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Table 1 Baseline characteristics of LYM3001 patients with high-risk FL (ITT population)

From: Bortezomib plus rituximab versus rituximab in patients with high-risk, relapsed, rituximab-naïve or rituximab-sensitive follicular lymphoma: subgroup analysis of a randomized phase 3 trial

  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)
  1. *Including 21%/12% from Russia, 10%/14% from People’s Republic of China, 9%/14% from India, and 9%/11% from Brazil in the bortezomib-rituximab/rituximab arms.
  2. ECOG, Eastern Cooperative Oncology Group; GELF, Groupe d’Etude des Lymphomas Folliculaires; FLIPI, Follicular Lymphoma International Prognostic Index; LDH, lactate dehydrogenase.