iRECIST Time-Point Response (Immunotherapy Trials)

iRECIST time-point response for clinical trials testing immunotherapeutics (Seymour and colleagues, Lancet Oncology 2017).

Open the calculator → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.

Example

Target-lesion response by RECIST 1.1 criteria
Partial response in target lesions by RECIST 1.1 criteria.
Non-target-lesion response
Neither complete response nor progression in non-target lesions.
Whether new lesions are present
No
Whether iUPD was recorded at the IMMEDIATELY PRECEDING assessment
Yes
Target disease
No
Non-target disease
No
New lesions
No
Whether RECIST 1.1 defined progression is now present in a lesion category…
No

Result: iPR, after a prior iUPD.

The tool opens with these values already filled in. Replace them with your own.

What the result means

iUPD
Unconfirmed progression. The first scan meeting RECIST 1.1 progression criteria. Never assign progression on one scan.
iCPD
Confirmed progression. Requires a prior iUPD plus FURTHER increase on a scan 4 to 8 weeks later.
Reset
Shrinkage against baseline after iUPD resets the bar: iCR, iPR or iSD IS assigned, unlike RECIST 1.1.
Persistence
No change from a prior iUPD remains iUPD. Confirmation needs further increase, not persistence.
New lesions
Produce iUPD, not progression. Recorded separately as NLT/NLNT, never added to the baseline target sum.
Thresholds
Target: 5 mm further increase. Non-target: any increase, need not be unequivocal. New lesions: 5 mm NLT, any NLNT, or more lesions.
Scope
A trial data-collection standard. Not a decision to continue or stop therapy.

What you enter

  • Target-lesion response by RECIST 1.1 criteria
  • Non-target-lesion response
  • Whether new lesions are present.
  • Whether iUPD was recorded at the IMMEDIATELY PRECEDING assessment.
  • Target disease: further increase in the sum of measures of AT LEAST 5 MM since the prior iUPD.
  • Non-target disease: ANY further increase since the prior iUPD.
  • New lesions: sum of measures of new lesion-target up by at least 5 mm, OR any increase in new lesion-non-target, OR additional new lesions, since the prior iUPD.
  • Whether RECIST 1.1 defined progression is now present in a lesion category that had NOT previously met progression criteria.
Full field descriptions
  • Target-lesion response by RECIST 1.1 criteria [iCR = Complete response in target lesions by RECIST 1.1 criteria. iPR = Partial response in target lesions by RECIST 1.1 criteria. iSD = Stable disease in target lesions by RECIST 1.1 criteria. iUPD = Target lesions meet RECIST 1.1 criteria for progression. Under iRECIST this is unconfirmed.]
  • Non-target-lesion response [iCR = Complete response in non-target lesions. non-iCR-non-iUPD = Neither complete response nor progression in non-target lesions. iUPD = Non-target lesions meet RECIST 1.1 criteria for unequivocal progression. Under iRECIST this is unconfirmed.]
  • Whether new lesions are present. A new lesion produces iUPD but does not by itself confirm progression, and new lesions are recorded separately rather than added to the baseline target sum of measures.
  • Whether iUPD was recorded at the IMMEDIATELY PRECEDING assessment. REQUIRED: without a prior iUPD, iCPD is not reachable at all, because progression is never confirmed on a single scan.
  • Target disease: further increase in the sum of measures of AT LEAST 5 MM since the prior iUPD. Read only when iUPD was recorded previously and this assessment is still progressed.
  • Non-target disease: ANY further increase since the prior iUPD. It explicitly NEED NOT meet RECIST 1.1 criteria for unequivocal progression, so the 5 mm bar does not apply here.
  • Whether RECIST 1.1 defined progression is now present in a lesion category that had NOT previously met progression criteria. This also confirms iCPD.
How this is calculated

Seymour L, Bogaerts J, Perrone A, et al. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017;18(3):e143-e152. Read the source ↗

A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.

Browse all tools

Built by Clay Good. Source on GitHub.