Bortezomib-rituximab (N=103) | Rituximab (N=98) | |
---|---|---|
Median age, years (range) | 61 (38–83) | 60 (21–84) |
Aged >65 years, n (%) | 31 (30) | 25 (26) |
Male, n (%) | 53 (51) | 42 (43) |
Race, n (%) | ||
White | 78 (76) | 65 (66) |
Asian | 20 (19) | 29 (30) |
Other | 5 (5) | 4 (4) |
Region, n (%) | ||
USA and Canada | 8 (8) | 10 (10) |
European Union | 34 (33) | 28 (29) |
Rest of the World* | 61 (59) | 60 (61) |
ECOG performance status, n (%) | ||
0 | 36 (35) | 35 (36) |
1 | 56 (54) | 52 (53) |
2 | 11 (11) | 11 (11) |
Ann Arbor Stage, n (%) | ||
II | 0 | 1 (1) |
III | 36 (35) | 45 (46) |
IV | 67 (65) | 52 (53) |
High tumor burden by modified GELF criteria[12], n (%) | 103 (100) | 98 (100) |
High (≥3) FLIPI score[7], n (%) | 103 (100) | 98 (100) |
Elevated serum LDH, n (%) | 70 (68) | 61 (62) |
Median time from initial diagnosis, months (range) | 35.8 (2–233) | 38.5 (1–197) |
Number of prior lines of therapy, n (%) | ||
1 | 43 (42) | 35 (36) |
2 | 25 (24) | 31 (32) |
≥3 | 35 (34) | 32 (32) |
Common prior therapies, n (%) | ||
CHOP | 41 (40) | 40 (41) |
CVP | 35 (34) | 23 (23) |
Single-agent rituximab | 17 (17) | 13 (13) |
Chlorambucil-prednisone | 9 (9) | 14 (14) |
R-CHOP | 10 (10) | 12 (12) |
R-CVP | 9 (9) | 12 (12) |
Single-agent chlorambucil | 10 (10) | 10 (10) |
Any prior rituximab therapy, n (%) | 40 (39) | 40 (41) |
>1 year since last FL treatment, n (%) | 53 (51) | 48 (49) |
Creatinine clearance >30–60 mL/min, n (%) | 18 (17) | 24 (24) |