CJ, why did you make this statement: "Obviously, he fell back out of CR at some point."
Doesn't OR = PR + CR. They have only been reporting OR since 2-4-09 and a CR can still be included in OR population. What was it that I missed. Thanks.
In the setting of PR (or SD), if a lesion disappears and reappears at a subsequent time point it should continue to be measured. Response will depend upon the status of his/her other lesions. The lesion should simply be added into the sum.
In the setting of CR, reappearance of a lesion would be considered PD.
Most lesions do not actually ‘disappear’ but are not visualized because they are beyond the resolving power of the imaging modality employed.
In my post #45804 from 12/13/09, I pointed out that RECIST had changed the definition of PD (PFS) to better deal with tumors that shrink by a large amount. In my opinion this was done as a result of an inquiry from an investigator that was dealing with this problem.
"Some additional commentary regarding PFS. In my opinion, since PFS was first established prior to drugs that do a good job of shrinking tumors, like bavi, it's probably better suited to assess the efficacy of less effective drugs. The problem crops up when a tumor shrinks down to a very small size and just a small increase triggers a PFS response. It’s interesting that RECIST, back in January of this year, redefined PFS to help deal with this issue.
RECIST 1.1: Target Lesions: > 20% increase in the SLD taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir When sum becomes very small, increases within measurement error (2-3 mm) can lead to 20% increase
This helps the situation some, however, the way it's used in this protocol it still doesn't help the patient who benefits from bavi/chemo with a large amount of tumor shrinkage and then has a small rebound when the chemo is discontinued."
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