TABLE 1.
Description of cohort by trial enrollment status
Overall |
Not enrolled |
Enrolled |
|||||
---|---|---|---|---|---|---|---|
n | (%) | n | (%) | n | (%) | Pa | |
Total cohort | 274 | 100 | 122 | 45.5 | 152 | 55.5 | - |
Age (mean, median [range]) | 7.4, 5.2 [1.2–20.0] | 7.9, 5.6 [1.6–20.0] | 6.9, 4.8 [1.2–19.0] | 0.11 | |||
Age <15 | 238 | 87.0 | 103 | 84.4 | 135 | 88.8 | 0.26 |
Age ≥15 | 36 | 13.1 | 19 | 15.6 | 17 | 11.2 | |
Sex | |||||||
Female | 135 | 49.3 | 61 | 50.0 | 74 | 48.7 | 0.83 |
Male | 139 | 50.7 | 61 | 50.0 | 78 | 51.3 | |
Ethnicity | |||||||
Not-Hispanic | 78 | 28.5 | 28 | 23.0 | 50 | 32.9 | 0.07 |
Hispanic | 196 | 71.5 | 94 | 77.0 | 102 | 67.1 | |
Down syndrome | |||||||
Not Down syndrome | 267 | 97.4 | 119 | 97.5 | 148 | 97.4 | 1.00 |
Down syndrome | 7 | 2.6 | 3 | 2.5 | 4 | 2.6 | |
NCI/Rome risk | |||||||
SR | 167 | 60.9 | 74 | 60.7 | 93 | 61.2 | 0.93 |
HR | 107 | 39.1 | 48 | 39.3 | 59 | 38.8 | |
Presenting WBC (max) | |||||||
WBC (mean, median [range]) | 39.1, 9.0 [0.3–771.8] | 36.3, 8.3 [0.3–771.8] | 41.2, 11.5 [0.8–562] | 0.43 | |||
WBC <50 K/μl | 222 | 81.0 | 100 | 82.0 | 122 | 80.3 | 0.72 |
WBC ≥50 K/μl | 52 | 19.0 | 22 | 18.0 | 30 | 19.7 | |
CNS status | |||||||
CNS1 | 244 | 89.1 | 108 | 88.5 | 136 | 89.5 | 0.38 |
CNS2 | 28 | 10.2 | 14 | 11.5 | 14 | 9.2 | |
CNS3 | 2 | 0.7 | 0 | 0 | 2 | 1.3 | |
Cytogenetic Categoryb | |||||||
Average | 157 | 57.3 | 79 | 64.8 | 78 | 51.3 | 0.02 |
Favorable | 113 | 41.2 | 43 | 35.2 | 70 | 46.1 | |
Unfavorable | 4 | 1.5 | 0 | 0 | 4 | 2.6 | |
EOI MRD | |||||||
<0.01% | 165 | 60.2 | 66 | 54.1 | 99 | 65.1 | 0.15 |
≥0.01% | 40 | 14.6 | 22 | 18.0 | 18 | 11.8 | |
Unknown | 69 | 25.2 | 34 | 27.9 | 35 | 22.7 | |
For MRD+ (median, [range]) | 0.26 [0.012–36] | 0.22 [0.026–36] | 0.30 [0.012–22.4] | 0.91 |
NCI, National Cancer Institute; WBC, white blood cell; CNS, central nervous system; EOI MRD, end of induction minimal residual disease (bone marrow).
Pearson chi-square, Fisher exact test, or K-S test; significance set at P < 0.05 (bolded).
Favorable includes “double trisomy” 4+10 (n = 45) and ETV6-RUNX1 (n = 69). Unfavorable includes hypodiploid (<44 chromosomes, n = 1), rMLL (n = 3), iAMP21 (n = 0).