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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Saal, J., Eckstein, M., Ritter, M., Brossart, P., Hölzel, M., Grünwald, V., & Klümper, N. (2024) · European Journal of Cancer · doi:10.1016/j.ejca.2024.115163 · Cited by 16
A perspective review on the systematic implementation of ctDNA in phase I clinical trial drug development
Guigal, N., Lockhart, B. P., Moser, T., & Heitzer, E. (2025) · Journal of Experimental & Clinical Cancer Research · doi:10.1186/s13046-025-03328-4 · Cited by 16
“Currently, radiological imaging (RECIST & iRECIST) remains the mainstay for assessing clinical benefit in early clinical development trials [27, 28].”
First-Line Pembrolizumab with or Without Platinum Doublet Chemotherapy in Non-Small-Cell Lung Cancer Patients with PD-L1 Expression ≥50%
Descourt, R., CHOUAID, C., Pérol, M., Besse, B., Greillier, L., Bylicki, O., Ricordel, C., Guisier, F., Gervais, R., Schött, R., et al. (2021) · Future Oncology · doi:10.2217/fon-2020-1202 · Cited by 16
Predictive role of the monocyte-to-lymphocyte ratio in advanced hepatocellular carcinoma patients receiving anti-PD-1 therapy
Zhu, Z., Zhuang, L., Zhang, C., Ning, Z., Wang, D., Sheng, J., Hua, Y.-Q., Xie, J., Xu, L., & Meng, Z. (2021) · Translational Cancer Research · doi:10.21037/tcr-21-1760 · Cited by 16
Predicting treatment outcomes using 18 F-FDG PET biomarkers in patients with non-small-cell lung cancer receiving chemoimmunotherapy
Kim, C. G., Hwang, S. H., Kim, K. H., Yoon, H. I., Shim, H. S., Lee, J. H., Han, Y., Ahn, B., Hong, M. H., Kim, H. R., et al. (2022) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359211068732 · Cited by 16
Five‐year survival and clinical correlates among patients with advanced non‐small cell lung cancer, melanoma and renal cell carcinoma treated with immune check‐point inhibitors in Australian tertiary oncology centres
Brown, L. J., da Silva, I. P., Moujaber, T., Gao, B., Hui, R., Gurney, H., Carlino, M. S., & Nagrial, A. M. (2022) · Cancer Medicine · doi:10.1002/cam4.5468 · Cited by 19
Clinical efficacy and safety of individualized pembrolizumab administration based on pharmacokinetic in advanced non-small cell lung cancer: A prospective exploratory clinical trial
Wang, N., Zheng, L., Li, M., Hou, X., Zhang, B., Chen, J., Su, L., & Chen, L. (2023) · Lung Cancer · doi:10.1016/j.lungcan.2023.02.009 · Cited by 16
Pathologic assessment of hepatocellular carcinoma in the era of immunotherapy: a narrative review
Wang, H., Qian, Y., Dong, H., & Cong, W. (2023) · HepatoBiliary Surgery and Nutrition · doi:10.21037/hbsn-22-527 · Cited by 19
“The transformation of immunophenotype of tumor cells is not unexpected and the positive stain of cholangiocyte marker, such as Cytokeratin 19, may signal drug resistance of tumor cells (57).”
Fluctuations in Gut Microbiome Composition During Immune Checkpoint Inhibitor Therapy
Sarkar, J., Gomez, E. C., Oba, T., Chen, H., Dy, G. K., Segal, B. H., Ernstoff, M. S., & Ito, F. (2023) · World Journal of Oncology · doi:10.14740/wjon1587 · Cited by 19
“After the initiation of either ICI alone or combination therapy with ICI and chemotherapy, clinical response was assessed during the first 12 weeks of treatment using immune response evaluation criteria in solid tumors (RECIST) (iRECIST) [25] criteria.”
Method
Predicting response to CCRT for esophageal squamous carcinoma by a radiomics-clinical SHAP model
Xu, C., Zhang, Y., Zhu, M., Sun, R., Liu, L., & Li, X. (2023) · BMC Medical Imaging · doi:10.1186/s12880-023-01089-0 · Cited by 16
“Evaluation of treatment outcome Two experienced radiation oncologists collaborated to assess the efficacy of the treatment using imaging examination within 3 months of the end of radiotherapy based on the efficacy evaluation criteria in the solid tumor criteria [21].”
Method
Phase II Clinical Trial of Pembrolizumab and Chemotherapy Reveals Distinct Transcriptomic Profiles by Radiologic Response in Metastatic Triple-Negative Breast Cancer
Wilkerson, A. D., Parthasarathy, P. B., Stabellini, N., Mitchell, C., Pavicic, P. G., Fu, P., Rupani, A. R., Husic, H., Rayman, P. A., Swaidani, S., et al. (2023) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-23-1349 · Cited by 16
A Phase 2 Trial of Talazoparib and Avelumab in Genomically Defined Metastatic Kidney Cancer
Kotecha, R. R., Doshi, S. D., Knežević, A., Chaim, J. L., Chen, Y., Jacobi, R., Zucker, M. R., Reznik, E., McHugh, D. J., Shah, N. J., et al. (2023) · European Urology Oncology · doi:10.1016/j.euo.2023.10.017 · Cited by 19
Penpulimab combined with anlotinib in patients with R/M HNSCC after failure of platinum-based chemotherapy: a single-arm, multicenter, phase Ⅱ study
Shi, Y., Gao, L., Tian, Y. E., Bai, C., Chen, J., Wang, J., Li, X., Zhang, C., Sun, Y. H., Su, H., et al. (2023) · ESMO Open · doi:10.1016/j.esmoop.2023.102194 · Cited by 16
Integrating Artificial Intelligence and PET Imaging for Drug Discovery: A Paradigm Shift in Immunotherapy
McGale, J., Howell, H. J., Beddok, A., Tordjman, M., Sun, R., Chen, D. L., Wu, A. M., Assi, T., Ammari, S., & Dercle, L. (2024) · Pharmaceuticals · doi:10.3390/ph17020210 · Cited by 16
“In addition to the biomarkers mentioned above, a modified version of the RECIST consensus guidelines has been developed, termed iRECIST, with the intent of addressing atypical tumor behavior observed in response to immunotherapy [44].”
Method
Reasons for Treatment Discontinuation and Their Effect on Outcomes of Immunotherapy in Southwest Finland: A Retrospective, Real-World Cohort Study
Virtanen, S., Pihlman, H., Silvoniemi, M., Vihinen, P., Jaakkola, P., & Mattila, K. (2024) · Cancers · doi:10.3390/cancers16040709 · Cited by 17
“[21] nor iRECIST criteria [22] in routine clinical practice.”
Background
Progressive sarcopenia and myosteatosis predict prognosis of advanced HCC patients treated with immune checkpoint inhibitors
Liu, M., Jin, Q., Wang, H., & Li, Y. (2024) · Frontiers in Immunology · doi:10.3389/fimmu.2024.1396927 · Cited by 16
Nuclear Molecular Imaging Strategies in Immune Checkpoint Inhibitor Therapy
Guldbrandsen, K. F., Hendel, H. W., Langer, S. W., & Fischer, B. M. (2017) · Diagnostics · doi:10.3390/diagnostics7020023 · Cited by 16
Surrogate End Points for Overall Survival in Trials of PD-(L)1 Inhibitors for Urinary Cancers: A Systematic Review
Abdel-Rahman, O. M. (2017) · Immunotherapy · doi:10.2217/imt-2017-0115 · Cited by 17
Intra-individual consistency of spectral detector CT-enabled iodine quantification of the vascular and renal blood pool
Lennartz, S., Abdullayev, N., Zopfs, D., Borggrefe, J., Neuhaus, V., ten Persigehl, T., Haneder, S., & Hokamp, N. G. (2019) · European Radiology · doi:10.1007/s00330-019-06266-w · Cited by 16
State of the Art of Natural Killer Cell Imaging: A Systematic Review
Varani, M., Auletta, S., Signore, A., & Galli, F. (2019) · Cancers · doi:10.3390/cancers11070967 · Cited by 16
Local Tumor Control and Patient Outcome Using Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma: iRECIST as a Potential Substitute for Traditional Criteria
Vernuccio, F., Godfrey, D., Meyer, M., Williamson, H. V., Salama, J. K., Niedzwiecki, D., Stephens, S. J., Ronald, J., Palta, M., & Marin, D. (2019) · American Journal of Roentgenology · doi:10.2214/ajr.18.20842 · Cited by 16
Retrospective analysis of treatment-naive Slovenian patients with metastatic melanoma treated with pembrolizumab – real-world experience
Hribernik, N., Boc, M., Ocvirk, J., Knez-Arbeiter, J., Mesti, T., Ignjatović, M. G., & Reberšek, M. (2020) · Radiology and Oncology · doi:10.2478/raon-2020-0003 · Cited by 18
Striving toward Improved Outcomes for Surgically Resectable Non-Small Cell Lung Cancer: the Promise and Challenges of Neoadjuvant Immunotherapy
Gentzler, R. D., Riley, D., & Martin, L. W. (2020) · Current Oncology Reports · doi:10.1007/s11912-020-00969-w · Cited by 16
Immune Response Evaluation and Treatment with Immune Checkpoint Inhibitors Beyond Clinical Progression: Response Assessments for Cancer Immunotherapy
Mushti, S. L., Mulkey, F. A., Tang, S. W., Singh, H., Lemery, S. J., Goldberg, K. B., Sridhara, R., Keegan, P., Kluetz, P. G., Pazdur, R., et al. (2020) · Current Oncology Reports · doi:10.1007/s11912-020-00974-z · Cited by 16
Two centres experience of lung cancer resection in patients with advanced non-small cell lung cancer upon treatment with immune checkpoint inhibitors: safety and clinical outcomes
Beattie, R., Furrer, K., Dolan, D. P., Fontecedro, A. C., Lee, D. N., Frauenfelder, T., Hoeller, S., Weder, W., Bueno, R., Opitz, I., et al. (2021) · European Journal of Cardio-Thoracic Surgery · doi:10.1093/ejcts/ezab340 · Cited by 16
Early dynamics of circulating tumor DNA predict clinical response to immune checkpoint inhibitors in metastatic renal cell carcinoma
Koh, Y., Nakano, K., Katayama, K., Yamamichi, G., Yumiba, S., Tomiyama, E., Matsushita, M., Hayashi, Y., Yamamoto, Y., Kato, T., et al. (2022) · International Journal of Urology · doi:10.1111/iju.14816 · Cited by 16
Cancer Imaging in Immunotherapy
Eleneen, Y., & Colen, R. R. (2017) · Advances in experimental medicine and biology · doi:10.1007/978-3-319-53156-4_7 · Cited by 16
Pseudoprogression of CNS metastatic disease of alveolar soft part sarcoma during anti-PDL1 treatment
Jagt, T. A. V., Davis, L. E., Thakur, M. D., Franz, C., & Pollock, J. M. (2018) · Radiology Case Reports · doi:10.1016/j.radcr.2018.05.013 · Cited by 16
Challenges of evaluating immunotherapy efficacy in solid tumors
Bai, R., Li, W., Du, N., & Cui, J. (2019) · Chinese Journal of Cancer Research · doi:10.21147/j.issn.1000-9604.2019.06.02 · Cited by 16
Development of a Prognostic AI-Monitor for Metastatic Urothelial Cancer Patients Receiving Immunotherapy
Trebeschi, S., Bodalal, Z., van Dijk, N., Boellaard, T., Apfaltrer, P., Bucho, T. M. T., Nguyen-Kim, T. D., van der Heijden, M. S., Aerts, H., & Beets-Tan, R. (2021) · Frontiers in Oncology · doi:10.3389/fonc.2021.637804 · Cited by 13
Clinical evidence for a biological effect of epigenetically active decitabine in relapsed or progressive rhabdoid tumors
Steinbügl, M., Nemes, K., Johann, P. D., Kröncke, T. J., Tüchert, S., Gil‐da‐Costa, M. J., Ebinger, M., Schüller, U., Sehested, A. M., Hauser, P., et al. (2021) · Pediatric Blood & Cancer · doi:10.1002/pbc.29267 · Cited by 16
Prognostic Value of 18F-FDG PET/CT Metabolic Parameters in Resectable Non–small Cell Lung Cancer Treated With Neoadjuvant Immunotherapy Plus Chemotherapy
Cheng, Y., Jiang, Z.-P., Chen, X., Lu, K.-Y., Liu, Z., & Shao, D. (2025) · Clinical Nuclear Medicine · doi:10.1097/rlu.0000000000005863 · Cited by 16
NeoPred: dual-phase CT AI forecasts pathologic response to neoadjuvant chemo-immunotherapy in NSCLC
Zheng, J., Yan, Z., Wang, R., Xiao, H., Chen, Z., Ge, X., Li, Z., Liu, Z., Yu, H., Liu, H., et al. (2025) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2025-011773 · Cited by 17
“Further validation across diverse patient populations and healthcare settings is necessary to fully realize the potential of NeoPred and similar AI-based models in clinical oncology.”
The neuroimmune axis in breast cancer: from mechanistic insights to clinical applications
Wu, Y., Zhang, K., 夏新亚, Zhang, T., Jiang, N., Zhang, Y., Zheng, F., Jiang, Y., Xiang, X., Miao, H., et al. (2026) · BMC Medicine · doi:10.1186/s12916-026-04870-4 · Cited by 15
“In such cases, RECIST cannot accurately predict the long-term therapeutic benefits of these patients [271].”
Pseudoprogression and Immunotherapy Phenomena
Waxman, E. S., & Gerber, C. D. L. (2020) · Journal of the Advanced Practitioner in Oncology · doi:10.6004/jadpro.2020.11.7.6 · Cited by 15
CT texture analysis as a predictor of favorable response to anti-PD1 monoclonal antibodies in metastatic skin melanoma
Bonnin, A., Durot, C., Barat, M., Djelouah, M., Grange, F., Mulé, S., Soyer, P. A., & Hoeffel, C. C. (2021) · Diagnostic and Interventional Imaging · doi:10.1016/j.diii.2021.09.009 · Cited by 15
Pembrolizumab combined with paclitaxel and platinum as induction therapy for locally advanced esophageal squamous cell carcinoma: a retrospective, single-center, three-arm study
Lin, W., Huang, Y., Zhu, L., Li, W., Zhao, L., Pan, X., Lin, J., & Guo, T. (2022) · Journal of Gastrointestinal Oncology · doi:10.21037/jgo-22-1196 · Cited by 15
ITA-IMMUNO-PET: The Role of [18F]FDG PET/CT for Assessing Response to Immunotherapy in Patients with Some Solid Tumors
Evangelista, L., Bianchi, A., Annovazzi, A., Sciuto, R., Traglia, S. D., Bauckneht, M., Lanfranchi, F., Morbelli, S. D., Nappi, A. G., Ferrari, C., et al. (2023) · Cancers · doi:10.3390/cancers15030878 · Cited by 15
Precision Surgery in NSCLC
Cannone, G., Comacchio, G. M., Pasello, G., Faccioli, E., Schiavon, M., Dell’Amore, A., Mammana, M., & Rea, F. (2023) · Cancers · doi:10.3390/cancers15051571 · Cited by 14
Real world evidence of Lenvatinib + anti PD-1 as an advanced line for metastatic melanoma
Stoff, R., Asher, N., Laks, S., Steinberg‐Silman, Y., Schachter, J., Shapira‐Frommer, R., Grynberg, S., & Ben‐Betzalel, G. (2023) · Frontiers in Oncology · doi:10.3389/fonc.2023.1180988 · Cited by 17
Immune checkpoint inhibition (ICI) in current systemic therapies for hepatocellular carcinoma (HCC)
van Bömmel, F., Berg, T., & Lordick, F. (2023) · ESMO Gastrointestinal Oncology · doi:10.1016/j.esmogo.2023.08.004 · Cited by 15
“80 However, a comparison of using mRECIST criteria versus RECIST 1.1 versus iRECIST 1.1 criteria for the evaluation of responses and outcomes in HCC patients receiving PD-1 antibody therapy has revealed that mRECIST was more powerful in discriminating between responders and non-responders.”
Influential

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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