Table 1A. Summary statistics.
| Characteristic | Statistic | N | All Patients | Abiraterone | Enzalutamide |
|---|---|---|---|---|---|
| Site |
Federico II Napoli Pascale Napoli University Bari St. Gallen UNC UCLA BCCA Gallarate |
598 | 127 (21.2) 17 (2.8) 21 (3.5) 29 (4.9) 41 (6.9) 15 (2.5) 342 (57.2) 6 (1.0) |
91 (19.0) 14 (2.9) 13 (2.7) 27 (5.6) 20 (4.2) 9 (1.9) 301 (62.7) 5 (1.0) |
36 (30.5) 3 (2.5) 8 (6.8) 2 (1.7) 21 (17.8) 6 (5.1) 41 (34.8) 1 (0.9) |
| Age |
Mean (std dev) Median (range) |
598 | 72.5 (9.0) 72 (42, 96) |
72.6 (9.0) 72 (42, 96) |
72.0 (8.8) 72 (43, 90) |
| Gleason Score | N (%) ≥8 | 540 | 306 (56.7) | 248/431 (57.5) | 58/109 (53.2) |
| Charlson Score |
Median (range) N (%) ≥10 |
598 | 10 (6, 17) 341 (57.0) |
10 (6, 17) 274/480 (57.1) |
10 (6, 15) 67/118 (56.8) |
| Baseline PSA | Median (range) | 588 | 87.3 (0, 7938) | 97.8 (0, 7938) | 61 (1.9, 2220) |
| Alkaline Phosphatase | Median (range) | 448 | 119 (8.9, 2189) | 120 (8.9, 2189) | 105 (39, 1791) |
| LDH | Median (range) | 259 | 264 (90, 2598) | 262 (90, 2598) | 266 (103, 2219) |
| Neutrophils/Lymphocyte Ratio | Median (range) | 530 | 3.4 (0.2, 37.5) | 3.5 (0.2, 34.5) | 2.7 (1.0, 37.5) |
| Hemoglobin | Median (range) | 555 | 11.9 (5.7, 15.8) | 11.9 (5.7, 15.8) | 11.8 (7.1, 15.6) |
| Months, Castration-sensitive Disease | Median (range) | 390 | 18.4 (0.2, 65.5) | 18.6 (0.2, 65.5) | 16.0 (0.8, 59.8) |
| Months, Diagnosis to Mets | Median (range) | 474 | 37.0 (0, 162.0) | 39.3 (0, 161.3) | 25.0 (0, 162.0) |
| Opiate Use | N (%) Yes | 587 | 191/587 (32.5) | 152/476 (31.9) | 39/111 (35.1) |
| Visceral Disease | N (%) Yes | 598 | 46 (7.7) | 31/480 (6.5) | 15/118 (12.7) |
| Treatment with abiraterone/enzalutamide ± statins | |||||
| Treatment | N (%) Abiraterone | 598 | 480 (80.3) | 480 (100.0) | 0 (0.0) |
| Concomitant Statins |
N (%) Yes Atorvastatin Lovastatin Pravastatin Rosuvastatin Simvastatin Unknown |
598 | 199/598 (33.3) 107 (53.8) 3 (1.5) 11 (5.5) 33 (16.6) 22 (11.1) 23 (11.6) |
157/480 (32.7) 93 (59.2) 2 (1.3) 8 (5.1) 30 (19.1) 20 (12.7) 4 (2.6) |
42/118 (35.6) 14 (33.3) 1 (2.4) 3 (7.1) 3 (7.1) 2 (4.8) 19 (45.2) |
| Dose of Statins | Median (range) | 122 | 20 (5, 80) | 20 (5, 80) | 20 (5, 40) |
| Simvastatin Equivalent Dose | Median (range) | 122 | 30 (8, 120) | 30 (8, 120) | 30 (10, 60) |
| Statins Prior to Abiraterone/Enzalutamide | N (%) Yes | 196 | 191/196 (97.5) | 151/154 (98.1) | 40/42 (95.2) |
| Statin Use Suspended during abiraterone/enzalutamide treatment | N (%) Yes | 196 | 3/196 (1.5) | 2/154 (1.3) | 1/42 (2.4) |
| Months, Duration of Abiraterone/Enzalutamide Treatment | Median (range) | 183 | 8.3 (0.4, 47.5) | 8.5 (0.4, 47.5) | 7.1 (1.4, 33.4) |
| Use Hydrophilic Statin | N (%) Yes | 176 | 44 (25.0) | 38/153 (24.8) | 6/23 (26.1) |
| Source of Statin Use Data |
Prescription data Claims |
598 | 543 (90.8%) 55 (9.2%) |
444 (92.5%) 36 (7.5%) |
99 (83.8%) 19 (16.1%) |
Characteristics of the study population grouped by treatment.