Table 2.
Summary of treatment exposure (safety population)
| Parameter | VR-CAP, n = 82 | R-CHOP, n = 79 |
|---|---|---|
| Completed 6 cycles of treatment, n (%) | 71 (87) | 73 (92) |
| Overall treatment duration in wk, median (range) | 16.7 (1-27) | 16.0 (1-21) |
| Median doses received, n | ||
| Rituximab | 6 | 6 |
| Doxorubicin | 6 | 6 |
| Cyclophosphamide | 6 | 6 |
| Prednisone | 30 | 30 |
| Bortezomib/vincristine | 22 | 6 |
| Patients receiving 6 cycles, n (%) | ||
| Rituximab | 72 (88) | 73 (92) |
| Doxorubicin | 70 (85) | 73 (92) |
| Cyclophosphamide | 70 (85) | 73 (92) |
| Prednisone | 72 (88) | 73 (92) |
| Bortezomib/vincristine | 67 (82) | 72 (91) |
| Relative dose intensity, mean (SD) | ||
| Rituximab | 1.00 (0.006) | 1.00 (0.009) |
| Doxorubicin | 0.96 (0.080) | 0.97 (0.082) |
| Cyclophosphamide | 0.96 (0.080) | 0.97 (0.056) |
| Prednisone | 0.99 (0.079) | 0.96 (0.101) |
| Bortezomib/vincristine* | 0.85 (0.140) | 0.79 (0.102) |
| Dose or schedule modified, n (%) | 70 (85) | 38 (48) |
| Any dose reduction | 46 (56) | 23 (29) |
| Dose bortezomib/vincristine withheld, n (%)† | 63 (77) | 3 (4) |
| Dose of bortezomib/vincristine reduced, n (%)† | 30 (37) | 4 (5) |
SD, standard deviation.
*
The dose of vincristine was capped at 2 mg.
†
Proportion of patients with ≥1 dose of bortezomib (VR-CAP arm) or vincristine (R-CHOP arm) withheld or reduced.