Criterion | RECIST v1.1 | irRC | imRECIST |
Tumor burden | Unidimensional | Bidimensional per WHO | Unidimensional, with other target lesion criteria (number, measurability) per RECIST v1.1 |
Up to five target lesions or two per organ | Up to 10 target lesions or five per organ | ||
New lesions | Always represent PD | New lesions do not categorically define PD | New lesions do not categorically define PD |
Measurable new lesions incorporated into the total tumor burden | Measurable new lesions incorporated into the total tumor burden | ||
Nonmeasurable new lesions preclude CR | Nonmeasurable new lesions preclude CR | ||
Nontarget lesions | Can contribute to defining CR or PD (unequivocal progression) | Nontarget progression does not define PD | Nontarget progression does not define PD |
Can only contribute to defining CR (complete disappearance required) | Can only contribute to defining CR (complete disappearance required) | ||
PD | ≥20% increase in the SLD (RECIST) and ≥5 mm increase compared with nadir, unequivocal progression in nontarget lesions, and/or appearance of new lesions | Determined only on the basis of measurable disease | Determined only on the basis of measurable disease |
Negated by subsequent non-PD assessment ≥4 weeks from the date first documented (lack of confirmation) | Negated by subsequent non-PD assessment ≥4 weeks from the date first documented (lack of confirmation) | ||
≥25% increase in the SLD compared with baseline/nadir | ≥20% increase in SLD (RECIST) compared with baseline/nadir | ||
Confirmation of PD not required | Best response may occur before confirmed PD | Best response may occur after any number of PD assessments |
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