Response definitions for clinical trials
| Response . | Definition . | Nodal masses . | Spleen, liver . | Bone marrow . |
|---|---|---|---|---|
| Complete remission (CR) | Disappearance of all evidence of disease | (a) FDG avid or PET+ prior to therapy: mass of any size permitted if PET−. (b) Variably FDG avid or PET−: regression to normal size on CT | Not palpable, nodules disappeared | Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative |
| Partial remission (PR) | Regression of measurable disease and no new sites | ≥ 50% decrease in SPD of up to 6 largest dominant masses. No increase in size of other nodes. (a) FDG avid or PET+ prior to therapy: one or more PET+ at previously involved site. (b) Variably FDG avid or PET−: Regression on CT | ≥ 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen | Irrelevant if positive prior to therapy; cell type should be specified |
| Stable disease (SD) | Failure to attain CR/PR or PD | (a) FDG avid or PET+ prior to therapy: PET+ at prior sites of disease and no new sites on CT or PET. (b) Variably FDG avid or PET−: no change in size of previous lesions on CT | — | — |
| Relapsed or progressive disease | Any new lesion or increase from nadir by ≥ 50% of previously involved sites | Appearance of a new lesion > 1.5 in any axis, ≥ 50% increase in the longest diameter of a previously identified node, > 1 cm in short axis or in the SPD of more than one node. Lesions PET+ if FDG avid lymphoma or PET+ prior to therapy | ≥ 50% increase from nadir in the SPD of any previous lesions | New or recurrent involvement |
| Response . | Definition . | Nodal masses . | Spleen, liver . | Bone marrow . |
|---|---|---|---|---|
| Complete remission (CR) | Disappearance of all evidence of disease | (a) FDG avid or PET+ prior to therapy: mass of any size permitted if PET−. (b) Variably FDG avid or PET−: regression to normal size on CT | Not palpable, nodules disappeared | Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative |
| Partial remission (PR) | Regression of measurable disease and no new sites | ≥ 50% decrease in SPD of up to 6 largest dominant masses. No increase in size of other nodes. (a) FDG avid or PET+ prior to therapy: one or more PET+ at previously involved site. (b) Variably FDG avid or PET−: Regression on CT | ≥ 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen | Irrelevant if positive prior to therapy; cell type should be specified |
| Stable disease (SD) | Failure to attain CR/PR or PD | (a) FDG avid or PET+ prior to therapy: PET+ at prior sites of disease and no new sites on CT or PET. (b) Variably FDG avid or PET−: no change in size of previous lesions on CT | — | — |
| Relapsed or progressive disease | Any new lesion or increase from nadir by ≥ 50% of previously involved sites | Appearance of a new lesion > 1.5 in any axis, ≥ 50% increase in the longest diameter of a previously identified node, > 1 cm in short axis or in the SPD of more than one node. Lesions PET+ if FDG avid lymphoma or PET+ prior to therapy | ≥ 50% increase from nadir in the SPD of any previous lesions | New or recurrent involvement |
— indicates not applicable.