Table 1.
Descriptive statistics by protocol
| Protocol | Total (N = 890) |
|||
|---|---|---|---|---|
| 58741 (N = 60) |
58831/2 (N = 199) |
58881 (N = 631) |
||
| N (%) | N (%) | N (%) | N (%) | |
| Sex | ||||
| Male | 30 (50.0) | 104 (52.3) | 337 (53.4) | 471 (52.9) |
| Female | 30 (50.0) | 95 (47.7) | 294 (46.6) | 419 (47.1) |
| Age at diagnosis, years | ||||
| < 6 | 37 (61.7) | 125 (62.8) | 418 (66.2) | 580 (65.2) |
| 6–9 | 14 (23.3) | 47 (23.6) | 120 (19.0) | 181 (20.3) |
| 10–17 | 9 (15.0) | 27 (13.6) | 93 (14.7) | 129 (14.5) |
| WBC at diagnosis, × 109/l | ||||
| < 25 | 41 (68.3) | 139 (69.8) | 432 (68.5) | 612 (68.8) |
| 25 ≤50 | 9 (15.0) | 30 (15.1) | 77 (12.2) | 116 (13.0) |
| ≥ 50 | 10 (16.7) | 30 (15.1) | 122 (19.3) | 162 (18.2) |
| CNS involvement at diagnosis | ||||
| N available data | 57 (95.0) | 197 (99.0) | 628 (99.5) | 882 (99.1) |
| No CNS involvement | 55 (96.5) | 192 (97.5) | 588 (93.6) | 835 (94.7) |
| CNS involvement | 2 (3.5) | 5 (2.5) | 40 (6.4) | 47 (5.3) |
| NCI risk group | ||||
| Standard Risk | 42 (70.0) | 145 (72.9) | 431 (68.3) | 618 (69.4) |
| High Risk | 18 (30.0) | 54 (27.1) | 200 (31.7) | 272 (30.6) |
| CRT | ||||
| No | 0 (0.0) | 153 (76.9) | 591 (93.7) | 744 (83.6) |
| Yes | 60 (100.0) | 46 (23.1) | 40 (6.3) | 146 (16.4) |
| HSCT | ||||
| No | 60 (100.0) | 182 (91.5) | 549 (87.0) | 791 (88.9) |
| Yes | 0 (0.0) | 17 (8.5) | 82 (13.0) | 99 (11.1) |
| HSCT conditioning | ||||
| N available data | 0 (0.0) | 16 (8.0) | 80 (12.7) | 96 (10.8) |
| HDCT only | 0 (0.0) | 2 (12.5) | 11 (13.8) | 13 (13.5) |
| TBI + HDCT | 0 (0.0) | 14 (87.5) | 69 (86.3) | 83 (86.5) |
| HSCT in first line treatment | ||||
| No | 60 (100.0) | 195 (98.0) | 615 (97.5) | 870 (97.8) |
| Yes | 0 (0.0) | 4 (2.0) | 16 (2.5) | 20 (2.2) |
| VHR after consolidation in protocol 58881 | ||||
| N available data | – | – | 614 (97.3) | |
| No | – | – | 564 (91.9) | – |
| Yes | – | – | 50 (8.1) | – |
| HD-Cytarabine arm in protocol 58881 | ||||
| N randomized patients | – | – | 207 (32.8) | – |
| No HD Cytarabine | – | – | 109 (52.7) | – |
| HD Cytarabine | – | – | 98 (47.3) | – |
| Relapse | ||||
| No | 36 (60.0) | 166 (83.4) | 514 (81.5) | 716 (80.4) |
| Yes | 24 (40.0) | 33 (16.6) | 117 (18.5) | 174 (19.6) |
| CNS relapse | ||||
| No | 42 (70.0) | 184 (92.5) | 579 (91.8) | 805 (90.4) |
| Yes | 18 (30.0) | 15 (7.5) | 52 (8.2) | 85 (9.6) |
| Survival status | ||||
| Alive | 42 (70.0) | 183 (92.0) | 579 (91.8) | 804 (90.3) |
| Dead | 18 (30.0) | 16 (8.0) | 52 (8.2) | 86 (9.7) |
CNS, central nervous system; CRT, cranial radiotherapy; HD Cytarabine, high-dose cytarabine; HSCT, hematopoietic stem cell transplantation; NCI, National Cancer Institute; TBI, total body irradiation; VHR, very high risk; WBC, white blood cells.