Table 3.
Comparison of EORTC and PERCIST response criteria, QIBA Profile Claims and current study.
| Category | EORTC criteria | PERCIST criteria | QIBA Profile Claim | This study (mPERCIST) |
|---|---|---|---|---|
| Measurable lesions | Region of high FDG uptake representing viable tumor | SULpeak (hottest tumor) ≥ (1.5 x mean liver uptake + 2 SD of liver region) | SUVmax ≥ 4 g/ml and diameter ≥ 2 cm | SULpeak (hottest tumor) ≥ (1.5 x mean liver uptake) |
| No change condition (stable disease for EORTC and PERCIST) | Increase in SUV < 25% or decrease of < 15% after one cycle of treatment (and < 25% after more than one treatment cycle) and no change in extent > 20% | Change in SULpeak < ± 30%, If there are other changes that indicate response or progression. | Claim 2: Increase in SUVmax < 39% and decrease in SUVmax < 28%. | SULpeak < 21% or and decrease in SULpeak <−17% or an increase in SUVmax < 19%, and decrease in SUVmax< −16% assuming a mean difference between test and retest of zero. |
| Conditions for valid measurements | Scanners should provide reproducible data | Normal liver SUL must be within 20% and 0.3 g/ml for baseline and follow-up studies | Acquisition and analysis must comply to the QIBA Profile checklists | Same as PERCIST. |
| Protocol | Specified | Refers to NIH-consensus (40) and Netherlands (41) protocols | Specified | Kurland 2019 and Peterson 2018 |
Note that this only contains an excerpt of the detailed EORTC and PERCIST response criteria. In addition, the EORTC and PERCIST response criteria are intended to provide information on disease status, while the QIBA Profile Claims are providing information about the statistical variability of SUVs under the assumption of no true biological change.
Acronyms. EORTC: European Organization for Research and Treatment of Cancer. PERCIST: PET Response Criteria in Solid Tumors. QIBA: Quantitative Imaging Biomarkers Alliance. FDG: 18F-flourodexyglucose. SUV: standardized uptake value. SUVmax,: SUV calculated using the maximum value of a region placed over the image of an FDG-avid lesion. SULpeak,: The mean SUV of a 1 cm diameter region centered over the maximum value of a an FDG avid lesion with biodistribution normalization by lean body mass.