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Table 2

Summary of pharmacokinetic and pharmacodynamic parameters

Values represent the mean, with coefficient of variation in parentheses (unless stated otherwise).

Variable600 mg group350 mg/m2 groupP                  a
Dose [mg (range)] 600 652 (490–875)  
CLb irinotecan lactone (liters/h) 74.4 (25.9) 74.7 (25.1) 0.93 
CL irinotecan carboxylate (liters/h) 11.2 (14.4) 11.9 (18.0) 0.28 
AUC irinotecan total (μg·h/ml) 18.3 (28.5) 20.0 (30.4) 0.62 
REC (%) 3.11 (47.8) 2.82 (42.7) 0.24 
REG 7.09 (71.2) 7.89 (72.4) 0.95 
BI 4.051 (86.7) 3.540 (61.9) 0.30 
WBC nadir (×109/liter) 3.99 (50.2) 3.30 (54.3) 0.84 
Decrease in WBC (%) 49.7 (45.9) 58.3 (41.3) 0.67 
ANC nadir (×109/liter) 2.44 (71.5) 1.62 (68.8) 0.14 
Decrease in ANC (%) 58.1 (39.7) 68.6 (34.4) 0.97 
Grade 3/4 diarrhea [N (%)] 5 (19) 4 (9) N/A 
Variable600 mg group350 mg/m2 groupP                  a
Dose [mg (range)] 600 652 (490–875)  
CLb irinotecan lactone (liters/h) 74.4 (25.9) 74.7 (25.1) 0.93 
CL irinotecan carboxylate (liters/h) 11.2 (14.4) 11.9 (18.0) 0.28 
AUC irinotecan total (μg·h/ml) 18.3 (28.5) 20.0 (30.4) 0.62 
REC (%) 3.11 (47.8) 2.82 (42.7) 0.24 
REG 7.09 (71.2) 7.89 (72.4) 0.95 
BI 4.051 (86.7) 3.540 (61.9) 0.30 
WBC nadir (×109/liter) 3.99 (50.2) 3.30 (54.3) 0.84 
Decrease in WBC (%) 49.7 (45.9) 58.3 (41.3) 0.67 
ANC nadir (×109/liter) 2.44 (71.5) 1.62 (68.8) 0.14 
Decrease in ANC (%) 58.1 (39.7) 68.6 (34.4) 0.97 
Grade 3/4 diarrhea [N (%)] 5 (19) 4 (9) N/A 
a

Modified Levene test for differences in variance.

b

CL, plasma clearance; AUC, area under the plasma-concentration time curve; REC, relative extent of conversion (AUC ratio of SN-38 to irinotecan); REG, relative extent of glucuronidation (AUC ratio of SN-38 to SN-38G); BI, biliary index (ratio of irinotecan AUC and REG); ANC, absolute neutrophil count; N/A, not available.

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