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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Self-citation

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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