Table 4. .
WHO | IrRC | RECIST 1.0 | RECIST 1.1 | irRECIST | iRECIST | |
CR | Complete resolution of lesions (confirmed at 4 weeks) | Complete resolution of lesions (confirmed at 4 weeks) from first irCR scan | Complete resolution of lesions | Complete resolution of non-nodal lesions and < 10 mm short-axis for lymph nodes | Complete resolution of non-nodal lesions and < 10 mm short-axis for lymph nodes. No confirmation necessary | Complete resolution of non-nodal lesions and < 10 mm short-axis for lymph nodes. No new lesions |
PR | ≥50% decrease in tumour burden (confirmed at 4 weeks) | ≥50% decrease in tumour burden (confirmed at 4 weeks) | ≥30% decrease in tumour burden | ≥30% decrease in tumour burden | ≥30% decrease in tumour burden | ≥30% decrease in tumour burden |
SD | Does not meet criteria for CR/PR/PD | Does not meet criteria for irCR/irPR/irPD | Does not meet criteria for CR/PR/PD | Does not meet criteria for CR/PR/PD | Does not meet criteria for irCR/irPR/irPD | Does not meet criteria for iCR/iPR/iUPD/iCPD |
PD | ≥25% increase in tumour burden relative to nadir; new lesions | ≥25% increase in tumour burden relative to nadir; new lesions. Confirmation of PD via a subsequent scan ≥ 4 weeks later is required | ≥20% increase in tumour burden relative to nadir; new lesions | ≥20% increase in tumour burden relative to nadir and a minimum absolute increase of 5 mm; new lesions | ≥20% increase in tumour burden relative to nadir and a minimum absolute increase of 5 mm; new lesions. Confirmation of PD via a subsequent scan ≥ 4 weeks later to detect delayed responses is required | iUPD—presence of new measurable/non- measurable lesions, or ≥ 20% increase in tumour burden relative to nadir iCPD-confirmation of IUPD with >/= 5 mm increase in size of target or new target lesions, increase in non-target or new non-target or increase in number of new lesions. |
CR, complete response; iCPD, immune-confirmed progressive disease; iCR, immune complete response; iPR, immune partial response; irCR, immune-related complete response; irPR, immune-related partial response; irPD, immune-related progressive disease; irRC, immune-related response criteria; irRECIST, immune-related Response Evaluation Criteria in Solid Tumours; iUPD, immune–unconfirmed progressive disease; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumours; SD, stable disease; WHO, World Health Organization.