Table 6.
Busulfan pharmacokinetics in hematologic malignant and non-malignant patients.
| PK Parameter Median (range) | 1st dose | 5th dose | 9th Dose | 13th Dose |
|---|---|---|---|---|
| AUC (μM.min) | ||||
| Malignant (n = 34) | 1181 (381.9–2025) | 1361 (680.2–1967) | 1405 (1042–2032) | 1391 (1021–1895) |
| Non-malignant (n = 21) | 1117 (654.7–1584) | 1322 (672.9–1617) | 1256 (970.3–1981) | 1160 (692.2–1666) |
| P-Value | 0.3868 | 0.0913 | 0.181 | 0.0002 |
| Cmax (ng/mL) | ||||
| Malignant (n = 34) | 1073 (634–1710) | 1405 (705.2–2135) | 1457 (1097–2373) | 1405 (1059–2200) |
| Non-malignant (n = 21) | 1158 (822.2–2777) | 1389 (692.5–2007) | 1404 (1061–2337) | 1368 (1020–2118) |
| P-Value | 0.391 | 0.9111 | 0.9521 | 0.8034 |
| T1/2 (h) | ||||
| Malignant (n = 34) | 2.403 (1.687–3.769) | 2.71 (1.765–3.998) | 2.661 (1.978–4.674) | 2.812 (2.012–4.427) |
| Non-malignant (n = 21) | 1.935 (1.417–3.259) | 2.243 (1.672–4.165) | 2.179 (1.438–3.936) | 2.108 (1.547–3.374) |
| P-Value | 0.0017 | 0.0027 | 0.0016 | 0.0001 |
| Vd (L/kg) | ||||
| Malignant (n = 34) | 0.536 (0.375–1.021) | 0.4075 (0.236–1.409) | 0.385 (0.229–0.917) | 0.3705 (0.215–0.931) |
| Non-malignant (n = 21) | 0.606 (0.266–0.949) | 0.466 (0.27–1.077) | 0.422 (0.245–0.644) | 0.4 (0.25–0.632) |
| P-Value | 0.2564 | 0.0461 | 0.1315 | 0.2428 |
| CL (mL/min/kg) | ||||
| Malignant (n = 34) | 2.457 (1.764–4.15) | 1.576 (0.903–9.223) | 1.563 (0.954–5.356) | 1.438 (0.767–5.254) |
| Non-malignant (n = 21) | 3.453 (1.5–6.391) | 2.305 (0.93–4.634) | 2.444 (0.794–4.051) | 2.32 (0.975–4.473) |
| P-Value | 0.0055 | 0.001 | 0.0016 | 0.0009 |
P-Value < 0.05 is significantly different (Mann Whitney U test).