Table 1.
Pharmacokinetic parameter | −Thalidomide | +Thalidomide | Mean difference (80% CI) | Mean difference (90% CI) | P |
---|---|---|---|---|---|
Irinotecan | |||||
AUC0–24 h (h mg/l) | 27.3 ± 8.6 | 27.8 ± 11.8 | 0.5 (−1.7 to 2.7) | 0.5 (−2.5 to 3.4) | 0.77 |
Cmax0–24h (mg/l) | 4.08 ± 0.94 | 4.38 ± 1.07 | 0.30 (−0.16 to 0.76) | 0.30 (−0.32 to 0.92) | 0.38 |
T1/2 (h) | 11 ± 3 | 12 ± 3 | 1 (−1 to 3) | 1 (−2 to 4) | 0.46 |
SN-38 | |||||
AUC0–24 h (h mg/l) | 0.333 ± 0.103 | 0.346 ± 0.159 | 0.013 (−0.035 to 0.061) | 0.013 (−0.051 to 0.077) | 0.72 |
Cmax0–24 h (mg/l) | 0.036 ± 0.015 | 0.033 ± 0.012 | −0.003 (−0.009 to 0.002) | −0.003 (−0.010 to 0.004) | 0.45 |
T1/2 (h) | 17 ± 11 | 15 ± 7 | −1 (−7 to 4) | −2 (−8 to 6) | 0.71 |
SN-38G | |||||
AUC0–24 h (h mg/l) | 1.02 ± 0.52 | 1.04 ± 0.78 | 0.02 (−0.15 to 0.18) | 0.02 (−0.20 to 0.24) | 0.88 |
Cmax0–24h (mg/l) | 0.100 ± 0.059 | 0.098 ± 0.054 | −0.002 (−0.022 to 0.017) | −0.002 (−0.029 to 0.024) | 0.87 |
T1/2 (h) | 17 ± 10 | 15 ± 6 | −2 (−9 to 5) | −2 (−12 to 7) | 0.70 |
APC | |||||
AUC0–24 h (h mg/l) | 3.01 ± 0.64 | 2.82 ± 1.16 | −0.19 (−0.70 to 0.32) | −0.19 (−0.87 to 0.50) | 0.62 |
Cmax0–24 h (mg/l) | 0.26 ± 0.09 | 0.22 ± 0.08 | −0.03 (−0.08 to 0.01) | −0.03 (−0.09 to 0.03) | 0.32 |
T1/2 (h) | 8.9 ± 2.3 | 10.9 ± 6.8 | 2.0 (−1.6 to 5.6) | 2.0 (−2.8 to 6.8) | 0.46 |
AUC0–24 h ratio | |||||
BI (h mg/l) | 9.8 ± 3.7 | 10.9 ± 6.1 | 1.1 (−1.2 to 3.4) | 1.1 (−2.0 to 4.2) | 0.53 |
GR | 3.2 ± 1.6 | 3.0 ± 1.4 | −0.2 (−0.7 to 0.4) | −0.2 (−0.9 to 0.6) | 0.70 |
REC | 0.013 ± 0.005 | 0.014 ± 0.005 | 0.000 (−0.001 to 0.001) | 0.000 (−0.001 to 0.002) | 0.64 |
MR | 0.052 ± 0.021 | 0.051 ± 0.021 | −0.001 (−0.005 to 0.003) | −0.001 (−0.007 to 0.004) | 0.65 |
AUC0–24 h Area under the plasma concentration-time curve from 0 to 24 h, Cmax maximum plasma concentration, T1/2 half life, SN-38G SN-38 glucuronide, BI biliary index, GR glucuronidation ratio, REC relative extent of conversion of irinotecan to SN-38, MR metabolic ratio