Assessing RECIST to prepare for new clinical trial models

The RECIST Working Group published their view on the continued relevance of RECIST guidelines and on the challenges to maintain RECIST as a standard for the assessment of tumour burden in clinical trials.

“While we recognise that RECIST cannot accommodate all possible protocol specificities, it remains the only general tool that provides harmonisation of tumour response assessment,” says Jan Bogaerts, Director Methodology at EORTC. “However, maintaining the validity and relevance of RECIST as a standard evaluation approach is challenging, in particular to maintain a balance between its specificity and generalizability.” The authors also note that the use of RECIST to guide treatment interventions and data collection in clinical trials might limit the utility of existing databases for the validation of new evaluation approaches to tumour response.

The result of a large collaboration between industry and academia,  RECIST remains an integral part of the assessment of tumour burden in many oncology clinical trials . However, key questions have been identified, notably relating to new classes of treatments and new imaging modalities. The RECIST Working Group is evaluating the possibility of integrating new end-points or models for drug activity, such as recommendations for targeted drugs, immunological drugs, FDG-PET imaging, and lesion site-specific rules. Work on all of these aspects is ongoing, with several publications planned in the course of 2017.

“RECIST is a community project that tries to serve many, often conflicting goals,” conclude the authors. “Our challenge remains to obtain the necessary scientific input from the oncology community – including large datasets – to enable us to keep this “standardization tool” relevant, up to date, and useful.”