Table 5.
S-1 analyte | ||||||||
---|---|---|---|---|---|---|---|---|
5-FU | CDHP | Tegafur | Oteracil | |||||
Aflibercept dose level | ||||||||
Mean ± SD | 2 mg/kg | 4 mg/kga | 2 mg/kg | 4 mg/kga | 2 mg/kg | 4 mg/kga | 2 mg/kg | 4 mg/kga |
Number of patients | 7 | 1 | 7 | 1 | 7 | 1 | 7 | 1 |
Cmax, ng/mL | 130 ± 35.0 | 104 | 367 ± 138 | 266 | 4730 ± 1840 | 4670 | 53.5 ± 38.7 | 29.5 |
Tmaxb, h |
2.00 (1.97–2.05) |
3.95 |
1.05 (0.97–2.05) |
1.97 |
1.05 (0.92–2.05) |
1.97 |
1.97 (0.97–2.05) |
3.95 |
AUCτ, ng·h/mL | 912 ± 174c | 654 | 1650 ± 540e | 1320 | 41,600 ± 19,500 | 47,100 | 306 ± 269g | 226 |
AUClast, ng·h/mL | 788c ± 370 | 817 | 1820e ± 825 | 1730 | 91,400 ± 52,600 | 113,000 | 378g ± 390 | 466 |
t1/2z, h | 3.66 ± 0.0225d | 3.87 | 3.63 ± 1.13f | 9.2 | 15.7 ± 4.26 | 19.6 | 5.72 ± 3.48h | 19.6 |
CDHP, gimeracil; 5-FU, 5-fluorouracil; SD, standard deviation. PK parameters reported are: AUClast area under the concentration versus time curve (AUC) from time 0 to the real time tlast; AUCτ, AUC from time 0 to the end of the dosing period; Cmax, maximum drug concentration observed; t1/2z, terminal half-life; Tmax, first time to reach Cmax
an = 1, individual values listed
bMedian (range)
cn = 3, 4 patients were not included in the calculation of summary statistics
dn = 2, 5 patients were not included in the calculation of summary statistics
en = 6, 1 patient was not included in the calculation of summary statistics
fn = 4, 3 patients were not included in the calculation of summary statistics
gn = 6, 1 patient was not included in the calculation of summary statistics
hn = 4, 3 patients were not included in the calculation of summary statistics
Profile of 1 patient was excluded for 5-FU, CDHP, tegafur and oteracil