Treatment results with and without prophylactic G-CSF
| . | Intent-to-treat . | Treated-as-assigned . | ||||
|---|---|---|---|---|---|---|
| No G-CSF . | G-CSF . | P . | No G-CSF . | G-CSF . | P . | |
| CR rate, no. patients (%) | ||||||
| Total | 149 (95.5) | 154 (95.7) | >.999 | 132 (95.7) | 140 (95.2) | >.999 |
| SR | 58 (92.1) | 55 (94.8) | .72 | 48 (92.3) | 52 (94.5) | .71 |
| HR | 73 (97.3) | 72 (94.7) | .68 | 67 (97.1) | 67 (94.4) | .68 |
| Down | 18 (100) | 27 (100) | 17 (100) | 21 (100) | ||
| Cumulative incidence of relapse at 5 y, % ± SE | ||||||
| Total | 29 ± 4 | 32 ± 4 | .45 | 29 ± 1 | 34 ± 1 | .32 |
| SR | 19 ± 6 | 32 ± 7 | .10 | 17 ± 6 | 32 ± 8 | .08 |
| HR | 44 ± 7 | 42 ± 7 | .88 | 45 ± 7 | 45 ± 7 | .94 |
| Down | 0 | 7 ± 5 | .24 | 0 | 5 ± 5 | .37 |
| 5-y EFS, % ± SE | ||||||
| Total | 59 ± 4 | 58 ± 4 | .66 | 59 ± 4 | 56 ± 4 | .48 |
| SR | 68 ± 6 | 56 ± 7 | .18 | 69 ± 7 | 55 ± 7 | .15 |
| HR | 45 ± 6 | 48 ± 6 | .91 | 45 ± 6 | 46 ± 6 | .96 |
| Down | 89 ± 7 | 89 ± 6 | .98 | 88 ± 8 | 90 ± 6 | .85 |
| Cumulative incidence of death in CCR at 5 years, % ± SE | ||||||
| Total | 5 ± 2 | 5 ± 2 | .95 | 6 ± 2 | 5 ± 2 | .69 |
| SR | 3 ± 2 | 7 ± 4 | .36 | 4 ± 3 | 7 ± 4 | .46 |
| HR | 5 ± 3 | 4 ± 3 | .69 | 6 ± 3 | 3 ± 3 | .39 |
| Down | 11 ± 7 | ± 4 | .35 | 12 ± 8 | 5 ± 5 | .45 |
| Second malignancy, no. patients | ||||||
| Total | 3 | 1 | 2 | 1 | ||
| SR | 1 | 0 | 1 | 0 | ||
| HR | 2 | 1 | 1 | 1 | ||
| Lost for follow-up, no. patients | ||||||
| Total | 2 | 1 | 2 | 1 | ||
| SR | 2 | 0 | 2 | 0 | ||
| HR | 0 | 1 | 0 | 1 | ||
| . | Intent-to-treat . | Treated-as-assigned . | ||||
|---|---|---|---|---|---|---|
| No G-CSF . | G-CSF . | P . | No G-CSF . | G-CSF . | P . | |
| CR rate, no. patients (%) | ||||||
| Total | 149 (95.5) | 154 (95.7) | >.999 | 132 (95.7) | 140 (95.2) | >.999 |
| SR | 58 (92.1) | 55 (94.8) | .72 | 48 (92.3) | 52 (94.5) | .71 |
| HR | 73 (97.3) | 72 (94.7) | .68 | 67 (97.1) | 67 (94.4) | .68 |
| Down | 18 (100) | 27 (100) | 17 (100) | 21 (100) | ||
| Cumulative incidence of relapse at 5 y, % ± SE | ||||||
| Total | 29 ± 4 | 32 ± 4 | .45 | 29 ± 1 | 34 ± 1 | .32 |
| SR | 19 ± 6 | 32 ± 7 | .10 | 17 ± 6 | 32 ± 8 | .08 |
| HR | 44 ± 7 | 42 ± 7 | .88 | 45 ± 7 | 45 ± 7 | .94 |
| Down | 0 | 7 ± 5 | .24 | 0 | 5 ± 5 | .37 |
| 5-y EFS, % ± SE | ||||||
| Total | 59 ± 4 | 58 ± 4 | .66 | 59 ± 4 | 56 ± 4 | .48 |
| SR | 68 ± 6 | 56 ± 7 | .18 | 69 ± 7 | 55 ± 7 | .15 |
| HR | 45 ± 6 | 48 ± 6 | .91 | 45 ± 6 | 46 ± 6 | .96 |
| Down | 89 ± 7 | 89 ± 6 | .98 | 88 ± 8 | 90 ± 6 | .85 |
| Cumulative incidence of death in CCR at 5 years, % ± SE | ||||||
| Total | 5 ± 2 | 5 ± 2 | .95 | 6 ± 2 | 5 ± 2 | .69 |
| SR | 3 ± 2 | 7 ± 4 | .36 | 4 ± 3 | 7 ± 4 | .46 |
| HR | 5 ± 3 | 4 ± 3 | .69 | 6 ± 3 | 3 ± 3 | .39 |
| Down | 11 ± 7 | ± 4 | .35 | 12 ± 8 | 5 ± 5 | .45 |
| Second malignancy, no. patients | ||||||
| Total | 3 | 1 | 2 | 1 | ||
| SR | 1 | 0 | 1 | 0 | ||
| HR | 2 | 1 | 1 | 1 | ||
| Lost for follow-up, no. patients | ||||||
| Total | 2 | 1 | 2 | 1 | ||
| SR | 2 | 0 | 2 | 0 | ||
| HR | 0 | 1 | 0 | 1 | ||