Table 5.
Grading scale for hematologic toxicity in CLL studies
| Grade* | Decrease in platelets† or Hb‡ (nadir) from pretreatment value, % | Absolute neutrophil count/μL§ (nadir) |
|---|---|---|
| 0 | No change to 10% | ≥ 2000 |
| 1 | 11%-24% | ≥ 1500 and <2000 |
| 2 | 25%-49% | ≥ 1000 and <1500 |
| 3 | 50%-74% | ≥ 500 and <1000 |
| 4 | ≥ 75% | <500 |
Grades: 1, mild; 2, moderate; 3, severe; 4, life-threatening; 5, fatal. Death occurring as a result of toxicity at any level of decrease from pretreatment will be recorded as grade 5.
Platelet counts must be below normal levels for grades 1 to 4. If, at any level of decrease, the platelet count is less than 20 × 109/L (20 000/μL), this will be considered grade 4 toxicity, unless a severe or life-threatening decrease in the initial platelet count (eg, 20 × 109/L) was present pretreatment, in which case the patient is not evaluable for toxicity referable to platelet counts.
Hb levels must be below normal levels for grades 1 to 4. Baseline and subsequent Hb determinations must be performed before any given transfusions. The use of erythropoietin is irrelevant for the grading of toxicity but should be documented.
If the absolute neutrophil count (ANC) reaches less than 109/L (1000/μL), it should be judged to be grade 3 toxicity. Other decreases in the white blood cell count, or in circulating granulocytes, are not to be considered because a decrease in the white blood cell count is a desired therapeutic endpoint. A gradual decrease in granulocytes is not a reliable index in CLL for stepwise grading of toxicity. If the ANC was less than 109/L before therapy, the patient is not evaluable for toxicity referable to the ANC. The use of G-CSF is irrelevant for the grading of toxicity but should be documented.