Table 1.

Comparison of RECIST 1.1, irRC and iRECIST

	RECIST 1.1	irRC	iRECIST
Complete Response	Disappearance of all target lesions or lymph nodes <10 mm in the short axis	Disappearance of all target lesions or lymph nodes in 2 consecutive observations not less than 4 weeks apart	Disappearance of all target lesions or lymph nodes <10 mm in the short axis
Partial Response	>30% decrease in tumor size or ≥15% decrease in tumor attenuation at CT, no new lesions	≥50% decrease in tumor burden compared with baseline in 2 observations at least 4 weeks apart	>30% decrease in tumor size or ≥15% decrease in tumor attenuation at CT, no new lesions
Progressive Disease	>20% increase of SPD of target lesions with an absolute increase of ≥5 mm, new lesions	≥25% increase of SLD compared with nadir (at any singe time point) in 2 consecutive observations at least 4 weeks apart	Differentiation between iUPD and iCPD (see below), iUPD can result in PR or CR
Stable Disease	None of the above	None of the above	None of the above
New Lesions	Results in PD	Results in PD that has to be confirmed in 2 observations at least 4 weeks apart	Results in iUPD and consequently in iCPD if additional new lesions appear or an increase of size of new lesions (>5 mm for SLD or any increase of non-target lesions)
Confirmation of PD	Not required (unless equivocal)	Required	Required
Consideration of clinical status	Not included in assessment	Not included in assessment	Clinical stability is considered in whether treatment is continued after iUPD

RECIST 1.1. Response Evaluation Criteria in Solid Tumors; irRC Immune-Related RECIST; iRECIST immune RECIST; PD progressive disease; CR complete response; SD stable disease; iUPD unconfirmed immune PD; iCPD confirmed immune PD; SPD sum of the products of diameters