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

Paula I 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 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; Gabriel Acosta-Haab; Marcelo Balancin; Enrique Bellolio; Wentao Yang; Pawan Kirtani; Tomohaura Sugie; Anna Ehinger; Carlos A Castaneda; Marleen Kok; Heather McArthur; Kalliopi Siziopikou; Sunil Badve; Susan Fineberg; Allen  Gown; Giuseppe Viale; Stuart J Schnitt; Giancarlo Pruneri; Frederique Penault-Llorca; Stephen Hewitt; E Aubrey Thompson; Kimberley 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 Harbeck; Ashley  Cimino-Matthews; Christos Sotiriou; Slyvia  Adams; Shi-Wei Liu; Sibylle Loibl; I Chun Chen; Sunil R Lakhani; Jonathan W Juco; Carsten Denkert; Elizabeth F Blackley; Sandra Demaria; Roberto Leon-Ferre; Oleg Gluz; Dimitrios Zardavas; Kenneth Emancipator; Scott Ely; Sherene Loi; Roberto Salgado; Melinda Sanders

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

Paula I 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 Bartlett, David L Rimm, Cecily Quinn, Dieter Peeters, Maria V Dieci, Anne Vincent-Salomon, Ian Cree, Akira I HidaJustin M Balko, Harry R Haynes, Isabel Frahm, Gabriel Acosta-Haab, Marcelo Balancin, Enrique Bellolio, Wentao Yang, Pawan Kirtani, Tomohaura Sugie, Anna Ehinger, Carlos A Castaneda, Marleen Kok, Heather McArthur, Kalliopi Siziopikou, Sunil Badve, Susan Fineberg, Allen Gown, Giuseppe Viale, Stuart J Schnitt, Giancarlo Pruneri, Frederique Penault-Llorca, Stephen Hewitt, E Aubrey Thompson, Kimberley 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 Harbeck, Ashley Cimino-Matthews, Christos Sotiriou, Slyvia Adams, Shi-Wei Liu, Sibylle Loibl, I Chun Chen, Sunil R Lakhani, Jonathan W Juco, Carsten Denkert, Elizabeth F Blackley, Sandra Demaria, Roberto Leon-Ferre, Oleg Gluz, Dimitrios Zardavas, Kenneth Emancipator , Scott Ely, Sherene Loi, Roberto Salgado, Melinda Sanders

Deanery of Molecular, Genetic and Population Health Sciences

Research output: Contribution to journal › Review article › peer-review

Original language	English
Journal	The Journal of Pathology
Publication status	Published - 4 Mar 2020

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Coates-edited-Risk-managment-PDL1-and-TILs-manuscript_final
This is a pre-copyedited, author-produced version of an article accepted for publication in The Journal of Pathology following peer review. The version of record "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" is available online at: https://doi.org/10.1002/path.5406
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Gonzalez-Ericsson, P. I., S Stovgaard, E., Sua, L. F., Reisenbichler, E., Kos, Z., Carter, J. M., Michiels, S., Quesne, J. L., O Nielsen, T., Laenkholm, A-V., B Fox, S., Adam, J., Bartlett, J., Rimm, D. L., Quinn, C., Peeters, D., V Dieci, M., Vincent-Salomon, A., Cree, I., ... Sanders, M. (2020). 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. The Journal of Pathology.

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

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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",

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

year = "2020",

month = mar,

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language = "English",

journal = "Journal of Pathology",

issn = "0022-3417",

publisher = "Wiley",

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Gonzalez-Ericsson, PI, S Stovgaard, E, Sua, LF, Reisenbichler, E, Kos, Z, Carter, JM, Michiels, S, Quesne, JL, O Nielsen, T, Laenkholm, A-V, B Fox, S, Adam, J, Bartlett, J, Rimm, DL, Quinn, C, Peeters, D, V Dieci, M, Vincent-Salomon, A, Cree, I, I Hida, A, Balko, JM, Haynes, HR, Frahm, I, Acosta-Haab, G, Balancin, M, Bellolio, E, Yang, W, Kirtani, P, Sugie, T, Ehinger, A, A Castaneda, C, Kok, M, McArthur, H, Siziopikou, K, Badve, S, Fineberg, S, Gown, A, Viale, G, J Schnitt, S, Pruneri, G, Penault-Llorca, F, Hewitt, S, Aubrey Thompson, E, H Allison, K, F Symmans, W, M Bellizzi, A, Brogi, E, A Moore, D, Larsimont, D, A Dillon, D, Lazar, A, Lien, H, P Goetz, M, Broeckx, G, El Bairi, K, Harbeck, N, Cimino-Matthews, A, Sotiriou, C, Adams, S, Liu, S-W, Loibl, S, Chen, IC, Lakhani, SR, W Juco, J, Denkert, C, F Blackley, E, Demaria, S, Leon-Ferre, R, Gluz, O, Zardavas, D, Emancipator , K, Ely, S, Loi, S, Salgado, R & Sanders, M 2020, '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', The Journal of Pathology.

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

In: The Journal of Pathology, 04.03.2020.

Research output: Contribution to journal › Review article › peer-review

TY - JOUR

T1 - 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

AU - Gonzalez-Ericsson, Paula I

AU - S Stovgaard, Elisabeth

AU - Sua, Luz F

AU - Reisenbichler, Emily

AU - Kos, Zuzana

AU - Carter, Jodi M

AU - Michiels, Stefan

AU - Quesne, John Le

AU - O Nielsen, Torsten

AU - Laenkholm, Anne-Vibeke

AU - B Fox, Stephen

AU - Adam, Julien

AU - Bartlett, John

AU - Rimm, David L

AU - Quinn, Cecily

AU - Peeters, Dieter

AU - V Dieci, Maria

AU - Vincent-Salomon, Anne

AU - Cree, Ian

AU - I Hida, Akira

AU - Balko, Justin M

AU - Haynes, Harry R

AU - Frahm, Isabel

AU - Acosta-Haab, Gabriel

AU - Balancin, Marcelo

AU - Bellolio, Enrique

AU - Yang, Wentao

AU - Kirtani, Pawan

AU - Sugie, Tomohaura

AU - Ehinger, Anna

AU - A Castaneda, Carlos

AU - Kok, Marleen

AU - McArthur, Heather

AU - Siziopikou, Kalliopi

AU - Badve, Sunil

AU - Fineberg, Susan

AU - Gown, Allen

AU - Viale, Giuseppe

AU - J Schnitt, Stuart

AU - Pruneri, Giancarlo

AU - Penault-Llorca, Frederique

AU - Hewitt, Stephen

AU - Aubrey Thompson, E

AU - H Allison, Kimberley

AU - F Symmans, William

AU - M Bellizzi, Andrew

AU - Brogi, Edi

AU - A Moore, David

AU - Larsimont, Denis

AU - A Dillon, Deborah

AU - Lazar, Alexander

AU - Lien, Huangchun

AU - P Goetz, Matthew

AU - Broeckx, Glenn

AU - El Bairi, Khalid

AU - Harbeck, Nadia

AU - Cimino-Matthews, Ashley

AU - Sotiriou, Christos

AU - Adams, Slyvia

AU - Liu, Shi-Wei

AU - Loibl, Sibylle

AU - Chen, I Chun

AU - Lakhani, Sunil R

AU - W Juco, Jonathan

AU - Denkert, Carsten

AU - F Blackley, Elizabeth

AU - Demaria, Sandra

AU - Leon-Ferre, Roberto

AU - Gluz, Oleg

AU - Zardavas, Dimitrios

AU - Emancipator , Kenneth

AU - Ely, Scott

AU - Loi, Sherene

AU - Salgado, Roberto

AU - Sanders, Melinda

PY - 2020/3/4

Y1 - 2020/3/4

M3 - Review article

JO - Journal of Pathology

JF - Journal of Pathology

SN - 0022-3417

ER -