Table 6.
Pharmacokinetic variable values for irinotecan, in patients who were and were not receiving EIAEDs
| Pharmacokinetic variables | Values in patients not receiving EIAEDs NABTC 9801
|
Mean (±SD) values in patients receiving EIAEDs at the indicated irinotecan dose (mg/m2)
|
||||
|---|---|---|---|---|---|---|
| 200 (n = 20) | 350 (n = 3) | 400 (n = 4) | 450 (n = 3) | 500 (n = 6) | 550 (n = 2) | |
| CPT-11 (free base) | ||||||
| Cpmax (μg/mL) | 1.76 (±0.61) | 2.83 (±0.43) | 2.76 (±0.41) | 3.31 (±0.67) | 4.01 (±1.13) | 3.57 (±0.11) |
| t1/2 (h) | 6.21 (±1.35) | 4.67 (±0.39) | 5.89 (±0.96) | 6.06 (±0.47) | 6.03 (±0.56) | 5.57 (±0.73) |
| AUC0-24 (μg × h/mL) | 9.01 (±3.28) | 12.38 (±1.46) | 11.98 (±1.72) | 13.36 (±5.49) | 18.99 (±3.88) | 17.53 (±5.67) |
| AUC (μg × h/mL) | 9.42 (±3.43) | 12.56 (±1.52) | 12.44 (±1.93) | 13.80 (±3.38) | 19.58 (±3.94) | 17.86 (±5.69) |
| CL (L/h/m2) | 20.31 (±11.15) | 24.48 (±3.09) | 28.48 (±4.45) | 31.76 (±10.08) | 23.05 (±5.09) | 28.22 (±9.00) |
| SN-38 | ||||||
| Cpmax (ng/mL) | 20.03 (±8.57) | 27.24 (±11.15) | 22.63 (±7.53) | 17.22 (±11.77) | 19.60 (±6.13) | 17.94 (±13.10) |
| t1/2 (h) | 14.71 (±6.71) | 9.04 (±3.10) | 12.96 (±6.93) | 11.75 (±3.13) | 13.59 (±4.60) | 12.71 (±14.65) |
| AUC0-24 (ng × h/mL) | 162.42 (±75.68) | 167.91 (±68.46) | 120.72 (±15.97) | 106.12 (±45.30) | 118.80 (±33.34) | 134.99 (±107) |
| AUC (ng × h/mL) | 254.10 (±34.49) | 188.19 (±73.10) | 157.90 (±37.84) | 135.55 (±77.65) | 153.13 (±45.16) | 166.10 (±88.58) |
| AUCSN-38/AUCCPT-11 (%) | 2.8 (±1.46) | 1.5 (±0.44) | 1.3 (±0.10) | 1.0 (±0.12) | 0.8 (±0.17) | 1.0 (±0.21) |
Abbreviations: CPT-11, irinotecan; CL, systemic clearance; Cpmax, maximal plasma concentration; t1/2, terminal half-life (harmonic mean).