Baseline characteristics
| . | Modal number ≤ 44, (n = 15) . | Modal number = 45, (n = 66) . | Total (n = 81) . |
|---|---|---|---|
| n (%) . | n (%) . | n (%) . | |
| Sex (male/female) | 10/5 (67/33) | 32/34 (48/52) | 42/39 (52/48) |
| Median age (range) | 9 (1-17) | 6 (0-17) | 6 (0-17) |
| Median WBC at diagnosis (109/L) (range) | 13.8 (2.4-315) | 16.6 (0.9-353) | 16.13 (0.9-353) |
| Median PB blast % at diagnosis, (range, n) | 46.5 (0-90, 13) | 45 (0-100, 59) | 46 (0-100, 73) |
| Median BM blast % at diagnosis, (range, n) | 80 (38-99, 13) | 74 (3-100, 57) | 75.5 (3-100, 70) |
| Median platelet count at diagnosis (109/L) (range, n) | 73 (34-121, 14) | 74 (5-359, 60) | 74 (5-369, 74) |
| FAB type | |||
| M0 | 4 (27) | 5 (8) | 9 (11) |
| M1 | 3 (20) | 6 (9) | 9 (11) |
| M2 | 2 (13) | 17 (26) | 19 (23) |
| M4 | 1 (7) | 11 (17) | 12 (5) |
| M5 | 2 (13) | 13 (20) | 15 (9) |
| M6 | 0 (0) | 1 (2) | 1 (1) |
| M7 | 1 (7) | 4 (6) | 5 (6) |
| Other/missing | 1/1 (7/7) | 4/5 (6/8) | 5/6 (6/7) |
| CNS involvement | |||
| Yes | 5 (33)∗ | 4 (6)∗ | 9 (11) |
| No | 10 (67) | 60 (91) | 70 (86) |
| No data | 0 (0) | 2 (3) | 2 (2) |
| Extramedullary disease | |||
| Yes | 4 (27) | 7 (11) | 11(14) |
| No | 11 (73) | 56 (85) | 67 (83) |
| No data | 0 (0) | 3 (4) | 3 (4) |
| Stem cell transplantation | |||
| CR1 | 5 (33) | 13 (20) | 18 (22) |
| After relapse | 2 (13) | 13 (20) | 15 (19) |
| No data (not CR1) | 0 (0) | 4 (6) | 4 (5) |
| Cytogenetics† and genetics | |||
| t(8;21) | 0 (0) | 1 (2) | 1 (1) |
| inv(16)/t(16;16) | 0 (0) | 2 (3) | 2 (1) |
| t(6;9) | 0 (0) | 1 (2) | 1 (1) |
| t(9;11) | 1 (7) | 1 (2) | 2 (1) |
| Other 11q23‡ | 1 (7) | 5 (8) | 7 (8) |
| Complex karyotype | 13 (87) | 35 (53) | 48 (59) |
| Monosomal karyotype | 14 (93) | 44 (67) | 58 (72) |
| FLT3-ITD (n %, 54 tested) | 0 (0, 10 tested) | 4 (9, 44 tested) | 4 (7, 54 tested) |
| TP53 (n %, 29 tested) | 0 (0, 5 tested) | 1 (4, 24 tested) | 1 (3, 29 tested) |
| Event status | |||
| No event | 4 (27) | 27 (41) | 31 (38) |
| Induction death, death in CR | 2 (13) | 2 (3) | 4 (5) |
| Refractory disease | 1 (7) | 6 (9) | 7 (9) |
| Relapse | 8 (53) | 30 (45) | 38 (47) |
| Secondary malignancy | 0 (0) | 1 (2) | 1 (1) |
| Outcome, n (%) (95% CI) | |||
| 5-year EFS | 21 (4-46) | 37 (24-49) | 34 (23-45) |
| 5-year OS | 33 (10-59) | 56 (42-68) | 52 (40-63) |
| . | Modal number ≤ 44, (n = 15) . | Modal number = 45, (n = 66) . | Total (n = 81) . |
|---|---|---|---|
| n (%) . | n (%) . | n (%) . | |
| Sex (male/female) | 10/5 (67/33) | 32/34 (48/52) | 42/39 (52/48) |
| Median age (range) | 9 (1-17) | 6 (0-17) | 6 (0-17) |
| Median WBC at diagnosis (109/L) (range) | 13.8 (2.4-315) | 16.6 (0.9-353) | 16.13 (0.9-353) |
| Median PB blast % at diagnosis, (range, n) | 46.5 (0-90, 13) | 45 (0-100, 59) | 46 (0-100, 73) |
| Median BM blast % at diagnosis, (range, n) | 80 (38-99, 13) | 74 (3-100, 57) | 75.5 (3-100, 70) |
| Median platelet count at diagnosis (109/L) (range, n) | 73 (34-121, 14) | 74 (5-359, 60) | 74 (5-369, 74) |
| FAB type | |||
| M0 | 4 (27) | 5 (8) | 9 (11) |
| M1 | 3 (20) | 6 (9) | 9 (11) |
| M2 | 2 (13) | 17 (26) | 19 (23) |
| M4 | 1 (7) | 11 (17) | 12 (5) |
| M5 | 2 (13) | 13 (20) | 15 (9) |
| M6 | 0 (0) | 1 (2) | 1 (1) |
| M7 | 1 (7) | 4 (6) | 5 (6) |
| Other/missing | 1/1 (7/7) | 4/5 (6/8) | 5/6 (6/7) |
| CNS involvement | |||
| Yes | 5 (33)∗ | 4 (6)∗ | 9 (11) |
| No | 10 (67) | 60 (91) | 70 (86) |
| No data | 0 (0) | 2 (3) | 2 (2) |
| Extramedullary disease | |||
| Yes | 4 (27) | 7 (11) | 11(14) |
| No | 11 (73) | 56 (85) | 67 (83) |
| No data | 0 (0) | 3 (4) | 3 (4) |
| Stem cell transplantation | |||
| CR1 | 5 (33) | 13 (20) | 18 (22) |
| After relapse | 2 (13) | 13 (20) | 15 (19) |
| No data (not CR1) | 0 (0) | 4 (6) | 4 (5) |
| Cytogenetics† and genetics | |||
| t(8;21) | 0 (0) | 1 (2) | 1 (1) |
| inv(16)/t(16;16) | 0 (0) | 2 (3) | 2 (1) |
| t(6;9) | 0 (0) | 1 (2) | 1 (1) |
| t(9;11) | 1 (7) | 1 (2) | 2 (1) |
| Other 11q23‡ | 1 (7) | 5 (8) | 7 (8) |
| Complex karyotype | 13 (87) | 35 (53) | 48 (59) |
| Monosomal karyotype | 14 (93) | 44 (67) | 58 (72) |
| FLT3-ITD (n %, 54 tested) | 0 (0, 10 tested) | 4 (9, 44 tested) | 4 (7, 54 tested) |
| TP53 (n %, 29 tested) | 0 (0, 5 tested) | 1 (4, 24 tested) | 1 (3, 29 tested) |
| Event status | |||
| No event | 4 (27) | 27 (41) | 31 (38) |
| Induction death, death in CR | 2 (13) | 2 (3) | 4 (5) |
| Refractory disease | 1 (7) | 6 (9) | 7 (9) |
| Relapse | 8 (53) | 30 (45) | 38 (47) |
| Secondary malignancy | 0 (0) | 1 (2) | 1 (1) |
| Outcome, n (%) (95% CI) | |||
| 5-year EFS | 21 (4-46) | 37 (24-49) | 34 (23-45) |
| 5-year OS | 33 (10-59) | 56 (42-68) | 52 (40-63) |