Table 4.
Overview of Response Criteria and Categories
| RECIST | mRECIST | |
|---|---|---|
|
| ||
| Definition | Based on 1D measurement of tumor size [46]. | Created to address the shortcomings of EASL (e.g. definition of target lesions) |
| Allows for quantitative determination of changes in tumor burden in response to treatment. | Now endorsed by the European Association for the Study of the Liver (EASL) as the preferred method of assessing treatment response in HCC [48]. | |
| Revised to RECIST version 1.1 in 2009 [47]. | ||
|
| ||
| Concepts | Classifies lesions at baseline as “measurable” and “non-measurable” lesions.
|
Incorporates the concept of viable tumor [49]. |
| Integrates the RECIST definitions of response categories and target lesion selection into EASL. | ||
| Uses 1D measurements of the viable component of the tumor (on CT or MRI) on arterial phase. Overall tumor burden (includes target lesions, non-target lesions and new lesions) is determined at the baseline image. Tumor response is then determined at each subsequent follow-up [49]. | ||
| Target lesion: 1) can be accurately measured in at least 1D as 1 cm or more, 2) shows intratumoral APHE on contrast-enhanced CT or MRI and 3) is suitable for repeat measurement. | ||
| In patients with HCC and cirrhosis, certain unique considerations are required for assessment of tumor response in non-target lesions, for example, portal vein thrombosis. | Nontarget lesions: All other measurable lesions (not included as target lesions) should be identified as nontarget lesions and are recorded at baseline. | |
| Overall response is determined by combining the response of both target and non-target lesions. | ||
|
| ||
| Response Categories | ||
|
| ||
| Complete Response (CR) | Disappearance of all target lesions and non-target lesions. | Disappearance of any intratumoral APHE in all target and non-target lesions. |
|
| ||
| Partial Response (PR) | > 30% decrease in the sum of the longest diameter of target lesions. | ≥ 30% decrease in the sum of diameters of viable target lesions. |
|
| ||
| Stable Disease (SD) | Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. | Any cases that do not qualify for either partial response or progressive disease. |
|
| ||
| Progressive Disease (PD) | > 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. RECIST 1.1 additionally requires at least a 5 mm absolute increase in the sum of the longest diameters of target lesions to avoid measurement errors in small lesions. | ≥ 20% increase in the sum of the diameters of viable target lesions or presence of one or more new lesions or unequivocal progression of existing non target lesions. |
Note: RECIST = Response Evaluation Criteria in Solid Tumors, mRECIST = Modified response evaluation criteria in solid tumors, HCC = hepatocellular carcinoma, APHE = arterial phase hyperenhancement.