Questions and Thoughts
The results for TU, TUORRES = target, non-target, or new target. This convention was designed for tumor assessment. Target and non-target have very specific definitions depending on the tumor under study. Generally for solid tumor, according to RECIST:
Measurable lesions - lesions that can be accurately measured in at least one dimension with longest diameter 20 mm using conventional techniques or 10 mm with spiral CT scan.
- All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline.
Non-measurable lesions - all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or <10 mm with spiral CT scan), i.e., bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, cystic lesions, and also abdominal masses that are not confirmed and followed by imaging techniques.
- All other lesions (or sites of disease) should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence or absence of each should be noted throughout follow-up.
Since TU is also shared by Lesion Identification, to have a result as "target" is misleading and doesn't always apply to non-tumor settings. When you say there is a target aneurysm, what does that mean? Target for treatment and response evaluation? what is the criteria that makes it a target? Usually an aneurysm larger than 5cm requires surgery. Does that mean the ones that are smaller than 5 cm are considered "non-target"? and non-target for what? surgery not needed? The values for TU responses right now, doesn't make sense for non-tumor lesion identification process.
CV endpoint TAUG
The example in the CV-end point TAUG use Target vs Non-target to mean: target for PVI or PCI treatment. There is NO criteria that defines what target means, i.e. size of the lesion, etc.