January 14 2025
Submitted by Laura Sorci, BS, CCRP; Senior Clinical Research Coordinator, Baystate Regional Cancer Program
Since it was first developed and published in 2000, RECIST (Response Evaluation Criteria in Solid Tumors) continues to be the gold standard for assessing how well a cancer patient is responding to treatment. After a version update in 2009, the current RECIST v1.1 guidelines are required to be followed in most solid tumor clinical trials that measure radiographic response as an endpoint. Due to its vital importance in statistical analysis and evaluating treatment outcomes, it is essential that all study staff responsible for documenting and reporting RECIST data are adequately trained to perform this task. Depending on individual preference, RECIST guidelines can be reviewed in PDF form or through a video tutorial, such as the ‘RECIST Basics’ module available on CTSU’s CLASS portal.(login required)
In 2016, the RECIST Committee summarized frequently asked questions and provided clarifications to the 2009 guidelines which can be found here.
Even with sufficient staff training, mistakes in documentation and reporting are frequent findings during an audit. The table (posted here) outlines some of the more common errors in RECIST documentation and the corresponding RECIST 1.1 guideline that should be followed.
To help address these issues, only physicians who are trained to measure tumor size, number, and location should be documenting RECIST measurements. They should be provided with a RECIST measurement worksheet (several options are available online; one example can be found on the RECIST website at https://recist.eortc.org) to aid in capturing the information correctly per RECIST guidelines. CRAs/DMs and other study personnel responsible for entering the data into RAVE should check to ensure (1) the correct number of target lesions/lesions per organ are being reported, (2) that the % of response upon reassessment is calculated correctly, and (3) that the appropriate response designation is given (e.g. CR, PR, SD, PD).
In addition to documentation errors, deviations or missed assessments can also play a role in inadequate RECIST reporting. It is vitally important to the patient and to the integrity of the clinical trial to adhere to the protocol scanning schedule and to use the same imaging type (CT, MRI, etc.) throughout the study. Scanning at protocol-specified intervals not only informs treatment response, but it is also critical for the statistical analysis of the protocol’s progression-free and/or overall survival endpoints. Several NRG protocols offer an Excel spreadsheet tool on CTSU to calculate scanning dates based on the requirements of the protocol. (Note that these dates are static and do not change in the case of a treatment delay, for example). If an Excel spreadsheet is not available for a protocol, one can be created from scratch, or an existing spreadsheet can be duplicated if the scan intervals are the same. Study staff could also use an online date calculator to project out scan dates and save them electronically.
Even minor mistakes in RECIST documentation and reporting can impact both treatment decisions and clinical trial results. For this reason, familiarity with RECIST guidelines and some of the more common pitfalls should be continuously reviewed among study staff to ensure adequate assessment and data submission.
Teslenko, Iryna, Belotserkovskiy, Maxim, Kumar, Akhil “Common Pitfalls of RECIST 1.1 Application in Clinical Trials”, ResearchGate, June 2015, https://www.researchgate.net/publication/280575735.
E.A. Eisenhauera,*, P. Therasseb, J. Bogaertsc, L.H. Schwartzd, D. Sargente, R. Fordf, J. Danceyg, S. Arbuckh, S. Gwytheri, M. Mooneyg, L. Rubinsteing, L. Shankarg, L. Doddg, R. Kaplanj, D. Lacombec, J. Verweijk “New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)”, European Journal of Cancer 45 (2009), https://ctep.cancer.gov/protocoldevelopment/docs/recist_guideline.pdf