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Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival
BACKGROUND: Patients treated with immune checkpoint inhibitors (ICIs) may experience pseudoprogression, which can be classified as progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1 and could lead to inappropriate treatment discontinuation. Immune-response criter...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8886415/ https://www.ncbi.nlm.nih.gov/pubmed/35228264 http://dx.doi.org/10.1136/jitc-2021-003302 |
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author | Manitz, Juliane D'Angelo, Sandra P Apolo, Andrea B Eggleton, S Peter Bajars, Marcis Bohnsack, Oliver Gulley, James L |
author_facet | Manitz, Juliane D'Angelo, Sandra P Apolo, Andrea B Eggleton, S Peter Bajars, Marcis Bohnsack, Oliver Gulley, James L |
author_sort | Manitz, Juliane |
collection | PubMed |
description | BACKGROUND: Patients treated with immune checkpoint inhibitors (ICIs) may experience pseudoprogression, which can be classified as progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1 and could lead to inappropriate treatment discontinuation. Immune-response criteria were developed to better capture novel response patterns seen with ICIs. METHODS: We pooled data from 1765 patients with 12 types of advanced solid tumors treated with avelumab (an anti-programmed death ligand 1 (PD-L1) monoclonal antibody) monotherapy in the JAVELIN Solid Tumor and JAVELIN Merkel 200 trials, conducted a comparative analysis of tumor assessments by investigators according to RECIST 1.1 and immune-related RECIST (irRECIST), and evaluated the correlation between progression-free survival (PFS) and overall survival (OS). RESULTS: In total, 147 patients (8.3%) had a best overall response (BOR) of PD by RECIST 1.1 but had immune-related disease control by irRECIST (defined as immune-related BOR (irBOR) of immune-related stable disease or better). This discordance was seen irrespective of PD-L1 status and observed across all tumor types. Overall, PFS and immune-related PFS showed similar imputed rank correlations with OS. CONCLUSIONS: The use of irRECIST identified a subset of patients with a BOR of PD by RECIST 1.1 but an irBOR of immune-related disease control by irRECIST with a distinctive survival curve, thereby providing more clinically relevant information than RECIST 1.1 alone. However, as a surrogate endpoint for OS in the whole population, immune-related PFS by irRECIST did not show improved predictive value compared with PFS by RECIST 1.1. |
format | Online Article Text |
id | pubmed-8886415 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-88864152022-03-17 Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival Manitz, Juliane D'Angelo, Sandra P Apolo, Andrea B Eggleton, S Peter Bajars, Marcis Bohnsack, Oliver Gulley, James L J Immunother Cancer Clinical/Translational Cancer Immunotherapy BACKGROUND: Patients treated with immune checkpoint inhibitors (ICIs) may experience pseudoprogression, which can be classified as progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1 and could lead to inappropriate treatment discontinuation. Immune-response criteria were developed to better capture novel response patterns seen with ICIs. METHODS: We pooled data from 1765 patients with 12 types of advanced solid tumors treated with avelumab (an anti-programmed death ligand 1 (PD-L1) monoclonal antibody) monotherapy in the JAVELIN Solid Tumor and JAVELIN Merkel 200 trials, conducted a comparative analysis of tumor assessments by investigators according to RECIST 1.1 and immune-related RECIST (irRECIST), and evaluated the correlation between progression-free survival (PFS) and overall survival (OS). RESULTS: In total, 147 patients (8.3%) had a best overall response (BOR) of PD by RECIST 1.1 but had immune-related disease control by irRECIST (defined as immune-related BOR (irBOR) of immune-related stable disease or better). This discordance was seen irrespective of PD-L1 status and observed across all tumor types. Overall, PFS and immune-related PFS showed similar imputed rank correlations with OS. CONCLUSIONS: The use of irRECIST identified a subset of patients with a BOR of PD by RECIST 1.1 but an irBOR of immune-related disease control by irRECIST with a distinctive survival curve, thereby providing more clinically relevant information than RECIST 1.1 alone. However, as a surrogate endpoint for OS in the whole population, immune-related PFS by irRECIST did not show improved predictive value compared with PFS by RECIST 1.1. BMJ Publishing Group 2022-02-28 /pmc/articles/PMC8886415/ /pubmed/35228264 http://dx.doi.org/10.1136/jitc-2021-003302 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Clinical/Translational Cancer Immunotherapy Manitz, Juliane D'Angelo, Sandra P Apolo, Andrea B Eggleton, S Peter Bajars, Marcis Bohnsack, Oliver Gulley, James L Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival |
title | Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival |
title_full | Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival |
title_fullStr | Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival |
title_full_unstemmed | Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival |
title_short | Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival |
title_sort | comparison of tumor assessments using recist 1.1 and irrecist, and association with overall survival |
topic | Clinical/Translational Cancer Immunotherapy |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8886415/ https://www.ncbi.nlm.nih.gov/pubmed/35228264 http://dx.doi.org/10.1136/jitc-2021-003302 |
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