Table 1.
Criterion | CR | PR | MR | SD | PD |
---|---|---|---|---|---|
Target lesions | None | ≥50% decrease in area relative to baseline | ≥25% and <50% decrease in area relative to baseline | <25% decrease relative to baseline but <25% increase in area relative to nadir | ≥25% increase in area relative to nadir* |
Nontarget lesions | None | Stable or improved | Stable or improved | Stable or improved | Unequivocal PD* |
New lesion(s)** | None | None | None | None | Present* |
Corticosteroids | None | Stable or decreased | Stable or decreased | Stable or decreased | NA+ |
Clinical status | Stable or improved | Stable or improved | Stable or improved | Stable or improved | Worse* |
Requirement for response | All | All | All | All | Any+ |
NA, not applicable.
*Progression occurs when this criterion is met.
**New lesion = new lesion not present on prior scans and visible in at least 2 projections. If a new lesion is equivocal, for example because of its small size, continued therapy may be considered, and follow-up evaluation will clarify if it represents truly new disease. If repeat scans confirm there is definitely a new lesion, then progression should be declared using the date of the initial scan showing the new lesion. For immunotherapy-based approaches, new lesions alone do not define progression (see “Guidance in the case of new lesion(s) while on immunotherapy”).
+Increase in corticosteroids alone will not be taken into account in determining progression in the absence of persistent clinical deterioration.