Table 3.
Cumulative percentage excretion of bendamustine, the metabolites γ-hydroxy-bendamustine, N-desmethyl-bendamustine, and dihydroxy bendamustine, and total radioactivity in urine over 24 hours and total radioactivity in urine and feces over 168 hours and until the end of the collection period following an intravenous 60-minute infusion of 120 mg/m2 of 14C-bendamustine hydrochloride
Collection | Patient | Mean [SD] | ||||||
---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | 6 | |||
Urine (% excretion) | ||||||||
0–24 hours | Bendamustine | 1.46 | 5.17 | 1.65 | 1.85 | 3.74 | 5.98 | 3.31 [1.95] |
M3 | 0.64 | 0.36 | 0.5 | 0.7 | 0.76 | 1.42 | 0.73 [0.37] | |
M4 | 0 | 0.12 | 0.08 | 0 | 0 | 0.27 | 0.08 [0.11] | |
HP2 | 8.65 | 4.09 | 4.18 | 8.25 | 2.12 | 2.04 | 4.89 [2.9] | |
Suma | 10.75 | 9.74 | 6.41 | 10.8 | 6.62 | 9.71 | 9.01 [1.99] | |
TRA | 36.36 | 36.08 | 36.53 | 34.77 | 32.83 | 43.1 | 36.61 [3.47] | |
0–168 hours | TRA | 42.16 | 50.69 | 45.26 | 40.44 | 43.11 | 51.11 | 45.46 [4.49] |
0–EoCb | TRA | 47.6 | 57.93 | 48.26 | 40.44 | 47.86 | 51.93 | 49 [5.75] |
Feces (% excretion) | ||||||||
0–168 hours | TRA | 30.3 | 8.92 | 34.44 | 31.88 | 29.45 | 16.1 | 25.18 [10.22] |
0–EoCb | TRA | 32.64 | 8.92 | 34.44 | 31.88 | 35.08 | 18.89 | 26.98 [10.67] |
Total (% excretion) | ||||||||
0–168 hours | TRA | 72.46 | 59.61 | 79.7 | 72.32 | 72.56 | 67.21 | 70.64 [6.71] |
0–EoCb | TRA | 80.24 | 66.85 | 82.7 | 72.32 | 82.94 | 70.82 | 75.98 [6.86] |
EoC end of collection period, HP2 dihydroxy bendamustine, M3 γ-hydroxy-bendamustine, M4 N-desmethyl-bendamustine, SD standard deviation, TRA total radioactivity
aThese values represent the sum of bendamustine, M3, M4, and HP2
bThe time of the EoC varied among patients and ranged from 168 to 504 hours