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 | ||
