Table. Patient Demographic and Baseline Characteristics.
| Characteristic | ARI treatment cohorta | P valueb | ||
|---|---|---|---|---|
| Darolutamide (n = 362) | Enzalutamide (n = 382) | Apalutamide (n = 126) | ||
| Age, y | ||||
| Median (range) | 80 (53-98) | 79 (55-99) | 80 (52-96) | .77 |
| Mean (SD) | 79.0 (8.5) | 78.6 (8.9) | 79.2 (8.8) | |
| Age group, y | ||||
| ≤74 | 109 (30.1) | 118 (30.9) | 36 (28.6) | .99 |
| 75-84 | 154 (42.5) | 160 (41.9) | 56 (44.4) | |
| ≥85 | 99 (27.3) | 104 (27.2) | 34 (27.0) | |
| Race and ethnicity | ||||
| Black or African American | 80 (22.1) | 82 (21.5) | 25 (19.8) | .36 |
| White | 238 (65.7) | 254 (66.5) | 93 (73.8) | |
| Other or unknownc | 44 (12.2) | 46 (12.0) | 8 (6.3) | |
| Insurance coverage | ||||
| Commercial | 103 (28.5) | 88 (23.0) | 32 (25.4) | .07 |
| Public | 247 (68.2) | 287 (75.1) | 94 (74.6) | |
| Unknown | 12 (3.3) | 7 (1.8) | 0 | |
| Index period | ||||
| 2019-2020 | 203 (56.1) | 255 (66.8) | 73 (57.9) | .009 |
| 2021-2022 | 159 (43.9) | 127 (33.2) | 53 (42.1) | |
| Time from nmCRPC to index date, mo | ||||
| Median (range) | 5.3 (0-247.9) | 3.4 (0-130.0) | 6.5 (0-131.2) | .08 |
| Mean (SD) | 14.8 (24.6) | 13.3 (22.2) | 14.9 (21.5) | |
| Patients starting at approved ARI dosed | ||||
| Yes | 351 (97.0) | 360 (94.2) | 124 (98.4) | .05 |
| No | 11 (3.0) | 22 (5.8) | 2 (1.6) | |
| PSA level, ng/mLe | ||||
| Median (range) | 3.3 (0-321.4) | 3.6 (0-417.0) | 3.4 (0-114.2) | .85 |
| Mean (SD) | 9.4 (24.9) | 12.4 (38.5) | 8.7 (16.8) | |
| PSA group, ng/mLe | ||||
| <2.0 | 127 (35.1) | 134 (35.1) | 47 (37.3) | .17 |
| ≥2.0 and <10.0 | 148 (40.9) | 135 (35.3) | 48 (38.1) | |
| ≥10.0 | 65 (18.0) | 76 (19.9) | 27 (21.4) | |
| Missing | 22 (6.1) | 37 (9.7) | 4 (3.2) | |
| PSADT, mof | ||||
| Median (range) | 6.8 (0-100.0) | 6.4 (0.6-100.0) | 7.4 (1.2-100.0) | .19 |
| Mean (SD) | 9.9 (11.3) | 13.4 (21.4) | 11.8 (17.2) | |
| PSADT group, mof | ||||
| ≤6 | 120 (33.1) | 119 (31.2) | 37 (29.4) | .02 |
| >6 and ≤10 | 64 (17.7) | 51 (13.4) | 31 (24.6) | |
| >10 | 85 (23.5) | 81 (21.2) | 28 (22.2) | |
| Missing | 93 (25.7) | 131 (34.3) | 30 (23.8) | |
| Gleason score at initial PC diagnosisg | ||||
| 4-7 | 161 (44.5) | 139 (36.4) | 45 (35.7) | .08 |
| 8-10 | 133 (36.7) | 153 (40.1) | 58 (46.0) | |
| Missing | 68 (18.8) | 90 (23.6) | 23 (18.3) | |
| Follow-up, mo | ||||
| Median (range) | 22.2 (2.2-40.3) | 22.7 (0.9-41.5) | 23.3 (2.6-41.7) | .80 |
| Mean (SD) | 22.8 (8.7) | 23.1 (10.2) | 23.5 (10.9) | |
Abbreviations: ARI, androgen receptor inhibitor; nmCRPC, nonmetastatic castration-resistant prostate cancer; PSA, prostate-specific antigen; PSADT, prostate-specific antigen doubling time.
SI conversion factor: To convert PSA to μg/L, multiply by 1.0.
Unless otherwise indicated, data are expressed as No. (%) of patients. Percentages have been rounded and may not total 100.
Statistically significant differences among the 3 treatment cohorts were checked by χ2 tests for categorical variables and 1-way analysis of variance parametric comparisons for continuous variables. Nonparametric tests (Wilcoxon-Mann-Whitney) were used to compare median values across the 3 cohorts for continuous variables with a highly skewed distribution (PSA level, PSADT, and time from nmCRPC to index date).
Includes self-reported American Indian or Alaska Native, Asian, Hispanic or Latino, other race, and not reported.
Indicates 1200 mg for darolutamide, 160 mg for enzalutamide, and 240 mg for apalutamide.
Indicates value closest to index date (340 patients for darolutamide, 345 for enzalutamide, and 122 for apalutamide).
Calculated using the Sloan Kettering method, which is based on at least 3 PSA values of at least 0.2 ng/mL taken at least 1 month apart, within the 12 months prior to index date (269 patients for darolutamide, 251 for enzalutamide, and 96 for apalutamide). Values after 100 months were capped at 100 for 13 patients.
Higher scores indicate higher cancer grade.