Sapienza University of Rome, Rome, Italy.
Jazyk: angličtina
Zdroj: Critical reviews in oncology/hematology [Crit Rev Oncol Hematol] 2023 Oct; Vol. 190, pp. 104103. Date of Electronic Publication: 2023 Aug 16.
DOI: 10.1016/j.critrevonc.2023.104103
Abstrakt: Pembrolizumab has received approval as a first-line treatment for unresectable/metastatic triple-negative breast cancer (mTNBC) with a PD-L1 combined positive score (CPS) of ≥ 10. However, assessing CPS in mTNBC poses challenges. Firstly, it represents a novel analysis for breast pathologists. Secondly, the heterogeneity of PD-L1 expression in mTNBC further complicates the assessment. Lastly, the lack of standardized assays and staining platforms adds to the complexity. In KEYNOTE trials, PD-L1 expression was evaluated using the IHC 22C3 pharmDx kit as a companion diagnostic test. However, both the 22C3 pharmDx and VENTANA PD-L1 (SP263) assays are validated for CPS assessment. Consequently, assay-platform choice, staining conditions, and scoring methods can significantly impact the testing outcomes. This consensus paper aims to discuss the intricacies of PD-L1 CPS testing in mTNBC and provide practical recommendations for pathologists. Additionally, we present findings from a nationwide Italian survey elucidating the state-of-the-art in PD-L1 CPS testing in mTNBC.
Competing Interests: Declaration of Competing Interest Nicola Fusco has received honoraria for consulting, advisory role, speaker bureau, travel, and/or research grants from Merck Sharp & Dohme (MSD), Novartis, AstraZeneca, Roche, Daiichi Sankyo, GlaxoSmithKline (GSK), Gilead, Diaceutics, Adicet Bio, and Sermonix. Mariia Ivanova from Agilent Technologies Denmark ApS. Carmen Criscitiello reports personal fees for consulting, advisory role, and speakers’ bureau from Lilly, Roche, Novartis, MSD, Seagen, Gilead, Daiichi Sankyo, AstraZeneca, and Pfizer. Bruna Cerbelli from MSD and Novartis. Fabio Pagni from MSD, Novartis, Roche, and Amgen. Mauro Mastropasqua from Exact Sciences. Alfredo Santinelli from Roche-Ventana, Novartis, Astrazeneca, Amgen. Giuseppe Curigliano has received honoraria for speaker’s engagement: Roche, Seattle Genetics, Novartis, Lilly, Pfizer, Foundation Medicine, NanoString, Samsung, Celltrion, BMS, MSD; Honoraria for providing consultancy: Roche, Seattle Genetics, NanoString; Honoraria for participating in Advisory Board: Roche, Lilly, Pfizer, Foundation Medicine, Samsung, Celltrion, Mylan; Honoraria for writing engagement: Novartis, BMS; Honoraria for participation in Ellipsis Scientific Affairs Group; Institutional research funding for conducting phase I and II clinical trials: Pfizer, Roche, Novartis, Sanofi, Celgene, Servier, Orion, AstraZeneca, Seattle Genetics, AbbVie, Tesaro, BMS, Merck Serono, Merck Sharp Dome, Janssen-Cilag, Philogen, Bayer, Medivation, Medimmune. Elena Guerini-Rocco from Thermo Fisher Scientific, Novartis, AstraZeneca, Roche, Biocartis, Exact Science, GSK, and Illumina. Paolo Graziano Consulting/Honoraria from Eli-Lilly, Pfizer, Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, MSD, Amgen. Giulia d’Amati from MSD, Roche, Astrazeneca, Daiichi Sankyo. These companies had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, and/or in the decision to publish the results. All other authors declare no potential conflicts of interest.
(Copyright © 2023 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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