Timing of scans to confirm iCPD

Timing of scans to confirm iCPD

iRECIST recommends that imaging be repeated 4-8 weeks after iUPD was detected. Questions: Scans were repeated 9 weeks after the iUPD was first detected, because of scheduling issues.  Can those scans not be used? Answer: In order to ensure that patients do not have real and continuing disease progression that requires a change in management,

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Duration of i-response (iDOR).

iDOR is defined as the time from the date of the first response iCR/iPR (whichever is first recorded) to the date of PD (iUPD confirmed as iCPD.  iDOR is only defined for subjects who have best overall response of iCR or iPR.  If a patient has  iPR (#1) followed by a iUPD (#1) which is not

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How do new lesions define progression?

New lesions by themselves may define iUPD (when they appear), or iCPD when they increase in size (5mm or more if they are target, or any increase if non target), or another lesion appears. However, as noted, the rules of RECIST1.1 always apply – if new lesions appear but then decrease in size or stay

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Classification of assessments (Time Point Responses (TPR)) after unconfirmed progression (iUPD) has occurred but was not subsequently confirmed (iCPD), specifically when iPR (partial response) can be assigned.

In the paper and as reproduced below, scenario B shows that the appearance of a new lesion (NL) does not preclude the next assessment (time-point, TP) being iPR (immune partial response, because of further shrinkage of target lesions after the new lesion is recorded), while in scenario D, iUPD (i-unconfirmed progressive disease) occurs at TP3

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