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. 2021 Mar 24;48(12):3975–3989. doi: 10.1007/s00259-021-05211-8

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