Journal article
The path to a better biomarker: application of a risk management framework for the implementation of PD‐L1 and TILs as immuno‐oncology biomarkers in breast cancer clinical trials and daily practice
The Journal of pathology, Vol.250(5), pp.667-684
04/2020
DOI: 10.1002/path.5406
PMID: 32129476
Abstract
Immune checkpoint inhibitor therapies targeting PD-1/PD-L1 are now the standard of care in oncology across several hematologic and solid tumor types, including triple negative breast cancer (TNBC). Patients with metastatic or locally advanced TNBC with PD-L1 expression on immune cells occupying ≥1% of tumor area demonstrated survival benefit with the addition of atezolizumab to nab-paclitaxel. However, concerns regarding variability between immunohistochemical PD-L1 assay performance and inter-reader reproducibility have been raised. High tumor-infiltrating lymphocytes (TILs) have also been associated with response to PD-1/PD-L1 inhibitors in patients with breast cancer (BC). TILs can be easily assessed on hematoxylin and eosin-stained slides and have shown reliable inter-reader reproducibility. As an established prognostic factor in early stage TNBC, TILs are soon anticipated to be reported in daily practice in many pathology laboratories worldwide. Because TILs and PD-L1 are parts of an immunological spectrum in BC, we propose the systematic implementation of combined PD-L1 and TIL analyses as a more comprehensive immuno-oncological biomarker for patient selection for PD-1/PD-L1 inhibition-based therapy in patients with BC. Although practical and regulatory considerations differ by jurisdiction, the pathology community has the responsibility to patients to implement assays that lead to optimal patient selection. We propose herewith a risk-management framework that may help mitigate the risks of suboptimal patient selection for immuno-therapeutic approaches in clinical trials and daily practice based on combined TILs/PD-L1 assessment in BC. © 2020 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.
Details
- Title: Subtitle
- The path to a better biomarker: application of a risk management framework for the implementation of PD‐L1 and TILs as immuno‐oncology biomarkers in breast cancer clinical trials and daily practice
- Creators
- Paula Gonzalez-Ericsson - Vanderbilt University Medical CenterElisabeth Stovgaard - University of CopenhagenLuz Sua - Icesi UniversityEmily Reisenbichler - Yale UniversityZuzana Kos - BC Cancer AgencyJodi Carter - Mayo ClinicStefan Michiels - Université Paris-SudJohn Le Quesne - University of CambridgeTorsten Nielsen - University of British ColumbiaAnne-Vibeke Laenkholm - Department of PathologyStephen Fox - The University of MelbourneJulien Adam - Institut Gustave RoussyJohn MS Bartlett - Ontario Institute for Cancer ResearchDavid Rimm - Yale UniversityCecily Quinn - University College DublinDieter PeetersMaria Dieci - University of PaduaIan Cree - Centre international de recherche sur le cancerAkira HidaJustin Balko - Vanderbilt UniversityHarry Haynes - University of BristolIsabel FrahmGabriela Acosta-HaabMarcelo Balancin - Universidade de São PauloEnrique Bellolio - Universidad de La FronteraWentao Yang - Fudan UniversityPawan KirtaniTomoharu Sugie - Kansai Medical UniversityAnna Ehinger - Lund UniversityCarlos Castaneda - Ctr Biomol Struct & OrgMarleen Kok - The Netherlands Cancer InstituteHeather McArthur - Cedars-Sinai Medical CenterKalliopi Siziopikou - Northwestern UniversitySunil Badve - Purdue University West LafayetteSusan Fineberg - Albert Einstein College of MedicineAllen GownGiuseppe Viale - University of MilanStuart Schnitt - Harvard UniversityGiancarlo Pruneri - University of MilanFrédérique Penault-Llorca - Centre Jean PerrinStephen Hewitt - National Institutes of HealthE Aubrey Thompson - Mayo ClinicKimberly Allison - Stanford UniversityWilliam Symmans - The University of Texas MD Anderson Cancer CenterAndrew Bellizzi - University of Iowa Hospitals and ClinicsEdi Brogi - Memorial Sloan Kettering Cancer CenterDavid Moore - University College HospitalDenis Larsimont - Université Libre de BruxellesDeborah Dillon - Harvard UniversityAlexander Lazar - The University of Texas MD Anderson Cancer CenterHuangchun Lien - National Taiwan UniversityMatthew Goetz - Mayo ClinicGlenn Broeckx - University of AntwerpKhalid El Bairi - Université Mohamed 1 Oujda MAROCNadia Harbeck - Ludwig-Maximilians-Universität MünchenAshley Cimino-MathewsChristos Sotiriou - Université Libre de BruxellesSylvia Adams - York UniversityShi-Wei Liu - Sichuan Cancer HospitalI-Chun ChenSibylle Loibl - German Breast groupSunil Lakhani - The University of QueenslandJonathan Juco - Merck & Co.Carsten Denkert - University Hospital of Giessen and MarburgElizabeth Blackley - Peter MacCallum Cancer CentreSandra Demaria - Cornell UniversityRoberto Leon-FerreOleg Gluz - West German Study GroupDimitrios Zardavas - Breast International GroupKenneth Emancipator - Merck & Co.Scott Ely - Bristol-Myers SquibbSherene Loi - The University of MelbourneRoberto Salgado - Peter MacCallum Cancer CentreMelinda Sanders - Vanderbilt UniversityPaula Gonzalez‐EricssonAnne Vincent‐SalomonInternational Immuno-Oncology Biomarker Working Group
- Resource Type
- Journal article
- Publication Details
- The Journal of pathology, Vol.250(5), pp.667-684
- DOI
- 10.1002/path.5406
- PMID
- 32129476
- NLM abbreviation
- J Pathol
- ISSN
- 0022-3417
- eISSN
- 1096-9896
- Publisher
- Wiley
- Grant note
- DOI: 10.13039/501100001026, name: National Breast Cancer Foundation; DOI: 10.13039/100001006, name: Breast Cancer Research Foundation
- Language
- English
- Date published
- 04/2020
- Academic Unit
- Pathology
- Record Identifier
- 9984185277802771
Metrics
22 Record Views