Demographic, laboratory, and clinical characteristics of patients with or without MRD at the EOI1
| Characteristic . | EOI1 MRD status . | ||||
|---|---|---|---|---|---|
| MRD− at EOI1, N = 544 . | MRD+ at EOI1, N = 240 . | P . | |||
| n . | % or range . | n . | % or range . | ||
| Total | 544 | 240 | |||
| Sex | |||||
| Male | 274 | 50.4 | 119 | 49.6 | .840 |
| Female | 270 | 49.6 | 121 | 50.4 | |
| Age group, y | |||||
| 0-1 | 107 | 19.7 | 49 | 20.4 | .809 |
| 2-10 | 194 | 35.7 | 82 | 34.2 | .686 |
| >11 | 243 | 44.7 | 109 | 45.4 | .846 |
| Cytogenetics | |||||
| Normal | 102 | 19.3 | 75 | 32.1 | <.001 |
| t(8;21) | 87 | 16.4 | 19 | 8.1 | .002 |
| inv(16) | 78 | 14.7 | 7 | 3.0 | <.001 |
| t(9;11)/11q23 | 129 | 24.4 | 31 | 13.2 | .001 |
| t(6;9) | 7 | 1.3 | 6 | 2.6 | .234 |
| Monosomy 7 | 3 | 0.6 | 14 | 6.0 | <.001 |
| Del(7q) | 3 | 0.6 | 8 | 3.4 | .005 |
| −5/5q | 7 | 1.3 | 5 | 2.1 | .528 |
| +8 | 25 | 4.7 | 26 | 11.1 | .001 |
| Other | 88 | 16.6 | 43 | 18.4 | .557 |
| Unknown | 15 | 6 | |||
| ITD status | |||||
| Negative | 459 | 87.6 | 168 | 74.3 | <.001 |
| Positive | 65 | 12.4 | 58 | 25.7 | |
| HAR | 34 | 6.5 | 32 | 14.2 | |
| Low allelic ratio | 31 | 5.9 | 26 | 11.5 | |
| Unknown | 20 | 14 | |||
| CEBPA status | |||||
| Negative | 491 | 94.4 | 214 | 95.1 | .702 |
| Positive | 29 | 5.6 | 11 | 4.9 | |
| Unknown | 24 | 15 | |||
| NPM1 status | |||||
| Negative | 475 | 91.2 | 209 | 92.9 | .435 |
| Positive | 46 | 8.8 | 16 | 7.1 | |
| Unknown | 23 | 15 | |||
| Risk group, cyto/mutation | |||||
| Standard | 267 | 50.0 | 137 | 57.8 | .045 |
| Low | 224 | 41.9 | 49 | 20.7 | <.001 |
| High | 43 | 8.1 | 51 | 21.5 | <.001 |
| Unknown | 10 | 3 | |||
| Risk group, cytogenetic only | |||||
| Standard | 354 | 66.9 | 189 | 80.8 | <.001 |
| Low | 165 | 31.2 | 26 | 11.1 | <.001 |
| High | 10 | 1.9 | 19 | 8.1 | <.001 |
| Unknown | 15 | 6 | |||
| Response by end of course 1 | |||||
| CR | 463 | 86.2 | 113 | 47.3 | <.001 |
| Partial remission, >5% to 15% | 42 | 7.8 | 52 | 21.8 | <.001 |
| PD, >15% | 25 | 4.7 | 66 | 27.6 | <.001 |
| CNS refractory, declared off therapy | 7 | 1.3 | 7 | 2.9 | .144 |
| Death | 0 | 0.0 | 1 | 0.4 | .308 |
| Not evaluable | 7 | 1 | |||
| Response by end of course 2 | |||||
| CR | 510 | 95.1 | 159 | 71.3 | <.001 |
| Refractory disease | 6 | 1.1 | 51 | 22.9 | <.001 |
| Relapse | 18 | 3.4 | 10 | 4.5 | .453 |
| Death | 2 | 0.4 | 3 | 1.3 | .154 |
| Not evaluable | 8 | 17 | |||
| Age, y | |||||
| Median (range) | 9.6 | (0.02-23.8) | 10.1 | (0.003-29.8) | .978 |
| WBC, ×103/µL | |||||
| Median (range) | 21.35 | (0.2-827.2) | 31.65 | (0.6-447.3) | .014 |
| BM blasts, % | |||||
| Median (range) | 65 | (0.4-100) | 74.75 | (0-99) | .031 |
| Protocol SCT received? | |||||
| Yes | 70 | 12.9 | 52 | 21.7 | .002 |
| No | 474 | 87.1 | 188 | 78.3 | |
| Characteristic . | EOI1 MRD status . | ||||
|---|---|---|---|---|---|
| MRD− at EOI1, N = 544 . | MRD+ at EOI1, N = 240 . | P . | |||
| n . | % or range . | n . | % or range . | ||
| Total | 544 | 240 | |||
| Sex | |||||
| Male | 274 | 50.4 | 119 | 49.6 | .840 |
| Female | 270 | 49.6 | 121 | 50.4 | |
| Age group, y | |||||
| 0-1 | 107 | 19.7 | 49 | 20.4 | .809 |
| 2-10 | 194 | 35.7 | 82 | 34.2 | .686 |
| >11 | 243 | 44.7 | 109 | 45.4 | .846 |
| Cytogenetics | |||||
| Normal | 102 | 19.3 | 75 | 32.1 | <.001 |
| t(8;21) | 87 | 16.4 | 19 | 8.1 | .002 |
| inv(16) | 78 | 14.7 | 7 | 3.0 | <.001 |
| t(9;11)/11q23 | 129 | 24.4 | 31 | 13.2 | .001 |
| t(6;9) | 7 | 1.3 | 6 | 2.6 | .234 |
| Monosomy 7 | 3 | 0.6 | 14 | 6.0 | <.001 |
| Del(7q) | 3 | 0.6 | 8 | 3.4 | .005 |
| −5/5q | 7 | 1.3 | 5 | 2.1 | .528 |
| +8 | 25 | 4.7 | 26 | 11.1 | .001 |
| Other | 88 | 16.6 | 43 | 18.4 | .557 |
| Unknown | 15 | 6 | |||
| ITD status | |||||
| Negative | 459 | 87.6 | 168 | 74.3 | <.001 |
| Positive | 65 | 12.4 | 58 | 25.7 | |
| HAR | 34 | 6.5 | 32 | 14.2 | |
| Low allelic ratio | 31 | 5.9 | 26 | 11.5 | |
| Unknown | 20 | 14 | |||
| CEBPA status | |||||
| Negative | 491 | 94.4 | 214 | 95.1 | .702 |
| Positive | 29 | 5.6 | 11 | 4.9 | |
| Unknown | 24 | 15 | |||
| NPM1 status | |||||
| Negative | 475 | 91.2 | 209 | 92.9 | .435 |
| Positive | 46 | 8.8 | 16 | 7.1 | |
| Unknown | 23 | 15 | |||
| Risk group, cyto/mutation | |||||
| Standard | 267 | 50.0 | 137 | 57.8 | .045 |
| Low | 224 | 41.9 | 49 | 20.7 | <.001 |
| High | 43 | 8.1 | 51 | 21.5 | <.001 |
| Unknown | 10 | 3 | |||
| Risk group, cytogenetic only | |||||
| Standard | 354 | 66.9 | 189 | 80.8 | <.001 |
| Low | 165 | 31.2 | 26 | 11.1 | <.001 |
| High | 10 | 1.9 | 19 | 8.1 | <.001 |
| Unknown | 15 | 6 | |||
| Response by end of course 1 | |||||
| CR | 463 | 86.2 | 113 | 47.3 | <.001 |
| Partial remission, >5% to 15% | 42 | 7.8 | 52 | 21.8 | <.001 |
| PD, >15% | 25 | 4.7 | 66 | 27.6 | <.001 |
| CNS refractory, declared off therapy | 7 | 1.3 | 7 | 2.9 | .144 |
| Death | 0 | 0.0 | 1 | 0.4 | .308 |
| Not evaluable | 7 | 1 | |||
| Response by end of course 2 | |||||
| CR | 510 | 95.1 | 159 | 71.3 | <.001 |
| Refractory disease | 6 | 1.1 | 51 | 22.9 | <.001 |
| Relapse | 18 | 3.4 | 10 | 4.5 | .453 |
| Death | 2 | 0.4 | 3 | 1.3 | .154 |
| Not evaluable | 8 | 17 | |||
| Age, y | |||||
| Median (range) | 9.6 | (0.02-23.8) | 10.1 | (0.003-29.8) | .978 |
| WBC, ×103/µL | |||||
| Median (range) | 21.35 | (0.2-827.2) | 31.65 | (0.6-447.3) | .014 |
| BM blasts, % | |||||
| Median (range) | 65 | (0.4-100) | 74.75 | (0-99) | .031 |
| Protocol SCT received? | |||||
| Yes | 70 | 12.9 | 52 | 21.7 | .002 |
| No | 474 | 87.1 | 188 | 78.3 | |
Table 1 shows N = 200 (74 + 126) not in CR. The N = 185 in the text of the results consists of patients with partial remission or PD without a CNS relapse. The N = 15 difference consists of patients who had a CNS relapse or who died during induction 1. Bold values in the table body represent statistically significant P values.