Table 2.
Pharmacokinetic details of the per-protocol cohort of the s.c. trastuzumab.
| Parameter | Category | Thigh (N = 17) | Abdominal wall (N = 13) |
|---|---|---|---|
| Cmax | Mean (SD) | 150.73 (44.81) | 100.00 (31.14) |
| (μg/ml) | CV% | 29.73 | 31.14 |
| Geo-Mean (SD) | 142.08 (1.49) | 94.00 (1.49) | |
| GLSM (95%CI) | 129.70 (113.77; 147.87) | 100.48 (85.96; 117.47) | |
| AUC(0-21d) | Mean (SD) | 2377.05 (639.24) | 1589.95 (568.96) |
| (μg day/ml) | CV% | 26.89 | 35.78 |
| Geo-Mean (SD) | 2246.41 (1.50) | 1468.45 (1.57) | |
| GLSM (95%CI) | 2060.38 (1777.64; 2388.32) | 1595.50 (1338.29; 1902.35) | |
| Tmax | Mean (SD) | 5.18 (2.24) | 5.23 (2.39) |
| (day) | Median | 4 | 4 |
| Min; Max | 2; 8 | 2; 8 | |
| C(trough) | Mean (SD) | 87.02 (26.05) | 58.67 (23.23) |
| (μg/ml) | CV% | 29.94 | 39.60 |
| Geo-Mean (SD) | 81.24 (1.56) | 54.31 (1.52) | |
| GLSM (95%CI) | 76.67 (64.34; 91.38) | 58.26 (47.27; 71.79) |
AUC(0-21d), area under the plasma concentration-time curve from day 0 to day 21; Cmax peak drug concentration; C(trough), concentration at the end of the dosage interval; CV, coefficient of variation; Geo-Mean, back-transformed geometric mean of log transformed values; GLSM, model-adjusted geometric least square means; SD, standard deviation; Tmax, time-to-peak drug plasma concentrations.