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

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 +10 more·2017·The Lancet Oncology

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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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
Venue
The Lancet Oncology
Publisher
Elsevier BV
Published
2017-03
Volume
18
Issue
3
Pages
e143-e152
ISSN
1470-2045 (ISSN-L)
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 · 2015: 1 · 2012: 1
FWCI
21.17
Type
journal article
Language
en
Update notices
erratum (2019-05-01)
Open access
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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