title: RECIST - learning from the past to build the future.
abstract: Response Evaluation Criteria In Solid Tumours (RECIST) remain an integral part of the assessment of tumour burden in many clinical trials in oncology; these criteria are used to evaluate the activity and efficacy of new cancer therapeutics in solid tumours. We aim to define the purpose of RECIST, and reflect on the level of documentation needed to enable changes for these criteria to develop a new RECIST. Maintaining the applicability of RECIST as a standard evaluation approach is associated with many challenges, in particular with maintaining a balance between the specificity and generalizability, continued validation and innovation, and use of RECIST in early phase versus late-phase drug development, as well as its relevance in clinical trials versus clinical practice. Key questions relate to different modes of actions of new classes of treatments and new imaging modalities; thus, the RECIST Working Group remains committed to maintain RECIST as a standard for the oncology community.
authors.affiliation: EORTC Headquarters, Avenue E Mounier 83/11, 1200 Brussels, Belgium.
authors.forename: Saskia
authors.initials: S
authors.lastname: Litière
authors.affiliation: EORTC Headquarters, Avenue E Mounier 83/11, 1200 Brussels, Belgium.
authors.forename: Sandra
authors.initials: S
authors.lastname: Collette
authors.affiliation: Department of Medical Oncology, University Medical Center Groningen, Hanzeplein, 19713 GZ Groningen, The Netherlands.
authors.forename: Elisabeth G E
authors.initials: EG
authors.lastname: de Vries
authors.affiliation: Canadian Cancer Trials Group, Queen's University, 10 Stuart Street, Kingston, Ontario K7L 3N6, Canada.
authors.forename: Lesley
authors.initials: L
authors.lastname: Seymour
authors.affiliation: EORTC Headquarters, Avenue E Mounier 83/11, 1200 Brussels, Belgium.
authors.forename: Jan
authors.initials: J
authors.lastname: Bogaerts
mesh_terms: D014408:Biomarkers, Tumor / Q000378:metabolism; D002986:Clinical Trials as Topic; D023381:Endpoint Determination; D005544:Forecasting; D006801:Humans; D009369:Neoplasms / Q000473:pathology / Q000628:therapy*; D066066:Response Evaluation Criteria in Solid Tumors; D047368:Tumor Burden
chemical_list: D014408:Biomarkers, Tumor