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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Background
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“Data from these images were averaged to create a single measure per patient for each marker.”
Method
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Dissociated Responses in Patients with Metastatic Solid Tumors Treated with Immunotherapy
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Organ-Specific and Mixed Responses to Pembrolizumab in Patients with Unresectable or Metastatic Urothelial Carcinoma: A Multicenter Retrospective Study
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Immuno-PET Monitoring of Lymphocytes Using the CD8-Specific Antibody REGN5054
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Nanomaterials for Natural Killer Cell-Based Immunoimaging and Immunotherapies in Cancer
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Imaging endpoints for clinical trial use: a RECIST perspective
Litière, S., & Bogaerts, J. (2022) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2022-005092 · Cited by 18
Self-citation
Phase Ib/II study of nivolumab combined with palliative radiation therapy for bone metastasis in patients with HER2-negative metastatic breast cancer
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“Thereby, the combination of drugs may provide a better treatment efficacy for SLE patients (85).”
Background
The prognostic value of [18F]FDG PET/CT based response monitoring in metastatic melanoma patients undergoing immunotherapy: comparison of different metabolic criteria
Sachpekidis, C., Weru, V., Kopp-Schneider, A., Hassel, J., & Dimitrakopoulou-Strauss, A. (2023) · European Journal of Nuclear Medicine and Molecular Imaging · doi:10.1007/s00259-023-06243-y · Cited by 20
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Background
Phase 1 first-in-human dose-escalation study of ANV419 in patients with relapsed/refractory advanced solid tumors
Joerger, M., Calvo, E., Laubli, H. P., Lopez, J. S., Alonso, G., de la Fuente, E. C., Hess, D., König, D., Perez, V. S., Bucher, C. M., et al. (2023) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2023-007784 · Cited by 21
“The Response Eval-uable Population (for efficacy analysis) consisted of all patients who had one post-baseline assessment of tumor response or who were withdrawn due to progressive disease/death prior to the first response assessment.”
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Andresen, N. K., Røssevold, A. H., Quaghebeur, C., Gilje, B., Boge, B., Gombos, A., Falk, R. S., Mathiesen, R. R., Julsrud, L., Garred, Ø., et al. (2024) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2023-007990 · Cited by 21
Novel Blood Biomarkers for Response Prediction and Monitoring of Stereotactic Ablative Radiotherapy and Immunotherapy in Metastatic Oligoprogressive Lung Cancer
Zafra, J., Onieva, J. L., Oliver, J., Garrido-Barros, M., González-Hernández, A., Martínez-Gálvez, B., Roman, A., Marmolejo, R. O., Pérez-Ruiz, E., Benítez, J. C., et al. (2024) · International Journal of Molecular Sciences · doi:10.3390/ijms25084533 · Cited by 20
“Response is assessed by Immune Response Evaluation Criteria in Solid Tumors (iRECIST) [47] with computed tomography scanning (CT scan) 2 months after SABR and subsequently every 3 months.”
Method
The role of endobronchial ultrasound transbronchial needle aspiration for programmed death ligand 1 testing and next generation sequencing in advanced non-small cell lung cancer
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Heterogeneity of Hepatocellular Carcinoma on Imaging
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A comparison between the assessments of progression-free survival by local investigators versus blinded independent central reviews in phase III oncology trials
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Complete response and renal cell carcinoma in the immunotherapy era: The paradox of good news
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The prospect of immunotherapy combined with chemotherapy in patients with advanced non-small cell lung cancer: a narrative review
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Tumour Regression via Integrative Regulation of Neurological, Inflammatory, and Hypoxic Tumour Microenvironment
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New developments in the imaging of lung cancer
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FusionVAC22_01: a phase I clinical trial evaluating a DNAJB1-PRKACA fusion transcript-based peptide vaccine combined with immune checkpoint inhibition for fibrolamellar hepatocellular carcinoma and other tumor entities carrying the oncogenic driver fusion
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Neoadjuvant immune checkpoint inhibitors for hepatocellular carcinoma
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“However, due to the unique response mechanisms demonstrated by immune-based therapies 45 , immunotherapy RECIST (iRECIST) criteria were developed to evaluate responses to immunotherapeutics 46 .”
The changing scenario of 1st line therapy in non-oncogene addicted NSCLCs in the era of immunotherapy
Russo, A., Franchina, T., Ricciardi, G. R. R., Toscano, G., Schifano, S., Certo, G. L., Battaglia, A., Pantò, E., Fonti, M. S., & Adamo, V. (2018) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2018.06.007 · Cited by 19
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Immune checkpoint inhibition for the treatment of mesothelioma
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Renal Cell Carcinoma: The Evolving Role of Imaging in the 21st Century
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Advances in immune therapies for the treatment of microsatellite instability‑high/deficient mismatch repair metastatic colorectal cancer (Review)
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Neoadjuvant treatment strategies for hepatocellular carcinoma
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Management of Non-Melanoma Skin Cancer: Radiologists Challenging and Risk Assessment
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Efficacy and safety of preoperative immunotherapy alone followed by surgery in the treatment of advanced gastric cancer with MSI-H/dMMR or EBV-positive
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“11 revealed that ICOSLG (B7-H2) was significantly increased in tumors with lower NLR. KRT expression levels exhibited higher basal cell markers (KRT5 and KRT17) in the higher NLR group and lower differentiated cell markers (KRT8 and KRT18) in patients with TLS.”
Background
Proof-of-concept study of the caninized anti-canine programmed death 1 antibody in dogs with advanced non-oral malignant melanoma solid tumors
Igase, M., Inanaga, S., Nishibori, S., ITAMOTO, K., Sunahara, H., Nemoto, Y., Tani, K., Horikirizono, H., NAKAICHI, M., Baba, K., et al. (2024) · Journal of Veterinary Science · doi:10.4142/jvs.23144 · Cited by 21
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Background
Peripheral immune cells in metastatic breast cancer patients display a systemic immunosuppressed signature consistent with chronic inflammation
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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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