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

act of a variety of questions, such as the number of lesions needing to be measured. "Our consequent recommendation that the number of lesions measured should be reduced from ten to five will have a big implication for the workload in clinical trials and we found that it will have no impact on described study outcomes," said Prof Eisenhauer. "This change can be made without any loss of information."

Professors Verweij, Eisenhauer and Therasse (who is also co-editor of the special issue and now based at GlaxoSmithKline Biologicals, Rixensart, Belgium) say that in the future it would be desirable to incorporate the use of modern functional imaging techniques in assessing benefit to treatment. "Although there are many exciting developments in this field, none of these techniques was considered as ready to substitute for anatomical endpoint assessment in clinical trials yet, since their use.awaits validation in large datasets and their availability in trial centres is limited," they write in their introduction to the special issue. A discussion paper in the issue describes the process and the level of evidence that would be needed before functional imaging could be used in addition to, or instead of, anatomical imaging in clinical trials.

Professor Alexander M.M. Eggermont, president of ECCO (the European CanCer Organisation), welcomed the publication of RECIST 1.1. "This is an important and timely publication for all clinicians working in cancer clinical trials. I'm particularly pleased that some of the amendments will contribute to lessening the workload on trial investigators. This revision of the RECIST guidelines will enable researchers to work smarter and more effectively so that, ultimately, patients will benefit from improved treatments reaching them sooner."

(ends)

This release is embargoed to 00.01 hrs (GMT) on Tuesday 20 January 2009.

Notes: [1] European Journal of Cancer, Vol 45, issue 2 (January 2009), pages 225
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Contact: Emma Mason (media enquiries only)
wordmason@mac.com
44-077-112-96986
ECCO-the European CanCer Organisation
Source:Eurekalert

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