title: RECIST 1.1 - Standardisation and disease-specific adaptations: Perspectives from the RECIST Working Group.
abstract: Radiologic imaging of disease sites plays a pivotal role in the management of patients with cancer. Response Evaluation Criteria in Solid Tumours (RECIST), introduced in 2000, and modified in 2009, has become the de facto standard for assessment of response in solid tumours in patients on clinical trials. The RECIST Working Group considers the ability of the global oncology community to implement and adopt updates to RECIST in a timely manner to be critical. Updates to RECIST must be tested, validated and implemented in a standardised, methodical manner in response to therapeutic and imaging technology advances as well as experience gained by users. This was the case with the development of RECIST 1.1, where an expanded data warehouse was developed to test and validate modifications. Similar initiatives are ongoing, testing RECIST in the evaluation of response to non-cytotoxic agents, immunotherapies, as well as in specific diseases. The RECIST Working Group has previously outlined the level of evidence considered necessary to formally and fully validate new imaging markers as an appropriate end-point for clinical trials. Achieving the optimal level of evidence desired is a difficult feat for phase III trials; this involves a meta-analysis of multiple prospective, randomised multicentre clinical trials. The rationale for modifications should also be considered; the modifications may be proposed to improve surrogacy, to provide a more mechanistic imaging technique, or be designed to improve reproducibility of the imaging biomarker. Here, we present the commonly described modifications of RECIST, each of which is associated with different levels of evidence and validation.
authors.affiliation: Department of Radiology, Columbia University Medical Center, New York, NY, USA; New York Presbyterian Hospital, New York, NY, USA. Electronic address: LSchwartz@columbia.edu.
authors.forename: Lawrence H
authors.initials: LH
authors.lastname: Schwartz
authors.affiliation: Canadian Cancer Trials Group, Queen's University, Kingston, Canada.
authors.forename: Lesley
authors.initials: L
authors.lastname: Seymour
authors.affiliation: EORTC HQ, Brussels, Belgium.
authors.forename: Saskia
authors.initials: S
authors.lastname: Litière
authors.affiliation: Clinical Trials Imaging Consulting, NJ, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Ford
authors.affiliation: Department of Medical Imaging, East Surrey Hospital, Redhill, Surrey, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Gwyther
authors.affiliation: Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Sumithra
authors.initials: S
authors.lastname: Mandrekar
authors.affiliation: Clinical Trials Branch, Cancer Imaging Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland, USA.
authors.forename: Lalitha
authors.initials: L
authors.lastname: Shankar
authors.affiliation: EORTC HQ, Brussels, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Bogaerts
authors.affiliation: Early Clinical Trials Development Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland, USA.
authors.forename: Alice
authors.initials: A
authors.lastname: Chen
authors.affiliation: Canadian Cancer Trials Group, Queen's University, Kingston, Canada.
authors.forename: Janet
authors.initials: J
authors.lastname: Dancey
authors.affiliation: Exploratory Clinical & Translational Research, Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: Wendy
authors.initials: W
authors.lastname: Hayes
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: F Stephen
authors.initials: FS
authors.lastname: Hodi
authors.affiliation: Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Otto S
authors.initials: OS
authors.lastname: Hoekstra
authors.affiliation: National Cancer Institute, National Institutes of Health, Rockville, Maryland, USA.
authors.forename: Erich P
authors.initials: EP
authors.lastname: Huang
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Lin
authors.affiliation: EORTC HQ, Brussels, Belgium.
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Laboratoires Servier, Paris, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Therasse
authors.affiliation: Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical and Graduate Colleges, New York, NY, USA; Ludwig Institute for Cancer Research, New York, NY, USA.
authors.forename: Jedd D
authors.initials: JD
authors.lastname: Wolchok
authors.affiliation: Department of Internal Medicine, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: de Vries
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis*; D006801:Humans; D009369:Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology / Q000628:therapy*; D000072078:Positron Emission Tomography Computed Tomography; D015203:Reproducibility of Results; D066066:Response Evaluation Criteria in Solid Tumors; D014057:Tomography, X-Ray Computed / Q000379:methods
chemical_list: D014408:Biomarkers, Tumor
keywords: Modifications; RECIST; Tumour response