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 |