Table 1.
Patient’s baseline characteristics of the overall NAOS population
|
L1 ( N =285) |
L2+ ( N =200) |
Total ( N =485) |
||||
|---|---|---|---|---|---|---|
| Age at initiation (years) | ||||||
| median (IQR) | 73 | (69–79) | 77 | (70–3) | 75 | (70–81) |
| < 65, n (%) | 40 | (14.2) | 18 | (9.0) | 58 | (12.0) |
| ≥ 75, n (%) | 130 | (45.6) | 117 | (58.5) | 247 | (50.9) |
| Male, n (%) | 186 | (65.3) | 129 | (64.5) | 315 | (64.9) |
| ECOG PS, n (%)* | N =224 | N =159 | N =383 | |||
| 0 | 106 | (47.3) | 62 | (39.0) | 168 | (43.9) |
| 1 | 89 | (39.7) | 62 | (39.0) | 151 | (39.4) |
| ≥ 2 | 29 | (12.9) | 35 | (22.0) | 64 | (16.7) |
| Prior cardiovascular comorbidities* | N =278 | N =196 | N =474 | |||
| Yes (at least one), n (%) | 150 | (54.0) | 111 | (56.6) | 261 | (55.1) |
| Myocardial infarction, n (%) | 14 | (5.0) | 14 | (7.1) | 28 | (5.9) |
| Congestive heart failure, n (%) | 10 | (3.6) | 10 | (5.1) | 20 | (4.2) |
| Peripherical vascular disease, n (%) | 28 | (10.1) | 11 | (5.6) | 39 | (8.2) |
| Hypertension, n (%) | 121 | (43.5) | 90 | (45.9) | 211 | (44.5) |
| Cardiac rhythm disorders, n (%) | 26 | (9.4) | 33 | (16.8) | 59 | (12.4) |
| Including Atrial fibrillation | 18 | (6.3) | 23 | (11.5) | 41 | (8.5) |
| Atrial flutter | 3 | (1.1) | 2 | (1.0) | 5 | (1.0) |
| Treated with antithrombotic agent n (%) | 82 | (28.8) | 68 | (34.0) | 150 | (30.9) |
| Creatinine clearance (mL/min)* | N =209 | N =132 | N =341 | |||
| Median (IQR) | 72.7 | (57–83) | 63.7 | (51–78) | 70.0 | (54–82) |
| < 60 mL/min | 59 | (28.2) | 55 | (41.7) | 114 | (33.4) |
| Time from diagnosis of CLL (years) | ||||||
| median (IQR) | 3.0 | (0.9–6.4) | 9.1 | (5.3–13.2) | 5.1 | (1.9–9.9) |
| BINET assessment, n (%) | N =220 | N =135 | N =355 | |||
| Stade A | 27 | (12.3) | 20 | (14.8) | 47 | (13.2) |
| Stade B | 113 | (51.4) | 60 | (44.4) | 173 | (48.7) |
| Stade C | 80 | (36.4) | 55 | (40.7) | 135 | (38.0) |
| High-risk cytogenetic features* | ||||||
| Del(17p) * | N =207 | N =135 | N =342 | |||
| Yes, n (%) | 36 | (17.5) | 36 | (26.9) | 72 | (21.2) |
| Mutated TP53* | N =225 | N =137 | N=362 | |||
| Yes, n (%) | 35 | (15.8) | 34 | (25.6) | 69 | (19.4) |
| Del(17p) and/or TP53, n (%) | N =262 | N =150 | N =412 | |||
| Yes, n (%) | 52 | (19.8) | 55 | (33.3) | 107 | (25.1) |
| Del(17p) and TP53, n (%) | N =262 | N =150 | N =412 | |||
| Yes, n (%) | 19 | (7.3) | 15 | (9.1) | 34 | (8.0) |
| Unmutated IGHV* | N =189 | N =87 | N =276 | |||
| Yes, n (%) | 120 | (65.2) | 62 | (72.1) | 182 | (67.4) |
| Del (11q) | N =177 | N =115 | N =292 | |||
| Yes, n (%) | 48 | (27.1) | 46 | (40.4) | 94 | (32.3) |
| Complex karyotype*,** | N =150 | N =84 | N =234 | |||
| Yes, n (%) | 43 | (28.7) | 36 | (43.4) | 79 | (33.9) |
| Prior therapies, n (%) | N =200 | |||||
| Prior ibrutinib, n (%) | - | 71 | (35.5) | - | ||
| Prior venetoclax, n (%) | - | 31 | (15.5) | - | ||
| Prior CIT, n (%) | - | 135 | (67.5) | - | ||
| Type of treatment received, n (%) | ||||||
| Acalabrutinib in monotherapy | 219 | (76.8) | 186 | (93.0) | 405 | (83.5) |
| Acalabrutinib with Obinutuzumab | 63 | (22.1) | 11 | (5.5) | 74 | (15.3) |
| Acalabrutinib with other | 3 | (1.1) | 3 | (1.5) | 6 | (1.2) |
*Based on observed data (unknown/unavailable data are not included in observed data); **> 3 abnormalities