Table 2.
Variable | No. of Patients |
|||
---|---|---|---|---|
Cycle 1 |
Cycle 2 |
|||
No. | % | No. | % | |
Pharmacokinetic studies | 31 | 31 | ||
Fixed-dose topotecan* | 31 | 31† | ||
Dosing success | 14 | 12 | ||
Dosing failure | 17 | 19 | ||
Pharmacokinetic guided dosing‡ | 17 | 19 | ||
Targeting success | 12 | 14 | ||
Targeting failure | 5 | 5 | ||
Total successes | 26 | 84 | 26 | 84 |
Dosage to achieve target, mg/m2 | ||||
Median | 1.2 | 1.3 | ||
Range | 0.75-2.1 | 1.2-2.9 | ||
Dosage to achieve target, mg/kg | ||||
Median | 0.06 | 0.11 | ||
Range | 0.04-0.1 | 0.04-0.13 |
Success if target area under the curve of 50 to 70 ng/mL/hr was achieved after protocol-defined dose (cycle 1 or cycle 2) or cycle 1–based pharmacokinetic analysis (cycle 2).
Fixed dosage per protocol (n = 11) or dosage based on cycle 1 pharmacokinetic analyses.
Success if target area under the curve of 50 to 70 ng/mL/hr was achieved by pharmacokinetic-guided dosing.