Clinical Research News: European journal revises tumor size guidelines
European journal revises tumor size guidelines
The European Journal of Cancer has revised its 2000 guidelines used to measure tumor size, called the Response Evaluation Criteria in Solid Tumors (RECIST) in the journal's January, 2009, issue.1
RECIST is used by clinical trial investigators for phase II and phase III studies of new anticancer drugs. The guidelines assist investigators with measuring tumor shrinkage and time to the development of disease progression as trial endpoints.
The revised guidelines address some of the changing methodologies and treatments, simplifying and standardizing the assessment of tumor burden.
For example, one change calls for a reduction in the number of lesions to be assessed for response from 10 lesions to five. Also, the number of lesions per organ was reduced from five to two.1
In addition, the revised guidelines redefine disease progression to include both a 20% increase in the size of the lesion and a 5 mm absolute increase. This eliminates defining increases in very small tumors as disease progression when they might be within the range of measurement area.1
For more information about the revised RECIST guidelines, visit the journal's Web site at www.ejcancer.info.
Reference
- Vervweij J, Therasse P, Eisenhauer E. Cancer clinical trial outcomes: Any progress in tumor-size assessment? Europ J Cancer. 2009;45(2):225-227.
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