Table 1.
Total | AML-BFM 2004 | AML-BFM 98 | AML-BFM 93 | ||||||
---|---|---|---|---|---|---|---|---|---|
n | % | n | % | n | % | n | % | p-value | |
Registered patients | 249 | 99 | 82 | 68 | |||||
Protocol patients | 193 | 78 | 94 | 95 | 57 | 70 | 42 | 63 | < 0.0001 |
Age | |||||||||
Median (Q1–Q3) | 9.5 | (2.5–13.4) | 8.6 | (2.2–14.6) | 9.9 | (3.0–12.8) | 9.5 | (2.9–12.2) | 0.675 |
< 1 year | 15 | 8 | 7 | 7 | 3 | 5 | 5 | 12 | 0.862 |
1≤ 10 years | 88 | 45 | 45 | 48 | 27 | 47 | 16 | 37 | |
≥ 10 years | 91 | 47 | 42 | 45 | 27 | 47 | 22 | 51 | |
Gender | |||||||||
Males | 96 | 50 | 46 | 49 | 27 | 47 | 23 | 55 | 0.605 |
Females | 97 | 50 | 48 | 51 | 30 | 53 | 19 | 45 | |
Leukocytes (× 109/l) | |||||||||
< 10 | 93 | 48 | 47 | 50 | 27 | 47 | 19 | 45 | 0.552 |
10–< 100 | 71 | 37 | 36 | 38 | 17 | 30 | 18 | 43 | |
≥ 100 | 29 | 15 | 11 | 12 | 13 | 23 | 5 | 12 | |
CNS leukemia | 11 | 6 | 8 | 7 | 2 | 4 | 1 | 2 | 0.129 |
FAB types | |||||||||
M0 | 12 | 6 | 5 | 5 | 3 | 5 | 4 | 10 | 0.508 |
M1 | 19 | 10 | 11 | 12 | 7 | 12 | 1 | 2 | |
M2 | 53 | 27 | 27 | 29 | 13 | 23 | 13 | 31 | |
M3 | 21 | 11 | 12 | 13 | 5 | 9 | 4 | 10 | |
M4 | 24 | 12 | 5 | 5 | 10 | 18 | 9 | 21 | |
M4Eo | 18 | 9 | 8 | 9 | 8 | 14 | 2 | 5 | |
M5 | 24 | 12 | 13 | 14 | 5 | 9 | 6 | 14 | |
M6 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | |
M7 | 19 | 10 | 10 | 11 | 6 | 11 | 3 | 7 | |
Other | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | |
Not classified | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | |
Genetic aberrations | |||||||||
t(8;21) | 20 | 10 | 9 | 10 | 5 | 9 | 6 | 14 | 0.606 |
t(15;17) | 19 | 10 | 10 | 11 | 5 | 9 | 4 | 10 | |
inv(16) | 18 | 9 | 7 | 7 | 8 | 14 | 3 | 7 | |
MLL | 45 | 23 | 19 | 20 | 13 | 23 | 13 | 30 | |
Normal | 26 | 13 | 12 | 13 | 9 | 16 | 5 | 12 | |
Other | 52 | 27 | 29 | 30 | 13 | 23 | 10 | 23 | |
Down | 11 | 6 | 7 | 7 | 4 | 7 | n.a. | n.a. | |
Not classified | 2 | 1 | 1 | 1 | 0 | 0 | 1 | 2 | |
Risk group | |||||||||
SR | 72 | 37 | 36 | 38 | 22 | 39 | 14 | 33 | 0.735 |
HR | 117 | 61 | 58 | 62 | 32 | 56 | 27 | 64 | |
Not classified | 4 | 2 | 0 | 0 | 3 | 5 | 1 | 2 | |
Median follow-up | |||||||||
In years (Q1–Q3) | 6.7 | (4.0–9.7) | 4.0 | (1.8–6.0) | 9.0 | (7.9–10.5) | 11.6 | (9.0–15.0) |
AML acute myeloid leukemia, CNS central nervous system, SR standard risk, HR high-risk