Table 3. Difference in pharmacokinetics of capecitabine and its metabolites in male and female subjects.
| Female | Male | P-value | |
|---|---|---|---|
| No. patients |
9 |
20 |
|
| Age (years) |
74.44±8.93 |
72.10±9.64 |
0.541 |
| Weight (kg) |
74.03±11.78 |
80.87±13.52 |
0.203 |
| BSA (m2) |
1.76±0.15 |
1.95±0.14 |
0.003 |
| CrCL (ml min–1 per 1.73 m2) |
77.61±13.82 |
64.51±14.39 |
0.035 |
| MDRD (ml min–1 per 1.73 m2) |
73.41±14.09 |
79.45±18.43 |
0.391 |
|
Capecitabine PK | |||
| Cmax (ng ml–1) | 12 391±8346 | 6109±5612 | 0.028* |
| T1/2 (h) | 0.715±0.198 | 0.793±0.339 | 0.654 |
| Kel (h−1) | 1.195±0.290 | 0.781±0.461 | 0.020* |
| AUC (h ng ml–1) | 11 607±7224 | 8087±5727 | 0.169 |
| CLtotal/F (l h–1 m–2) | 127.28±81.19 | 244.98±327.56 | 0.268 |
| Vd/F (l m–2) |
125.12±75.04 |
269.27±392.46 |
0.248 |
|
DFCR PK | |||
| Cmax (ng ml–1) | 7519±3967 | 6041±4350 | 0.393 |
| T1/2 (h) | 0.737±0.216 | 0.960±0.562 | 0.621 |
| Kel (h−1) | 1.039±0.410 | 0.911±0.385 | 0.621 |
| AUC (h ng ml–1) |
14 599±10 408 |
11 325±6082 |
0.525 |
|
DFUR PK | |||
| Cmax (ng ml–1) | 13 212±4824 | 9065±5762 | 0.030* |
| T1/2 (h) | 0.885±0.307 | 1.148±0.811 | 0.588 |
| Kel (h−1) | 0.870±0.302 | 0.790±0.330 | 0.540 |
| AUC (h ng ml–1) |
25 567±11 438 |
17 501±7875 |
0.045 |
|
5FU PK | |||
| Cmax (ng ml–1) | 2575±2073 | 2002±1794 | 0.334 |
| T1/2 (h) | 0.782±0.204 | 1.212±0.581 | 0.041* |
| Kel (h−1) | 0.948±0.276 | 0.708±0.353 | 0.036* |
| AUC (h ng ml–1) | 4030±2337 | 3846±3050 | 0.759 |
Abbreviations: AUC=area under the curve; BSA=body surface area; Cmax=maximum concentration; CL/F=total clearance; CrCl=creatinine clearance; DFCR=5'-deoxy-5-fluorocytidine; DFUR=5'-deoxy-5-fluorouridine; 5FU=5-fluorouracil; Kel= elimination constant; MDRD= modified diet for renal disease; PK=pharmacokinetic; T1/2=half-life; Vd/F= volume of distribution.
Statistical comparisons used with either unpaired t-test or Mann–Whitney test where (*) P<0.05 is denote.