Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials
Journal
npj Breast Cancer
Journal Volume
6
Journal Issue
1
Date Issued
2020
Author(s)
Hudeček J.
Voorwerk L.
van Seijen M.
Nederlof I.
de Maaker M.
van den Berg J.
van de Vijver K.K.
Sikorska K.
Adams S.
Demaria S.
Viale G.
Hirsch F.R.
Klauschen F.
Penault-Llorca F.
Acosta Haab G.
Farshid G.
van den Eynden G.
Curigliano G.
Floris G.
Broeckx G.
Gonzalez-Ericsson, Koeppen H.
Nielsen T.O.
Haynes H.R.
McArthur H.
Joensuu H.
Olofsson H.
Cree I.
Frahm I.
Brcic I.
Chan J.
Badve S.S.
Ziai J.
Brock J.
Wesseling J.
Giltnane J.
Kerner J.K.
Thagaard J.
Braybrooke J.P.
van der Laak J.A.W.M.
Lemonnier J.
Zha J.
Michiels S.
Ribeiro J.
Lennerz J.K.
Carter J.M.
Saltz J.
Hartman J.
Hainfellner J.
Quesne J.L.
Juco J.W.
Reis-Filho J.
Sanchez J.
Symmans W.F.
Sparano J.
Cucherousset J.
Araya J.C.
Adam J.
Balko J.M.
Saeger K.
Siziopikou K.
Willard-Gallo K.
Weber K.
Pogue-Geile K.L.
Sotiriou C.
Steele K.E.
Emancipator K.
AbdulJabbar K.
El Bairi K.
Blenman K.R.M.
Allison K.H.
Korski K.
Pusztai L.
Comerma L.
Buisseret L.
Rimm D.L.
Cooper L.A.D.
Shi L.
Kooreman L.F.S.
Molinero L.
Estrada M.V.
Lacroix-Triki M.
Al Bakir M.
Sebastian M.M.
van de Vijver M.
Balancin M.L.
Hewitt S.M.
Dieci M.V.
Mathieu M.-C.
Rebelatto M.C.
Piccart M.
Hanna M.G.
Goetz M.P.
Preusser M.
Khojasteh M.
Sanders M.E.
Regan M.M.
Denkert C.
Barnes M.
Christie M.
Misialek M.
Ignatiadis M.
van Bockstal M.
Castillo M.
Amgad M.
Harbeck N.
Tung N.
Laudus N.
Loibl S.
Sirtaine N.
Burchardi N.
Ternes N.
Radosevic-Robin N.
Gluz O.
Grimm O.
Nuciforo P.
Jank P.
Gonzalez-Ericsson P.
Kirtani P.
Loi S.
Jelinic P.
Watson P.H.
Savas P.
Francis P.A.
Russell P.A.
Singh R.
Kim R.S.
Pierce R.H.
Hills R.
Leon-Ferre R.
Bartlett J.M.S.
de Wind R.
Shui R.
De Clercq S.
Leung S.
Tabbarah S.
Souza S.C.
O’Toole S.
Swain S.
Dudgeon S.
Willis S.
Pruneri G.
Ely S.
Kim S.-R.
Bedri S.
Irshad S.
Liu S.-W.
Goel S.
Hendry S.
Bianchi S.
Bragança S.
Paik S.
Dillon D.A.
Wienert S.
Fox S.B.
Luen S.J.
Naber S.
Schnitt S.J.
Sua L.F.
Lakhani S.R.
Fineberg S.
Soler T.
Gevaert T.
Cheang M.C.U.
D’Alfonso T.
John T.
Sugie T.
Kurkure U.
Bossuyt V.
Manem V.
Cámara V.P.
Tong W.
Chen W.
Yang W.
Tutt A.
Tran W.T.
Wang Y.
Yuan Y.
Allory Y.
Husain Z.
Bago-Horvath Z.
International Immuno-Oncology Biomarker Working Group
Hall J.A.
Kos Z.
Salgado R.
Kok M.
Horlings H.M.
Hyytiäinen A.
Hida A.I.
Thompson A.
Lefevre A.
Lazar A.J.
Gown A.
Lo A.
Sapino A.
Madabhushi A.
Moreira A.
Richardson A.
Vingiani A.
Beck A.H.
Bellizzi A.M.
Guerrero A.
Grigoriadis A.
Ehinger A.
Garrido-Castro A.
Vincent-Salomon A.
Laenkholm A.-V.
Sharma A.
Cimino-Mathews A.
Srinivasan A.
Acs B.
Singh B.
Calhoun B.
Haibe-Kans B.
Solomon B.
Thapa B.
Nelson B.H.
Gallas B.D.
Castaneda C.
Ballesteros-Merino C.
Criscitiello C.
Boeckx C.
Colpaert C.
Quinn C.
Chennubhotla C.S.
Swanton C.
Solinas C.
Hiley C.
Drubay D.
Bethmann D.
Moore D.A.
Larsimont D.
Sabanathan D.
Peeters D.
Zardavas D.
Höflmayer D.
Johnson D.B.
Thompson E.A.
Brogi E.
Perez E.
ElGabry E.A.
Stovgaard E.S.
Blackley E.F.
Roblin E.
Reisenbichler E.
Bellolio E.
Balslev E.
Chmielik E.
Gaire F.
Andre F.
Lu F.-I.
Azmoudeh-Ardalan F.
Rojo F.
Gruosso T.
Ciompi F.
Peale F.
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. ? 2020, The Author(s).
SDGs
Other Subjects
biological marker; cisplatin; cyclophosphamide; doxorubicin; nivolumab; biobank; biopsy; cancer immunotherapy; clinical practice; clinical research; human; immune response; integration; monotherapy; patient safety; patient selection; phase 2 clinical trial (topic); phase 3 clinical trial (topic); practice guideline; predictive value; priority journal; Review; risk factor; risk management; tissue microarray; triple negative breast cancer; tumor associated leukocyte; workflow
Publisher
Nature Research
Type
review