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Incorporating lesion-to-lesion heterogeneity into early oncology decision making
RECISTv1.1 (Response Evaluation Criteria In Solid Tumors) is the most commonly used response grading criteria in early oncology trials. In this perspective, we argue that RECISTv1.1 is ambiguous regarding lesion-to-lesion variation that can introduce bias in decision making. We show theoretical exam...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10282604/ https://www.ncbi.nlm.nih.gov/pubmed/37350966 http://dx.doi.org/10.3389/fimmu.2023.1173546 |
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author | Kumar, Rukmini Qi, Timothy Cao, Yanguang Topp, Brian |
author_facet | Kumar, Rukmini Qi, Timothy Cao, Yanguang Topp, Brian |
author_sort | Kumar, Rukmini |
collection | PubMed |
description | RECISTv1.1 (Response Evaluation Criteria In Solid Tumors) is the most commonly used response grading criteria in early oncology trials. In this perspective, we argue that RECISTv1.1 is ambiguous regarding lesion-to-lesion variation that can introduce bias in decision making. We show theoretical examples of how lesion-to-lesion variability causes bias in RECISTv1.1, leading to misclassification of patient response. Next, we review immune checkpoint inhibitor (ICI) clinical trial data and find that lesion-to-lesion heterogeneity is widespread in ICI-treated patients. We illustrate the implications of ignoring lesion-to-lesion heterogeneity in interpreting biomarker data, selecting treatments for patients with progressive disease, and go/no-go decisions in drug development. Further, we propose that Quantitative Systems Pharmacology (QSP) models can aid in developing better metrics of patient response and treatment efficacy by capturing patient responses robustly by considering lesion-to-lesion heterogeneity. Overall, we believe patient response evaluation with an appreciation of lesion-to-lesion heterogeneity can potentially improve decision-making at the early stage of oncology drug development and benefit patient care. |
format | Online Article Text |
id | pubmed-10282604 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-102826042023-06-22 Incorporating lesion-to-lesion heterogeneity into early oncology decision making Kumar, Rukmini Qi, Timothy Cao, Yanguang Topp, Brian Front Immunol Immunology RECISTv1.1 (Response Evaluation Criteria In Solid Tumors) is the most commonly used response grading criteria in early oncology trials. In this perspective, we argue that RECISTv1.1 is ambiguous regarding lesion-to-lesion variation that can introduce bias in decision making. We show theoretical examples of how lesion-to-lesion variability causes bias in RECISTv1.1, leading to misclassification of patient response. Next, we review immune checkpoint inhibitor (ICI) clinical trial data and find that lesion-to-lesion heterogeneity is widespread in ICI-treated patients. We illustrate the implications of ignoring lesion-to-lesion heterogeneity in interpreting biomarker data, selecting treatments for patients with progressive disease, and go/no-go decisions in drug development. Further, we propose that Quantitative Systems Pharmacology (QSP) models can aid in developing better metrics of patient response and treatment efficacy by capturing patient responses robustly by considering lesion-to-lesion heterogeneity. Overall, we believe patient response evaluation with an appreciation of lesion-to-lesion heterogeneity can potentially improve decision-making at the early stage of oncology drug development and benefit patient care. Frontiers Media S.A. 2023-06-07 /pmc/articles/PMC10282604/ /pubmed/37350966 http://dx.doi.org/10.3389/fimmu.2023.1173546 Text en Copyright © 2023 Kumar, Qi, Cao and Topp https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Immunology Kumar, Rukmini Qi, Timothy Cao, Yanguang Topp, Brian Incorporating lesion-to-lesion heterogeneity into early oncology decision making |
title | Incorporating lesion-to-lesion heterogeneity into early oncology decision making |
title_full | Incorporating lesion-to-lesion heterogeneity into early oncology decision making |
title_fullStr | Incorporating lesion-to-lesion heterogeneity into early oncology decision making |
title_full_unstemmed | Incorporating lesion-to-lesion heterogeneity into early oncology decision making |
title_short | Incorporating lesion-to-lesion heterogeneity into early oncology decision making |
title_sort | incorporating lesion-to-lesion heterogeneity into early oncology decision making |
topic | Immunology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10282604/ https://www.ncbi.nlm.nih.gov/pubmed/37350966 http://dx.doi.org/10.3389/fimmu.2023.1173546 |
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