iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics
By L. Seymour, J. Bogaerts, A. Perrone, R. Ford, Lawrence H. Schwartz, Sumithra J. Mandrekar, N. Lin, S. Litière, J. Dancey, Alice P. Chen and 8 more. The Lancet Oncology, 2017
2,028 citations recorded by the source corpus.
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.
Subfields: Cancer Research, Oncology, Pathology and Forensic Medicine
View Paper: https://www.semanticscholar.org/paper/26dffed827673c8d0ddb2b7a5fb8cacbaed246f7
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Citations in the corpus
- Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. (2018, methodology): “More recently, the RECIST working group published a proposition of new criteria called immune-RECIST (iRECIST), to standardise response assessment among immunotherapy clinical trials [83].”
- Hyperprogressive Disease in Patients With Advanced Non–Small Cell Lung Cancer Treated With PD-1/PD-L1 Inhibitors or With Single-Agent Chemotherapy (2018, methodology): “In cases of progression, if the patient was clinically stable, PD-1/PD-L1 inhibitors could be continued, with a subsequent evaluation at least 4 weeks later, according to immunotherapy response criteria recommendations.(12) Pseudoprogression was defined as initial progression, followed by complete r”
- Development of PD-1 and PD-L1 inhibitors as a form of cancer immunotherapy: a comprehensive review of registration trials and future considerations (2018, methodology): “sponse and progression to cancer immunotherapy [87].”
- The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC) (2019, positive): “sponse metrics, such as the immune-related response criteria (irRC) and immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) [77, 80].”
- TROP2 expression in head and neck squamous cell carcinoma: association with the tumor immune microenvironment and clinical outcome (2026, unknown): “Tumor response was evaluated according to the RECIST 1.1 guidelines (23, 24).”