Table II.
Demographics of Patient Population
| De novo patient characteristics for patients on CCG-2941 and CCG-2961 | |||||||
|---|---|---|---|---|---|---|---|
| g/g (n=91) | t/g (n=183) | t/t (n=184) | |||||
| N | % | N | % | N | % | p-value | |
| Study | |||||||
| CCG-2941 | 8 | 9% | 17 | 9% | 12 | 7% | 0.599 |
| CCG-2961 | 83 | 91% | 166 | 91% | 172 | 93% | |
| Gender | |||||||
| Male | 50 | 55% | 108 | 59% | 95 | 52% | 0.363 |
| Female | 41 | 45% | 75 | 41% | 89 | 48% | |
| Age [yrs] | |||||||
| Median [range] | 10.4 | [0.17 – 19.7] | 10.0 | [0.01 – 20.9] | 10.3 | [0.20 – 19.5] | 0.829 |
| 0–2 y | 14 | 15% | 51 | 28% | 47 | 26% | 0.070 |
| 3–10 y | 34 | 37% | 53 | 29% | 49 | 27% | 0.179 |
| 11–21 y | 43 | 47% | 79 | 43% | 88 | 48% | 0.640 |
| Race | |||||||
| White | 55 | 60% | 128 | 70% | 132 | 72% | 0.142 |
| Black | 1 | 1% | 9 | 5% | 28 | 15% | <0.001 |
| Hispanic | 28 | 31% | 30 | 16% | 14 | 8% | <0.001 |
| Asian | 4 | 4% | 7 | 4% | 3 | 2% | 0.334 |
| Other | 3 | 3% | 8 | 4% | 7 | 4% | 0.901 |
| Unknown | 0 | 1 | 0 | ||||
| Hepatomegaly | 23 | 25% | 69 | 38% | 59 | 32% | 0.113 |
| Splenomegaly | 22 | 24% | 64 | 35% | 64 | 35% | 0.150 |
| WBC (×103/μL]) - median [range] | 22.7 | [1.0 – 684.0] | 22.5 | [1.0 – 648.2] | 17.7 | [0.3 – 860.0] | 0.351 |
| BM Blasts % | 70 | [6 – 100] | 72 | [0 – 100] | 70 | [1 – 100] | 0.417 |
| Platelets (×103/μL) - median [range] | 45 | [2 – 800] | 49.5 | [5 – 610] | 46.5 | [3 – 452] | 0.593 |
| Hemoglobin (gm/dL)- median [range] | 7.8 | [2.8 – 30.7] | 8.3 | [0.4 – 20.4] | 8.5 | [1.8 – 27.1] | 0.315 |
| Days hospitalized, Course 1 - median [range] | 37 | [4 – 150] | 35.5 | [1 – 79] | 35 | [2 – 105] | 0.363 |
| Days hospitalized, Course 2 - median [range] | 34 | [6 – 100] | 34 | [5 – 109] | 34 | [5 – 127] | 0.585 |
| CNS involvement at study entry | |||||||
| Yes | 6 | 7% | 9 | 5% | 9 | 5% | 0.817 |
| No | 85 | 93% | 173 | 95% | 174 | 95% | |
| Unknown | 0 | 1 | 1 | ||||
| Chloroma at study entry | |||||||
| Yes | 7 | 8% | 27 | 15% | 14 | 8% | 0.051 |
| No | 84 | 92% | 156 | 85% | 170 | 92% | |
| Unknown | 0 | 0 | 0 | ||||
| FAB Classification | |||||||
| M0 | 5 | 6% | 12 | 7% | 10 | 5% | 0.873 |
| M1 | 14 | 16% | 24 | 13% | 31 | 17% | 0.631 |
| M2 | 29 | 32% | 48 | 27% | 48 | 26% | 0.563 |
| M4 | 27 | 30% | 46 | 26% | 50 | 27% | 0.754 |
| M5 | 9 | 10% | 41 | 23% | 31 | 17% | 0.031 |
| M6 | 4 | 4% | 2 | 1% | 4 | 2% | 0.217 |
| M7 | 2 | 2% | 6 | 3% | 8 | 4% | 0.649 |
| De novo (NOS) | 1 | 4 | 2 | ||||
| Cytogenetics | |||||||
| Normal | 16 | 31% | 22 | 21% | 27 | 23% | 0.362 |
| t(8;21) | 6 | 12% | 12 | 12% | 25 | 21% | 0.111 |
| Abnormal 16 | 7 | 14% | 12 | 12% | 9 | 8% | 0.402 |
| Abnormal 11 | 10 | 20% | 25 | 24% | 24 | 20% | 0.706 |
| t(6;9)(p23;q34) | 2 | 4% | 1 | 1% | 2 | 2% | 0.432 |
| −7/7q- | 1 | 2% | 2 | 2% | 5 | 4% | 0.549 |
| −5/5q- | 2 | 4% | 1 | 1% | 1 | 1% | 0.269 |
| +8 | 1 | 2% | 6 | 6% | 11 | 9% | 0.199 |
| +21 | 0 | 0% | 1 | 1% | 1 | 1% | 0.788 |
| Pseudodiploid | 5 | 10% | 15 | 15% | 8 | 7% | 0.157 |
| Hyperdiploid | 0 | 0% | 4 | 4% | 4 | 3% | 0.378 |
| Hypodiploid | 1 | 2% | 2 | 2% | 2 | 2% | 0.987 |
| No data | 40 | 80 | 65 | ||||