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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Evaluation and Prediction of Treatment Response for Hepatocellular Carcinoma
Tsujita, Y., Sofue, K., Ueshima, E., Ueno, Y. R., Hori, M., Tsurusaki, M., & Murakami, T. (2023) · Magnetic Resonance in Medical Sciences · doi:10.2463/mrms.rev.2022-0118 · Cited by 14
Pretreatment levels of serum alkaline phosphatase are associated with the prognosis of patients with non‑small cell lung cancer receiving immune checkpoint inhibitors
Yang, T., Cheng, J., Fu, S., Sun, T., Yang, K., You, J., & Li, F. (2023) · Oncology Letters · doi:10.3892/ol.2023.13740 · Cited by 14
Atypical patterns of responses in the era of immune checkpoint inhibitors in head and neck cancer
Doumas, S., Foukas, P. G., Economopoulou, P., Kotsantis, I., & Psyrri, A. K. (2019) · Oral Oncology · doi:10.1016/j.oraloncology.2019.104477 · Cited by 14
Imaging and clinical correlates with regorafenib in metastatic colorectal cancer
Khan, K. H., Cascinu, S., Cunningham, D., Kim, S., Oki, E., Seery, T. E., Shen, L., Siena, S., Tournigand, C., Turhal, N. S., et al. (2020) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2020.102020 · Cited by 14
Durable Response and Good Tolerance to the Triple Combination of Toripalimab, Gemcitabine, and Nab-Paclitaxel in a Patient With Metastatic Pancreatic Ductal Adenocarcinoma
Shui, L., Cheng, K., Li, X., Shui, P., Li, S., Peng, Y., Li, J., Guo, F., Cheng, Y., & Cao, D. (2020) · Frontiers in Immunology · doi:10.3389/fimmu.2020.01127 · Cited by 14
PD ‐1 blockade using pembrolizumab in adolescent and young adult patients with advanced bone and soft tissue sarcoma
Scheinberg, T., Lomax, A. J., Tattersall, M., Thomas, D. M., McCowage, G. B., Sullivan, M. J., Karim, R. Z., Luk, P. P., Mahar, A. M., Bonar, F., et al. (2020) · Cancer Reports · doi:10.1002/cnr2.1327 · Cited by 14
Local ablative therapies in oligometastatic NSCLC-upfront or outback?—a narrative review
Tjong, M. C., Louie, A. V., Iyengar, P., Solomon, B., Palma, D. A., & Siva, S. (2021) · Translational Lung Cancer Research · doi:10.21037/tlcr-20-994 · Cited by 13
CT-Based Peritumoral and Intratumoral Radiomics as Pretreatment Predictors of Atypical Responses to Immune Checkpoint Inhibitor Across Tumor Types: A Preliminary Multicenter Study
He, S., Feng, Y., Lin, Q., Wang, L.-H. H., Wei, L.-J., Tong, J., Zhang, Y.-W., Liu, Y., Ye, Z.-X., Guo, Y., et al. (2021) · Frontiers in Oncology · doi:10.3389/fonc.2021.729371 · Cited by 11
Efficacy of pembrolizumab and comprehensive CD274/PD-L1 profiles in patients previously treated with chemoradiation therapy as radical treatment in bladder cancer
Nishimura, K., Nishio, K., Hirosuna, K., Komura, K., Hayashi, T., Fukuokaya, W., Ura, A., Uchimoto, T., Nakamura, K., Fukushima, T., et al. (2022) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2021-003868 · Cited by 14
The Cancer Immunogram: A Pledge for a Comprehensive Biomarker Approach for Personalized Immunotherapy in Urothelial Cancer
Zahoor, H., & Grivas, P. D. (2018) · European Urology · doi:10.1016/j.eururo.2018.12.005 · Cited by 14
Identification of nonsense-mediated decay inhibitors that alter the tumor immune landscapePreprint
Cook, A. L., Sur, S., Dobbyn, L., Watson, E., Cohen, J. D., Ptak, B., Lee, B. S., Paul, S., Hsiue, E. H.-C., Popoli, M., et al. (2024) · eLife · doi:10.7554/elife.95952 · Cited by 16
Lenvatinib Plus Pembrolizumab, Pemetrexed, and a Platinum as First-Line Therapy for Metastatic Nonsquamous NSCLC: Phase 3 LEAP-006 Study
Herbst, R. S., Cho, B. C., Zhou, C., Burotto, M., Cobo, M., Şendur, M. A. N., Moiseyenko, V. M., Casarini, I., Nishio, M., Hui, R., et al. (2025) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2025.05.016 · Cited by 13
Distinct Clinicogenomic Features and Immunotherapy Associations in Pulmonary Sarcomatoid Carcinoma: A Multicenter Retrospective Study
Hong, L., Federico, A. D., Liu, B., Cooper, A. J., Alessi, J. V., Clark, P., Rinsurongkawong, W., Young, C., Li, H., Qin, K., et al. (2025) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2025.07.121 · Cited by 17
Pathological regression patterns following neoadjuvant chemo-immunotherapy in head and neck squamous cell carcinoma: a pilot study
Wang, D., Zeng, F., Zhang, S., Hu, W., Wang, Y., Ouyang, D., Zeng, B., Zeng, G., Li, J., Liao, G., et al. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1627442 · Cited by 13
Ferroptosis and the cGAS–STING pathway into precision nano-immuno-theranostics: A mechanistic paradigm for reversing drug resistance in hepatocellular carcinoma
Elmetwalli, A. (2025) · Drug Resistance Updates · doi:10.1016/j.drup.2025.101326 · Cited by 16
Metastatic cutaneous apocrine adenocarcinoma responsive to the programmed cell death protein 1 inhibitor pembrolizumab
Rogatsch, M., Schmid, J., Lax, S., Uranitsch, M., Schmid‐Zalaudek, K., Giuffrida, R., & Zalaudek, I. (2017) · European Journal of Cancer · doi:10.1016/j.ejca.2017.11.008 · Cited by 13
BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours
Kasi, P. M., Chakrabarti, S., Sawyer, S. D., Krainock, M. R., Poklepovic, A. S., Ansstas, G., Maninder, M., Malhotra, M., Ensor, J., Gao, L., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-060342 · Cited by 13
Hyperpolarized Carbon-13 MRI in Breast Cancer
Woitek, R., & Brindle, K. M. (2023) · Diagnostics · doi:10.3390/diagnostics13132311 · Cited by 14
“This can potentially delay the diagnosis of true disease progression and the treatment changes this would entail [78].”
Background
Neoadjuvant immune checkpoint inhibitor therapy in resectable non-small cell lung cancer
Conroy, M. R., Dennehy, C., & Forde, P. M. (2023) · Lung Cancer · doi:10.1016/j.lungcan.2023.107314 · Cited by 13
Immune checkpoint inhibitor use and the incidence of hepatitis B virus reactivation or immune‐related hepatitis in non–small cell lung cancer patients with chronic hepatitis B
Hong, J.-H., Lee, J., Park, S., Jung, H., Sun, J., Lee, S., Ahn, J. S., Sinn, D. H., & Ahn, M. (2024) · Cancer · doi:10.1002/cncr.35175 · Cited by 14
“19,20 The Kruskal–Wallis rank ‐ sum test and post hoc analysis using the Bonferroni correction were used to compare age among the three groups.”
Method
Intratumoral therapies in head and neck squamous cell carcinoma: A systematic review and future perspectives
Jiménez-Labaig, P., Rullan, A., Braña, I., Hernando‐Calvo, A., Moreno, V., Doger, B., Bitar, G. G., Dafydd, D. A., Melcher, A. A., & Harrington, K. J. (2024) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2024.102746 · Cited by 13
Prognostic significance of CT-determined sarcopenia in older patients with advanced squamous cell lung cancer treated with programmed death-1 inhibitors
Ying, L., Xu, L., Yang, J. H., & Zhang, Q. (2024) · Scientific Reports · doi:10.1038/s41598-024-62825-2 · Cited by 13
“Response evaluation was performed using a CT scan of the target lesions and classified according to the immune-related response evaluation criteria in solid tumors 23 .”
Method
Hybridizing mechanistic modeling and deep learning for personalized survival prediction after immune checkpoint inhibitor immunotherapy
Butner, J. D., Dogra, P., Chung, C. D., Koay, E. J., Welsh, J. W., Hong, D. S., Vittorio Cristini, C., & Wang, Z. (2024) · npj Systems Biology and Applications · doi:10.1038/s41540-024-00415-8 · Cited by 13
“To date, research on ICI outcome assessment has been primarily focused on retrospective assessment of response after treating with ICI for a period; these include immune RECIST 9 and immune-related response criteria 10 .”
MethodInfluential
Brief Report: Methylation-Based ctDNA Serial Monitoring Correlates With Immunotherapy Response in NSCLC
Hsiao, A., Woodward, B. D., Ye, P. P., Varga, M. G., Altaie, G., Lu, K., Searle, N., Viens, R., Langpap, S., Li, Z., et al. (2024) · Clinical Lung Cancer · doi:10.1016/j.cllc.2024.10.013 · Cited by 13
Early Change in C-Reactive Protein and Venous Thromboembolism in Patients Treated With Immune Checkpoint Inhibitors
Moik, F., Riedl, J. M., Barth, D. A., Berton, F., Fink, M. K., Englisch, C., Höeller, C., Fuereder, T., Ay, L., Pabinger, I., et al. (2024) · JACC CardioOncology · doi:10.1016/j.jaccao.2024.09.007 · Cited by 13
Translating radiomics into clinical practice: A step-by-step guide to study design and evaluation
Chen, M., Linton‐Reid, K., Aboagye, E. O., & Copley, S. J. (2025) · Clinical Radiology · doi:10.1016/j.crad.2025.107053 · Cited by 15
Nonconventional Patterns of Benefit of Solid Tumors Treated with PD-(L)1 Inhibitors: a Systematic Review
Abdel-Rahman, O. M. (2017) · Immunotherapy · doi:10.2217/imt-2017-0074 · Cited by 13
Assessing Treatment Benefit in Immuno-oncology
Buyse, M., Saad, E., Burzykowski, T., & Péron, J. (2020) · Statistics in Biosciences · doi:10.1007/s12561-020-09268-1
Molecularly matched therapy in the context of sensitivity, resistance, and safety; patient outcomes in end-stage cancer – the MetAction study
Ree, A. H., Nygaard, V., Boye, K., Heinrich, D., Dueland, S., Bergheim, I. R., Johansen, C., Beiske, K., Negård, A., Lund‐Iversen, M., et al. (2020) · Acta Oncologica · doi:10.1080/0284186x.2020.1742377 · Cited by 13
Overall survival benefit of continuing immune checkpoint inhibitors treatment post dissociated response in patients with advanced lung cancer
Zhou, H., Sun, Y., Xiu, W., Han, J., Zhong, L., Suo, J., Hao, W., Wang, Y., & Zhu, J. (2020) · Journal of Cancer Research and Clinical Oncology · doi:10.1007/s00432-020-03282-y · Cited by 13
Classification of Molecular Biomarkers
Shah, A., Grimberg, D. C., & Inman, B. A. (2020) · Société Internationale d’Urologie Journal · doi:10.48083/akui6936 · Cited by 13
Radiation therapy and immunotherapy in breast cancer treatment: preliminary data and perspectives
Cao, K. I., Abbassi, L., Romano, E., & Kirova, Y. (2020) · Expert Review of Anticancer Therapy · doi:10.1080/14737140.2021.1868993 · Cited by 13
A Case of Pseudoprogression in Hepatocellular Carcinoma Treated With Atezolizumab Plus Bevacizumab
Watanabe, Y., Ogawa, M., Tamura, Y., Suda, S., Kaneko, M., Kumagawa, M., Hirayama, M., Matsumoto, N., Yamamoto, T., & Moriyama, M. (2021) · Journal of Investigative Medicine High Impact Case Reports · doi:10.1177/23247096211058489 · Cited by 13
Adapting Imaging Protocols for PET-CT and PET-MRI for Immunotherapy Monitoring
Beuthien‐Baumann, B., Sachpekidis, C., Gnirs, R., & Sedlaczek, O. (2021) · Cancers · doi:10.3390/cancers13236019 · Cited by 14
Prognostic value of the fluctuation in the neutrophil–lymphocyte ratio at 6 weeks of pembrolizumab treatment is specific to the clinical response in metastatic urothelial carcinoma
Uchimoto, T., Nakamura, K., Komura, K., Fukuokaya, W., Yano, Y., Nishimura, K., Kinoshita, S., Nishio, K., Fukushima, T., Nakamori, K., et al. (2022) · Urologic Oncology Seminars and Original Investigations · doi:10.1016/j.urolonc.2022.02.012 · Cited by 13
First-Line Pembrolizumab Monotherapy for Advanced NSCLC With Programmed Death-Ligand 1 Expression Greater Than or Equal to 50%: Real-World Study Including Older Patients in Japan
Goto, Y., Tamura, A., Matsumoto, H., Isobe, K., Ozaki, T., Santorelli, M. L., Taniguchi, K., Kamitani, T., Irisawa, M., Kanda, K., et al. (2022) · JTO Clinical and Research Reports · doi:10.1016/j.jtocrr.2022.100397 · Cited by 13
“1 and immune Response Evaluation Criteria in Solid Tumors that are used in prospective clinical trials.(34,35)”
Predicting immunotherapy outcomes in patients with MSI tumors using NLR and CT global tumor volume
Belkouchi, Y., Nebot-Bral, L., Lawrance, L., Kind, M., David, C., Ammari, S., Cournède, P.-H., Talbot, H., Vuagnat, P., Smolenschi, C., et al. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.982790 · Cited by 13
Differentially Expressed Genes and Signaling Pathways Potentially Involved in Primary Resistance to Chemo-Immunotherapy in Advanced-Stage Gastric Cancer Patients
Pinto, M. P., Muñoz‐Medel, M., Retamal, I. N., Bravo, M. L., Latapiat, V., Córdova‐Delgado, M., Hill, C. N., Fernández, M. F., Sánchez, C., Sáez, M., et al. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms24010001 · Cited by 13
“According to iRECIST criteria [49], 16 patients were categorized as responders (n = 16) and 18 were non-responders (n = 18) at 12–16 weeks of treatment.”
Background
A case of hepatocellular carcinoma with “pseudoprogression” followed by complete response to atezolizumab plus bevacizumab
Odagiri, N., Tamori, A., Kotani, K., Motoyama, H., Kawamura, E., Hagihara, A., Fujii, H., Uchida‐Kobayashi, S., Enomoto, M., & Kawada, N. (2023) · Clinical Journal of Gastroenterology · doi:10.1007/s12328-023-01761-6 · Cited by 13
Efficacy, safety and biomarker analysis of durvalumab in patients with mismatch-repair deficient or microsatellite instability-high solid tumours
Geurts, B. S., Battaglia, T., Henegouwen, J. M. V. B., Zeverijn, L. J., de Wit, G. F., Hoes, L. R., van der Wijngaart, H., van der Noort, V., Roepman, P., de Leng, W. W. J., et al. (2023) · BMC Cancer · doi:10.1186/s12885-023-10663-2 · Cited by 14
“Additionally, as response evaluations were performed according to RECIST criteria, potential pseudoprogression could not be taken into consideration [52].”
Method
[18F]FDG PET/CT in the Evaluation of Melanoma Patients Treated with Immunotherapy
Losada, M. M., Romero-Robles, L. R., Melero, A. M., García-Megías, I., Torres, A. V., Garrastachu-Zumaran, P., Chollet, X. B., Lopci, E., Lasanta, R. R., & Bolton, R. D. (2023) · Diagnostics · doi:10.3390/diagnostics13050978 · Cited by 9
Molecular imaging for cancer immunotherapy
Yu, J., & Gao, B. (2023) · iRadiology · doi:10.1002/ird3.12 · Cited by 14
NLR Outperforms Low Hemoglobin and High Platelet Count as Predictive and Prognostic Biomarker in Metastatic Renal Cell Carcinoma Treated with Immune Checkpoint Inhibitors
Young, M., Tapia, J. C., Szabados, B. E., Jovaisaite, A., Jackson‐Spence, F., Nally, E., & Powles, T. B. (2024) · Clinical Genitourinary Cancer · doi:10.1016/j.clgc.2024.102072 · Cited by 15
Thoracic Imaging of Non-Small Cell Lung Cancer Treated With Anti-programmed Death Receptor-1 Therapy
Hammer, M. M., Bagley, S. J., Aggarwal, C., Bauml, J. M., Nachiappan, A. C., Simone, C. B., Langer, C. J., & Katz, S. I. (2018) · Current Problems in Diagnostic Radiology · doi:10.1067/j.cpradiol.2018.01.005 · Cited by 13
Stereophotogrammetric three‐dimensional photography is an accurate and precise planimetric method for the clinical visualization and quantification of human papilloma virus‐induced skin lesions
Rijsbergen, M., Pagan, L., der Kolk, T. N., Rijneveld, R., Hogendoorn, G., Lemoine, C., Miranda, Y. M., Feiss, G. L., Bavink, J. N. B., Burggraaf, J., et al. (2019) · Journal of the European Academy of Dermatology and Venereology · doi:10.1111/jdv.15474 · Cited by 14
PET/CT in Pediatric Oncology
States, L. J., & Voss, S. D. (2019) · Pediatric oncology · doi:10.1007/978-3-030-03777-2_3 · Cited by 13

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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