Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials
Creators: name: Hudeček, Jan
name: Voorwerk, Leonie
name: Van Seijen, Maartje
name: Nederlof, Iris
name: De Maaker, Michiel
name: Van Den Berg, Jose
name: Van De Vijver, Koen K.
name: Sikorska, Karolina
name: Adams, Sylvia
name: Demaria, Sandra
name: Viale, Giuseppe
name: Nielsen, Torsten O.
name: Badve, Sunil S.
name: Michiels, Stefan
name: Symmans, William Fraser
name: Sotiriou, Christos
name: Rimm, David L.
name: Hewitt, Stephen M.
name: Denkert, Carsten
name: Loibl, Sibylle
name: Loi, Sherene
name: Bartlett, John M. S.
name: Pruneri, Giancarlo
name: Dillon, Deborah A.
name: Cheang, Maggie C. U.
name: Tutt, Andrew
name: Hall, Jacqueline A.
name: Kos, Zuzana
name: Salgado, Roberto
name: Kok, Marleen
name: Horlings, Hugo M.
name: Hyytiäinen, Aini
name: Hida, Akira I.
name: Thompson, Alastair
name: Lefevre, Alex
name: Lazar, Alexander J.
name: Gown, Allen
name: Lo, Amy
name: Sapino, Anna
name: Madabhushi, Anant
name: Moreira, Andre
name: Richardson, Andrea
name: Vingiani, Andrea
name: Beck, Andrew H.
name: Bellizzi, Andrew M.
name: Guerrero, Angel
name: Grigoriadis, Anita
name: Ehinger, Anna
name: Garrido-Castro, Ana
name: Vincent-Salomon, Anne
name: Laenkholm, Anne-Vibeke
name: Sharma, Ashish
name: Cimino-Mathews, Ashley
name: Srinivasan, Ashok
name: Acs, Balazs
name: Singh, Baljit
name: Calhoun, Benjamin
name: Haibe-Kans, Benjamin
name: Solomon, Benjamin
name: Thapa, Bibhusal
name: Nelson, Brad H.
name: Gallas, Brandon D.
name: Castaneda, Carlos
name: Ballesteros-Merino, Carmen
name: Criscitiello, Carmen
name: Boeckx, Carolien
name: Colpaert, Cecile
name: Quinn, Cecily
name: Chennubhotla, Chakra S.
name: Swanton, Charles
name: Solinas, Cinzia
name: Hiley, Crispin
name: Drubay, Damien
name: Bethmann, Daniel
name: Moore, David A.
name: Larsimont, Denis
name: Sabanathan, Dhanusha
name: Peeters, Dieter
name: Zardavas, Dimitrios
name: Höflmayer, Doris
name: Johnson, Douglas B.
name: Thompson, E. Aubrey
name: Brogi, Edi
name: Perez, Edith
name: ElGabry, Ehab A.
name: Stovgaard, Elisabeth Specht
name: Blackley, Elizabeth F.
name: Roblin, Elvire
name: Reisenbichler, Emily
name: Bellolio, Enrique
name: Balslev, Eva
name: Chmielik, Ewa
name: Gaire, Fabien
name: Andre, Fabrice
name: Lu, Fang-I
name: Azmoudeh-Ardalan, Farid
name: Rojo, Federico
name: Gruosso, Tina
name: Ciompi, Francesco
name: Peale, Franklin
name: Hirsch, Fred R.
name: Klauschen, Frederick
name: Penault-Llorca, Frédérique
name: Acosta Haab, Gabriela
name: Farshid, Gelareh
name: Van Den Eynden, Gert
name: Curigliano, Giuseppe
name: Floris, Giuseppe
name: Broeckx, Glenn
name: Gonzalez-Ericsson
name: Koeppen, Harmut
name: Haynes, Harry R.
name: McArthur, Heather
name: Joensuu, Heikki
name: Olofsson, Helena
name: Lien, Huang-Chun
name: Chen, I-Chun
name: Cree, Ian
name: Frahm, Isabel
name: Brcic, Iva
name: Chan, Jack
name: Ziai, James
name: Brock, Jane
name: Wesseling, Jelle
name: Giltnane, Jennifer
name: Kerner, Jennifer K.
name: Thagaard, Jeppe
name: Braybrooke, Jeremy P.
name: Van Der Laak, Jeroen A. W. M.
name: Lemonnier, Jerome
name: Zha, Jiping
name: Ribeiro, Joana
name: Lennerz, Jochen K.
name: Carter, Jodi M.
name: Saltz, Joel
name: Hartman, Johan
name: Hainfellner, Johannes
name: Quesne, John Le
name: Juco, Jonathon W.
name: Reis-Filho, Jorge
name: Sanchez, Joselyn
name: Sparano, Joseph
name: Cucherousset, Joël
name: Araya, Juan Carlos
name: Adam, Julien
name: Balko, Justin M.
name: Saeger, Kai
name: Siziopikou, Kalliopi
name: Willard-Gallo, Karen
name: Weber, Karsten
name: Pogue-Geile, Katherine L.
name: Steele, Keith E.
name: Emancipator, Kenneth
name: AbdulJabbar, Khalid
name: El Bairi, Khalid
name: Blenman, Kim R. M.
name: Allison, Kimberly H.
name: Korski, Konstanty
name: Pusztai, Lajos
name: Comerma, Laura
name: Buisseret, Laurence
name: Cooper, Lee A. D.
name: Shi, Leming
name: Kooreman, Loes F. S.
name: Molinero, Luciana
name: Estrada, M. Valeria
name: Lacroix-Triki, Magali
name: Al Bakir, Maise
name: Sebastian, Manu M.
name: Van De Vijver, Marc
name: Balancin, Marcelo Luiz
name: Dieci, Maria Vittoria
name: Mathieu, Marie-Christine
name: Rebelatto, Marlon C.
name: Piccart, Martine
name: Hanna, Matthew G.
name: Goetz, Matthew P.
name: Preusser, Matthias
name: Khojasteh, Mehrnoush
name: Sanders, Melinda E.
name: Regan, Meredith M.
name: Barnes, Michael
name: Christie, Michael
name: Misialek, Michael
name: Ignatiadis, Michail
name: Van Bockstal, Mieke
name: Castillo, Miluska
name: Amgad, Mohamed
name: Harbeck, Nadia
name: Tung, Nadine
name: Laudus, Nele
name: Sirtaine, Nicolas
name: Burchardi, Nicole
name: Ternes, Nils
name: Radosevic-Robin, Nina
name: Gluz, Oleg
name: Grimm, Oliver
name: Nuciforo, Paolo
name: Jank, Paul
name: Gonzalez-Ericsson, Paula
name: Kirtani, Pawan
name: Jelinic, Petar
name: Watson, Peter H.
name: Savas, Peter
name: Francis, Prudence A.
name: Russell, Prudence A.
name: Singh, Rajendra
name: Kim, Rim S.
name: Pierce, Robert H.
name: Hills, Robert
name: Leon-Ferre, Roberto
name: De Wind, Roland
name: Shui, Ruohong
name: De Clercq, Sabine
name: Leung, Sam
name: Tabbarah, Sami
name: Souza, Sandra C.
name: O’Toole, Sandra
name: Swain, Sandra
name: Dudgeon, Sarah
name: Willis, Scooter
name: Ely, Scott
name: Kim, Seong-Rim
name: Bedri, Shahinaz
name: Irshad, Sheeba
name: Liu, Shi-Wei
name: Goel, Shom
name: Hendry, Shona
name: Bianchi, Simonetta
name: Bragança, Sofia
name: Paik, Soonmyung
name: Wienert, Stephan
name: Fox, Stephen B.
name: Luen, Stephen J.
name: Naber, Stephen
name: Schnitt, Stuart J.
name: Sua, Luz F.
name: Lakhani, Sunil R.
name: Fineberg, Susan
name: Soler, Teresa
name: Gevaert, Thomas
name: D’Alfonso, Timothy
name: John, Tom
name: Sugie, Tomohagu
name: Kurkure, Uday
name: Bossuyt, Veerle
name: Manem, Venkata
name: Cámara, Vincente Peg
name: Tong, Weida
name: Chen, Weijie
name: Yang, Wentao
name: Tran, William T.
name: Wang, Yihong
name: Yuan, Yinyin
name: Allory, Yves
name: Husain, Zaheed
name: Bago-Horvath, Zsuzsanna
Publisher: name: Apollo - University of Cambridge Repository
Year: 2020
Subjects: Review Article
/631/67/1347
/692/53
/631/67/1857
/692/4028/67/580
review-article

description: Funder: Breast Cancer Research Foundation (BCRF); doi: https://doi.org/10.13039/100001006
description: Abstract: Stromal tumor-infiltrating lymphocytes (sTILs) are a potential predictive biomarker for immunotherapy response in metastatic triple-negative breast cancer (TNBC). To incorporate sTILs into clinical trials and diagnostics, reliable assessment is essential. In this review, we propose a new concept, namely the implementation of a risk-management framework that enables the use of sTILs as a stratification factor in clinical trials. We present the design of a biomarker risk-mitigation workflow that can be applied to any biomarker incorporation in clinical trials. We demonstrate the implementation of this concept using sTILs as an integral biomarker in a single-center phase II immunotherapy trial for metastatic TNBC (TONIC trial, NCT02499367), using this workflow to mitigate risks of suboptimal inclusion of sTILs in this specific trial. In this review, we demonstrate that a web-based scoring platform can mitigate potential risk factors when including sTILs in clinical trials, and we argue that this framework can be applied for any future biomarker-driven clinical trial setting.