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dc.contributor.authorHudeček, Jan
dc.contributor.authorVoorwerk, Leonie
dc.contributor.authorvan Seijen, Maartje
dc.contributor.authorNederlof, Iris
dc.contributor.authorde Maaker, Michiel
dc.contributor.authorvan den Berg, Jose
dc.contributor.authorvan de Vijver, Koen K.
dc.contributor.authorSikorska, Karolina
dc.contributor.authorAdams, Sylvia
dc.contributor.authorDemaria, Sandra
dc.contributor.authorViale, Giuseppe
dc.contributor.authorNielsen, Torsten O.
dc.contributor.authorBadve, Sunil S.
dc.contributor.authorMichiels, Stefan
dc.contributor.authorSymmans, William Fraser
dc.contributor.authorSotiriou, Christos
dc.contributor.authorRimm, David L.
dc.contributor.authorHewitt, Stephen M.
dc.contributor.authorDenkert, Carsten
dc.contributor.authorLoibl, Sibylle
dc.contributor.authorLoi, Sherene
dc.contributor.authorBartlett, John M. S.
dc.contributor.authorPruneri, Giancarlo
dc.contributor.authorDillon, Deborah A.
dc.contributor.authorCheang, Maggie C. U.
dc.contributor.authorTutt, Andrew
dc.contributor.authorHall, Jacqueline A.
dc.contributor.authorKos, Zuzana
dc.contributor.authorSalgado, Roberto
dc.contributor.authorKok, Marleen
dc.contributor.authorHorlings, Hugo M.
dc.contributor.authorHyytiäinen, Aini
dc.contributor.authorHida, Akira I.
dc.contributor.authorThompson, Alastair
dc.contributor.authorLefevre, Alex
dc.contributor.authorLazar, Alexander J.
dc.contributor.authorGown, Allen
dc.contributor.authorLo, Amy
dc.contributor.authorSapino, Anna
dc.contributor.authorMadabhushi, Anant
dc.contributor.authorMoreira, Andre
dc.contributor.authorRichardson, Andrea
dc.contributor.authorVingiani, Andrea
dc.contributor.authorBeck, Andrew H.
dc.contributor.authorBellizzi, Andrew M.
dc.contributor.authorGuerrero, Angel
dc.contributor.authorGrigoriadis, Anita
dc.contributor.authorEhinger, Anna
dc.contributor.authorGarrido-Castro, Ana
dc.contributor.authorVincent-Salomon, Anne
dc.contributor.authorLaenkholm, Anne-Vibeke
dc.contributor.authorSharma, Ashish
dc.contributor.authorCimino-Mathews, Ashley
dc.contributor.authorSrinivasan, Ashok
dc.contributor.authorAcs, Balazs
dc.contributor.authorSingh, Baljit
dc.contributor.authorCalhoun, Benjamin
dc.contributor.authorHaibe-Kans, Benjamin
dc.contributor.authorSolomon, Benjamin
dc.contributor.authorThapa, Bibhusal
dc.contributor.authorNelson, Brad H.
dc.contributor.authorGallas, Brandon D.
dc.contributor.authorCastaneda, Carlos
dc.contributor.authorBallesteros-Merino, Carmen
dc.contributor.authorCriscitiello, Carmen
dc.contributor.authorBoeckx, Carolien
dc.contributor.authorColpaert, Cecile
dc.contributor.authorQuinn, Cecily
dc.contributor.authorChennubhotla, Chakra S.
dc.contributor.authorSwanton, Charles
dc.contributor.authorSolinas, Cinzia
dc.contributor.authorHiley, Crispin
dc.contributor.authorDrubay, Damien
dc.contributor.authorBethmann, Daniel
dc.contributor.authorMoore, David A.
dc.contributor.authorLarsimont, Denis
dc.contributor.authorSabanathan, Dhanusha
dc.contributor.authorPeeters, Dieter
dc.contributor.authorZardavas, Dimitrios
dc.contributor.authorHöflmayer, Doris
dc.contributor.authorJohnson, Douglas B.
dc.contributor.authorThompson, E. Aubrey
dc.contributor.authorBrogi, Edi
dc.contributor.authorPerez, Edith
dc.contributor.authorElGabry, Ehab A.
dc.contributor.authorStovgaard, Elisabeth Specht
dc.contributor.authorBlackley, Elizabeth F.
dc.contributor.authorRoblin, Elvire
dc.contributor.authorReisenbichler, Emily
dc.contributor.authorBellolio, Enrique
dc.contributor.authorBalslev, Eva
dc.contributor.authorChmielik, Ewa
dc.contributor.authorGaire, Fabien
dc.contributor.authorAndre, Fabrice
dc.contributor.authorLu, Fang-I
dc.contributor.authorAzmoudeh-Ardalan, Farid
dc.contributor.authorRojo, Federico
dc.contributor.authorGruosso, Tina
dc.contributor.authorCiompi, Francesco
dc.contributor.authorPeale, Franklin
dc.contributor.authorHirsch, Fred R.
dc.contributor.authorKlauschen, Frederick
dc.contributor.authorPenault-Llorca, Frédérique
dc.contributor.authorAcosta Haab, Gabriela
dc.contributor.authorFarshid, Gelareh
dc.contributor.authorvan den Eynden, Gert
dc.contributor.authorCurigliano, Giuseppe
dc.contributor.authorFloris, Giuseppe
dc.contributor.authorBroeckx, Glenn
dc.contributor.authorGonzalez-Ericsson
dc.contributor.authorKoeppen, Harmut
dc.contributor.authorHaynes, Harry R.
dc.contributor.authorMcArthur, Heather
dc.contributor.authorJoensuu, Heikki
dc.contributor.authorOlofsson, Helena
dc.contributor.authorLien, Huang-Chun
dc.contributor.authorChen, I-Chun
dc.contributor.authorCree, Ian
dc.contributor.authorFrahm, Isabel
dc.contributor.authorBrcic, Iva
dc.contributor.authorChan, Jack
dc.contributor.authorZiai, James
dc.contributor.authorBrock, Jane
dc.contributor.authorWesseling, Jelle
dc.contributor.authorGiltnane, Jennifer
dc.contributor.authorKerner, Jennifer K.
dc.contributor.authorThagaard, Jeppe
dc.contributor.authorBraybrooke, Jeremy P.
dc.contributor.authorvan der Laak, Jeroen A. W. M.
dc.contributor.authorLemonnier, Jerome
dc.contributor.authorZha, Jiping
dc.contributor.authorRibeiro, Joana
dc.contributor.authorLennerz, Jochen K.
dc.contributor.authorCarter, Jodi M.
dc.contributor.authorSaltz, Joel
dc.contributor.authorHartman, Johan
dc.contributor.authorHainfellner, Johannes
dc.contributor.authorQuesne, John Le
dc.contributor.authorJuco, Jonathon W.
dc.contributor.authorReis-Filho, Jorge
dc.contributor.authorSanchez, Joselyn
dc.contributor.authorSparano, Joseph
dc.contributor.authorCucherousset, Joël
dc.contributor.authorAraya, Juan Carlos
dc.contributor.authorAdam, Julien
dc.contributor.authorBalko, Justin M.
dc.contributor.authorSaeger, Kai
dc.contributor.authorSiziopikou, Kalliopi
dc.contributor.authorWillard-Gallo, Karen
dc.contributor.authorWeber, Karsten
dc.contributor.authorPogue-Geile, Katherine L.
dc.contributor.authorSteele, Keith E.
dc.contributor.authorEmancipator, Kenneth
dc.contributor.authorAbdulJabbar, Khalid
dc.contributor.authorEl Bairi, Khalid
dc.contributor.authorBlenman, Kim R. M.
dc.contributor.authorAllison, Kimberly H.
dc.contributor.authorKorski, Konstanty
dc.contributor.authorPusztai, Lajos
dc.contributor.authorComerma, Laura
dc.contributor.authorBuisseret, Laurence
dc.contributor.authorCooper, Lee A. D.
dc.contributor.authorShi, Leming
dc.contributor.authorKooreman, Loes F. S.
dc.contributor.authorMolinero, Luciana
dc.contributor.authorEstrada, M. Valeria
dc.contributor.authorLacroix-Triki, Magali
dc.contributor.authorAl Bakir, Maise
dc.contributor.authorSebastian, Manu M.
dc.contributor.authorvan de Vijver, Marc
dc.contributor.authorBalancin, Marcelo Luiz
dc.contributor.authorDieci, Maria Vittoria
dc.contributor.authorMathieu, Marie-Christine
dc.contributor.authorRebelatto, Marlon C.
dc.contributor.authorPiccart, Martine
dc.contributor.authorHanna, Matthew G.
dc.contributor.authorGoetz, Matthew P.
dc.contributor.authorPreusser, Matthias
dc.contributor.authorKhojasteh, Mehrnoush
dc.contributor.authorSanders, Melinda E.
dc.contributor.authorRegan, Meredith M.
dc.contributor.authorBarnes, Michael
dc.contributor.authorChristie, Michael
dc.contributor.authorMisialek, Michael
dc.contributor.authorIgnatiadis, Michail
dc.contributor.authorvan Bockstal, Mieke
dc.contributor.authorCastillo, Miluska
dc.contributor.authorAmgad, Mohamed
dc.contributor.authorHarbeck, Nadia
dc.contributor.authorTung, Nadine
dc.contributor.authorLaudus, Nele
dc.contributor.authorSirtaine, Nicolas
dc.contributor.authorBurchardi, Nicole
dc.contributor.authorTernes, Nils
dc.contributor.authorRadosevic-Robin, Nina
dc.contributor.authorGluz, Oleg
dc.contributor.authorGrimm, Oliver
dc.contributor.authorNuciforo, Paolo
dc.contributor.authorJank, Paul
dc.contributor.authorGonzalez-Ericsson, Paula
dc.contributor.authorKirtani, Pawan
dc.contributor.authorJelinic, Petar
dc.contributor.authorWatson, Peter H.
dc.contributor.authorSavas, Peter
dc.contributor.authorFrancis, Prudence A.
dc.contributor.authorRussell, Prudence A.
dc.contributor.authorSingh, Rajendra
dc.contributor.authorKim, Rim S.
dc.contributor.authorPierce, Robert H.
dc.contributor.authorHills, Robert
dc.contributor.authorLeon-Ferre, Roberto
dc.contributor.authorde Wind, Roland
dc.contributor.authorShui, Ruohong
dc.contributor.authorDe Clercq, Sabine
dc.contributor.authorLeung, Sam
dc.contributor.authorTabbarah, Sami
dc.contributor.authorSouza, Sandra C.
dc.contributor.authorO’Toole, Sandra
dc.contributor.authorSwain, Sandra
dc.contributor.authorDudgeon, Sarah
dc.contributor.authorWillis, Scooter
dc.contributor.authorEly, Scott
dc.contributor.authorKim, Seong-Rim
dc.contributor.authorBedri, Shahinaz
dc.contributor.authorIrshad, Sheeba
dc.contributor.authorLiu, Shi-Wei
dc.contributor.authorGoel, Shom
dc.contributor.authorHendry, Shona
dc.contributor.authorBianchi, Simonetta
dc.contributor.authorBragança, Sofia
dc.contributor.authorPaik, Soonmyung
dc.contributor.authorWienert, Stephan
dc.contributor.authorFox, Stephen B.
dc.contributor.authorLuen, Stephen J.
dc.contributor.authorNaber, Stephen
dc.contributor.authorSchnitt, Stuart J.
dc.contributor.authorSua, Luz F.
dc.contributor.authorLakhani, Sunil R.
dc.contributor.authorFineberg, Susan
dc.contributor.authorSoler, Teresa
dc.contributor.authorGevaert, Thomas
dc.contributor.authorD’Alfonso, Timothy
dc.contributor.authorJohn, Tom
dc.contributor.authorSugie, Tomohagu
dc.contributor.authorKurkure, Uday
dc.contributor.authorBossuyt, Veerle
dc.contributor.authorManem, Venkata
dc.contributor.authorCámara, Vincente Peg
dc.contributor.authorTong, Weida
dc.contributor.authorChen, Weijie
dc.contributor.authorYang, Wentao
dc.contributor.authorTran, William T.
dc.contributor.authorWang, Yihong
dc.contributor.authorYuan, Yinyin
dc.contributor.authorAllory, Yves
dc.contributor.authorHusain, Zaheed
dc.contributor.authorBago-Horvath, Zsuzsanna
dc.date.accessioned2021-02-12T17:30:22Z
dc.date.available2021-02-12T17:30:22Z
dc.date.issued2020-05-12
dc.date.submitted2019-07-16
dc.identifier.others41523-020-0155-1
dc.identifier.other155
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/317559
dc.descriptionFunder: Breast Cancer Research Foundation (BCRF); doi: https://doi.org/10.13039/100001006
dc.description.abstractAbstract: 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.
dc.languageen
dc.publisherNature Publishing Group UK
dc.rightsAttribution 4.0 International (CC BY 4.0)en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/en
dc.subjectReview Article
dc.subject/631/67/1347
dc.subject/692/53
dc.subject/631/67/1857
dc.subject/692/4028/67/580
dc.subjectreview-article
dc.titleApplication of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials
dc.typeArticle
dc.date.updated2021-02-12T17:30:21Z
prism.issueIdentifier1
prism.publicationNamenpj Breast Cancer
prism.volume6
dc.identifier.doi10.17863/CAM.64672
dcterms.dateAccepted2020-02-18
rioxxterms.versionofrecord10.1038/s41523-020-0155-1
rioxxterms.versionVoR
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by/4.0/
dc.contributor.orcidHudeček, Jan [0000-0003-1071-5686]
dc.contributor.orcidvan de Vijver, Koen K. [0000-0002-2026-9790]
dc.contributor.orcidDemaria, Sandra [0000-0003-4426-0499]
dc.contributor.orcidBadve, Sunil S. [0000-0001-8861-9980]
dc.contributor.orcidSymmans, William Fraser [0000-0002-1526-184X]
dc.contributor.orcidRimm, David L. [0000-0001-5820-4397]
dc.contributor.orcidLoi, Sherene [0000-0001-6137-9171]
dc.contributor.orcidHall, Jacqueline A. [0000-0003-0708-1360]
dc.contributor.orcidHorlings, Hugo M. [0000-0003-4782-8828]
dc.identifier.eissn2374-4677


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Attribution 4.0 International (CC BY 4.0)
Except where otherwise noted, this item's licence is described as Attribution 4.0 International (CC BY 4.0)