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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.

Authors :
Gonzalez-Ericsson, Paula I
Stovgaard, Elisabeth ES
Sua, Luz F
Reisenbichler, Emily
Kos, Zuzana
Carter, Jodi M
Michiels, Stefan
Le Quesne, John
Nielsen, Torsten O
Laenkholm, Anne-Vibeke
Fox, Stephen B
Adam, Julien
Bartlett, John Ms
Rimm, David L
Quinn, Cecily
Peeters, Dieter
Dieci, Maria V
Vincent-Salomon, Anne
Cree, Ian
Hida, Akira I
Balko, Justin M
Haynes, Harry HR
Frahm, Isabel
Acosta-Haab, Gabriela
Balancin, Marcelo
Bellolio, Enrique
Yang, Wentao
Kirtani, Pawan
Sugie, Tomoharu
Ehinger, Anna
Castaneda, Carlos Altamirano
Kok, Marleen
McArthur, Heather
Siziopikou, Kalliopi
Badve, Sunil
Fineberg, Susan
Gown, Allen A.M.
Viale, Giuseppe
Schnitt, Stuart J
Pruneri, Giancarlo
Penault-Llorca, Frederique
Hewitt, Stephen M
Thompson, E Aubrey
Allison, Kimberly H
Symmans, William Fraser
Bellizzi, Andrew M
Brogi, Edi
Moore, David A
Larsimont, Denis
Dillon, Deborah A
Lazar, Alexander
Lien, Huangchun
Goetz, Matthew P
Broeckx, Glenn
El Bairi, Khalid
Harbeck, Nadia
Cimino-Mathews, Ashley
Sotiriou, Christos
Adams, Sylvia
Liu, Shi-Wei
Loibl, Sibylle
Chen, I-Chun
Lakhani, Sunil R
Juco, Jonathan W
Denkert, Carsten
Blackley, Elizabeth EF
Demaria, Sandra
Leon-Ferre, Roberto
Gluz, Oleg
Zardavas, Dimitrios
Emancipator, Kenneth
Ely, Scott
Loi, Sherene
Salgado, Roberto
Sanders, Melinda M.E.
International Immuno-Oncology Biomarker Working Group
Gonzalez-Ericsson, Paula I
Stovgaard, Elisabeth ES
Sua, Luz F
Reisenbichler, Emily
Kos, Zuzana
Carter, Jodi M
Michiels, Stefan
Le Quesne, John
Nielsen, Torsten O
Laenkholm, Anne-Vibeke
Fox, Stephen B
Adam, Julien
Bartlett, John Ms
Rimm, David L
Quinn, Cecily
Peeters, Dieter
Dieci, Maria V
Vincent-Salomon, Anne
Cree, Ian
Hida, Akira I
Balko, Justin M
Haynes, Harry HR
Frahm, Isabel
Acosta-Haab, Gabriela
Balancin, Marcelo
Bellolio, Enrique
Yang, Wentao
Kirtani, Pawan
Sugie, Tomoharu
Ehinger, Anna
Castaneda, Carlos Altamirano
Kok, Marleen
McArthur, Heather
Siziopikou, Kalliopi
Badve, Sunil
Fineberg, Susan
Gown, Allen A.M.
Viale, Giuseppe
Schnitt, Stuart J
Pruneri, Giancarlo
Penault-Llorca, Frederique
Hewitt, Stephen M
Thompson, E Aubrey
Allison, Kimberly H
Symmans, William Fraser
Bellizzi, Andrew M
Brogi, Edi
Moore, David A
Larsimont, Denis
Dillon, Deborah A
Lazar, Alexander
Lien, Huangchun
Goetz, Matthew P
Broeckx, Glenn
El Bairi, Khalid
Harbeck, Nadia
Cimino-Mathews, Ashley
Sotiriou, Christos
Adams, Sylvia
Liu, Shi-Wei
Loibl, Sibylle
Chen, I-Chun
Lakhani, Sunil R
Juco, Jonathan W
Denkert, Carsten
Blackley, Elizabeth EF
Demaria, Sandra
Leon-Ferre, Roberto
Gluz, Oleg
Zardavas, Dimitrios
Emancipator, Kenneth
Ely, Scott
Loi, Sherene
Salgado, Roberto
Sanders, Melinda M.E.
International Immuno-Oncology Biomarker Working Group
Source :
Journal of pathology
Publication Year :
2020

Abstract

Immune checkpoint inhibitor therapies targeting PD-1/PD-L1 are now 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. 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. Since TILs and PD-L1 are parts of an immunological spectrum in breast cancer, we propose the systematic implementation of combined PD-L1 and TIL analyses as a more comprehensive immune-oncological biomarker for patient selection for PD-1/PD-L1 inhibition-based therapy in patients with breast cancer. 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 breast cancer. This article is protected by copyright. All rights reserved.<br />SCOPUS: re.j<br />info:eu-repo/semantics/published

Details

Database :
OAIster
Journal :
Journal of pathology
Notes :
1 full-text file(s): application/pdf, English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1192456166
Document Type :
Electronic Resource