Table 2.
Comparison between conventional criteria and immune‐related response assessment systems
| WHO (1979) | irRC (2009) | RECIST1.0 (2000) | RECIST1.1 (2009) | irRECIST (2013) | iRECIST (2017) | |
|---|---|---|---|---|---|---|
| Measurements | BD | BD | UD | UD | UD | UD |
| New, measurable lesions | Designates PD | Incorporates into TTB for the assessment of PD | Designates PD | Designates PD | Incorporates into TTB for the assessment of PD | Separately documents; adds into the assessment of PD |
| CR |
Disappearance of all IL and NIL Nodal short axis diameter <10 mm No new lesions |
|||||
| PRa | ≥50% decrease in TB, non‐unequivocal progression for NIL or no new lesions | ≥50% decrease in TTB, non‐unequivocal progression for NIL or no new lesions | ≥30% decrease in TB, non‐unequivocal progression for NIL or no new lesions | ≥30% decrease in TB, non‐unequivocal progression for NIL or no new lesions | ≥30% decrease in TTB, non‐unequivocal progression for NIL or no new lesions | ≥30% decrease in TB, non‐unequivocal progression for NIL or no new lesions |
| SD | Neither PR nor PD | |||||
| PDb | ≥25% increase in TB and/or progression of NIL and/or new lesions | ≥25% increase in TTB | ≥20% increase in TB and/or progression of NIL and/or new lesions | ≥20% increase in TB and ≥5 mm increase in absolute value, and/or progression of NIL and/or new lesions | ≥20% increase in TTB and ≥5 mm increase in absolute value, and/or progression of NIL and/or new lesions | iUPD—≥20% increase in TB and/or progression of NIL and/or new lesions |
| Confirmation of PD | NA | ≥25% increase in TTB | NA | NA | New unequivocal progression or continued progression from the first PD; presence of another new lesions | iCPD—≥5 mm increase in new IL, increased size of IL or NIL, progression of new NIL, presence of another new lesions |
Abbreviations: BD, bidimensional (longest diameter × longest perpendicular diameter for both nonnodal lesions and lymph nodes); CR, complete response; iCPD, immune‐confirmed progressive disease; IL, index lesions; iRECIST, immune RECIST; irRC, immune‐related response criteria; irRECIST, immune‐related RECIST; iUPD, immune‐unconfirmed progressive disease; NA, not available; NIL, non‐index lesions; PD, progressive disease; PR, partial response; SD, stable disease; RECIST, response evaluation criteria in solid tumors; TB, tumor burden; TTB, total tumor burden; UD, unidimensional (longest diameter for nonnodal lesions, longest perpendicular diameter for lymph nodes); WHO, World Health Organization.
In reference to the baseline.
In reference to the nadir (minimum recorded TB).