Table 2.
Treosulfan dose (g/m2) | |||
---|---|---|---|
10 | 12 | 14 | |
N | 5 | 10 | 4 |
PK Parameter | |||
Age (years) *,+,#,‡ | 1 (0.9–1) | 6 (4–8) | 9 (9–11) |
BSA (m2) *,+,#,‡ | 0.43 (0.38–0.50) | 0.86 (0.52–0.99) | 1.11 (1.05–1.40) |
Weight (kg) *,+,#,‡ | 9.2 (8.1–14.6) | 22.7 (19.4–25.1) | 30.7 (30.1–37.5) |
AUC (mcg/mL*h)† | 2762 ± 1058 | 2240 ± 538 | 2235 ± 96 |
Cmax (mcg/mL)† | 977 ± 412 | 799 ± 201 | 788 ± 28 |
t½ (h)† | 1.39 ± 0.25 | 1.49 ± 0.14 | 1.38 ± 0.11 |
Vss (L) *,+,† | 6.7± 2.3 | 9.5 ± 2.5 | 9.9 ± 0.6 |
CL (mL/min) *,+,† | 69.4 ± 22.5 | 94.9 ± 18.2 | 104.5 ± 4.5 |
AUC: area under the curve; Cmax: maximum concentration; t½: half-life; Vss: volume of distribution; CL: total clearance
AUC, Cmax, t½Vss and CL expressed in mean + standard deviation (SD)
Age, BSA and weight expressed in median (range)
*,+,#Significant differences between BSA-based treosulfan doses (p < 0.05 (using t-test)):
10 vs.12 g/m2;
10 vs.14 g/m2;
12 vs.14g/m2