Response definition after treatment of CLL patients
| Group . | Parameter . | CR . | PR . | PD . | SD . |
|---|---|---|---|---|---|
| A | Lymph nodes | None ≥1.5 cm | Decrease ≥50% (from baseline)* | Increase ≥50% from baseline or from response | Change of −49% to +49% |
| Liver and/or spleen size† | Spleen size <13 cm; liver size normal | Decrease ≥50% (from baseline) | Increase ≥50% from baseline or from response | Change of −49% to +49% | |
| Constitutional symptoms | None | Any | Any | Any | |
| Circulating lymphocyte count | Normal | Decrease ≥50% from baseline | Increase ≥50% over baseline | Change of −49% to +49% | |
| B | Platelet count | ≥100 × 109/L | ≥100 × 109/L or increase ≥50% over baseline | Decrease of ≥50% from baseline secondary to CLL | Change of −49 to +49% |
| Hemoglobin | ≥11.0 g/dL (untransfused and without erythropoietin) | ≥11 g/dL or increase ≥50% over baseline | Decrease of ≥2 g/dL from baseline secondary to CLL | Increase <11.0 g/dL or <50% over baseline, or decrease <2 g/dL | |
| Marrow | Normocellular, no CLL cells, no B-lymphoid nodules | Presence of CLL cells, or of B-lymphoid nodules, or not done | Increase of CLL cells by ≥50% on successive biopsies | No change in marrow infiltrate |
| Group . | Parameter . | CR . | PR . | PD . | SD . |
|---|---|---|---|---|---|
| A | Lymph nodes | None ≥1.5 cm | Decrease ≥50% (from baseline)* | Increase ≥50% from baseline or from response | Change of −49% to +49% |
| Liver and/or spleen size† | Spleen size <13 cm; liver size normal | Decrease ≥50% (from baseline) | Increase ≥50% from baseline or from response | Change of −49% to +49% | |
| Constitutional symptoms | None | Any | Any | Any | |
| Circulating lymphocyte count | Normal | Decrease ≥50% from baseline | Increase ≥50% over baseline | Change of −49% to +49% | |
| B | Platelet count | ≥100 × 109/L | ≥100 × 109/L or increase ≥50% over baseline | Decrease of ≥50% from baseline secondary to CLL | Change of −49 to +49% |
| Hemoglobin | ≥11.0 g/dL (untransfused and without erythropoietin) | ≥11 g/dL or increase ≥50% over baseline | Decrease of ≥2 g/dL from baseline secondary to CLL | Increase <11.0 g/dL or <50% over baseline, or decrease <2 g/dL | |
| Marrow | Normocellular, no CLL cells, no B-lymphoid nodules | Presence of CLL cells, or of B-lymphoid nodules, or not done | Increase of CLL cells by ≥50% on successive biopsies | No change in marrow infiltrate |
For a detailed description of the response parameters, see section 5.
Sum of the products of 6 or fewer lymph nodes (as evaluated by CT scans and physical examination in clinical trials or by physical examination in general practice).
Spleen size is considered normal if <13 cm. There is not firmly established international consensus of the size of a normal liver; therefore, liver size should be evaluated by imaging and manual palpation in clinical trials and be recorded according to the definition used in a study protocol.
CR, complete remission (all of the criteria have to be met); PD, progressive disease (at least 1 of the criteria of group A or group B has to be met); PR, partial remission (for a PR, at least 2 of the parameters of group A and 1 parameter of group B need to improve if previously abnormal; if only 1 parameter of both groups A and B is abnormal before therapy, only 1 needs to improve); SD, stable disease (all of the criteria have to be met; constitutional symptoms alone do not define PD).