Table 5.
irRC (2D), 2009 | irRECIST (1D), 2013 | iRECIST (1D), 2017 | imRECIST (1D), 2018 | |
Minimum number of target lesions | 10 lesions in total; 5 lesions per organ | 5 lesions in total; 2 lesions per organ | 5 lesions in total; 2 lesions per organ | 5 lesions in total; 2 lesions per organ |
New lesions | Included in the sum of the measurements | Included in the sum of the measurements | iUPD; becomes iCPD if PD eventually confirmed | Included in the sum of the measurements |
CR | Disappearance of all lesions | Disappearance of all lesions | Disappearance of all lesions | Disappearance of all lesions |
PR | ≥ 50% decrease from baseline | ≥ 30% decrease from baseline | ≥ 30% decrease from baseline | ≥ 30% decrease from baseline |
SD | Neither CR nor PD | Neither CR nor PD | Neither CR nor PD | Neither CR nor PD |
PD | ≥ 25% increase in the nadir | ≥ 20% increase in the nadir (minimum 5 mm) | ≥ 20% increase in the nadir (minimum 5 mm) | ≥ 20% increase in the nadir (minimum 5 mm) |
Confirmation of PD | Yes | Yes1 | Yes2 | Yes3 |
At least 4 wk after, and up to 12 wk;
At least 4 wk after, and up to 8 wk;
4 wk after. 1D: Unidimensional; 2D: Bidimensional; CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; iUPD: Immune unconfirmed progressive disease; iCPD: Immune confirmed progressive disease; irRECIST: İmmune-related Response Evaluation Criteria in Solid Tumors; iRECIST: İmmunotherapy Response Evaluation Criteria in Solid Tumors; irRC: İmmune-specific related response criteria; imRECIST: Immune-Modified Response Evaluation Criteria In Solid Tumors.