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iRECIST (Immune-related RECIST)

1.0.0

Applies iRECIST (Seymour 2017) to solid-tumor immunotherapy assessments. Apparent progression or new lesions first score as unconfirmed progressive disease (iUPD); confirmed progressive disease (iCPD) requires repeat imaging 4-8 weeks later showing further increase in tumor burden or worsening/new lesions. New lesions are measured in a separate sum and are not added to the original target-lesion sum.

Also searched as: immunotherapy · pseudoprogression · iUPD · iCPD · solid tumor · response criteria · tumor response · oncology

Assessment type

Use confirmatory mode only when the immediately prior evaluable time-point was iUPD and this scan is the planned confirmation study.

Baseline sum of target-lesion diameters

RECIST 1.1 baseline sum (longest diameters; lymph nodes short axis). Up to 5 targets, <=2 per organ.

mm
Nadir sum since baseline (smallest sum on study)

Smallest target sum recorded after baseline while on study. If blank, baseline is used as the reference for progression.

mm
Current sum of (original) target-lesion diameters

Sum of the same baseline target lesions at this time-point. Do NOT include new lesions here.

mm
All pathological lymph nodes now < 10 mm short axis

Required for iCR (same rule as RECIST 1.1).

Non-target lesion status (original non-targets)
New lesions at this time-point

New lesions are measured separately (NL-T sum; max 5, <=2/organ). They are never added to the original target sum.

Current sum of measurable new-lesion targets (NL-T)

Optional documentation. NL-T uses RECIST 1.1 measurability (>=10 mm long axis; nodes >=15 mm short axis).

mm
Information
Incomplete input
  • Please provide: assessment type.

How this tool works

iRECIST extends RECIST 1.1 for checkpoint-inhibitor and other immunotherapy trials. Target and non-target rules mirror RECIST 1.1 (unidimensional longest diameters; nodes by short axis), but progressive disease is split into iUPD (unconfirmed) and iCPD (confirmed). Pseudoprogression - transient enlargement or new lesions from immune-cell infiltration - must not automatically end treatment. After iUPD, if the patient is clinically stable, imaging is repeated at 4-8 weeks. iCPD is assigned only if there is further growth in the category that drove iUPD (target sum increase >=5 mm from the iUPD time point, any further non-target increase, new-lesion sum increase >=5 mm for measurable new targets, any increase in non-target new lesions, or appearance of additional new lesions) or if a new RECIST-defined progression category appears. If tumor burden subsequently shrinks to meet iCR/iPR/iSD, the bar resets and a fresh iUPD is required before iCPD can be declared. New lesions are recorded as a separate new-lesion target sum (NL-T, up to 5 lesions, <=2 per organ) plus qualitative NL-NT; they are never folded into the original baseline target sum (unlike irRC/irRECIST).

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