Cumulative doses of selected chemotherapeutic agents and radiation of ALL-BFM trials 79 to 90 according to the risk groups
| Study Risk Group . | Patients* (%) . | DNR mg/m2 . | DOX mg/m2 . | CPM g/m2 . | MTX mg IT† . | MTX G/m2 IV . | CRT (Gy) by Age . | Others . |
|---|---|---|---|---|---|---|---|---|
| BFM 79 | < 1y-< 2y-≥ 2y | |||||||
| A (RI ≤ 2) | 62/4.2 | 100 (4) | 50 (2) | 3 (3) | 75 (6)+ | — | 12-15-18 | |
| B (RI > 2) | 38/2.6 | 100 (4) | 100 (4) | 4 (4) | 75 (6)+ | — | 16-20-24 | |
| BFM 81 | ||||||||
| SR (RF < 1.2) random | 30/3.7 | 120 (4) | 60 (2) | 2 (2) | 72 (6) | — | 12-15-18 | |
| 29/3.6 | 120 (4) | 60 (2) | 2 (2) | 120 (10) | 2 (4) | — | ||
| MR (RF < 1.7) | 34/4.1 | 120 (4) | 120 (4) | 3 (3) | 72 (6) | 16-20-24 | ||
| HR (RF > 1.7) | 7/0.9 | 120 (4) | 120 (4) | 3 (3) | 72 (6) | 16-20-24 | 0.66 g (4) VM26 | |
| BFM 83 | ||||||||
| SRL (RF < 0.8) random | 30/4.1 | 120 (4) | 0 | 2 (2) | 72 (6) | 2 (4) | — | |
| 120 (4) | 60 (2) | 2 (2) | 96 (8) | 2 (4) | — | |||
| SRH (RF < 1.2) random | 29/4.0 | 120 (4) | 60 (2) | 2 (2) | 96 (8) | 2 (4) | 12 | |
| 120 (4) | 60 (2) | 2 (2) | 96 (8) | 2 (4) | 12-15-18 | |||
| MR (RF < 1.7) | 33/4.6 | 120 (4) | 120 (4) | 3 (3) | 108 (9) | 2 (4) | 12-15-18 | |
| HR (RF ≥ 1.7) | 8/1.0 | 120 (4) | 120 (4) | 5 (13) | 132 (11) | 3 (6) | 16-20-24 | 0.33 g |
| (4) VM26 | ||||||||
| BFM 86 | ||||||||
| SRG (RF < 0.8) | 28/5.9 | 160 (4) | 0 | 2 (2) | 84 (7) | 20 (4) | — | |
| RG (RF ≥ 0.8) random (PGR) | 37/8.0 | 160 (4) | 120 (4) | 3 (3) | 108 (9) | 20 (4) | RF < 1.2:12 | 0.66 g (4) VM26 |
| 23/4.9 | 160 (4) | 120 (4) | 3 (3) | 108 (9) | 20 (4) | RF ≥ 1.2:18 | 12 mg (4) VDS | |
| < 1 y 0 | 4 g (4) IFO | |||||||
| EG (PPR) | 12/2.5 | 160 (4) | 120 (4) | 3 (3) | 108 (9) | 20 (4) | 0-12-18 | 40 mg (4) Mitox |
| 8 g (8) IFO | ||||||||
| BFM 90 | ||||||||
| SRG (RF < 0.8) | 28/13.1 | 120 (4) | 120 (4) | 3 (3) | 132 (11) | 20 (4) | — | |
| MR (RF ≥ 0.8) random (PGR) | 29/13.2 | 120 (4) | 120 (4) | 3 (3) | 132 (11) | 20 (4) | 0-12 | |
| 31/14.4 | 120 (4) | 120 (4) | 3 (3) | 132 (11) | 20 (4) | 0-12 | ||
| HRG (PPR) | 12/5.2 | 270 (7) | 0 | 0 | 144 (12)‡ | 30 (6) | 0-12 | 9 mg (3) VDS |
| 1.3 g (9) VP16 | ||||||||
| 6 g (15) IFO |
| Study Risk Group . | Patients* (%) . | DNR mg/m2 . | DOX mg/m2 . | CPM g/m2 . | MTX mg IT† . | MTX G/m2 IV . | CRT (Gy) by Age . | Others . |
|---|---|---|---|---|---|---|---|---|
| BFM 79 | < 1y-< 2y-≥ 2y | |||||||
| A (RI ≤ 2) | 62/4.2 | 100 (4) | 50 (2) | 3 (3) | 75 (6)+ | — | 12-15-18 | |
| B (RI > 2) | 38/2.6 | 100 (4) | 100 (4) | 4 (4) | 75 (6)+ | — | 16-20-24 | |
| BFM 81 | ||||||||
| SR (RF < 1.2) random | 30/3.7 | 120 (4) | 60 (2) | 2 (2) | 72 (6) | — | 12-15-18 | |
| 29/3.6 | 120 (4) | 60 (2) | 2 (2) | 120 (10) | 2 (4) | — | ||
| MR (RF < 1.7) | 34/4.1 | 120 (4) | 120 (4) | 3 (3) | 72 (6) | 16-20-24 | ||
| HR (RF > 1.7) | 7/0.9 | 120 (4) | 120 (4) | 3 (3) | 72 (6) | 16-20-24 | 0.66 g (4) VM26 | |
| BFM 83 | ||||||||
| SRL (RF < 0.8) random | 30/4.1 | 120 (4) | 0 | 2 (2) | 72 (6) | 2 (4) | — | |
| 120 (4) | 60 (2) | 2 (2) | 96 (8) | 2 (4) | — | |||
| SRH (RF < 1.2) random | 29/4.0 | 120 (4) | 60 (2) | 2 (2) | 96 (8) | 2 (4) | 12 | |
| 120 (4) | 60 (2) | 2 (2) | 96 (8) | 2 (4) | 12-15-18 | |||
| MR (RF < 1.7) | 33/4.6 | 120 (4) | 120 (4) | 3 (3) | 108 (9) | 2 (4) | 12-15-18 | |
| HR (RF ≥ 1.7) | 8/1.0 | 120 (4) | 120 (4) | 5 (13) | 132 (11) | 3 (6) | 16-20-24 | 0.33 g |
| (4) VM26 | ||||||||
| BFM 86 | ||||||||
| SRG (RF < 0.8) | 28/5.9 | 160 (4) | 0 | 2 (2) | 84 (7) | 20 (4) | — | |
| RG (RF ≥ 0.8) random (PGR) | 37/8.0 | 160 (4) | 120 (4) | 3 (3) | 108 (9) | 20 (4) | RF < 1.2:12 | 0.66 g (4) VM26 |
| 23/4.9 | 160 (4) | 120 (4) | 3 (3) | 108 (9) | 20 (4) | RF ≥ 1.2:18 | 12 mg (4) VDS | |
| < 1 y 0 | 4 g (4) IFO | |||||||
| EG (PPR) | 12/2.5 | 160 (4) | 120 (4) | 3 (3) | 108 (9) | 20 (4) | 0-12-18 | 40 mg (4) Mitox |
| 8 g (8) IFO | ||||||||
| BFM 90 | ||||||||
| SRG (RF < 0.8) | 28/13.1 | 120 (4) | 120 (4) | 3 (3) | 132 (11) | 20 (4) | — | |
| MR (RF ≥ 0.8) random (PGR) | 29/13.2 | 120 (4) | 120 (4) | 3 (3) | 132 (11) | 20 (4) | 0-12 | |
| 31/14.4 | 120 (4) | 120 (4) | 3 (3) | 132 (11) | 20 (4) | 0-12 | ||
| HRG (PPR) | 12/5.2 | 270 (7) | 0 | 0 | 144 (12)‡ | 30 (6) | 0-12 | 9 mg (3) VDS |
| 1.3 g (9) VP16 | ||||||||
| 6 g (15) IFO |
SR: standard risk; SRL: low standard risk; SRH: high standard risk; MR: medium risk; HR: high risk; RG: risk group; EG: experimental group; RF: risk factor; RI: risk index; PGR: prednisone good response; PPR: prednisone poor response; DOX: doxorubicin; CPM: cyclophosphamide; DNR: daunorubicin; IFO: ifosphamide; MTX: methotrexate; CRT: cranial radiotherapy; VM: teniposide; VP: etoposide.
In parentheses: number of dosages by which cumulative dose was administered.
Proportion of patients in percent of the trial, as well as of the whole study population.
Single dose 12 mg MTX intrathecally (IT), adjusted for children <3 y (MTX-dose: <1 y 6 mg; ≥1 y <2 y 8 mg; ≥2 and <3 y 10 mg; and ≥3 y 12 mg); +12.5 mg/m2 per dose.
Triple drug: MTX and cytarabin 144-270 mg and prednisolone 36-90 mg depending on age.