The path to a better biomarker: application of a risk management framework for the implementation of PD‐L1 and TILs as immuno‐oncology biomarkers into breast cancer clinical trials and daily practice

Forskningsoutput: TidskriftsbidragÖversiktsartikel

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.

Detaljer

Författare
  • Paula Gonzalez-Ericsson
  • Elisabeth S Stovgaard
  • Luz F Sua
  • Emily Reisenbichler
  • Zuzana Kos
  • Jodi M Carter
  • Stefan Michiels
  • John Le Quesne
  • Torsten O Nielsen
  • Anne Vibeke Laenkholm
  • Stephen B Fox
  • Julien Adam
  • John M S Bartlett
  • David L Rimm
  • Cecily Quinn
  • Dieter Peeters
  • Maria V Dieci
  • Anne Vincent-Salomon
  • Ian Cree
  • Akira I Hida
  • Justin M Balko
  • Harry R Haynes
  • Isabel Frahm
  • Gabriela Acosta-Haab
  • Marcelo Balancin
  • Enrique Bellolio
  • Wentao Yang
  • Pawan Kirtani
  • Tomoharu Sugie
  • Carlos A Castaneda
  • Marleen Kok
  • Heather McArthur
  • Kalliopi Siziopikou
  • Sunil Badve
  • Susan Fineberg
  • Allen M Gown
  • Giuseppe Viale
  • Stuart J Schnitt
  • Giancarlo Pruneri
  • Frédérique M Penault-Llorca
  • Stephen Hewitt
  • Aubrey Thompson
  • Kimberly H Allison
  • William F Symmans
  • Andrew M Bellizzi
  • Edi Brogi
  • David A. Moore
  • Denis Larsimont
  • Deborah A Dillon
  • Alexander Lazar
  • Huangchun Lien
  • Matthew P Goetz
  • Glenn Broeckx
  • Khalid El Bairi
  • Nadia Harbeckj
  • Ashley Cimino-Mathews
  • Christos Sotiriou
  • Sylvia Adams
  • Shi-wei Liu
  • Sibylle Loibl
  • I-Chun Chen
  • Sunil R Lakhani
  • Jonathan W Juco
  • Carsten Denkert
  • Elisabeth F Blackley
  • Sandra Demaria
  • Roberto Leon-Ferre
  • Oleg Gluz
  • Dimitrios Zardavas
  • Kenneth Emancipator
  • Scott Ely
  • Sherene Loi
  • Roberto Salgado
  • Melinda Sanders
Enheter & grupper
Externa organisationer
  • Vanderbilt University Medical Center
  • University of Copenhagen
  • Herlev Hospital
  • Gentofte Hospital
  • ICESI University
  • Yale University
  • British Columbia Cancer Agency
  • Mayo Clinic Minnesota
  • University of Leicester
  • University of Cambridge
  • University of British Columbia
  • Zealand University Hospital
  • University of Melbourne
  • Institut Gustave Roussy
  • University College Dublin
  • HistoGeneX NV
  • University of Padova
  • Curie Institute, Paris
  • International Agency for Research on Cancer, World Health Organization
  • Matsuyama Shimin Hospital
  • University of Bristol
  • Sanatorio Mater Dei
  • Hospital Maria Curie
  • University of São Paulo
  • University of La Frontera
  • Fudan University Shanghai Cancer Center (FUSCC)
  • Manipal Hospitals Dwarka
  • Kansai Medical University
  • Instituto Nacional de Enfermedades Neoplasicas
  • Netherlands Cancer Institute
  • Cedars-Sinai Medical Center
  • Indiana University
  • Montefiore Medical Center
  • University of Paris-Sud
  • University of Edinburgh
  • Ontario Institute for Cancer Research
  • PhenoPath Laboratories
  • European Institute of Oncology
  • University of Milan
  • Dana-Farber Cancer Institute
  • Brigham and Women's Hospital / Harvard Medical School
  • Istituto Nazionale dei Tumori
  • University of Auvergne
  • National Cancer Institute, NCI
  • Mayo Clinic Florida
  • Stanford University
  • University of Texas
  • University of Iowa Hospitals
  • Memorial Sloan-Kettering Cancer Center
  • Institut Jules Bordet
  • National Taiwan University Hospital
  • Antwerp University Hospital
  • Mohamed Premier University
  • University Hospital Munich
  • UCL Cancer Institute
  • Johns Hopkins Hospital
  • New York University
  • Sichuan Cancer Hospital and Institute
  • University Hospital Giessen and Marburg
  • Peter MacCallum Cancer Centre
  • Weill Cornell Medicine
  • Bristol-Myers Squibb
  • International Immuno-Oncology Biomarker Working Group on Breast Cancer
  • Free University of Brussels
  • German Breast Group
  • University of Queensland
  • Royal Brisbane and Women's Hospital
  • University of Antwerp
  • Skåne University Hospital
  • Northwestern University
  • Merck Sharp and Dohme (MSD)
  • Johanniter Krankenhaus
Forskningsområden

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Cancer och onkologi

Nyckelord

Originalspråkengelska
Sidor (från-till)667-684
Antal sidor18
TidskriftJournal of Pathology
Volym250
Utgåva nummer5
Tidigt onlinedatum2020 mar 4
StatusPublished - 2020 apr
PublikationskategoriForskning
Peer review utfördJa

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