Table 1.
Characteristics and outcomes of patients enrolled in the JACLS ALL-02 study (total n = 1138).
| n | 4yr-EFS (%) | 95% CI | Log rank p | 4yr-OS (%) | 95% CI | Log rank p | |
|---|---|---|---|---|---|---|---|
| All eligible patients | 1138 | 85.4 | 83.3–87.4 | 91.2 | 89.6–92.9 | ||
| NCI-SR | 815 | 88.2 | 85.7–90.2 | <0.0001 | 94.5 | 92.7–95.9 | <0.0001 |
| NCI-HR | 323 | 76.4 | 71.3–80.6 | 83.1 | 78.5–86.8 | ||
| ALL-02 SR | 456 | 90.4 | 87.2–92.8 | <0.0001 | 97.3 | 95.3–98.5 | <0.0001 |
| ALL-02 HR | 543 | 84.9 | 81.6–87.7 | 89.3 | 86.3–91.6 | ||
| ALL-02 ER | 139 | 66 | 57.5–73.3 | 78.9 | 71.1–84.8 | ||
| Prednisolone response | |||||||
| PGR | 1041 | 87.1 | 85.0–89.1 | <0.001 | 92.2 | 90.5–93.8 | <0.001 |
| PPR | 97 | 66.2 | 56.6–75.8 | 81 | 73.1–88.9 | ||
| Treatment according to upgraded risk based on BM at day 15 | |||||||
| Upgraded | 162 | 72 | 64.4–78.3 | <0.0001 | 84.4 | 77.8–89.2 | <0.0001 |
| Not upgraded | 928 | 89.8 | 87.8–91.6 | 94.6 | 92.9–95.9 | ||
| Sex | |||||||
| Male | 599 | 83.1 | 79.8–85.9 | 0.11 | 91 | 88.4–93.1 | 0.38 |
| Female | 539 | 86.7 | 83.5–89.3 | 91.5 | 88.8–93.6 | ||
| Age at diagnosis (years) | |||||||
| 1–9 | 923 | 87.5 | 85.1–89.5 | <0.0001 | 94 | 92.2–95.3 | <0.0001 |
| 10–18 | 215 | 73.4 | 67.0–78.8 | 79.8 | 73.7–84.6 | ||
| WBC at onset (/μL) | |||||||
| <10,000 | 666 | 86.9 | 84.1–89.3 | 0.0005 | 93.6 | 91.4–95.2 | 0.0001 |
| 10,000–50,000 | 334 | 84.9 | 80.5–88.3 | 90 | 86.2–92.8 | ||
| 50,000–100,000 | 72 | 80.5 | 69.3–88.0 | 87.5 | 77.4–93.3 | ||
| ≥100,000 | 66 | 68 | 55.2–77.8 | 78.5 | 66.4–86.9 | ||
| Immunophenotype | |||||||
| B cell precursor | 1086 | 85.8 | 83.4–87.9 | <0.0001 | 92 | 90.3–93.5 | <0.0001 |
| Mixed/Unclassified | 52 | 63.5 | 48.9–74.9 | 74.7 | 60.4–84.5 | ||
| CNS status | |||||||
| CNS1 | 949 | 86 | 83.8–88.2 | 0.54 | 91.7 | 89.9–93.4 | 0.4 |
| CNS2 | 27 | 77.6 | 61.8–93.4 | 88.6 | 76.4–100 | ||
| CNS3 | 23 | 77.8 | 60.5–95.0 | 82.1 | 66.2–98.1 | ||
| Unknown | 139 | 83 | 76.6–89.3 | 90.3 | 85.3–95.3 | ||
| TLP | |||||||
| TLP+ | 6 | 33.3 | 0–71.1 | <0.001 | 50 | 10.0–100 | 0.004 |
| TLP− | 42 | 87.7 | 77.6–97.8 | 90 | 80.7–99.3 | ||
| Cytogenetics/chimeric fusion | |||||||
| Normal | 368 | 83.8 | 80.0–87.6 | <0.001 | 90.1 | 87.0–93.2 | <0.001 |
| Hyperdiploid | 222 | 89.4 | 85.3–93.5 | 94.9 | 92.0–97.9 | ||
| ETV6-RUNX1 | 205 | 94.4 | 89.0–96.1 | 97.5 | 94.0–98.9 | ||
| Hypodiploid | 4 | 25 | 0–67.4 | 50 | 1.0–99.0 | ||
| 11q23 rearrangement/KMT2A-related fusion | 22 | 81.3 | 64.8–97.9 | 85.6 | 70.6–100 | ||
| TCF3-PBX1/t(1;19) | 85 | 84.7 | 77.1–92.4 | 87 | 79.8–94.2 | ||
| Other abnormalities | 128 | 74.1 | 66.5–81.7 | 81 | 74.2–87.7 | ||
| Karyotypic failure | 104 | 81.6 | 73.9–89.3 | 94.2 | 89.6–98.7 | ||
EFS event-free survival, CI confidence interval, OS overall survival, NCI National Cancer Institute, SR standard risk, HR high risk, ER extremely high risk, PGR prednisolone good response, PPR prednisolone poor response, BM bone marrow, WBC white blood cell, CNS central nervous system, TLP traumatic lumbar puncture.