Response assessment | RECIST guideline, version 1.0[1] | RECIST guideline, version 1.1[2] |
Target lesions | ||
CR | Disappearance of all target lesions | Disappearance of all target lesions and reduction in the short axis measurement of all pathologic lymph nodes to ≤10 mm |
PR | ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline | ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline |
PD | ≥20% increase in the sum of the longest diameter of the target lesions compared with the smallest sum of the longest diameter recorded since treatment started OR The appearance of 1 or more new lesions | ≥20% increase of at least 5 mm in the sum of the longest diameter of the target lesions compared with the smallest sum of the longest diameter recorded OR The appearance of new lesions, including those detected by FDG-PET |
SD | Neither PR nor PD | Neither PR nor PD |
Non-target lesions | ||
CR | Disappearance of all non-target lesions and normalization of tumor marker levels | Disappearance of all non-target lesions and normalization of tumor marker levels |
IR, SD | Persistence of 1 or more non-target lesions and/or the maintenance of tumor marker levels above normal limits | Persistence of 1 or more non-target lesions and/or the maintenance of tumor marker levels above normal limits |
PD | Appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions | The appearance of 1 or more new lesions or unequivocal progression If patient has measurable disease, an increase in the overall level or substantial worsening in non-target lesions, such that tumor burden has increased, even if there is SD or PR in target lesions If no measurable disease, an increase in the overall tumor burden comparable in magnitude with the increase that would be required to declare PD in measurable disease (eg, an increase in pleural effusions from trace to large, or an increase in lymphangitic disease from localized to widespread) |
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