Prognostic variables and event-free survival (EFS)
| Variable . | No. of patients . | Percent of patients5-150 . | 6-year EFS . | P (log-rank)5-150 . |
|---|---|---|---|---|
| All patients | 2178 | 100.0 | 78 (1) | |
| Male | 1261 | 57.9 | 75 (1) | .0001 |
| Female | 917 | 42.1 | 82 (1) | |
| Age, y | ||||
| <1 | 59 | 2.7 | 50 (7) | .0001 |
| 1-5 | 1316 | 60.4 | 83 (1) | |
| 6-9 | 417 | 19.2 | 74 (2) | |
| 10-13 | 245 | 11.2 | 66 (3) | |
| 14-18 | 141 | 6.5 | 64 (4) | |
| WBC (×109/L) | ||||
| <10 | 1000 | 45.9 | 85 (1) | .0001 |
| 10 to <20 | 343 | 15.8 | 80 (2) | |
| 20 to <50 | 350 | 16.1 | 81 (2) | |
| 50 to <200 | 358 | 16.4 | 66 (3) | |
| ≥200 | 127 | 5.8 | 36 (5) | |
| BFM-RF | ||||
| <0.8 | 688 | 31.6 | 85 (2) | .0001 |
| 0.8 to <1.2 | 721 | 33.1 | 82 (1) | |
| 1.2 to <1.7 | 622 | 28.6 | 70 (2) | |
| ≥1.7 | 147 | 6.7 | 51 (4) | |
| CNS involvement | 54 | 2.5 | 48 (7) | .0001 |
| Liver enlargement >4 cm5-151 | 673 | 30.9 | 71 (2) | .0001 |
| Spleen enlargement >4 cm5-151 | 589 | 27.0 | 68 (2) | .0001 |
| Mediastinal mass | 171 | 8.1 | 64 (4) | .0001 |
| Hemoglobin (g/L) <80 | 1169 | 53.7 | 81 (1) | .0001 |
| Immunophenotype | ||||
| Pro-B | 103 | 4.9 | 54 (5) | .0001 |
| Common | 1364 | 64.6 | 82 (1) | |
| Pre-B | 359 | 17.0 | 78 (2) | |
| T cell | 284 | 13.5 | 61 (3) | |
| Myeloid markers | ||||
| Positive | 374 | 19.1 | 74 (3) | .14 |
| Negative | 1585 | 80.9 | 78 (1) | |
| DNA index | ||||
| <1.16 | 857 | 74.3 | 73 (2) | .0002 |
| ≥1.16 | 297 | 25.7 | 84 (2) | |
| NCI risk group5-152 | ||||
| Standard risk | 1395 | 65.8 | 86 (1) | .0001 |
| High risk | 724 | 34.2 | 64 (2) | |
| t(9;22) orBCR/ABL status | ||||
| Positive | 27 | 2.2 | 33 (9) | .0001 |
| Negative/others5-153 | 1178 | 97.8 | 77 (1) | |
| t(4;11) status | ||||
| Positive | 20 | 2.9 | 35 (11) | .0001 |
| Others5-153 | 678 | 97.1 | 76 (2) | |
| t(1;19) status | ||||
| Positive | 15 | 2.1 | 93 (6) | .13 |
| Others5-153 | 683 | 97.9 | 75 (2) | |
| Down syndrome | 26 | 1.2 | 55 (14) | .17 |
| Response to prednisone | ||||
| <1000 blasts/μL on day 8 | 1935 | 90.5 | 82 (1) | .0001 |
| ≥1000 blasts/μL on day 8 | 202 | 9.5 | 34 (3) |
| Variable . | No. of patients . | Percent of patients5-150 . | 6-year EFS . | P (log-rank)5-150 . |
|---|---|---|---|---|
| All patients | 2178 | 100.0 | 78 (1) | |
| Male | 1261 | 57.9 | 75 (1) | .0001 |
| Female | 917 | 42.1 | 82 (1) | |
| Age, y | ||||
| <1 | 59 | 2.7 | 50 (7) | .0001 |
| 1-5 | 1316 | 60.4 | 83 (1) | |
| 6-9 | 417 | 19.2 | 74 (2) | |
| 10-13 | 245 | 11.2 | 66 (3) | |
| 14-18 | 141 | 6.5 | 64 (4) | |
| WBC (×109/L) | ||||
| <10 | 1000 | 45.9 | 85 (1) | .0001 |
| 10 to <20 | 343 | 15.8 | 80 (2) | |
| 20 to <50 | 350 | 16.1 | 81 (2) | |
| 50 to <200 | 358 | 16.4 | 66 (3) | |
| ≥200 | 127 | 5.8 | 36 (5) | |
| BFM-RF | ||||
| <0.8 | 688 | 31.6 | 85 (2) | .0001 |
| 0.8 to <1.2 | 721 | 33.1 | 82 (1) | |
| 1.2 to <1.7 | 622 | 28.6 | 70 (2) | |
| ≥1.7 | 147 | 6.7 | 51 (4) | |
| CNS involvement | 54 | 2.5 | 48 (7) | .0001 |
| Liver enlargement >4 cm5-151 | 673 | 30.9 | 71 (2) | .0001 |
| Spleen enlargement >4 cm5-151 | 589 | 27.0 | 68 (2) | .0001 |
| Mediastinal mass | 171 | 8.1 | 64 (4) | .0001 |
| Hemoglobin (g/L) <80 | 1169 | 53.7 | 81 (1) | .0001 |
| Immunophenotype | ||||
| Pro-B | 103 | 4.9 | 54 (5) | .0001 |
| Common | 1364 | 64.6 | 82 (1) | |
| Pre-B | 359 | 17.0 | 78 (2) | |
| T cell | 284 | 13.5 | 61 (3) | |
| Myeloid markers | ||||
| Positive | 374 | 19.1 | 74 (3) | .14 |
| Negative | 1585 | 80.9 | 78 (1) | |
| DNA index | ||||
| <1.16 | 857 | 74.3 | 73 (2) | .0002 |
| ≥1.16 | 297 | 25.7 | 84 (2) | |
| NCI risk group5-152 | ||||
| Standard risk | 1395 | 65.8 | 86 (1) | .0001 |
| High risk | 724 | 34.2 | 64 (2) | |
| t(9;22) orBCR/ABL status | ||||
| Positive | 27 | 2.2 | 33 (9) | .0001 |
| Negative/others5-153 | 1178 | 97.8 | 77 (1) | |
| t(4;11) status | ||||
| Positive | 20 | 2.9 | 35 (11) | .0001 |
| Others5-153 | 678 | 97.1 | 76 (2) | |
| t(1;19) status | ||||
| Positive | 15 | 2.1 | 93 (6) | .13 |
| Others5-153 | 683 | 97.9 | 75 (2) | |
| Down syndrome | 26 | 1.2 | 55 (14) | .17 |
| Response to prednisone | ||||
| <1000 blasts/μL on day 8 | 1935 | 90.5 | 82 (1) | .0001 |
| ≥1000 blasts/μL on day 8 | 202 | 9.5 | 34 (3) |
Values for percent of patients are for the percentage of patients analyzed. Values in parentheses are SE.
Based on a univariate comparison with the complementary group.
Organ enlargement in centimeters below the costal margin, measured in the midclavicular line.
Infants (patients <1 year of age) are not included; for definitions, see text and reference 46.
Others had another numerical or structural abnormality or a normal karyotype.