Table 1.
Baseline characteristics
Ibrutinib n = 136 |
Chlorambucil n = 133 |
|
---|---|---|
Median age (range), years | 73 (65–89) | 72 (65–90) |
≥70 years, n (%) | 96 (71) | 93 (70) |
Male, n (%) | 88 (65) | 81 (61) |
ECOG performance status, n (%) | ||
0 | 60 (44) | 54 (41) |
1–2 | 76 (56) | 79 (59) |
Rai stage III or IV, n (%) | 60 (44) | 62 (47) |
CIRS score >6, n (%) | 42 (31) | 44 (33) |
Creatinine clearance <60 mL/min, n (%) | 60 (44) | 67 (50) |
Bulky disease ≥5 cm, n (%) | 54 (40) | 40 (30) |
β2-microglobulin >3.5 mg/L, n (%) | 85 (63) | 89 (67) |
Hemoglobin ≤11 g/dL, n (%) | 51 (38) | 55 (41) |
Platelet count ≤100 × 109/L, n (%) | 35 (26) | 28 (21) |
del(11q), n/N (%) | 29/130 (22) | 25/121 (21) |
Unmutated IGHV, n/N (%) | 58/101 (57) | 60/103 (58) |
TP53 mutation n/N (%) | 12/124 (10) | 3/94 (3) |
High prognostic risk features,a n (%) | 74 (54) | 69 (52) |
CIRS Cumulative Illness Rating Scale, ECOG Eastern Cooperative Oncology Group, IGHV immunoglobulin heavy chain variable region
aTP53 mutation, del(11q), and/or unmutated IGHV