Baseline population demographics
| . | All patients (n = 582) . | CLL patients (n = 433) . |
|---|---|---|
| Age, median (range), y | 65 (23 to >89) | 65 (26 to >89) |
| Sex, male, n (%) | 406 (69.8) | 301 (69.5) |
| Race, n (%) | ||
| White | 540 (92.8) | 398 (91.9) |
| Black | 31 (5.3) | 27 (6.2) |
| Others* | 11 (1.8) | 8 (1.9) |
| ECOG performance status, n (%) | ||
| 0-1 | 530 (92.5) | 402 (94.6) |
| 2 | 39 (6.8) | 23 (5.4) |
| 3-4 | 4 (0.6) | 0 (0) |
| Primary malignancy, n (%) | ||
| CLL | 433 (74.4) | 433 (100) |
| MCL | 57 (9.8) | — |
| WM | 12 (2.1) | — |
| Others† | 80 (13.7) | — |
| CLL, Rai stage (n = 433), n (%) | ||
| 0 (low risk) | — | 3 (0.7) |
| 1-2 (intermediate risk) | — | 118 (27.2) |
| 3-4 (high risk) | — | 307 (70.9) |
| Unknown | — | 5 (1.2) |
| CLL, risk stratification (n = 433), n (%) | ||
| Del11q22 | — | 138 (32.7) |
| Trisomy 12 | — | 88 (21) |
| Del13q14 | — | 219 (51.9) |
| Del17p13 | — | 160 (37.9) |
| IGHV mutated, >2% | — | 78 (21.4) |
| Cancer stage (MCL, WM, other) (n = 149), n (%) | ||
| 1-2 | 8 (5.4) | — |
| 3-4 | 114 (76.5) | — |
| Not applicable, unknown | 27 (18.1) | — |
| Treatment history, n (%) | ||
| Prior therapies, median (range) | 3 (0-18) | 3 (0-18) |
| Untreated | 37 (6.4) | 26 (6.0) |
| Prior anthracycline | 134 (23) | 29 (11.3) |
| Prior autologous HSCT | 38 (6.5) | 4 (0.9) |
| Prior allogeneic HSCT | 21 (3.6) | 10 (2.3) |
| Concomitant therapies with ibrutinib, n (%) | ||
| Any anticancer therapy | 175 (30.1) | 102 (23.6) |
| Anthracyclines | 9 (1.5) | 8 (1.9) |
| MoAb therapy | 143 (24.6) | 91 (21.0) |
| Baseline AF risk factors | ||
| Hypertension, n (%) | 262 (45) | 187 (43.2) |
| Diabetes mellitus, n (%) | 76 (13.1) | 50 (11.6) |
| Myocardial infarction, n (%) | 36 (6.2) | 28 (6.5) |
| Coronary artery disease, n (%) | 66 (11.3) | 49 (11.3) |
| Congestive heart failure, n (%) | 14 (2.4) | 11 (2.5) |
| Obstructive sleep apnea, n (%) | 46 (7.9) | 36 (8.3) |
| Valvular heart disease, n (%) | 22 (3.8) | 20 (4.6) |
| Hyperthyroidism, n (%) | 5 (0.9) | 5 (1.2) |
| Coronary artery bypass graft, n (%) | 12 (2.1) | 9 (2.1) |
| TIA or stroke, n (%) | 22 (3.8) | 13 (3.0) |
| History of AF | 34 (5.8) | 23 (5.3) |
| Cardiac murmur, n (%) | 67 (11.5) | 52 (12.0) |
| Smoking, n (%) | 262 (45) | 195 (45.1) |
| Baseline systolic BP, median (range), mm Hg | 129 (86-186) | 128 (90-174) |
| Baseline PR interval,‡ median (range), ms | 156 (80-302) | 156 (80-302) |
| Predicted AF risk | ||
| FHS-AF risk,§ median (range), % | 6.8 (0.02 to >30) | 6.8 (0.1 to >30) |
| Low risk (<10%), n (%) | 257 (63.3) | 177 (63.0) |
| Intermediate risk (10%-20%), n (%) | 94 (23.2) | 68 (24.2) |
| High risk (>20%), n (%) | 55 (13.6) | 36 (12.8) |
| Missing data, n (%) | 176 (30.2) | 152 (35.1) |
| . | All patients (n = 582) . | CLL patients (n = 433) . |
|---|---|---|
| Age, median (range), y | 65 (23 to >89) | 65 (26 to >89) |
| Sex, male, n (%) | 406 (69.8) | 301 (69.5) |
| Race, n (%) | ||
| White | 540 (92.8) | 398 (91.9) |
| Black | 31 (5.3) | 27 (6.2) |
| Others* | 11 (1.8) | 8 (1.9) |
| ECOG performance status, n (%) | ||
| 0-1 | 530 (92.5) | 402 (94.6) |
| 2 | 39 (6.8) | 23 (5.4) |
| 3-4 | 4 (0.6) | 0 (0) |
| Primary malignancy, n (%) | ||
| CLL | 433 (74.4) | 433 (100) |
| MCL | 57 (9.8) | — |
| WM | 12 (2.1) | — |
| Others† | 80 (13.7) | — |
| CLL, Rai stage (n = 433), n (%) | ||
| 0 (low risk) | — | 3 (0.7) |
| 1-2 (intermediate risk) | — | 118 (27.2) |
| 3-4 (high risk) | — | 307 (70.9) |
| Unknown | — | 5 (1.2) |
| CLL, risk stratification (n = 433), n (%) | ||
| Del11q22 | — | 138 (32.7) |
| Trisomy 12 | — | 88 (21) |
| Del13q14 | — | 219 (51.9) |
| Del17p13 | — | 160 (37.9) |
| IGHV mutated, >2% | — | 78 (21.4) |
| Cancer stage (MCL, WM, other) (n = 149), n (%) | ||
| 1-2 | 8 (5.4) | — |
| 3-4 | 114 (76.5) | — |
| Not applicable, unknown | 27 (18.1) | — |
| Treatment history, n (%) | ||
| Prior therapies, median (range) | 3 (0-18) | 3 (0-18) |
| Untreated | 37 (6.4) | 26 (6.0) |
| Prior anthracycline | 134 (23) | 29 (11.3) |
| Prior autologous HSCT | 38 (6.5) | 4 (0.9) |
| Prior allogeneic HSCT | 21 (3.6) | 10 (2.3) |
| Concomitant therapies with ibrutinib, n (%) | ||
| Any anticancer therapy | 175 (30.1) | 102 (23.6) |
| Anthracyclines | 9 (1.5) | 8 (1.9) |
| MoAb therapy | 143 (24.6) | 91 (21.0) |
| Baseline AF risk factors | ||
| Hypertension, n (%) | 262 (45) | 187 (43.2) |
| Diabetes mellitus, n (%) | 76 (13.1) | 50 (11.6) |
| Myocardial infarction, n (%) | 36 (6.2) | 28 (6.5) |
| Coronary artery disease, n (%) | 66 (11.3) | 49 (11.3) |
| Congestive heart failure, n (%) | 14 (2.4) | 11 (2.5) |
| Obstructive sleep apnea, n (%) | 46 (7.9) | 36 (8.3) |
| Valvular heart disease, n (%) | 22 (3.8) | 20 (4.6) |
| Hyperthyroidism, n (%) | 5 (0.9) | 5 (1.2) |
| Coronary artery bypass graft, n (%) | 12 (2.1) | 9 (2.1) |
| TIA or stroke, n (%) | 22 (3.8) | 13 (3.0) |
| History of AF | 34 (5.8) | 23 (5.3) |
| Cardiac murmur, n (%) | 67 (11.5) | 52 (12.0) |
| Smoking, n (%) | 262 (45) | 195 (45.1) |
| Baseline systolic BP, median (range), mm Hg | 129 (86-186) | 128 (90-174) |
| Baseline PR interval,‡ median (range), ms | 156 (80-302) | 156 (80-302) |
| Predicted AF risk | ||
| FHS-AF risk,§ median (range), % | 6.8 (0.02 to >30) | 6.8 (0.1 to >30) |
| Low risk (<10%), n (%) | 257 (63.3) | 177 (63.0) |
| Intermediate risk (10%-20%), n (%) | 94 (23.2) | 68 (24.2) |
| High risk (>20%), n (%) | 55 (13.6) | 36 (12.8) |
| Missing data, n (%) | 176 (30.2) | 152 (35.1) |
–, Not applicable; BP, blood pressure; ECOG, Eastern Cooperative Oncology Group; HSCT, hematopoietic stem cell transplant; MoAb, monoclonal antibody.
Hispanic, Asian, mixed.
Diffuse large B-cell lymphoma, graft-versus-host disease, marginal zone lymphoma, hairy cell leukemia, follicular lymphoma; BP, normal considered <120 mm Hg.
Normal range = 120-200 ms.
FHS 10-y risk of first AF, calculated according to Schnabel et al24 using the following variables: age, sex, body mass index, systolic blood pressure, treatment of hypertension, PR interval, significant murmur, prevalent heart failure.