Table 1 Demographic and clinical characteristics of patients at baseline, by starting treatment.
APA + ADT N = 315 | ENZ + ADT N = 1181 | AAP + ADT N = 1760 | DTX + ADT N = 432 | ADT alone N = 1249 | |
|---|---|---|---|---|---|
Age, mean (SD) | 73.08 (8.68) | 74.38 (8.68) | 73.63 (8.82) | 68.99 (9.00) | 74.20 (9.08) |
18–54 | 2 (0.6%) | 27 (2.3%) | 35 (2.0%) | 22 (5.1%) | 29 (2.3%) |
55–64 | 61 (19.4%) | 139 (11.8%) | 261 (14.8%) | 106 (24.5%) | 177 (14.2%) |
65–74 | 99 (31.4%) | 394 (33.4%) | 610 (34.7%) | 184 (42.6%) | 379 (30.3%) |
75–84 | 122 (38.7%) | 467 (39.5%) | 670 (38.1%) | 106 (24.5%) | 508 (40.7%) |
>85 | 31 (9.8%) | 154 (13.0%) | 184 (10.5%) | 14 (3.2%) | 156 (12.5%) |
BMI, mean (SD) | 27.83 (4.89) | 27.72 (4.91) | 27.71 (4.47) | 27.57 (4.99) | 27.91 (4.83) |
Underweight ( < 18.5 kg/m2) | 0 | 0 | 0 | 0 | 0 |
Normal weight (18.5 to <25 kg/m2) | 56 (31.3%) | 200 (29.3%) | 313 (28.1%) | 83 (31.3%) | 251 (29.8%) |
Overweight (25.0 to <30.0 kg/m2) | 71 (39.7%) | 285 (41.7%) | 489 (44.0%) | 106 (40.0%) | 311 (37.0%) |
Obese ( ≥ 30.0 kg/m2) | 52 (29.1%) | 198 (29.0%) | 310 (27.9%) | 76 (28.7%) | 279 (33.2%) |
Unknown | 136 (43.2%) | 498 (42.2%) | 648 (36.8%) | 167 (38.7%) | 408 (32.7%) |
Site of metastases, n (%) | |||||
Bone | 188 (88.7%) | 738 (89.7%) | 1056 (87.6%) | 251 (75.8%) | 702 (81.6%) |
Nodal | 15 (7.1%) | 45 (5.5%) | 88 (7.3%) | 24 (7.3%) | 85 (9.9%) |
Visceral | 9 (4.2%) | 40 (4.9%) | 61 (5.1%) | 56 (16.9%) | 73 (8.5%) |
Unknown | 103 (32.7%) | 358 (30.3%) | 555 (31.5%) | 101 (23.4%) | 389 (31.1%) |
Baseline PSA (ng/dL), median (Q1, Q3) | 6.1 (1.0, 34.1) | 10.7 (1.5, 47.0) | 11.0 (1.3, 51.3) | 19.8 (3.2, 96.5) | 1.7 (0.1, 20.4) |
Mean (SD) | 41.28 (86.65) | 50.51 (92.64) | 53.47 (94.82) | 74.61 (112.43) | 34.50 (81.92) |
Baseline ECOG PS, n (%) | |||||
Not available | 136 (43.2%) | 508 (43.0%) | 861 (48.9%) | 172 (39.8%) | 599 (48.0%) |
0–1 | 144 (80.4%) | 528 (78.5%) | 720 (80.1%) | 211 (81.2%) | 519 (79.8%) |
2–3 | 34 (19.0%) | 137 (20.4%) | 175 (19.5%) | 47 (18.1%) | 126 (19.4%) |
4+ | 1 (0.6%) | 8 (1.2%) | 4 (0.4%) | 2 (0.8%) | 5 (0.8%) |
CCI, median (Q1, Q3) | 0.0 (0.0,1.0) | 0.0 (0.0, 1.0) | 0.0 (0.0, 1.0) | 0.0 (0.0, 1.0) | 0.0 (0.0, 1.0) |
CCI score, n (%) | |||||
0 | 210 (66.7%) | 823 (69.7%) | 1187 (67.4%) | 294 (68.1%) | 796 (63.7%) |
1 | 49 (15.6%) | 150 (12.7%) | 290 (16.5%) | 78 (18.1%) | 204 (16.3%) |
2 | 35 (11.1%) | 100 (8.5%) | 160 (9.1%) | 35 (8.1%) | 132 (10.6%) |
3 | 11 (3.5%) | 52 (4.4%) | 59 (3.4%) | 12 (2.8%) | 57 (4.6%) |
4 | 5 (1.6%) | 26 (2.2%) | 33 (1.9%) | 4 (0.9%) | 30 (2.4%) |
5 + | 5 (1.6%) | 30 (2.5%) | 31 (1.8%) | 9 (2.1%) | 30 (2.4%) |
Comorbidities, n (%) | |||||
AIDS | 0 (0.0%) | 2 (0.2%) | 6 (0.3%) | 0 (0.0%) | 3 (0.2%) |
Acute myocardial infarction | 7 (2.2%) | 14 (1.2%) | 12 (0.7%) | 6 (1.4%) | 18 (1.4%) |
Cerebrovascular disease | 12 (3.8%) | 41 (3.5%) | 64 (3.6%) | 13 (3.0%) | 58 (4.6%) |
COPD | 9 (2.9%) | 63 (5.3%) | 121 (6.9%) | 30 (6.9%) | 87 (7.0%) |
Congestive heart failure | 17 (5.4%) | 67 (5.7%) | 115 (6.5%) | 24 (5.6%) | 83 (6.6%) |
Dementia | 5 (1.6%) | 19 (1.6%) | 19 (1.1%) | 0 (0.0%) | 16 (1.3%) |
Diabetes | 37 (11.7%) | 125 (10.6%) | 155 (8.8%) | 55 (12.7%) | 138 (11.0%) |
Diabetes with complications | 10 (3.2%) | 57 (4.8%) | 54 (3.1%) | 14 (3.2%) | 48 (3.8%) |
History of myocardial infarction | 4 (1.3%) | 17 (1.4%) | 21 (1.2%) | 6 (1.4%) | 17 (1.4%) |
Mild liver disease | 12 (3.8%) | 28 (2.4%) | 38 (2.2%) | 12 (2.8%) | 42 (3.4%) |
Moderate/severe liver disease | 0 (0.0%) | 2 (0.2%) | 3 (0.2%) | 1 (0.2%) | 5 (0.4%) |
Paralysis | 4 (1.3%) | 6 (0.5%) | 14 (0.8%) | 1 (0.2%) | 7 (0.6%) |
Peptic ulcer disease | 3 (1.0%) | 8 (0.7%) | 7 (0.4%) | 3 (0.7%) | 9 (0.7%) |
Peripheral vascular disease | 13 (4.1%) | 56 (4.7%) | 87 (4.9%) | 25 (5.8%) | 80 (6.4%) |
Renal disease | 28 (8.9%) | 101 (8.6%) | 142 (8.1%) | 21 (4.9%) | 127 (10.2%) |
Rheumatologic disease | 2 (0.6%) | 5 (0.4%) | 17 (1.0%) | 5 (1.2%) | 8 (0.6%) |
Treatment duration (months), median (Q1, Q3) | 13.4 (6.4, 24.4) | 12.3 (5.7, 23.3) | 14.1 (6.5, 25.5) | 7.9 (4.1, 15.7) | 10.3 (3.7, 19.2) |
