Table 1.
Patients’ and disease characteristics at ibrutinib initiation
| Characteristic | Value no. (%) |
|---|---|
| Median age, y (range) | 70.1 (40-95) |
| <65 y/≥65 y | 228 (32.0)/484 (68.0) |
| Sex: male/female | 478 (67.1)/234 (32.9) |
| ECOG-PS 0-1/>1 | 601 (84.4)/111 (15.6) |
| CIRS median (range) CIRS ≤6/CIRS* > 6 |
5 (0-30) 470 (66.0)/242 (34.0) |
| CIRS3+ | 147 (20.7) |
| CIRS* > 6 and CIRS3+ | 105 (14.7) |
| CrCl mL/min ≥50/30-49/<30 |
548 (76.9)/147 (21.6)/17 (2.5) |
| Pts with cardio-comorbidity | 113 (15.9) |
| CCI median (range) CCI < 2/CCI ≥2 |
4 (0-35) 124 (17.4)/588 (82.6) |
| Median no. concomitant medications (range) Pts with >3 concomitant medications Pts treated with CYP3A4 inhibitors |
4 (0-14) 347 (48.7) 75 (10.5) |
| Pts treated with anticoagulants and/or antiplatelets Anticoagulants only Antiplatelets only Anticoagulant + antiplatelets Dual antiplatelet therapy |
165 (23.2) 49 (29.7) 110 (66.7) 6 (3.6) 2 (1.2) |
| RAI stage | |
| 0-2 | 397 (55.8) |
| 3-4 | 315 (44.2) |
| Prior Tx median (range) | 1 (0-10) |
| 0 | 174 (24.4) |
| 1-2 | 420 (59.0) |
| ≥3 | 118 (16.6) |
| IGHV unmutated | 473 (72.7) |
| del(17p) and TP53mut del(17p) TP53mut |
272 (38.7) 211 151 |
| High risk† del(17p) and/or TP53mut and/or unmutated IGHV and/or del(11q) | 580 (81.5) |
| Grade 3 to 4 neutropenia | 67 (9.4) |
Pts, patients; Tx, therapy.
*
Medical conditions that deemed to be complications of CLL not included as part of the total CIRS score.
†
High risk defined as del(17p) and/or TP53mut and/or del(11q) and or unmutated IGHV.