Table 1.
Baseline Characteristics.
| Overall Population | Metastatic Population | |||
|---|---|---|---|---|
|
Relugolix
(N = 717) |
Leuprolide
(N = 357) |
Relugolix
(N = 290) |
Leuprolide
(N = 144) |
|
| Age category | ||||
| ≤75 years | 509 (71.0%) | 254 (71.1%) | 205 (70.7%) | 101 (70.1%) |
| >75 years | 208 (29.0%) | 103 (28.9%) | 85 (29.3%) | 43 (29.9%) |
| Age, years | ||||
| Median | 71.0 | 71.0 | 71.0 | 71.0 |
| Min, Max | 48, 91 | 47, 97 | 48, 91 | 47, 89 |
| Geographic region | ||||
| North America | 208 (29.0%) | 102 (28.6%) | 70 (24.1%) | 33 (22.9%) |
| South America | 45 (6.3%) | 24 (6.7%) | 22 (7.6%) | 13 (9.0%) |
| Europe | 271 (37.8%) | 135 (37.8%) | 116 (40.0%) | 57 (39.6%) |
| Asia | 155 (21.6%) | 86 (24.1%) | 62 (21.4%) | 36 (25.0%) |
| Rest of World | 38 (5.3%) | 10 (2.8%) | 20 (6.9%) | 5 (3.5%) |
| Location of metastasis at study entry | ||||
| Bone only | 161 (22.5%) | 70 (19.6%) | 161 (55.5%) | 70 (48.6%) |
| Lymph node only | 40 (5.6%) | 24 (6.7%) | 40 (13.8%) | 24 (16.7%) |
| Visceral only | 8 (1.1%) | 3 (0.8%) | 8 (2.8%) | 3 (2.1%) |
| Multiple | 79 (11.0%) | 47 (13.2%) | 79 (27.2%) | 47 (32.6%) |
| PSA | ||||
| PSA ≥ 20 | 289 (40.3%) | 144 (40.3%) | 182 (62.8%) | 100 (69.4%) |
| Laboratory Markers | ||||
| LDH above ULN | 43 (6.0%) | 32 (9.0%) | 25 (8.6%) | 22 (15.3%) |
| ALP above ULN | 74 (10.3%) | 39 (10.9%) | 67 (23.1%) | 36 (25.0%) |
| Gleason score | ||||
| 2–4 | 0 | 1 (0.3%) | 0 | 0 |
| 5–6 | 101 (14.1%) | 47 (13.2%) | 27 (3.8%) | 12 (3.4%) |
| 7 | 255 (35.6%) | 137 (38.4%) | 77 (10.7%) | 37 (10.4%) |
| 8–10 | 341 (47.6%) | 166 (46.5%) | 178 (24.8%) | 92 (25.8%) |
| Missing | 20 (2.8%) | 6 (1.7%) | 8 (1.1%) | 3 (0.8%) |
Abbreviations: ALP = alkaline phosphatase; LDH = lactate dehydrogenase; ULN = upper limit of normal.