Table 1. Assessment of response by RECIST 1.0 and RECIST 1.1.
Criteria | RECIST 1.0 | RECIST 1.1 | Comment |
---|---|---|---|
Minimum target lesion diameter by CT or MRI at baseline | ≥20 mm | ≥10 mm | Entry was restricted to those with measurable disease |
Measurable lesions | Up to five per organ and ten lesions in total, representative of all involved organs | Up to two per organ and maximum of five lesions in total, representative of all involved organs | |
Prior treatment | Tumor lesions that are situated in a previously irradiated area not considered measurable | Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion | |
Non-target lesions | All other lesions (or sites of disease) were identified as non-target lesions and recorded at baseline | Multiple non-target lesions involving the same organ were assessed as a single item on the case record form (e.g., “multiple enlarged pelvic lymph nodes” or “multiple liver metastases”) | |
Criteria for response (according to sum of target lesions diameters) | Confirmation of CR or PR after at least 28 days required for RECIST 1.0 only and for RECIST 1.1 if primary endpoint Both target and non-target lesions in the liver were assessed at follow-up Note: appearance of new lesion as indicator of progression is only relevant for overall response evaluation |
||
CR | Disappearance of lesions | Disappearance of lesions | |
PR | ≥30% decrease | ≥30% decrease | |
SD | <30% decrease or <20% increase | <30% decrease or <20% increase | |
PD | Any increase | ≥20% or ≥5 mm increase | |
PET | No specific recommendations | FDG-PET may be considered to complement CT scanning in assessment of progression and the confirmation of CR | Results from PET were not considered in this study |
RECIST, Response Evaluation Criteria in Solid Tumors; CT, computed tomography; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; PET, positron emission tomography.