Table 1.
Demographics and baseline disease characteristics in integrated safety analysis
| Characteristic | Ibrutinib (N = 330) |
|---|---|
| Age, median (range), y | 70 (30-89) |
| Male sex | 217 (66) |
| ECOG performance status | |
| 0 | 139 (42) |
| 1 | 181 (55) |
| 2 | 10 (3) |
| Baseline Rai stage III/IV | 169 (51) |
| Bulky disease ≥5 cm, n/N (%) | 178/329 (54) |
| Del(11q), n/N (%) | 92/319 (29) |
| Del(17p)*, n/N (%) | 60/328 (18) |
| Unmutated IGHV, n/N (%) | 156/235 (66) |
| Complex karyotype, n/N (%) | 45/245 (18) |
| β2-microglobulin >3.5 mg/L, n/N (%) | 238/309 (77) |
| Creatinine clearance <60 mL/min, n/N (%) | 121/329 (37) |
| CIRS score, median (range) | 5 (0-20) |
| Cytopenia at baseline | |
| Any cytopenia | 196 (59) |
| Absolute neutrophil count ≤1.5 × 109/L | 51 (15) |
| Platelets ≤100 × 109/L | 109 (33) |
| Hemoglobin ≤11 g/dL | 140 (42) |
| No. of prior regimens | |
| 0 | 135 (41) |
| 1 | 35 (11) |
| ≥2 | 160 (48) |
Unless otherwise indicated, data are n (%).
CIRS, Cumulative Illness Rating Scale; ECOG, Eastern Cooperative Oncology Group; IGHV, immunoglobulin heavy chain variable.
*
RESONATE enrolled patients with del(17p); RESONATE-2 excluded patients with del(17p).