Yan Liu1, Saskia Litière2, Elisabeth Ge de Vries3, Daniel Sargent4, Lalitha Shankar5, Jan Bogaerts2, Lesley Seymour6. 1. European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium. Electronic address: yan.liu@eortc.be. 2. European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium. 3. Department of Medical Oncology, University of Groningen, University Medical Center, Groningen, The Netherlands. 4. Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA. 5. National Cancer Institute, Cancer Imaging Program, USA. 6. National Cancer Institute of Canada Clinical trials group, Queens University, Kingston, Canada.
Abstract
PURPOSE: With the increasing use of novel targeted agents and the development of high imaging techniques, response evaluation criteria in solid tumour (RECIST) 1.1 developed primarily for cytotoxic agents and anatomic imaging, has demonstrated limitations. A survey was conducted of RECIST users to identify concerns and their suggestions for future RECIST criteria. METHODS: 140 key partners of the RECIST collaboration were asked to complete a questionnaire. The 49 questions concerned (a) satisfaction and concerns with RECIST 1.1; (b) use of modified RECIST criteria and (c) suggestions for the next RECIST Version. RESULTS: Sixty-five replies were received. 52.3% responders were satisfied with RECIST 1.1, while 10.8% indicated dissatisfaction. Areas of potential weakness included: (a) lack of incorporation of potential early indicators of response such as functional imaging, (b) lack of validation in rarer tumour types and (c) lack of validation for novel (targeted) agents. Suggestions were multiple, with highest numbers on two points: developing sub-criteria for certain disease types and including advanced imaging techniques for the evaluation. CONCLUSIONS: Constructive suggestions were received for optimising the next version. Ongoing data collection will make it possible to investigate the possible utilisation of fluorodeoxyglucose-positron emission tomography (FDG-PET) imaging in tumour assessment, to verify whether RECIST is/can still be applicable in novel targeted therapy and to consider the need for criteria for specific disease types.
PURPOSE: With the increasing use of novel targeted agents and the development of high imaging techniques, response evaluation criteria in solid tumour (RECIST) 1.1 developed primarily for cytotoxic agents and anatomic imaging, has demonstrated limitations. A survey was conducted of RECIST users to identify concerns and their suggestions for future RECIST criteria. METHODS: 140 key partners of the RECIST collaboration were asked to complete a questionnaire. The 49 questions concerned (a) satisfaction and concerns with RECIST 1.1; (b) use of modified RECIST criteria and (c) suggestions for the next RECIST Version. RESULTS: Sixty-five replies were received. 52.3% responders were satisfied with RECIST 1.1, while 10.8% indicated dissatisfaction. Areas of potential weakness included: (a) lack of incorporation of potential early indicators of response such as functional imaging, (b) lack of validation in rarer tumour types and (c) lack of validation for novel (targeted) agents. Suggestions were multiple, with highest numbers on two points: developing sub-criteria for certain disease types and including advanced imaging techniques for the evaluation. CONCLUSIONS: Constructive suggestions were received for optimising the next version. Ongoing data collection will make it possible to investigate the possible utilisation of fluorodeoxyglucose-positron emission tomography (FDG-PET) imaging in tumour assessment, to verify whether RECIST is/can still be applicable in novel targeted therapy and to consider the need for criteria for specific disease types.
Authors: Lawrence H Schwartz; Lesley Seymour; Saskia Litière; Robert Ford; Stephen Gwyther; Sumithra Mandrekar; Lalitha Shankar; Jan Bogaerts; Alice Chen; Janet Dancey; Wendy Hayes; F Stephen Hodi; Otto S Hoekstra; Erich P Huang; Nancy Lin; Yan Liu; Patrick Therasse; Jedd D Wolchok; Elisabeth de Vries Journal: Eur J Cancer Date: 2016-05-26 Impact factor: 9.162
Authors: Lesley Seymour; Jan Bogaerts; Andrea Perrone; Robert Ford; Lawrence H Schwartz; Sumithra Mandrekar; Nancy U Lin; Saskia Litière; Janet Dancey; Alice Chen; F Stephen Hodi; Patrick Therasse; Otto S Hoekstra; Lalitha K Shankar; Jedd D Wolchok; Marcus Ballinger; Caroline Caramella; Elisabeth G E de Vries Journal: Lancet Oncol Date: 2017-03-02 Impact factor: 41.316
Authors: Renata Fockink Dos Anjos; Dalton Alexandre Dos Anjos; Danielle Leal Vieira; André Ferreira Leite; Paulo Tadeu de Souza Figueiredo; Nilce Santos de Melo Journal: Medicine (Baltimore) Date: 2016-08 Impact factor: 1.889