If iUPD is driven by non-target disease, how is progression confirmed at the next assessment?

Per RECIST 1.1, in exceptional circumstances, unequivocal progression in non-target disease may result in RECIST 1.1 PD / iRECIST iUPD. Any increase in non-target tumour burden at the next assessment would allow iCPD to be confirmed; the increase does NOT have to be unequivocal (per RECIST 1.1) again.

The same is true for new lesions. A new lesion results in iUPD; if the new lesions are non-target, any increase in size at the next assessment allows iCPD to be assigned – the increase does not need to be unequivocal as defined by a RECIST 1.1

Lesions designated as non-target disease should be categorised on the case record form as for example

  • no change from baseline or nadir (NC)
  • increased from baseline or nadir (INC)
  • no change from last assessment (NCLA)
  • further increase from last assessment (INCLA)
  • unequivocal increase (UNE)

Assessments with NC, UNE, NCLA can then be differentiated in the database from NC, UNE, INCLA with the former being iUPD/iUPD and the latter iUPD/iCPD

β€˜New’ progression in other disease categories such as target disease, or another new lesion can of course also confirm progression.