TY - JOUR
T1 - How Does Target Lesion Selection Affect RECIST?
T2 - A Computer Simulation Study
AU - Tareco Bucho, Teresa M
AU - Tissier, Renaud L M
AU - Groot Lipman, Kevin B W
AU - Bodalal, Zuhir
AU - Delli Pizzi, Andrea
AU - Nguyen-Kim, Thi Dan Linh
AU - Beets-Tan, Regina G H
AU - Trebeschi, Stefano
N1 - Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.
PY - 2024/6/1
Y1 - 2024/6/1
N2 - OBJECTIVES: Response Evaluation Criteria in Solid Tumors (RECIST) is grounded on the assumption that target lesion selection is objective and representative of the change in total tumor burden (TTB) during therapy. A computer simulation model was designed to challenge this assumption, focusing on a particular aspect of subjectivity: target lesion selection.MATERIALS AND METHODS: Disagreement among readers and the disagreement between individual reader measurements and TTB were analyzed as a function of the total number of lesions, affected organs, and lesion growth.RESULTS: Disagreement rises when the number of lesions increases, when lesions are concentrated on a few organs, and when lesion growth borders the thresholds of progressive disease and partial response. There is an intrinsic methodological error in the estimation of TTB via RECIST 1.1, which depends on the number of lesions and their distributions. For example, for a fixed number of lesions at 5 and 15, distributed over a maximum of 4 organs, the error rates are observed to be 7.8% and 17.3%, respectively.CONCLUSIONS: Our results demonstrate that RECIST can deliver an accurate estimate of TTB in localized disease, but fails in cases of distal metastases and multiple organ involvement. This is worsened by the "selection of the largest lesions," which introduces a bias that makes it hardly possible to perform an accurate estimate of the TTB. Including more (if not all) lesions in the quantitative analysis of tumor burden is desirable.
AB - OBJECTIVES: Response Evaluation Criteria in Solid Tumors (RECIST) is grounded on the assumption that target lesion selection is objective and representative of the change in total tumor burden (TTB) during therapy. A computer simulation model was designed to challenge this assumption, focusing on a particular aspect of subjectivity: target lesion selection.MATERIALS AND METHODS: Disagreement among readers and the disagreement between individual reader measurements and TTB were analyzed as a function of the total number of lesions, affected organs, and lesion growth.RESULTS: Disagreement rises when the number of lesions increases, when lesions are concentrated on a few organs, and when lesion growth borders the thresholds of progressive disease and partial response. There is an intrinsic methodological error in the estimation of TTB via RECIST 1.1, which depends on the number of lesions and their distributions. For example, for a fixed number of lesions at 5 and 15, distributed over a maximum of 4 organs, the error rates are observed to be 7.8% and 17.3%, respectively.CONCLUSIONS: Our results demonstrate that RECIST can deliver an accurate estimate of TTB in localized disease, but fails in cases of distal metastases and multiple organ involvement. This is worsened by the "selection of the largest lesions," which introduces a bias that makes it hardly possible to perform an accurate estimate of the TTB. Including more (if not all) lesions in the quantitative analysis of tumor burden is desirable.
KW - RECIST
KW - cancer imaging
KW - reader variability
KW - simulation
KW - Reproducibility of Results
KW - Computer Simulation
KW - Humans
KW - Sensitivity and Specificity
KW - Response Evaluation Criteria in Solid Tumors
KW - Tumor Burden
KW - Neoplasms/diagnostic imaging
KW - Observer Variation
U2 - 10.1097/RLI.0000000000001045
DO - 10.1097/RLI.0000000000001045
M3 - Journal article
C2 - 37921780
SN - 0020-9996
VL - 59
SP - 465
EP - 471
JO - Investigative Radiology
JF - Investigative Radiology
IS - 6
ER -