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iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics
Open accessAbstract
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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“Other studies using TβRI small molecule inhibitors confirmed attenuation of metastasis in various carcinoma types325.”
From TGFβ biology in cancer progression and immunotherapy (2021) · cites this paper as [325]
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“TGF-β inhibition as monotherapy, using neutralizing antibodies, ligand traps or receptor kinase inhibitors, has seen some success in mouse models of carcinomas, primarily in reducing metastatic spread rather than reducing growth of the primary tumor325 (Table 1).”
From TGFβ biology in cancer progression and immunotherapy (2021) · cites this paper as [325]
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PD-1 and PD-L1 Immune Checkpoint Blockade to Treat Breast Cancer
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New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
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Self-citationNew Guidelines to Evaluate the Response to Treatment in Solid Tumors
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Self-citationAdverse Renal Effects of Immune Checkpoint Inhibitors: A Narrative Review
Wanchoo, R., Karam, S., Uppal, N. N., Barta, V. S., Deray, G., Devoe, C., Launay‐Vacher, V., Jhaveri, K. D., & on behalf of Cancer and Kidney International Network Workgroup on Immune Checkpoint Inhibitors (2017) · American Journal of Nephrology · doi:10.1159/000455014 · Cited by 15,320
Improved Survival with Ipilimumab in Patients with Metastatic Melanoma
Hodi, F. S., O'Day, S. J., McDermott, D. F., Weber, R. W., Sosman, J. A., Haanen, J. B., Gonzalez, R., Robert, C., Schadendorf, D., Hassel, J. C., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1003466 · Cited by 15,155
Self-citationThe blockade of immune checkpoints in cancer immunotherapy
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Reck, M., Rodríguez-Abreu, D., Robinson, A. G., Hui, R., Csőszi, T., Fülöp, A., Gottfried, M., Peled, N., Tafreshi, A., Cuffe, S., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1606774 · Cited by 10,089
Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer
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Nivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer
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Metadata
- 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
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2017-03
- Volume
- 18
- Issue
- 3
- Pages
- e143-e152
- ISSN
- 1470-2045 (ISSN-L)
- 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
- 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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