Table 1.

Pharmacokinetics of irinotecan and metabolites

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

AUC_{0–24 h} Area under the plasma concentration-time curve from 0 to 24 h, C_max maximum plasma concentration, T_1/2 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