Patients with AML in CR randomized to consolidation with chemotherapy (cycle 3) or ASCT: demographics at diagnosis and preceding remission induction therapy
| . | Cycle 3, no. (%) . | ASCT, no. (%) . |
|---|---|---|
| Total | 259 (100) | 258 (100) |
| Male sex | 126 (49) | 132 (51) |
| Age, y | ||
| Median, y | 47 | 49 |
| 16-40 y | 98 (38) | 79 (31) |
| 41-50 y | 57 (22) | 60 (23) |
| 50-61 y | 104 (40) | 119 (46) |
| WBC at diagnosis, × 109/L | ||
| ≤ 20 | 138 (53) | 125 (49) |
| 20-100 | 89 (34) | 96 (37) |
| > 100 | 32 (12) | 36 (14) |
| FAB type | ||
| M0 | 7 (3) | 12 (5) |
| M1 | 55 (21) | 64 (25) |
| M2 | 70 (27) | 62 (24) |
| M4 | 50 (19) | 60 (23) |
| M5 | 53 (20) | 46 (18) |
| M6 | 10 (4) | 6 (2) |
| M7 | 0 (0) | 2 (1) |
| RAEB | 3 (1) | 2 (1) |
| RAEB-t | 4 (2) | 3 (1) |
| Unknown | 7 (3) | 1 (0) |
| Secondary leukemia | 11 (4) | 18 (7) |
| Extra-medullary disease | 37 (14) | 31 (12) |
| Cytogenetics | ||
| Favorable | ||
| t(8;21) | 4 (2) | 5 (2) |
| inv(16) | 17 (7) | 13 (5) |
| Intermediate | 195 (70) | 213 (72) |
| CN X-Y | 138 (53) | 145 (56) |
| CA rest | 67 (26) | 68 (26) |
| Unfavorable | 16 (6) | 16 (6) |
| Very unfavorable (monosomal karyotype) | 17 (7) | 11 (4) |
| Not determined | 16 (6) | 16 (6) |
| Remission induction with G-CSF priming* | ||
| No | 195 (75) | 191 (74) |
| Yes | 64 (25) | 67 (26) |
| Remission induction with cytarabine* | ||
| Intermediate-dose level | 51 (58) | 45 (54) |
| High-dose level | 37 (42) | 38 (46) |
| CR reached† | ||
| Cycle 1 (early CR) | 210 (81) | 203 (79) |
| Cycle 2 (late CR) | 49 (19) | 55 (21) |
| . | Cycle 3, no. (%) . | ASCT, no. (%) . |
|---|---|---|
| Total | 259 (100) | 258 (100) |
| Male sex | 126 (49) | 132 (51) |
| Age, y | ||
| Median, y | 47 | 49 |
| 16-40 y | 98 (38) | 79 (31) |
| 41-50 y | 57 (22) | 60 (23) |
| 50-61 y | 104 (40) | 119 (46) |
| WBC at diagnosis, × 109/L | ||
| ≤ 20 | 138 (53) | 125 (49) |
| 20-100 | 89 (34) | 96 (37) |
| > 100 | 32 (12) | 36 (14) |
| FAB type | ||
| M0 | 7 (3) | 12 (5) |
| M1 | 55 (21) | 64 (25) |
| M2 | 70 (27) | 62 (24) |
| M4 | 50 (19) | 60 (23) |
| M5 | 53 (20) | 46 (18) |
| M6 | 10 (4) | 6 (2) |
| M7 | 0 (0) | 2 (1) |
| RAEB | 3 (1) | 2 (1) |
| RAEB-t | 4 (2) | 3 (1) |
| Unknown | 7 (3) | 1 (0) |
| Secondary leukemia | 11 (4) | 18 (7) |
| Extra-medullary disease | 37 (14) | 31 (12) |
| Cytogenetics | ||
| Favorable | ||
| t(8;21) | 4 (2) | 5 (2) |
| inv(16) | 17 (7) | 13 (5) |
| Intermediate | 195 (70) | 213 (72) |
| CN X-Y | 138 (53) | 145 (56) |
| CA rest | 67 (26) | 68 (26) |
| Unfavorable | 16 (6) | 16 (6) |
| Very unfavorable (monosomal karyotype) | 17 (7) | 11 (4) |
| Not determined | 16 (6) | 16 (6) |
| Remission induction with G-CSF priming* | ||
| No | 195 (75) | 191 (74) |
| Yes | 64 (25) | 67 (26) |
| Remission induction with cytarabine* | ||
| Intermediate-dose level | 51 (58) | 45 (54) |
| High-dose level | 37 (42) | 38 (46) |
| CR reached† | ||
| Cycle 1 (early CR) | 210 (81) | 203 (79) |
| Cycle 2 (late CR) | 49 (19) | 55 (21) |
Favorable indicates core-binding factor abnormalities t(8;21) (q22;q22), inv(16)(p13.1;q22), or t(16;16)(p13.1;q22); Unfavorable, patients with an unfavorable karyotype and patients with a monosomal karyotype; and Intermediate, all other patients, including those without cytogenetic abnormalities.
WBC indicates white blood cell count; FAB, French-American-British; RAEB, refractory anemia with excess blasts; RAEB-t, refractory anemia with excess blasts in transformation; CN, normal cytogenetics; and CA rest, AML with any other cytogenetic abnormalities.
Remission induction therapy varied according to a randomized study for remission induction that compared 2 dose levels of cytarabine in remission induction and yes versus no G-CSF priming.
Achieved after 1 or 2 induction therapies.