Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials

Autor: Hudeček, Jan, Voorwerk, Leonie, Van Seijen, Maartje, Nederlof, Iris, De Maaker, Michiel, Van Den Berg, Jose, Van De Vijver, Koen K., Sikorska, Karolina, Adams, Sylvia, Demaria, Sandra, Viale, Giuseppe, Nielsen, Torsten O., Badve, Sunil S., Michiels, Stefan, Symmans, William Fraser, Sotiriou, Christos, Rimm, David L., Hewitt, Stephen M., Denkert, Carsten, Loibl, Sibylle, Loi, Sherene, Bartlett, John M. S., Pruneri, Giancarlo, Dillon, Deborah A., Cheang, Maggie C. U., Tutt, Andrew, Hall, Jacqueline A., Kos, Zuzana, Salgado, Roberto, Kok, Marleen, Horlings, Hugo M., Hyytiäinen, Aini, Hida, Akira I., Thompson, Alastair, Lefevre, Alex, Lazar, Alexander J., Gown, Allen, Lo, Amy, Sapino, Anna, Madabhushi, Anant, Moreira, Andre, Richardson, Andrea, Vingiani, Andrea, Beck, Andrew H., Bellizzi, Andrew M., Guerrero, Angel, Grigoriadis, Anita, Ehinger, Anna, Garrido-Castro, Ana, Vincent-Salomon, Anne, Laenkholm, Anne-Vibeke, Sharma, Ashish, Cimino-Mathews, Ashley, Srinivasan, Ashok, Acs, Balazs, Singh, Baljit, Calhoun, Benjamin, Haibe-Kans, Benjamin, Solomon, Benjamin, Thapa, Bibhusal, Nelson, Brad H., Gallas, Brandon D., Castaneda, Carlos, Ballesteros-Merino, Carmen, Criscitiello, Carmen, Boeckx, Carolien, Colpaert, Cecile, Quinn, Cecily, Chennubhotla, Chakra S., Swanton, Charles, Solinas, Cinzia, Hiley, Crispin, Drubay, Damien, Bethmann, Daniel, Moore, David A., Larsimont, Denis, Sabanathan, Dhanusha, Peeters, Dieter, Zardavas, Dimitrios, Höflmayer, Doris, Johnson, Douglas B., Thompson, E. Aubrey, Brogi, Edi, Perez, Edith, ElGabry, Ehab A., Stovgaard, Elisabeth Specht, Blackley, Elizabeth F., Roblin, Elvire, Reisenbichler, Emily, Bellolio, Enrique, Balslev, Eva, Chmielik, Ewa, Gaire, Fabien, Andre, Fabrice, Lu, Fang-I, Azmoudeh-Ardalan, Farid, Rojo, Federico, Gruosso, Tina, Ciompi, Francesco, Peale, Franklin, Hirsch, Fred R., Klauschen, Frederick, Penault-Llorca, Frédérique, Acosta Haab, Gabriela, Farshid, Gelareh, Van Den Eynden, Gert, Curigliano, Giuseppe, Floris, Giuseppe, Broeckx, Glenn, Gonzalez-Ericsson, Koeppen, Harmut, Haynes, Harry R., McArthur, Heather, Joensuu, Heikki, Olofsson, Helena, Lien, Huang-Chun, Chen, I-Chun, Cree, Ian, Frahm, Isabel, Brcic, Iva, Chan, Jack, Ziai, James, Brock, Jane, Wesseling, Jelle, Giltnane, Jennifer, Kerner, Jennifer K., Thagaard, Jeppe, Braybrooke, Jeremy P., Van Der Laak, Jeroen A. W. M., Lemonnier, Jerome, Zha, Jiping, Ribeiro, Joana, Lennerz, Jochen K., Carter, Jodi M., Saltz, Joel, Hartman, Johan, Hainfellner, Johannes, Quesne, John Le, Juco, Jonathon W., Reis-Filho, Jorge, Sanchez, Joselyn, Sparano, Joseph, Cucherousset, Joël, Araya, Juan Carlos, Adam, Julien, Balko, Justin M., Saeger, Kai, Siziopikou, Kalliopi, Willard-Gallo, Karen, Weber, Karsten, Pogue-Geile, Katherine L., Steele, Keith E., Emancipator, Kenneth, AbdulJabbar, Khalid, El Bairi, Khalid, Blenman, Kim R. M., Allison, Kimberly H., Korski, Konstanty, Pusztai, Lajos, Comerma, Laura, Buisseret, Laurence, Cooper, Lee A. D., Shi, Leming, Kooreman, Loes F. S., Molinero, Luciana, Estrada, M. Valeria, Lacroix-Triki, Magali, Al Bakir, Maise, Sebastian, Manu M., Van De Vijver, Marc, Balancin, Marcelo Luiz, Dieci, Maria Vittoria, Mathieu, Marie-Christine, Rebelatto, Marlon C., Piccart, Martine, Hanna, Matthew G., Goetz, Matthew P., Preusser, Matthias, Khojasteh, Mehrnoush, Sanders, Melinda E., Regan, Meredith M., Barnes, Michael, Christie, Michael, Misialek, Michael, Ignatiadis, Michail, Van Bockstal, Mieke, Castillo, Miluska, Amgad, Mohamed, Harbeck, Nadia, Tung, Nadine, Laudus, Nele, Sirtaine, Nicolas, Burchardi, Nicole, Ternes, Nils, Radosevic-Robin, Nina, Gluz, Oleg, Grimm, Oliver, Nuciforo, Paolo, Jank, Paul, Gonzalez-Ericsson, Paula, Kirtani, Pawan, Jelinic, Petar, Watson, Peter H., Savas, Peter, Francis, Prudence A., Russell, Prudence A., Singh, Rajendra, Kim, Rim S., Pierce, Robert H., Hills, Robert, Leon-Ferre, Roberto, De Wind, Roland, Shui, Ruohong, De Clercq, Sabine, Leung, Sam, Tabbarah, Sami, Souza, Sandra C., O’Toole, Sandra, Swain, Sandra, Dudgeon, Sarah, Willis, Scooter, Ely, Scott, Kim, Seong-Rim, Bedri, Shahinaz, Irshad, Sheeba, Liu, Shi-Wei, Goel, Shom, Hendry, Shona, Bianchi, Simonetta, Bragança, Sofia, Paik, Soonmyung, Wienert, Stephan, Fox, Stephen B., Luen, Stephen J., Naber, Stephen, Schnitt, Stuart J., Sua, Luz F., Lakhani, Sunil R., Fineberg, Susan, Soler, Teresa, Gevaert, Thomas, D’Alfonso, Timothy, John, Tom, Sugie, Tomohagu, Kurkure, Uday, Bossuyt, Veerle, Manem, Venkata, Cámara, Vincente Peg, Tong, Weida, Chen, Weijie, Yang, Wentao, Tran, William T., Wang, Yihong, Yuan, Yinyin, Allory, Yves, Husain, Zaheed, Bago-Horvath, Zsuzsanna
Předmět:
ISSN: 1000-0100
Popis: Funder: Breast Cancer Research Foundation (BCRF); doi: https://doi.org/10.13039/100001006
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.
Databáze: OpenAIRE