Category | RECIST v1.1 | irRC |
Measurement of tumor burden | Unidimensional | Bidimensional |
Target lesions | Maximum, 5* | Maximum, 15 index lesions |
New lesion | Results in progressive disease at first appearance | Up to 10 new visceral lesions and 5 cutaneous lesions may be added to the sum of the products of the two largest perpendicular diameters of all index lesions at any time point |
Complete response | Disappearance of all target and nontarget lesions Nodes must regress to <10 mm short axis No new lesions Confirmation required | |
Partial response | ≥30% decrease in tumor burden compared with baseline Confirmation required | ≥50% decrease in tumor burden compared with baseline¶ Confirmation required |
Progressive disease | ≥20% + 5 mm absolute increase in tumor burden compared with nadir Appearance of new lesions or progression of nontarget lesions | ≥25% increase in tumor burden compared with nadir or reset baseline¶ New lesions added to tumor burden Confirmation required |
Stable disease | Neither partial response nor progressive disease |
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