The only real endpoint is whether the patient deve
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Posted On: 01/24/2020 3:01:12 PM
The only real endpoint is whether the patient develops/resolves metastases or not. CTC is only a surrogate end point for a reason. Ultimately, metastases must be clinically determined by imaging. See https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6505632/ for a discussion of the difficulties with CTC levels and prognostics.
Yes, of course, CTC levels are very important; however, in this case, this patient is not a mTNBC patient but a HER2+ patient not involved in the actual mTNBC study but a compassionate use patient.
Would I like to know what her CTC levels are? Of course. But, we would need to know before tx what they were and what they are now. With advanced metastases, however, there is likely to be a fair amount of variability. So, with this patient, imaging is the test that has by far the most significance to us or the FDA.
As you say, with patients with minimal or early disease, CTC levels are a good surrogate.
Yes, of course, CTC levels are very important; however, in this case, this patient is not a mTNBC patient but a HER2+ patient not involved in the actual mTNBC study but a compassionate use patient.
Would I like to know what her CTC levels are? Of course. But, we would need to know before tx what they were and what they are now. With advanced metastases, however, there is likely to be a fair amount of variability. So, with this patient, imaging is the test that has by far the most significance to us or the FDA.
As you say, with patients with minimal or early disease, CTC levels are a good surrogate.
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