Cited by 2,472Cancer Immunotherapy and BiomarkersMedical Imaging Techniques and ApplicationsStatistical Methods in Clinical Trials

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iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics

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Seymour, Lesley, Bogaerts, Jan, Perrone, Andrea, Ford, Robert, Schwartz, Lawrence H, Mandrekar, Sumithra, Lin, Nancy U, Litière, Saskia, Dancey, Janet, Chen, Alice, Hodi, F Stephen, Therasse, Patrick, Hoekstra, Otto S, Shankar, Lalitha K, Wolchok, Jedd D, Ballinger, Marcus, Caramella, Caroline, de Vries, Elisabeth G E·2017·The Lancet Oncology

DOI 10.1016/s1470-2045(17)30074-8PMC PMC5648544

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Abstract

Tumours respond differently to immunotherapies compared with chemotherapeutic drugs, raising questions about the assessment of changes in tumour burden-a mainstay of evaluation of cancer therapeutics that provides key information about objective response and disease progression. A consensus guideline-iRECIST-was developed by the RECIST working group for the use of modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) in cancer immunotherapy trials, to ensure consistent design and data collection, facilitate the ongoing collection of trial data, and ultimate validation of the guideline. This guideline describes a standard approach to solid tumour measurements and definitions for objective change in tumour size for use in trials in which an immunotherapy is used. Additionally, it defines the minimum datapoints required from future trials and those currently in development to facilitate the compilation of a data warehouse to use to later validate iRECIST. An unprecedented number of trials have been done, initiated, or are planned to test new immune modulators for cancer therapy using a variety of modified response criteria. This guideline will allow consistent conduct, interpretation, and analysis of trials of immunotherapies.

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PET/MRI Improves Management of Children with Cancer
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Pseudoprogression in lung cancer patients treated with immunotherapy
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Comparison of tumor assessments using RECIST 1.1 and irRECIST, and association with overall survival
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Immunotherapy: Recent Advances and Its Future as a Neoadjuvant, Adjuvant, and Primary Treatment in Colorectal Cancer
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Pembrolizumab in Patients with Advanced Metastatic Germ Cell Tumors
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Immunotherapy Targeting PD-1/PD-L1 in Early-Stage Triple-Negative Breast Cancer
Yang, T.-L., Li, W., Huang, T., & Zhou, J. (2023) · Journal of Personalized Medicine · doi:10.3390/jpm13030526 · Cited by 43
BRAF V600E/RAS Mutations and Lynch Syndrome in Patients With MSI-H/dMMR Metastatic Colorectal Cancer Treated With Immune Checkpoint Inhibitors
Colle, R., Lonardi, S., Cachanado, M., Overman, M. J., Élez, E., Fakih, M., Corti, F., Jayachandran, P., Svrcek, M., Dardenne, A., et al. (2023) · The Oncologist · doi:10.1093/oncolo/oyad082 · Cited by 41
In silico cancer immunotherapy trials uncover the consequences of therapy-specific response patterns for clinical trial design and outcome
Creemers, J. H. A., Ankan, A., Roes, K. C. B., Schröder, G., Mehra, N., Figdor, C. G., de Vries, I. J. M., & Textor, J. C. (2023) · Nature Communications · doi:10.1038/s41467-023-37933-8 · Cited by 39
“Theseissuesledtothedevelopmentofinnovativemethodssuchas novel radiological criteria to quantify tumor responses 9,14,15 , (surrogate) endpoints to capture unique survival kinetics 10,16 – 19 , biomarkers to enrich for patients more likely to respond to treatment 20 – 23 , and…”
New insights into immune cells in cancer immunotherapy: from epigenetic modification, metabolic modulation to cell communication
Qin, S., Xie, B., Wang, Q., Yang, R., Sun, J., Hu, C., Liu, S., Tao, Y., & Xiao, D. (2024) · MedComm · doi:10.1002/mco2.551 · Cited by 40
“295 Currently, cancer immunotherapy approaches mainly include (1) using cytokines such as IL2 and interferon to activate and promote the immune cell killing ability of the patient; (2) monoclonal antibody therapy such as ibritumomab, nabumomab, pembrolizumab that targeting immune checkpoints; (3)…”
Method
Using MRI cell tracking to monitor immune cell recruitment in response to a peptide‐based cancer vaccine
Tremblay, M., Davis, C., Bowen, C. V., Stanley, O., Parsons, C., Weir, G., Karkada, M., Stanford, M. M., & Brewer, K. (2017) · Magnetic Resonance in Medicine · doi:10.1002/mrm.27018 · Cited by 40
The Potential of In Vivo Imaging for Optimization of Molecular and Cellular Anti-cancer Immunotherapies
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Safety and efficacy of immune checkpoint inhibitors for end-stage renal disease patients undergoing dialysis: a retrospective case series and literature review
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T-cell functionality testing is highly relevant to developing novel immuno-tracers monitoring T cells in the context of immunotherapies and revealed CD7 as an attractive target
Mayer, K. E., Mall, S., Yusufi, N., Gosmann, D., Steiger, K., Russelli, L., Bianchi, H. D. O., Audehm, S., Wagner, R., Bräunlein, E., et al. (2018) · Theranostics · doi:10.7150/thno.27275 · Cited by 40
Current Status and Future Perspectives of Immunotherapy for Locally Advanced or Metastatic Urothelial Carcinoma: A Comprehensive Review
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Dissociated responses at initial computed tomography evaluation is a good prognostic factor in non-small cell lung cancer patients treated with anti-programmed cell death-1/ligand 1 inhibitors
Tozuka, T., Kitazono, S., Sakamoto, H., Yoshida, H., Amino, Y., Uematsu, S., Yoshizawa, T., Hasegawa, T., Uchibori, K., Yanagitani, N., et al. (2020) · BMC Cancer · doi:10.1186/s12885-020-6704-z · Cited by 40
How Non-invasive in vivo Cell Tracking Supports the Development and Translation of Cancer Immunotherapies
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Impact of pseudoprogression and treatment beyond progression on outcome in patients with non-small cell lung cancer treated with immune checkpoint inhibitors
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Hyperprogression: A novel response pattern under immunotherapy
Han, X., Alu, A., Xiao, Y., Wei, Y., & Wei, X. (2020) · Clinical and Translational Medicine · doi:10.1002/ctm2.167 · Cited by 41
Endpoints in clinical trials for liver cancer and their value in evidence-based clinical decision making: An unresolved Gordian knot
Bruix, J. (2021) · Journal of Hepatology · doi:10.1016/j.jhep.2021.01.033 · Cited by 40
Prospective assessment of circulating tumor DNA in patients with metastatic uveal melanoma treated with tebentafusp
Rodrigues, M. J., Ramtohul, T., Rampanou, A., Sandoval, J. L., Houy, A., Servois, V., Mailly-Giacchetti, L., Pierron, G., Vincent‐Salomon, A., Cassoux, N., et al. (2024) · Nature Communications · doi:10.1038/s41467-024-53145-0 · Cited by 40
Immune checkpoint inhibitors in esophageal squamous cell carcinoma: progress and opportunities
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Single‐Arm Clinical Trials as Pivotal Evidence for Cancer Drug Approval: A Retrospective Cohort Study of Centralized European Marketing Authorizations Between 2010 and 2019
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Role of imaging in management of hepatocellular carcinoma: surveillance, diagnosis, and treatment response
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Baseline IFN-γ and IL-10 expression in PBMCs could predict response to PD-1 checkpoint inhibitors in advanced melanoma patients
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Comparison of RECIST 1.1 and iRECIST in Patients Treated with Immune Checkpoint Inhibitors: A Systematic Review and Meta-Analysis
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PD0325901, an ERK inhibitor, enhances the efficacy of PD-1 inhibitor in non-small cell lung carcinoma
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Potential of circulating tumor DNA as a predictor of therapeutic responses to immune checkpoint blockades in metastatic renal cell carcinoma
Kim, Y. J., Kang, Y., Kim, J. S., Sung, H. H., Jeon, H. G., Jeong, B. C., Seo, S. I., Jeon, S. S., Lee, H. M., Park, D., et al. (2021) · Scientific Reports · doi:10.1038/s41598-021-85099-4 · Cited by 39
Safety and feasibility of an in situ vaccination and immunomodulatory targeted radionuclide combination immuno-radiotherapy approach in a comparative (companion dog) setting
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A phase 2 trial of avelumab in men with aggressive-variant or neuroendocrine prostate cancer
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iRECIST and atypical patterns of response to immuno-oncology drugs
Ramón-Patiño, J. L., Schmid, S., Lau, S. C. M., Seymour, L., Gaudreau, P.-O., Li, J. J. N., Bradbury, P. A., & Calvo, E. (2022) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2022-004849 · Cited by 39
Self-citation
Lenvatinib Plus Programmed Cell Death Protein-1 Inhibitor Beyond First-Line Systemic Therapy in Refractory Advanced Biliary Tract Cancer: A Real-World Retrospective Study in China
Shi, C., Li, Y., Yang, C., Qiao, L., Tang, L., Zheng, Y., Chen, X., Qian, Y., Yang, J., Wu, D., et al. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.946861 · Cited by 39
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“Secondary endpoints were disease-free survival (DFS), calculated as the time from the date of first administration of BA until the date of documented recurrence or development of distant metastasis by RECIST (30); overall survival (OS), calculated as the time from the date of first administration of BA to the date of…”
MethodInfluential
Analysis of Human Leukocyte Antigen DR Alleles, Immune-Related Adverse Events, and Survival Associated With Immune Checkpoint Inhibitor Use Among Patients With Advanced Malignant Melanoma
Aktürk, H. K., Couts, K. L., Baschal, E. E., Karakus, K. E., Gulick, R. J. V., Turner, J. A., Pyle, L. L., Robinson, W. A., & Michels, A. W. (2022) · JAMA Network Open · doi:10.1001/jamanetworkopen.2022.46400 · Cited by 41
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Abbas, E., Fanni, S. C., Bandini, C., Francischello, R., Febi, M., Aghakhanyan, G., Ambrosini, I., Faggioni, L., Cioni, D., Lencioni, R. A., et al. (2023) · European Journal of Radiology Open · doi:10.1016/j.ejro.2023.100511 · Cited by 38
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“After cell infusion, the evaluation of objective response and disease progression are next needed under consensus guidelines, such as Response Evaluation Criteria in Solid Tumors [162].”
Method
The current evidence for a biomarker-based approach in cancer of unknown primary
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Renal Cell Carcinoma: the Oncologist Asks, Can PSMA PET/CT Answer?
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Total metabolic tumor volume on 18 F-FDG PET/CT is a game-changer for patients with metastatic lung cancer treated with immunotherapy
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Moreno, V., Calvo, E., Middleton, M. R., Barlési, F., Gaudy‐Marqueste, C., Italiano, A., Romano, E., Marabelle, A., Chartash, E., Dobrenkov, K., et al. (2022) · Cancer Immunology Immunotherapy · doi:10.1007/s00262-022-03191-8 · Cited by 37
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irRECIST and iRECIST: the devil is in the details
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Self-citation
Translating preclinical MRI methods to clinical oncology
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Authors: Seymour, L., Bogaerts, J., Perrone, A., Ford, R., Schwartz, L. H., Mandrekar, S., Lin, N. U., Litière, S., Dancey, J., Chen, A., Hodi, F. S., Therasse, P., Hoekstra, O. S., Shankar, L. K., Wolchok, J. D., Ballinger, M., Caramella, C., & de Vries, E. G. E.
Affiliations: Queen's University (CA)
European Organisation for Research and Treatment of Cancer (BE)
Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
NewYork–Presbyterian Hospital (US)
Mayo Clinic (US)
National Institutes of Health (US)
Harvard University (US)
Institut de Recherches Internationales Servier (France) (FR)
Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
Memorial Sloan Kettering Cancer Center (US)
Genentech (US)
Institut Gustave Roussy (FR)
Corresponding author: Seymour, Lesley
ORCID: Seymour, Lesley
Bogaerts, Jan
Ford, Robert
Mandrekar, Sumithra
Litière, Saskia
Dancey, Janet
Chen, Alice
Hodi, F Stephen
Hoekstra, Otto S
Shankar, Lalitha K
Wolchok, Jedd D
Caramella, Caroline
Venue: The Lancet Oncology
Publisher: Elsevier BV
Published: 2017-03
Volume: 18
Issue: 3
Pages: e143-e152
ISSN: 1470-2045 (ISSN-L)
DOI: 10.1016/s1470-2045(17)30074-8
PMC: PMC5648544
OpenAlex: W2592144107
Cited by: 2,472
References: 37
Citations by year: 2026: 264 · 2025: 267 · 2024: 319 · 2023: 305 · 2022: 270 · 2021: 308 · 2020: 304 · 2019: 223 · 2018: 146 · 2017: 62
FWCI: 21.17
Type: journal article
Language: en
Update notices: erratum (2019-05-01)
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet Oncology (publishedVersion)
PubMed (publishedVersion)
Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Pure Amsterdam UMC (submittedVersion)
University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
Data Archiving and Networked Services (DANS) (submittedVersion)
Funders: National Cancer Institute (U10CA011488, P30CA008748)
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Medical Imaging Techniques and Applications
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: iRECIST, cancer immunotherapy, response evaluation criteria, disease progression, immunomodulators, clinical trial data collection, data warehouse
MeSH terms: Humans, Immunotherapy, Neoplasms, Practice Guidelines as Topic, Disease Progression, Tumor Burden, Response Evaluation Criteria in Solid Tumors

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iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics

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