Table 1.
Patient demographics and clinical characteristics at baseline.
| Characteristic at baseline | Black subgroup | Overall populationa | ||
|---|---|---|---|---|
| Darolutamide + ADT + docetaxel (n = 26) |
Placebo + ADT + docetaxel (n = 28) |
Darolutamide + ADT + docetaxel (n = 651) |
Placebo + ADT + docetaxe (n = 654a) |
|
| Age, median (range), yr | 63.5 (52-84) | 63 (47-82) | 67 (41-89) | 67 (42-86) |
| Age group, n (%) | ||||
| <65 yr | 15 (57.7) | 16 (57.1) | 243 (37.3) | 234 (35.8) |
| 65-74 yr | 9 (34.6) | 11 (39.3) | 303 (46.5) | 306 (46.8) |
| ≥75 yr | 2 (7.7) | 1 (3.6) | 105 (16.1) | 114 (17.4) |
| ECOG performance status, n (%) | ||||
| 0 | 15 (57.7) | 19 (67.9) | 466 (71.6) | 462 (70.6) |
| 1 | 11 (42.3) | 9 (32.1) | 185 (28.4) | 190 (29.1) |
| Gleason score at initial diagnosis, n (%) | ||||
| <8 | 6 (23.1) | 5 (17.9) | 122 (18.7) | 118 (18.0) |
| ≥8 | 19 (73.1) | 21 (75.0) | 505 (77.6) | 516 (78.9) |
| Missing | 1 (3.8) | 2 (7.1) | 24 (3.7) | 20 (3.1) |
| Metastatic stage at initial diagnosis, n (%) | ||||
| De novo | 20 (76.9) | 20 (71.4) | 558 (85.7) | 566 (86.5) |
| Recurrent | 5 (19.2) | 8 (28.6) | 86 (13.2) | 82 (12.5) |
| Distant metastasis not assessed | 1 (3.8) | 0 | 7 (1.1) | 6 (0.9) |
| Metastasis stage at screening, n (%) | ||||
| M1a, nonregional LN only | 1 (3.8) | 1 (3.6) | 23 (3.5) | 16 (2.4) |
| M1b, bone ± LN | 20 (76.9) | 23 (82.1) | 517 (79.4) | 520 (79.5) |
| M1c, visceral ± LN or bone | 5 (19.2) | 4 (14.3) | 111 (17.1) | 118 (18.0) |
| PSA, median (range), ng/mLb | 38.2 (0.0-949.0) | 33.0 (0.2-5255.0) | 30.3 (0.0-9219.0) | 24.2 (0.0-11 947.0) |
| ALP, median (range), U/Lb | 113.5 (59-1031) | 107.0 (55-2065) | 148 (40-4885) | 140 (36-7680) |
| ALP, n (%)b | ||||
| <ULN | 14 (53.8) | 17 (60.7) | 209 (44.5) | 291 (44.5) |
| ≥ULN | 12 (46.2) | 11 (39.3) | 361 (55.5) | 363 (55.5) |
Data for the overall population are from the New England Journal of Medicine, Smith MR, Hussain M, Saad F, et al, Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer, volume 386, pages 1132-1142. Copyright © 2022 Massachusetts Medical Society. Reprinted with permission.
aOne patient randomized to placebo but who received darolutamide was included in the placebo group for the full analysis set.
bCentrally assessed; samples were collected while patients were receiving ADT.
Abbreviations: ADT: androgen-deprivation therapy; ALP: alkaline phosphatase; ECOG: Eastern Cooperative Oncology Group; LN: lymph node; PSA: prostate-specific antigen; ULN: upper limit of normal.