TY - JOUR
T1 - Twenty Years On
T2 - RECIST as a Biomarker of Response in Solid Tumours an EORTC Imaging Group – ESOI Joint Paper
AU - Fournier, Laure
AU - de Geus-Oei, Lioe-Fee
AU - Regge, Daniele
AU - Oprea-Lager, Daniela-Elena
AU - D’Anastasi, Melvin
AU - Bidaut, Luc
AU - Bäuerle, Tobias
AU - Lopci, Egesta
AU - Cappello, Giovanni
AU - Lecouvet, Frederic
AU - Mayerhoefer, Marius
AU - Kunz, Wolfgang G.
AU - Verhoeff, Joost J. C.
AU - Caruso, Damiano
AU - Smits, Marion
AU - Hoffmann, Ralf-Thorsten
AU - Gourtsoyianni, Sofia
AU - Beets-Tan, Regina
AU - Neri, Emanuele
AU - deSouza, Nandita M.
AU - Deroose, Christophe M.
AU - Caramella, Caroline
N1 - Funding Information: We would like to thank the numerous colleagues for their insightful discussions and comments that have facilitated the work in this manuscript. Publisher Copyright: Copyright © 2022 Fournier, de Geus-Oei, Regge, Oprea-Lager, D’Anastasi, Bidaut, Bäuerle, Lopci, Cappello, Lecouvet, Mayerhoefer, Kunz, Verhoeff, Caruso, Smits, Hoffmann, Gourtsoyianni, Beets-Tan, Neri, deSouza, Deroose and Caramella.
PY - 2022/1/10
Y1 - 2022/1/10
N2 - Response evaluation criteria in solid tumours (RECIST) v1.1 are currently the reference standard for evaluating efficacy of therapies in patients with solid tumours who are included in clinical trials, and they are widely used and accepted by regulatory agencies. This expert statement discusses the principles underlying RECIST, as well as their reproducibility and limitations. While the RECIST framework may not be perfect, the scientific bases for the anticancer drugs that have been approved using a RECIST-based surrogate endpoint remain valid. Importantly, changes in measurement have to meet thresholds defined by RECIST for response classification within thus partly circumventing the problems of measurement variability. The RECIST framework also applies to clinical patients in individual settings even though the relationship between tumour size changes and outcome from cohort studies is not necessarily translatable to individual cases. As reproducibility of RECIST measurements is impacted by reader experience, choice of target lesions and detection/interpretation of new lesions, it can result in patients changing response categories when measurements are near threshold values or if new lesions are missed or incorrectly interpreted. There are several situations where RECIST will fail to evaluate treatment-induced changes correctly; knowledge and understanding of these is crucial for correct interpretation. Also, some patterns of response/progression cannot be correctly documented by RECIST, particularly in relation to organ-site (e.g. bone without associated soft-tissue lesion) and treatment type (e.g. focal therapies). These require specialist reader experience and communication with oncologists to determine the actual impact of the therapy and best evaluation strategy. In such situations, alternative imaging markers for tumour response may be used but the sources of variability of individual imaging techniques need to be known and accounted for. Communication between imaging experts and oncologists regarding the level of confidence in a biomarker is essential for the correct interpretation of a biomarker and its application to clinical decision-making. Though measurement automation is desirable and potentially reduces the variability of results, associated technical difficulties must be overcome, and human adjudications may be required.
AB - Response evaluation criteria in solid tumours (RECIST) v1.1 are currently the reference standard for evaluating efficacy of therapies in patients with solid tumours who are included in clinical trials, and they are widely used and accepted by regulatory agencies. This expert statement discusses the principles underlying RECIST, as well as their reproducibility and limitations. While the RECIST framework may not be perfect, the scientific bases for the anticancer drugs that have been approved using a RECIST-based surrogate endpoint remain valid. Importantly, changes in measurement have to meet thresholds defined by RECIST for response classification within thus partly circumventing the problems of measurement variability. The RECIST framework also applies to clinical patients in individual settings even though the relationship between tumour size changes and outcome from cohort studies is not necessarily translatable to individual cases. As reproducibility of RECIST measurements is impacted by reader experience, choice of target lesions and detection/interpretation of new lesions, it can result in patients changing response categories when measurements are near threshold values or if new lesions are missed or incorrectly interpreted. There are several situations where RECIST will fail to evaluate treatment-induced changes correctly; knowledge and understanding of these is crucial for correct interpretation. Also, some patterns of response/progression cannot be correctly documented by RECIST, particularly in relation to organ-site (e.g. bone without associated soft-tissue lesion) and treatment type (e.g. focal therapies). These require specialist reader experience and communication with oncologists to determine the actual impact of the therapy and best evaluation strategy. In such situations, alternative imaging markers for tumour response may be used but the sources of variability of individual imaging techniques need to be known and accounted for. Communication between imaging experts and oncologists regarding the level of confidence in a biomarker is essential for the correct interpretation of a biomarker and its application to clinical decision-making. Though measurement automation is desirable and potentially reduces the variability of results, associated technical difficulties must be overcome, and human adjudications may be required.
KW - RECIST
KW - biomarker
KW - imaging
KW - response
KW - tumour
UR - http://www.scopus.com/inward/record.url?scp=85123498555&partnerID=8YFLogxK
U2 - https://doi.org/10.3389/fonc.2021.800547
DO - https://doi.org/10.3389/fonc.2021.800547
M3 - Review article
C2 - 35083155
SN - 2234-943X
VL - 11
JO - Frontiers in Oncology
JF - Frontiers in Oncology
M1 - 800547
ER -