Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials
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J Hudeček L Voorwerk M van Seijen I Nederlof M de Maaker J van den Berg KK van de Vijver K Sikorska S Adams S Demaria G Viale TO Nielsen SS Badve S Michiels WF Symmans C Sotiriou DL Rimm SM Hewitt C Denkert S Loibl S Loi JMS Bartlett G Pruneri DA Dillon MCU Cheang A Tutt JA Hall Z Kos R Salgado M Kok HM Horlings International Immuno-Oncology Biomarker Working Group A Hyytiäinen AI Hida A Thompson A Lefevre AJ Lazar A Gown A Lo A Sapino A Madabhushi A Moreira A Richardson A Vingiani AH Beck AM Bellizzi A Guerrero A Grigoriadis A Ehinger A Garrido-Castro A Vincent-Salomon AV Laenkholm A Sharma A Cimino-Mathews A Srinivasan B Acs B Singh B Calhoun B Haibe-Kans B Solomon B Thapa BH Nelson BD Gallas C Castaneda C Ballesteros-Merino C Criscitiello C Boeckx C Colpaert C Quinn CS Chennubhotla Charles Swanton C Solinas C Hiley D Drubay D Bethmann DA Moore D Larsimont D Sabanathan D Peeters D Zardavas D Höflmayer DB Johnson EA Thompson E Brogi E Perez EA ElGabry ES Stovgaard EF Blackley E Roblin E Reisenbichler E Bellolio E Balslev E Chmielik F Gaire F Andre FI Lu F Azmoudeh-Ardalan F Rojo T Gruosso F Ciompi F Peale Toggle all authors (101)
Abstract
© 2020, The Author(s). 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.
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Journal npj Breast Cancer
Volume 6
Issue number 1
Pages 15
Available online
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