Table 1.
Baseline patient characteristics
| Variable | Patients with treatment-naïve disease | Patients with relapsed/refractory disease | Total |
|---|---|---|---|
| Patients, n | 102 | 186 | 288 |
| Median age (range), y | 67 (41-83) | 62 (33-85) | 65 (33-85) |
| Sex, n (%) | |||
| Female | 40 (39) | 49 (26) | 89 (31) |
| Male | 62 (61) | 137 (74) | 199 (69) |
| Binet stage, n (%) | |||
| A | 32 (31) | 61 (33) | 93 (32) |
| B | 36 (35) | 71 (38) | 107 (37) |
| C | 32 (31) | 52 (28) | 84 (29) |
| Unknown | 2 (3) | 2 (1) | 4 (2) |
| ECOG performance score, n (%) | |||
| 0 | 38 (37) | 54 (29) | 92 (32) |
| 1 | 59 (58) | 123 (66) | 182 (63) |
| 2 | 4 (4) | 6 (3) | 10 (3) |
| Unknown | 1 (1) | 3 (2) | 4 (2) |
| IGHV status, n (%) | |||
| Unmutated | 51 (50) | 135 (73) | 186 (65) |
| Mutated | 38 (37) | 33 (18) | 71 (25) |
| Unknown | 13 (13) | 18 (9) | 31 (10) |
| Hierarchical model by FISH, n (%) | |||
| Del(17p) | 9 (9) | 33 (18) | 42 (15) |
| Del(11q) | 23 (23) | 45 (24) | 68 (24) |
| Tri(12) | 20 (20) | 25 (13) | 45 (16) |
| Del(13p) | 29 (28) | 40 (22) | 69 (24) |
| None | 17 (17) | 28 (15) | 45 (16) |
| Conventional karyotyping, n (%) | |||
| <3 aberrations | 93 (91) | 149 (80) | 242 (84) |
| ≥3 aberrations (complex) | 9 (9) | 37 (20) | 46 (16) |
| Median baseline laboratory values (range) | |||
| White blood cell count, 109/L | 79.35 (4.9-244.6) | 31.45 (1.9-243.9) | 45.85 (1.9-244.6) |
| Hemoglobin level, g/dL | 12.2 (8.9-16.4) | 12.55 (8.2-16.5) | 12.4 (8.2-16.5) |
| Platelet count, 109/L | 147.5 (45-464) | 119.5 (22-494) | 126.5 (22-494) |
| β2M level, mg/L | 3.9 (1.4-10.5) | 4.1 (1.5-18.3) | 4 (1.4-18.3) |
| ZAP-70 expression, n (%) | 40 (40) | 20 (11) | 60 (21) |