title: iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics.
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.
authors.affiliation: Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada. Electronic address: lseymour@ctg.queensu.ca.
authors.forename: Lesley
authors.initials: L
authors.lastname: Seymour
authors.affiliation: EORTC Headquarters, Brussels, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Bogaerts
authors.affiliation: Translational Medicine, Merck & Co, Kenilworth, NJ, USA.
authors.forename: Andrea
authors.initials: A
authors.lastname: Perrone
authors.affiliation: Clinical Trials Imaging Consulting, LLC, Belle Mead, NJ, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Ford
authors.affiliation: Department of Radiology, Columbia University Medical Center, New York, NY, USA; New York Presbyterian Hospital, New York, NY, USA.
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Schwartz
authors.affiliation: Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.
authors.forename: Sumithra
authors.initials: S
authors.lastname: Mandrekar
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
authors.forename: Nancy U
authors.initials: NU
authors.lastname: Lin
authors.affiliation: EORTC Headquarters, Brussels, Belgium.
authors.forename: Saskia
authors.initials: S
authors.lastname: Litière
authors.affiliation: Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
authors.forename: Janet
authors.initials: J
authors.lastname: Dancey
authors.affiliation: Early Clinical Trials Development Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.
authors.forename: Alice
authors.initials: A
authors.lastname: Chen
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
authors.forename: F Stephen
authors.initials: FS
authors.lastname: Hodi
authors.affiliation: Institut de Recherche International Servier, Paris, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Therasse
authors.affiliation: Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Otto S
authors.initials: OS
authors.lastname: Hoekstra
authors.affiliation: Diagnostic Imaging Branch, National Cancer Institute, Bethesda, MD, USA.
authors.forename: Lalitha K
authors.initials: LK
authors.lastname: Shankar
authors.affiliation: Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
authors.forename: Jedd D
authors.initials: JD
authors.lastname: Wolchok
authors.affiliation: Weill Cornell Medical and Graduate Colleges, New York, NY, USA; Ludwig Institute for Cancer Research, New York, NY, USA; Genentech Inc, San Francisco, CA, USA.
authors.forename: Marcus
authors.initials: M
authors.lastname: Ballinger
authors.affiliation: Department of Radiology, Gustav Roussy Cancer Campus, Villejuif, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Caramella
authors.affiliation: Department of Medical Oncology, University Medical Center Groningen, Groningen, Netherlands.
authors.forename: Elisabeth G E
authors.initials: EGE
authors.lastname: de Vries
mesh_terms: D018450:Disease Progression; D006801:Humans; D007167:Immunotherapy; D009369:Neoplasms / Q000628:therapy*; D017410:Practice Guidelines as Topic / Q000592:standards*; D066066:Response Evaluation Criteria in Solid Tumors; D047368:Tumor Burden