Since the year 2000, an international committee promulgated unified, easily
applicable criteria for measuring tumor response using X-ray, CT and MRI which
is known as
Response Evaluation Criteria in Solid Tumors
(RECIST). The
technique is recommended but not mandatory for NCI sponsored trials and
involves formalized rules for measurement of tumor target lesions.
Guidelines and a
RECIST Quick Reference for incorporating the procedure are
available online, and detailed explanations for application of the method in
clinical trials can be found at the
European Organization for Research and Treatment
of Cancer (EORTC) RECIST Web page. NCI-funded cooperative groups are
encouraged, but not required, to use RECIST criteria.
RECIST criteria are a voluntary, international standard, and are not an NCI
standard. They are based on a simplification of former methods (WHO, ECOG) and
based on measurable disease, i.e., the presence of at least one measurable
lesion.
RECIST criteria offer a simplified, conservative, extraction of imaging data
for wide application in clinical trials. They presume that linear measures are
an adequate substitute for 2-D methods and registers four response categories:
-
CR (complete response) = disappearance of all target lesions
-
PR (partial response) = 30% decrease in the sum of the longest diameter of
target lesions
-
PD (progressive disease) = 20% increase in the sum of the longest diameter of
target lesions
-
SD (stable disease) = small changes that do not meet above criteria
Plans call for improving on RECIST methodology by developing and validating
clinical trial-acceptable methods and standards to incorporate:
-
volumetric (3D) anatomical imaging
-
dynamic contrast imaging
-
functional (molecular) imaging
If successful, the use of medical image data as a surrogate endpoint in
clinical trials could lead to:
-
Smaller clinical trials with fewer patients
-
Earlier go/no decisions on drug compounds
-
Faster regulatory approval for new drugs
-
Earlier use in clinical care
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