Portal de Periódicos da CAPES

Revisão Acesso aberto Produção Nacional Revisado por pares

BIBTEX RIS

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

2020; Volume: 250; Issue: 5 Linguagem: Inglês

10.1002/path.5406

1096-9896

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

Lymphoma Diagnosis and Treatment

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.