Table 1 Characteristics and treatment response of patients with CBF-AML in the AML-05 and AML99 studies
AML-05 (n=154) | AML99 (n=89) | P-value | |
|---|---|---|---|
Sex, n (%) | |||
Male | 92 (59.7) | 53 (59.5) | |
Female | 62 (40.2) | 36 (40.4) | 0.976 |
Age at diagnosis (years) | |||
Median | 8.5 | 8 | |
Range | 0–17 | 0–15 | 0.655 |
WBC at diagnosis (/μl) | |||
Median | 15 540 | 14 800 | |
Range | 617–266 900 | 1 340–365 000 | 0.250 |
FAB classification, n (%) | |||
M1 | 16 (10.3) | 10 (11.2) | |
M2 | 82 (53.2) | 63 (70.7) | |
M4 | 14 (9.0) | 9 (10.1) | |
M4Eo | 14 (9.0) | 4 (4.4) | |
M5 | 2 (1.2) | 3 (3.3) | |
RAEB-T* | 25 (16.2) | 0 (0.0) | |
ND | 1 (0.6) | 0 (0.0) | <0.001 |
Cytogenetics, n (%) | |||
t(8;21) | 122 (79.2) | 77 (86.5) | |
inv(16) | 32 (20.7) | 12 (13.4) | 0.154 |
FLT3-ITD status, n (%) | |||
Positive | 5 (3.2) | 2 (2.2) | |
Negative | 149 (96.7) | 51 (57.3) | |
NE | 0 (0.0) | 36 (40.4) | 0.796 |
Induction response, n (%) | |||
CR after induction 1 | 144 (93.5) | 84 (94.3) | 0.785 |
CR after induction 2 | 147 (95.4) | 87 (97.7) | 0.361 |
Early death | 1 (0.6) | 0 (0.0) | 0.446 |
Non-response (after induction 2) | 3 (1.9) | 2 (2.2) | 0.185 |
Survival of all CBF-AML patients, % (s.e.) | |||
3-year pEFS | 68.3 (3.9) | 80.9 (4.1) | 0.058 |
3-year pOS | 92.1 (2.4) | 92.1 (2.8) | 0.953 |
3-year CIR | 29.9 (3.8) | 17.1 (4.0) | 0.041 |
Survival of t(8;21) patients, % (s.e.) | |||
3-year pEFS | 67.0 (4.4) | 79.2 (4.6) | 0.112 |
3-year pOS | 91.0 (2.8) | 90.9 (3.2) | 0.912 |
3-year CIR | 31.5 (4.3) | 18.5 (4.4) | 0.068 |
Survival of inv(16) patients, % (s.e.) | |||
3-year pEFS | 74.1 (7.9) | 91.6 (7.9) | 0.218 |
3-year pOS | 96.8 (3.0) | 100 | 0.540 |
3-year CIR | 23.2 (7.7) | 8.3 (7.9) | 0.278 |
Survival of CBF-AML patients without t(8;21) and WBC>50 000/μl, RAEB-T or FLT3-ITD, % (s.e.) | |||
3-year pEFS | 68.6 (4.6) | 82.6 (4.3) | 0.051 |
3-year pOS | 95.0 (2.4) | 94.6 (2.5) | 0.953 |
3-year CIR | 31.3 (4.6) | 16.2 (4.2) | 0.031 |
