Introduction
Methods
Treatment regimens in the bendamustine–rituximab combination and bendamustine monotherapy studies
Population pharmacokinetic model for bendamustine monotherapy
Patient characteristic | Bendamustine–rituximab combination (n = 49) | Bendamustine monotherapy [18] (n = 80) |
---|---|---|
Age (years) | ||
Median | 64 | 57.5 |
Minimum, maximum | 37, 84 | 31, 84 |
Body surface area (m2) | ||
Median | 2.00 | 2.0 |
Minimum, maximum | 1.4, 2.6 | 1.3, 2.7 |
Sex, n (%) | ||
Male | 31 (63.3) | 50 (62.5) |
Female | 18 (36.7) | 30 (37.5) |
Race, n (%) | ||
Caucasian | 45 (91.8) | 71 (88.8) |
Black | – | 5 (6.3) |
Asian | 1 (2.0) | 1 (1.3) |
Hispanic | – | 1 (1.3) |
Other | 3 (6.1) | 2 (2.5) |
Creation of the bendamustine–rituximab combination analysis dataset
Pharmacokinetic sampling data in the bendamustine–rituximab combination study
Rituximab data from the published literature
Methods for evaluating the effect of rituximab on bendamustine
Methods for evaluating the effect of bendamustine on rituximab
General statistical methods
Results
Description of bendamustine–rituximab combination pharmacokinetic data and the patient population
The effect of rituximab on bendamustine pharmacokinetics
Dosing regimen | Statistic | Clearance (L/h) | Log-transformed clearancea
|
---|---|---|---|
Bendamustine–rituximab combination (n = 49) | Mean (SD) | 32.1 (12.8) | 3.33 (0.672) |
% CV | 39.9 % | 20.2 % | |
Median | 32.9 | 3.50 | |
Minimum, maximum | (0.9, 58.5) | (−0.097, 4.07) | |
Bendamustine monotherapy (n = 78) | Mean (SD) | 33.0 (10.10) | 3.45 (0.305) |
% CV | 30.6 % | 8.8 % | |
Median | 31.8 | 3.46 | |
Minimum, maximum | (13.1, 70.6) | (2.58, 4.26) |