Table 1.
Baseline Characteristics
| Characteristic | Acalabrutinib Monotherapy (n = 155) | Investigator’s Choice (IdR/BR) (n = 155) | Total (N = 310) |
|---|---|---|---|
| Age, median (range), y | 68 (32–89) | 67 (34–90) | 67 (32–90) |
| ≥65 y, n (%) | 97 (63) | 98 (63) | 195 (63) |
| Men, n (%) | 108 (70) | 100 (65) | 208 (67) |
| Baseline Rai stage, n (%) | |||
| 0–II | 90 (58) | 90 (58) | 180 (58) |
| III–IV | 65 (42) | 64 (41) | 129 (42) |
| Unknown | 0 | 1 (0.6) | 1 (0.3) |
| ECOG PS, n (%) | |||
| 0 | 58 (37) | 55 (35) | 113 (36) |
| 1 | 78 (50) | 79 (51) | 157 (51) |
| 2 | 19 (12) | 21 (14) | 40 (13) |
| Cytopenia(s), n (%) | |||
| Absolute neutrophil count ≤1.5 × 109/L | 14 (9) | 9 (6) | 23 (7) |
| Hemoglobin ≤11 g/dL | 49 (32) | 46 (30) | 95 (31) |
| Platelets ≤100 × 109/L | 57 (37) | 57 (37) | 114 (37) |
| β2-microglobulin >3.5 mg/L, n (%) | 120 (77) | 126 (81) | 246 (79) |
| Bulky disease, n (%) | |||
| <5 cm | 79 (51) | 80 (52) | 159 (51) |
| ≥5 cm | 76 (49) | 75 (48) | 151 (49) |
| Genomic status, n (%) | |||
| del(11q) | 39 (25) | 44 (28) | 83 (27) |
| del(17p)a | 27 (17) | 21 (14) | 48 (16) |
| TP53 mutation | 39 (25) | 34 (22) | 73 (24) |
| del(17p)a and/or TP53 mutation | 44 (28) | 42 (27) | 86 (28) |
| del(17p)a and TP53 mutation | 22 (14) | 13 (8) | 35 (11) |
| del(17p)a without TP53 mutation | 5 (3) | 8 (5) | 13 (4) |
| TP53 mutation without del(17p) | 17 (11) | 20 (13) | 37 (12) |
| Unmutated IGHV | 109 (70) | 119 (77) | 228 (74) |
| Complex karyotypeb | 3 (2) | 3 (2) | 6 (2) |
aMutation status for patients with del(17p) were based on those recorded in the clinical database.
bComplex karyotype was defined as .3 aberrations.
BR = bendamustine plus rituximab; ECOG PS = Eastern Cooperative Oncology Group performance status; IdR = idelalisib plus rituximab; IGHV = immunoglobulin heavy chain variable region genes; TP53 = tumor protein p53.