Table 2

Summary of treatment exposure (safety population)

ParameterVR-CAP, n = 82R-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 
 Doxorubicin 
 Cyclophosphamide 
 Prednisone 30 30 
 Bortezomib/vincristine 22 
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) 
ParameterVR-CAP, n = 82R-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 
 Doxorubicin 
 Cyclophosphamide 
 Prednisone 30 30 
 Bortezomib/vincristine 22 
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.

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