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. 2020 Jan 3;4:2. doi: 10.1186/s41747-019-0134-1

Table 3.

Comparison of the different criteria developed for the assessment of response to immunotherapy

Criteria, year [reference] irRC, 2009 [17] irRECIST, 2013 [33] iRECIST, 2017 [34] imRECIST, 2018 [35]
Baseline
 Definition of target lesion World Health Organization criteria +5 cutaneous targets RECIST 1.1 RECIST 1.1 RECIST 1.1
 Definition of non-target lesion Not specified RECIST 1.1 RECIST 1.1 RECIST 1.1
 Definition of lymph node Not specified RECIST 1.1 RECIST 1.1 RECIST 1.1
Follow-up
 New lesion

≥ 5 × 5 mm; up to 5/organ; 5 new cutaneous and 10 visceral lesions

PD not defined

Measurement of new lesions included in the total tumour burden

RECIST 1.1

PD not defined

Measurement of new lesions included in the total tumour burden

RECIST 1.1

Defined unconfirmed PD

RECIST 1.1

PD not defined

Non-target lesion Only to define irCR Only to define irCR

RECIST 1.1

May define UPD

Only to define irCR
PD definition

Determined only on measurable disease (≥ 25% increase in the sum of target lesions and new lesions from the nadir)

Negated by subsequent non-PD assessment ≥ 4 weeks

Determined only on measurable disease (≥ 20% increase in the sum of target lesions and new lesions from the nadir)

Negated by subsequent non-PD assessment ≥ 4 weeks

Confirmed PD if :

- Unconfirmed PD of target lesions on previous exam and increase in tumour burden of target lesions ≥ 5 mm

- Unconfirmed PD of non-target lesions and their significant increase

- Unconfirmed PD for new lesions and increase in tumour burden ≥ 5 mm or increase in the number of new lesion

Determined only on measurable disease (≥ 20% increase in the sum of target lesion and new lesions from the nadir)

The presence of new lesions does not define PD

Negated by subsequent non-PD assessment ≥ 4 weeks

irRC Immune-related response criteria, imRECIST Immune-modified RECIST, PD Progressive disease