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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

Gonzalez-Ericsson, Paula ; Stovgaard, Elisabeth S ; Sua, Luz F ; Reisenbichler, Emily ; Kos, Zuzana ; Carter, Jodi M ; Michiels, Stefan ; Le Quesne, John ; Nielsen, Torsten O and Laenkholm, Anne Vibeke , et al. (2020) In Journal of Pathology 250(5). p.667-684
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... (More)
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. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
PD-L1, Breast cancer
in
Journal of Pathology
volume
250
issue
5
pages
18 pages
publisher
John Wiley & Sons Inc.
external identifiers
  • scopus:85083463990
  • pmid:32129476
ISSN
1096-9896
DOI
10.1002/path.5406
language
English
LU publication?
yes
id
db4cb1a0-ead8-4b6d-b738-f5799f601b37
date added to LUP
2020-03-05 16:25:02
date last changed
2022-04-18 20:57:56
@article{db4cb1a0-ead8-4b6d-b738-f5799f601b37,
  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.}},
  author       = {{Gonzalez-Ericsson, Paula and Stovgaard, Elisabeth S and Sua, Luz F and Reisenbichler, Emily and Kos, Zuzana and Carter, Jodi M and Michiels, Stefan and Le Quesne, John and Nielsen, Torsten O and Laenkholm, Anne Vibeke and Fox, Stephen B and Adam, Julien and Bartlett, John M S and Rimm, David L and Quinn, Cecily and Peeters, Dieter and Dieci, Maria V and Vincent-Salomon, Anne and Cree, Ian and Hida, Akira I and Balko, Justin M and Haynes, Harry R and Frahm, Isabel and Acosta-Haab, Gabriela and Balancin, Marcelo and Bellolio, Enrique and Yang, Wentao and Kirtani, Pawan and Sugie, Tomoharu and Ehinger, Anna and Castaneda, Carlos A and Kok, Marleen and McArthur, Heather and Siziopikou, Kalliopi and Badve, Sunil and Fineberg, Susan and Gown, Allen M and Viale, Giuseppe and Schnitt, Stuart J and Pruneri, Giancarlo and Penault-Llorca, Frédérique M and Hewitt, Stephen and Thompson, Aubrey and Allison, Kimberly H and Symmans, William F and Bellizzi, Andrew M and Brogi, Edi and Moore, David A. and Larsimont, Denis and Dillon, Deborah A and Lazar, Alexander and Lien, Huangchun and Goetz, Matthew P and Broeckx, Glenn and El Bairi, Khalid and Harbeckj, Nadia and Cimino-Mathews, Ashley and Sotiriou, Christos and Adams, Sylvia and Liu, Shi-wei and Loibl, Sibylle and Chen, I-Chun and Lakhani, Sunil R and Juco, Jonathan W and Denkert, Carsten and Blackley, Elisabeth F and Demaria, Sandra and Leon-Ferre, Roberto and Gluz, Oleg and Zardavas, Dimitrios and Emancipator, Kenneth and Ely, Scott and Loi, Sherene and Salgado, Roberto and Sanders, Melinda}},
  issn         = {{1096-9896}},
  keywords     = {{PD-L1; Breast cancer}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{667--684}},
  publisher    = {{John Wiley & Sons Inc.}},
  series       = {{Journal of Pathology}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1002/path.5406}},
  doi          = {{10.1002/path.5406}},
  volume       = {{250}},
  year         = {{2020}},
}