RE:RE:RE:RE:RE:RE:RE:RE:RE:At least give us news about no news ... They keep giving patients drug as long as their disease doesn't progress and if they remain healthy enough to stay on trial. Disease progression is defined as more than 30%tumour increase, at that point they are considered non-responders, the drug isn't working for them, and there is no reason to keep taking the drug. If they are stable disease (between 30% tumour growth or 30% tumour reduction) or are responders (more than 30% reduction) then they just keep getting drug unless a health issue arises.
It would be a form of cruelty to give the patient a cycle or two of drug, get a response, and then say no more drug for you. While they remain eligible they keep getting drug cycles.
SPCEO1 wrote: Actually, I think we agree. You restated what I was saying as best I can tell. In phase 1a, do we know how many cycles they are giving the patients? I am not sure depsite having listened to everything very closely over time. But maybe I still missed it and they are doing at least three cycles. At times I thought that but I am no longer sure they are doing more than one or two. It would be nice to have that cleared up.
jfm1330 wrote: I don't agree. Preliminary indication of efficacy is after the first cycle of treatment. Efficacy, or confirmed efficacy, is after several cycles of treatment. The time factor is important when assessing efficacy. You need to see it over time. After a single treatment, the tumor shrinkage can be too small to be sure it's real efficacy. Radiologists will tell you that from scan to scan, some tumors can move, and just the angle of it can make it look smaller or bigger within a 10% range. That's why a partial response is considered to be 30% size reduction or more. You are unlikely to have 30% shrinkage after a single cycle of treatment.
- Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- https://www.verywellhealth.com/partial-response-pr-2252162
SPCEO1 wrote: I
One thing I have been thinking is that we need to listen to their words closely. When they say "preliminary indications of efficacy" I think they are talking about phase 1a and when they just say "efficacy", I think they are talking about phase 1b.