Table 5.
Definition of response after treatment of patients with T-PLL
| Group and parameter | CR (all met) | PR (≥2 in A and ≥1 in B) | SD (all met) | PD (≥1 in A or B met) |
|---|---|---|---|---|
| Group A | ||||
| Lymph nodes | long-axis diameters to <1.0 cm | Decrease ≥30% in SLD | Change of − <30% to + ≤20% | Increase >20% in SLD |
| Spleen | Spleen size <13 cm | Decrease ≥50% in vertical length beyond normal from baseline | Change of −49% to +49% beyond normal from baseline | Increase ≥50% in vertical length beyond normal from baseline |
| Constitutional symptoms | None | Any | Any | Any |
| Circulating lymphocyte count | <4 × 109/L | ≤30 × 109/L and decrease ≥50% from baseline | >30 × 109/L or change of −49% to +49% | Increase ≥50% from baseline |
| Marrow | T-PLL cells <5% of mononuclear cells | Any | Any | Any |
| Any other specific site involvement* | None | Any | Any | Any |
| Group B | ||||
| Platelet count | ≥100 × 109/L | ≥100 × 109/L or increase ≥50% from baseline | Change of −49% to +49% | Decrease of ≥50% from baseline |
| Hemoglobin | ≥11.0 g/dL (untransfused) | ≥11 g/dL or increase ≥50% from baseline | <11.0 g/dL or <50% from baseline, or change <2 g/dL | Decrease of ≥2 g/dL from baseline |
| Neutrophils | ≥1.5 × 109/L | ≥1.5 × 109/L or increase ≥50% from baseline | Change of −49% to +49% | Decrease of ≥50% from baseline |
CR, all of the criteria have to be met); CRi, all CR criteria of group A are met but at least 1 in B is not achieved; PR, at least 2 parameters of group A and 1 of group B need to improve if previously abnormal; PD, at least 1 of the criteria of group A or group B has to be met; SD, all the criteria have to be met, constitutional symptoms alone do not define PD; SLD, sum of long-axis diameters of up to 3 target lesions.
*
Pleural or peritoneal effusion, skin infiltration, central nervous system involvement.