Patient characteristics at diagnosis (no further therapy vs GO postremission therapy)
| . | Postremission arm, no. (%) . | |
|---|---|---|
| None . | GO . | |
| Total | 119 (100) | 113 (100) |
| Age, y | ||
| ≤ 65 | 49 (41) | 44 (39) |
| 66-70 | 45 (38) | 46 (41) |
| > 70 | 25 (21) | 23 (20) |
| Mean ± SD | 67 ± 4 | 67 ± 4 |
| Median (range) | 66 (60-78) | 67 (60-77) |
| Sex | ||
| Male | 65 (55) | 63 (56) |
| Female | 54 (45) | 50 (44) |
| WHO performance status | ||
| 0 | 41 (35) | 44 (39) |
| 1-2 | 77 (65) | 68 (61) |
| Type of AML | ||
| De novo | 102 (86) | 94 (83) |
| Previous MDS | 10 (8) | 12 (11) |
| Previous chemo/RT | 7 (6) | 7 (6) |
| AML/MDS | 100/19 (84/16) | 100/13 (88/12) |
| Extramedullary disease | 9 (8) | 14 (12) |
| Hepatomegaly | 8 (7) | 14 (12) |
| Splenomegaly | 9 (8) | 9 (8) |
| Cytogenetics | ||
| CBF | 6 (5) | 9 (8) |
| CN-X-Y | 58 (49) | 52 (46) |
| CA other | 23 (19) | 23 (20) |
| Unfavorable | 9 (8) | 11 (10) |
| Monosomal karyotype | 7 (6) | 8 (7) |
| ND/fail | 16 (13) | 10 (9) |
| Induction arm | ||
| Conventional dose daunorubicin (45 mg/m2)* | 56 (47) | 53 (47) |
| High-dose daunorubicin (90 mg/m2)† | 63 (53) | 60 (53) |
| CR reached | ||
| After cycle I | 84 (71) | 78 (69) |
| After cycle II | 35 (29) | 35 (31) |
| . | Postremission arm, no. (%) . | |
|---|---|---|
| None . | GO . | |
| Total | 119 (100) | 113 (100) |
| Age, y | ||
| ≤ 65 | 49 (41) | 44 (39) |
| 66-70 | 45 (38) | 46 (41) |
| > 70 | 25 (21) | 23 (20) |
| Mean ± SD | 67 ± 4 | 67 ± 4 |
| Median (range) | 66 (60-78) | 67 (60-77) |
| Sex | ||
| Male | 65 (55) | 63 (56) |
| Female | 54 (45) | 50 (44) |
| WHO performance status | ||
| 0 | 41 (35) | 44 (39) |
| 1-2 | 77 (65) | 68 (61) |
| Type of AML | ||
| De novo | 102 (86) | 94 (83) |
| Previous MDS | 10 (8) | 12 (11) |
| Previous chemo/RT | 7 (6) | 7 (6) |
| AML/MDS | 100/19 (84/16) | 100/13 (88/12) |
| Extramedullary disease | 9 (8) | 14 (12) |
| Hepatomegaly | 8 (7) | 14 (12) |
| Splenomegaly | 9 (8) | 9 (8) |
| Cytogenetics | ||
| CBF | 6 (5) | 9 (8) |
| CN-X-Y | 58 (49) | 52 (46) |
| CA other | 23 (19) | 23 (20) |
| Unfavorable | 9 (8) | 11 (10) |
| Monosomal karyotype | 7 (6) | 8 (7) |
| ND/fail | 16 (13) | 10 (9) |
| Induction arm | ||
| Conventional dose daunorubicin (45 mg/m2)* | 56 (47) | 53 (47) |
| High-dose daunorubicin (90 mg/m2)† | 63 (53) | 60 (53) |
| CR reached | ||
| After cycle I | 84 (71) | 78 (69) |
| After cycle II | 35 (29) | 35 (31) |
Cytogenetics: CBF: AML with CBF chromosomal abnormalities, ie, (t8;21) or inv(16)/t(16;16). CN-X-Y: normal cytogenetics or -X or -Y as single abnormalities only.
Unfavorable refers to complex abnormalities or −5/7(q), abn 3q, t(6;9), t(9;22), abn 11q23, and no CBF and no MK (for details, see Löwenberg et al19 ).
CA other indicates other cytogenetic abnormalities; CR, complete remission; GO, gemtuzumab ozogamicin; MDS, myelodysplastic syndrome; ND, not determined; RT, radiation therapy; and WHO, World Health Organization.
Remission induction treatment arm with a “conventional” daunorubicin dose of 45 mg/m2 3-hour infusion on days 1 to 3 and cytarabine 200 mg/m2 continuously intravenously days 1 to 7.
Remission induction treatment arm with high-dose daunorubicin dose of 90 mg/m2 3-hour infusion on days 1 to 3 and cytarabine 200 mg/m2 continuously intravenously days 1 to 7.