Table 1.
Overview CT-based criteria for response assessment
| RECIST 1.1 (2009) | irRC (2009) | irRECIST (2013) | iRECIST (2017) | imRECIST (2018) | |
|---|---|---|---|---|---|
| Complete response |
• Disappearance of all TL/NTL • Nodal SAD < 1.0 cm • No new lesion |
• Disappearance of all lesions (measurable or not) • No new lesions • Confirmation by consecutive CSI control in ≥ 4 weeks |
• Disappearance of all TL/NTL • Nodal SAD < 1.0 cm • No new lesion |
• Disappearance of all TL/NTL • Nodal SAD < 1.0 cm • No new lesion |
• Disappearance of all TL/NTL • Nodal SAD < 1.0 cm • No new lesion |
| Partial response |
• ≥ 30% decrease relative to baseline • No new lesion |
• ≥ 50% relative to baseline • Confirmation by consecutive CSI control in ≥ 4 weeks |
• ≥ 30% decrease relative to baseline • No new lesion |
• > 30% decrease relative to baseline • No new lesion |
• ≥ 30% decrease relative to baseline • No new lesion |
| Stable Disease | • Neither CR, PR nor PD | • Neither CR, PR nor PD | • Neither CR, PR nor PD | • Neither CR, PR nor PD | • Neither CR, PR nor PD |
| Progressive Disease |
• ≥ 20% increase relative to baseline • Or progression of NTL • Or new lesion |
• ≥ 25% increase relative to nadir • New lesions added to tumor burden • Confirmation by consecutive CSI control in ≥4 weeks |
• ≥ 20% increase • And ≥ 5 mm absolute increase in total measured tumor burden relative to nadir(i. E. minimum recorded tumor burden). • Confirmation of progression in ≥4 weeks after suspected PD |
iUPD: PD RECIST 1.1 iCPD: • Confirmation 4–8 weeks later • Any further size increase in TL sum >5 mm • Any progression of NTL • Any further size increase of the sum of new TL > 5 mm • Appearance of another new lesion |
• ≥ 20% increase of summed tumor burden of TL including new lesions compared to nadir • New lesions/NTL progression do not necessarily define PD • Negated in a subsequent follow-up ≥ 4 weeks with non-PD |
| Reference | [21] | [22] | [23, 24] | [25] | [26] |
Abbreviations: TL target lesion; NTL non-target lesion; SAD short-axis-diameter, CSI cross sectional imaging; PD progressive disease; iUPD unconfirmed PD; iCPD confirmed PD