Influence of induction randomization on disease-free survival, survival, and relapse rate in complete responding patients randomized to postremission therapy
| Induction randomization . | GM-CSF . | Placebo . | ||
|---|---|---|---|---|
| Postremission randomization . | Ara-C . | Ara-C+M . | Ara-C . | Ara-C+M . |
| No. patients | 37 | 42 | 45 | 45 |
| Median DFS (mo) | 9 | 9 | 11 | 10 |
| 95% CI | 8-12 | 7-15 | 9-18 | 8-15 |
| Median survival (mo) | 19 | 16 | 20 | 17 |
| 95% CI | 15-24 | 13-28 | 14-32 | 13-27 |
| No. (%) relapses | 31 (84) | 36 (86) | 32 (71) | 35 (78) |
| No. deaths in CR | 4 | 3 | 6 | 6 |
| Total no. (%) events | 35 (95) | 39 (93) | 38 (84) | 41 (91) |
| 5-year survival (%) | 11 | 21 | 16 | 18 |
| 95% CI | 5-23 | 12-35 | 8-28 | 10-30 |
| 5-year DFS (%) | 5 | 14 | 16 | 11 |
| 95% CI | 2-15 | 7-27 | 8-28 | 5-22 |
| Induction randomization . | GM-CSF . | Placebo . | ||
|---|---|---|---|---|
| Postremission randomization . | Ara-C . | Ara-C+M . | Ara-C . | Ara-C+M . |
| No. patients | 37 | 42 | 45 | 45 |
| Median DFS (mo) | 9 | 9 | 11 | 10 |
| 95% CI | 8-12 | 7-15 | 9-18 | 8-15 |
| Median survival (mo) | 19 | 16 | 20 | 17 |
| 95% CI | 15-24 | 13-28 | 14-32 | 13-27 |
| No. (%) relapses | 31 (84) | 36 (86) | 32 (71) | 35 (78) |
| No. deaths in CR | 4 | 3 | 6 | 6 |
| Total no. (%) events | 35 (95) | 39 (93) | 38 (84) | 41 (91) |
| 5-year survival (%) | 11 | 21 | 16 | 18 |
| 95% CI | 5-23 | 12-35 | 8-28 | 10-30 |
| 5-year DFS (%) | 5 | 14 | 16 | 11 |
| 95% CI | 2-15 | 7-27 | 8-28 | 5-22 |
No statistically significant differences in outcome parameters among the treatment cohorts were noted.
DFS indicates disease-free survival; CI, confidence interval; CR, complete remission; for other abbreviations, see Table 2.