Table 1:
Baseline Characteristics
| COG Standard PEG-ASP (>1000 units/m2) | Reduced PEG-ASP (≤1000 units/m2) | p-value | |
|---|---|---|---|
| Patients, n | 25 | 26 | |
| Age, median (range) | 36.6 (18–64) | 49.0 (19–76) | 0.0275 |
| AYA (age 18–39), n (%) | 13 (52%) | 10 (38.5%) | 0.245 |
| Age ≥ 60, n(%) | 1 (4%) | 8 (30.8%) | 0.024 |
| Male gender, n (%) | 16 (64%) | 17 (65%) | 1 |
| Ethnicity, n (%) | 0.564 | ||
| Caucasian | 16 (64%) | 14 (53.9%) | |
| African American | 2 (8%) | 6 (23.1%) | |
| Hispanic | 4 (16%) | 3 (11.5%) | |
| Other | 3 (12%) | 3 (11.5%) | |
| Disease Status, n (%) | 0.703 | ||
| Newly diagnosed | 21 (84%) | 23 (88.5%) | |
| Relapsed/Refractory | 4 (16%) | 3 (11.5%) | |
| Phenotype, n (%) | 1 | ||
| B-cell | 18 (72%) | 17 (65.4%) | |
| T-cell | 5 (20%) | 6 (23.1%) | |
| Mixed | 2 (8%) | 3 (11.5%) | |
| Initial WBC count (x109/L), median | 7.5 | 6.8 | 0.899 |
| BMI (kg/m2) during induction, median | 28.7 | 28.7 | 0.914 |
| History of Liver Disease, n (%) | 1 (4%) | 5 (19.2%) | 0.191 |
| History of Pancreatitis, n (%) | 0 (0%) | 0 (0%) | 1 |
| History of Diabetes, n (%) | 3 (12%) | 8 (30.8%) | 0.173 |
| History of VTE, n (%) | 2 (8%) | 5 (19.2%) | 0.419 |
| Received allogeneic SCT in CR, n (%) | 7 (28%) | 4 (15.4%) | 0.324 |
| Induction PEG-ASP dose, units, median | 4450 | 1537 | <0.001 |
| Induction PEG-ASP dose, units/m2, median (IQR) | 2500 (1900–2500) | 500 (500–1000) | <0.001 |
| Day +7 ASNase activity level - IU/mL, median (range) | - | 0.16 (0.037–0.85) | - |
| Achieved Guideline Adherent Day +7 ASNase Induction Level, n (%) | - | 22 (84.6%) | - |
Abbreviations: ASNase = Asparaginase, AYA = Adolescent and young adult, BMI = body mass index, COG = Children’s Oncology Group, CR = complete remission, PEG-ASP = Pegylated asparaginase, SCT = stem cell transplant, VTE = venous thromboembolism, WBC = white blood cell