Table 2.
Patients with CNS Events, by Drug Therapy, at 3-Month Intervals
| CNS events | Abiraterone (N = 1067) | Enzalutamide (N = 592) | Bicalutamide (N = 5524) | Chemotherapya (N = 256) | CNS events | Abiraterone (N = 1067) | Enzalutamide (N = 592) | Bicalutamide (N = 5524) | Chemotherapya (N = 256) |
|---|---|---|---|---|---|---|---|---|---|
| Patients with 3 months of exposure, N (%) | 665 (62.3) | 326 (55.1) | 2422 (43.8) | 133 (52.0) | Patients with 9 months of exposure, N (%) | 284 (26.6) | 89 (15.0) | 784 (14.2) | 9 (3.5) |
| Any CNS event | 78 (11.7) | 54 (16.6) | 244 (10.1) | 23 (17.3) | Any CNS event | 80 (28.2) | 29 (32.6) | 194 (24.7) | 3 (33.3) |
| Fatigue/asthenia | 25 (3.8) | 27 (8.3) | 94 (3.9) | 12 (9.0) | Fatigue/asthenia | 31 (10.9) | 11 (12.4) | 87 (11.1) | 0 (0.0) |
| Pain | 19 (2.9) | 15 (4.6) | 41 (1.7) | 6 (4.5) | Pain | 20 (7.0) | 6 (6.7) | 32 (4.1) | 1 (11.1) |
| Dizziness | 9 (1.4) | 6 (1.8) | 39 (1.6) | 1 (0.8) | Dizziness | 17 (6.0) | 2 (2.2) | 44 (5.6) | 0 (0.0) |
| Weakness | 6 (0.9) | 5 (1.5) | 14 (0.6) | 3 (2.3) | Weakness | 10 (3.5) | 6 (6.7) | 21 (2.7) | 2 (22.2) |
| Headaches | 6 (0.9) | 4 (1.2) | 24 (1.0) | 2 (1.5) | Headaches | 10 (3.5) | 1 (1.1) | 19 (2.4) | 1 (11.1) |
| Paresthesia | 5 (0.8) | 1 (0.3) | 21 (0.9) | 2 (1.5) | Paresthesia | 5 (1.8) | 1 (1.1) | 18 (2.3) | 1 (11.1) |
| Insomnia | 5 (0.8) | 3 (0.9) | 12 (0.5) | 1 (0.8) | Insomnia | 6 (2.1) | 0 (0.0) | 8 (1.0) | 1 (11.1) |
| Amnesia/memory impairment | 5 (0.8) | 2 (0.6) | 8 (0.3) | 0 (0.0) | Amnesia/memory impairment | 3 (1.1) | 2 (2.2) | 3 (0.4) | 0 (0.0) |
| Cognitive disorders | 2 (0.3) | 0 (0.0) | 4 (0.2) | 0 (0.0) | Cognitive disorders | 2 (0.7) | 0 (0.0) | 2 (0.3) | 0 (0.0) |
| Seizures | 2 (0.3) | 1 (0.3) | 5 (0.2) | 0 (0.0) | Seizures | 1 (0.4) | 2 (2.2) | 4 (0.5) | 0 (0.0) |
| Anxiety | 3 (0.5) | 2 (0.6) | 17 (0.7) | 1 (0.8) | Anxiety | 4 (1.4) | 1 (1.1) | 16 (2.0) | 1 (11.1) |
| Ataxia | 1 (0.2) | 0 (0.0) | 10 (0.4) | 1 (0.8) | Ataxia | 3 (1.1) | 1 (1.1) | 5 (0.6) | 1 (11.1) |
| Convulsions | 1 (0.2) | 0 (0.0) | 4 (0.2) | 0 (0.0) | Convulsions | 4 (1.4) | 2 (2.2) | 4 (0.5) | 1 (11.1) |
| Falls | 1 (0.2) | 2 (0.6) | 3 (0.1) | 0 (0.0) | Falls | 3 (1.1) | 1 (1.1) | 4 (0.5) | 0 (0.0) |
| Confusion | 1 (0.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | Confusion | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hallucinations | 0 (0.0) | 0 (0.0) | 1 (0.0) | 0 (0.0) | Hallucinations | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Disturbance in attention | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | Disturbance in attention | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Other CNS disorders | 5 (0.8) | 7 (2.1) | 19 (0.8) | 2 (1.5) | Other CNS disorders | 5 (1.8) | 3 (3.4) | 13 (1.7) | 1 (11.1) |
| Patients with 6 months of exposure, N (%) | 448 (42.0) | 170 (28.7) | 1319 (23.9) | 41 (16.0) | Patients with 12 months of exposure, N (%) | 160 (15.0) | 42 (7.1) | 478 (8.7) | 4 (1.6) |
| Any CNS event | 89 (19.9) | 43 (25.3) | 255 (19.3) | 9 (22.0) | Any CNS event | 59 (36.9) | 19 (45.2) | 142 (29.7) | 1 (25.0) |
| Fatigue/asthenia | 32 (7.1) | 19 (11.2) | 104 (7.9) | 2 (4.9) | Fatigue/asthenia | 24 (15.0) | 8 (19.0) | 63 (13.2) | 1 (25.0) |
| Pain | 21 (4.7) | 9 (5.3) | 36 (2.7) | 3 (7.3) | Pain | 15 (9.4) | 5 (11.9) | 23 (4.8) | 1 (25.0) |
| Dizziness | 15 (3.3) | 8 (4.7) | 52 (3.9) | 1 (2.4) | Dizziness | 8 (5.0) | 2 (4.8) | 32 (6.7) | 0 (0.0) |
| Weakness | 10 (2.2) | 5 (2.9) | 18 (1.4) | 2 (4.9) | Weakness | 11 (6.9) | 5 (11.9) | 16 (3.3) | 1 (25.0) |
| Headaches | 9 (2.0) | 4 (2.4) | 28 (2.1) | 4 (9.8) | Headaches | 6 (3.8) | 1 (2.4) | 16 (3.3) | 0 (0.0) |
| Paresthesia | 7 (1.6) | 2 (1.2) | 27 (2.0) | 2 (4.9) | Paresthesia | 5 (3.1) | 1 (2.4) | 15 (3.1) | 0 (0.0) |
| Insomnia | 6 (1.3) | 1 (0.6) | 13 (1.0) | 2 (4.9) | Insomnia | 3 (1.9) | 0 (0.0) | 8 (1.7) | 0 (0.0) |
| Amnesia/memory impairment | 4 (0.9) | 2 (1.2) | 6 (0.5) | 0 (0.0) | Amnesia/memory impairment | 3 (1.9) | 1 (2.4) | 4 (0.8) | 0 (0.0) |
| Cognitive disorders | 2 (0.4) | 0 (0.0) | 2 (0.2) | 0 (0.0) | Cognitive disorders | 2 (1.3) | 0 (0.0) | 3 (0.6) | 0 (0.0) |
| Seizures | 1 (0.2) | 1 (0.6) | 4 (0.3) | 0 (0.0) | Seizures | 0 (0.0) | 1 (2.4) | 5 (1.0) | 0 (0.0) |
| Anxiety | 3 (0.7) | 2 (1.2) | 17 (1.3) | 1 (2.4) | Anxiety | 2 (1.3) | 1 (2.4) | 12 (2.5) | 0 (0.0) |
| Ataxia | 2 (0.4) | 0 (0.0) | 8 (0.6) | 1 (2.4) | Ataxia | 5 (3.1) | 1 (2.4) | 4 (0.8) | 1 (25.0) |
| Convulsions | 3 (0.7) | 1 (0.6) | 3 (0.2) | 1 (2.4) | Convulsions | 3 (1.9) | 1 (2.4) | 4 (0.8) | 1 (25.0) |
| Falls | 2 (0.4) | 2 (1.2) | 1 (0.1) | 0 (0.0) | Falls | 1 (0.6) | 0 (0.0) | 4 (0.8) | 0 (0.0) |
| Confusion | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | Confusion | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hallucinations | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | Hallucinations | 0 (0.0) | 0 (0.0) | 1 (0.2) | 0 (0.0) |
| Disturbance in attention | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | Disturbance in attention | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Other CNS disorders | 4 (0.9) | 4 (2.4) | 16 (1.2) | 0 (0.0) | Other CNS disorders | 2 (1.3) | 3 (7.1) | 9 (1.9) | 0 (0.0) |
a
Chemotherapy includes cabazitaxel, docetaxel, mitoxantrone hydrochloride, and estramustine.
CNS indicates central nervous system.