Table 1.
The patient characteristics.
| Protocol | AML-PPLLSG 83 | AML-PPLLSG 94 | AML-PPLLSG 98 | AML-BFM 2004 Interim | AML-BFM 2012 Registry |
|---|---|---|---|---|---|
| Period | 1983–1993 | 1994–1997 | 1998–2003 | 2004–2014 | 2015–2019 |
| Follow-up end-point | 31/03/2002 | 31/03/2002 | 31/07/2015 | 31/12/2020 | 31/12/2020 |
| Median observation time (months) | 128 | 93 | 119 | 90 | 37 |
| Number of patients | 187 | 74 | 151 | 356 | 131 |
| Age median/range (years) | 8.2/0.1–16.7 | 10.0/0.4–16.5 | 8.4/0–17.7 | 10.6/0–18 | 7.8/0.1–17.9 |
| Gender male/female | 93/94 | 36/38 | 87/64 | 184/172 | 73/58 |
| CNS involvement | 10 (5.3) | 5 (6.7) | 7 (5.8) | 40 (11.2) | 13 (9.9) |
| Extramedullary organ involvement | 40 (21.4) | 14 (18.9) | 31 (20.5) | 88 (24.7) | 23 (17.5) |
| FAB types | |||||
| M0 | 0 (0) | 3 (4.0) | 12 (8.1) | 28 (8.1) | 2 (1,7) |
| M1 | 44 (23.5) | 12 (16.2) | 27 (18.2) | 55 (16.0) | 10 (8.3) |
| M2 | 54 (28.9) | 24 (32.4) | 52 (35.1) | 94 (27.3) | 36 (30.0) |
| M4 | 50 (26.7) | 18 (24.3) | 29 (19.6) | 71 (20.6) | 18 (15.0) |
| M5 | 30 (16.0) | 11 (14.9) | 19 (12.8) | 70 (20.3) | 39 (32.5) |
| M6 | 8 (4.3) | 3 (4.0) | 6 (4.1) | 5 (1.4) | 1 (8.3) |
| M7 | 1 (0.5) | 1 (1.3) | 3 (2.0) | 21 (6.1) | 14 (11.7) |
| Non defined | 0 (0) | 2 (2.7) | 3 (2.0) | 12 (3.5) | 11 (9.2) |
| Risk groups | |||||
| SR | - | 30 (40.6) | 78 (51.7) | 71 (19.9) | 25 (18.5) |
| IR | - | - | - | - | 52 (40.0) |
| HR | - | 36 (48.6) | 65 (43.0) | 284 (79.8) | 52 (40.0) |
| Unknown | - | 8 (10.8) | 8 (5.3) | 1 (0.3) | 2 (1.5) |