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New criteria for measuring tumor size and progression will help ease workloads in clinical trials
Date:1/19/2009

, and in using the same measures and endpoints, the more reliably we are able to interpret the results from a variety of sources," she said.

Key changes in RECIST 1.1 that will simplify, optimise and standardise the assessment of tumour burden in clinical trials are as follows: A reduction in the number of lesions to be assessed for response from a maximum of ten to five, and from five to a maximum of two per organ; New guidance on making robust measurements of lymph node involvement; Confirmation of response is required for trials with objective response as a primary endpoint, but is no longer required for randomised studies, since the control arm of these studies provides appropriate means for interpreting results of the experimental arm; The definition of disease progression has been refined so that it not only includes a 20% increase in the size of the lesion, but also a 5 mm absolute increase as well, so that changes of just a few mms in very small tumours, which may be within the range of measurement error, are not unnecessarily described as disease progression; Guidance on imaging, including its use in the detection of new lesions and the interpretation of FDG-PET scan assessment.

Prof Eisenhauer stressed that the recommendations are evidence-based: "They are grounded in the literature and where such information didn't exist as was the case in some areas we set about generating the evidence to guide and support the changes. The EORTC Data Centre, under the leadership of Jan Bogaerts and Patrick Therasse (co-authors of RECIST 1.1), undertook to create a warehouse of data from clinical trials of solid tumours from both industry and cooperative groups. We were able to test the recommendations on these data to look at the impact of proposed changes and decide whether the evidence supported the change or not."

The database consisted of over 6500 patients with more than 18000 target lesions, and was used to investigate the imp
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Source:Eurekalert

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