Table 2.
Parameters of the relationship between rituximab mean-concentration and progression-free survival
| Value in study: | ||||||
|---|---|---|---|---|---|---|
| Parameter | Significance | Method | Pivotal [15, 17] (A) | Weng [22] (B) | van Oers [14] (C) | Cartron [20] (D) |
| λmax (month−1) | λ in absence of RTX or CT | Fixed for each study | 0.16 | 0.16 | 0.050 | 0.067 |
| Cm50,O (mg l−1) | Cm50 in overall population | Estimated in A, reported in studies B, C and D | 35.1 (2.2)* | – | – | – |
| Cm50,R (mg l−1) | Cm50 in responders | 18.0 (0.87)* | – | – | – | |
| Cm50,VV (mg l−1) | Cm50 in VV patients | Calculated from study B (HRFx/VV) and Cm50,O | 7.8 | 7.8 | 7.8 | 7.8 |
| Cm50,Fx (mg l−1) | Cm50 in Fx patients | 78.9 | 78.9 | 78.9 | 78.9 | |
| γO | γ in overall population | Estimated in A, reported in studies B, C and D | 0.48 (0.052)* | – | – | – |
| γR | γ in responders | 1.5 (0.11)* | – | – | – | |
| γVV | γ in VV patients | Fixed | 2.0 | 2.0 | 2.0 | 2.0 |
| γFx | γ in Fx patients | 0.48 | 0.5 | 0.5 | 0.5 | |
*
In study A, for estimated parameters, results are presented as: estimation (standard deviation). CT, chemotherapy; Cm50, mean-time concentrations leading to 50% of the maximum hazard; γ, shape factor; λ, hazard; RTX, rituximab.