Summary of measurement approaches for two assessments
| irRC simulating RECIST1.0 | irRC simulating RECIST1.1 | |
|---|---|---|
| Number of target lesions | Up to 5 per organ, up to 10 in total | Up to 2 per organ, up to 5 in total |
| Measurable lesions | ≥10 mm in the longest diameter for all lesions | ≥10 mm in the longest diameter for all lesions except for lymph nodes |
| ≥15 mm in short axis for nodes | ||
| Measurement of each lesion | The longest diameter for all target lesions | The longest diameter for non-nodal lesions, short axis for lymph nodes |
| New lesions | The presence of new lesion does not define progression | Same as irRC simulating RECIST1.0 except: |
| The measurements of the new lesion (s) are included in the sum of the measurements | A lymph node has to be ≥15 mm in short axis to be a measurable new lesion and its short axis measurement is included in the sum | |
| Up to 5 new lesions per organ, up to 10 new lesions in total can be added to measurements | Up to 2 new lesions per organ, up to 5 new lesions in total can be added to the measurements |