Table 2.
Results of different study periods
| AML-BFM 2004 | AML-BFM 98 | AML-BFM 93 | |||||
|---|---|---|---|---|---|---|---|
| n/% | %/SE | n/% | %/SE | n/% | %/SE | p-value | |
| Protocol patients | 94 | 57 | 42 | ||||
| Blasts day 15 > 5 % | 20 | 22 | 13 | 24 | 8 | 20 | |
| Response (first CR) | |||||||
| Early death | 0 | 0 | 2 | 4 | 1 | 2 | 0.868 |
| Nonresponse | 8 | 9 | 6 | 10 | 1 | 2 | |
| CR achieved | 86 | 91 | 49 | 84 | 40 | 95 | |
| 5-year cumulative incidence of the first event | |||||||
| ED/Aplasia/NR | 9 | 3 | 14 | 5 | 5 | 3 | 0.274 |
| Relapses | 39 | 6 | 21 | 5 | 40 | 8 | 0.058 |
| Second malignancy | 1 | 1 | 2 | 2 | 0 | 0 | 0.702 |
| Death in CCR | 1 | 1 | 2 | 2 | 7 | 4 | 0.138 |
| Freedom of all events | 50 | 6 | 61 | 7 | 48 | 8 | 0.406 |
| 5-year cumulative incidence of the first relapse | 41 | 6 | 28 | 6 | 40 | 8 | 0.322 |
| 5-year cumulative incidence of second malignancy | 1 | 1 | 2 | 2 | 0 | 0 | 0.698 |
| 5-year-pSU | 62 | 6 | 75 | 6 | 57 | 8 | 0.046 |
| 5-year-pEFS | 50 | 6 | 61 | 7 | 48 | 8 | 0.406 |
| 5-year-pSU standard risk | 81 | 9 | 91 | 6 | 86 | 9 | 0.625 |
| 5-year-pEFS standard risk | 67 | 10 | 81 | 9 | 79 | 11 | 0.538 |
| 5-year-pSU high-risk | 52 | 8 | 66 | 8 | 40 | 10 | 0.039 |
| 5-year-pEFS high-risk | 41 | 7 | 50 | 9 | 30 | 9 | 0.456 |
AML acute myeloid leukemia, CCR continued complete remission, CR complete remission, ED early death, NR nonresponse, EFS event-free survival, pSU probability of survival, pEFS probability of event-free survival, SU survival, SE standard error