Patient Characteristics
| . | Control Group (%) . | GM-CSF Group (%) . |
|---|---|---|
| Sex | ||
| Male | 52 | 56 |
| Age | ||
| 61-69 | 64 | 58 |
| 70-79 | 33 | 39 |
| ≥80 | 3 | 3 |
| WBC* | ||
| <30 | 72 | 70 |
| 30-99 | 21 | 20 |
| ≥100 | 7 | 10 |
| FAB cytology | ||
| M0 | 6 | 4 |
| M1 | 21 | 23 |
| M2 | 36 | 35 |
| M3 | 2 | 1 |
| M4 | 11 | 12 |
| M5 | 19 | 17 |
| M6 | 2 | 4 |
| Unknown | 3 | 3 |
| Cytogenetics† | ||
| Normal karyotype | 22 | 32 |
| Good risk abnormality | 3 | 2 |
| Intermediate risk abnormality | 21 | 19 |
| Poor risk abnormality | 12 | 11 |
| Failure of analysis/not done | 42 | 36 |
| Performance status‡ | ||
| Normal (0) | 32 | 31 |
| Ambulatory (1) | 49 | 43 |
| Bed ridden less than 50% of time (2) | 16 | 22 |
| Bed ridden ≥ 50% (3) | 2 | 5 |
| AML | ||
| Secondary | 22 | 22 |
| De novo | 78 | 78 |
| Total | 161 | 157 |
| . | Control Group (%) . | GM-CSF Group (%) . |
|---|---|---|
| Sex | ||
| Male | 52 | 56 |
| Age | ||
| 61-69 | 64 | 58 |
| 70-79 | 33 | 39 |
| ≥80 | 3 | 3 |
| WBC* | ||
| <30 | 72 | 70 |
| 30-99 | 21 | 20 |
| ≥100 | 7 | 10 |
| FAB cytology | ||
| M0 | 6 | 4 |
| M1 | 21 | 23 |
| M2 | 36 | 35 |
| M3 | 2 | 1 |
| M4 | 11 | 12 |
| M5 | 19 | 17 |
| M6 | 2 | 4 |
| Unknown | 3 | 3 |
| Cytogenetics† | ||
| Normal karyotype | 22 | 32 |
| Good risk abnormality | 3 | 2 |
| Intermediate risk abnormality | 21 | 19 |
| Poor risk abnormality | 12 | 11 |
| Failure of analysis/not done | 42 | 36 |
| Performance status‡ | ||
| Normal (0) | 32 | 31 |
| Ambulatory (1) | 49 | 43 |
| Bed ridden less than 50% of time (2) | 16 | 22 |
| Bed ridden ≥ 50% (3) | 2 | 5 |
| AML | ||
| Secondary | 22 | 22 |
| De novo | 78 | 78 |
| Total | 161 | 157 |
Abbreviations: GM-CSF, granulocyte-macrophage colony-stimulating factor; WBC, white blood cell count; FAB, French-American-British Classification; AML, acute myeloid leukemia.
×109/L.
Cytogenetic categories as defined in Materials and Methods. Complex chromosome abnormalities were apparent in 4 patients of the control arm and 3 patients of the GM-CSF arm (ie, 8% of evaluated cases).
The comparison of the differences in performance status between the two treatment groups (performance status grade 0 v 1 v ≥2) gives a P value of .23 (χ2 test for linear trend).