Table 1.
Baseline demographics and clinical characteristics.
| GnRH antagonist N = 499 | GnRH agonist N = 15,127 | ||
|---|---|---|---|
| n (%) | n (%) | P value | |
| Age (years) | 0.4557 | ||
| ≤54 | 11 (2.2) | 280 (1.9) | |
| 55–59 | 18 (3.6) | 655 (4.3) | |
| 60–69 | 127 (25.5) | 4037 (26.7) | |
| 70–74 | 87 (17.4) | 2953 (19.5) | |
| ≥75 | 256 (51.3) | 7202 (47.6) | |
| Cancer TNM staging | <0.0001 | ||
| Localized | 132 (26.5) | 5905 (39.0) | |
| Locally advanced | 74 (14.8) | 2743 (18.1) | |
| Any T, N ≥ 1 | 39 (7.8) | 1218 (8.05) | |
| Any T, any N and M ≥ 1 | 254 (50.9) | 5261 (34.8) | |
| Gleason score | 0.0002 | ||
| 2–6 | 41 (8.2) | 2032 (13.4) | |
| 7 | 129 (25.9) | 4512 (29.8) | |
| 8–10 | 313 (62.7) | 8086 (53.5) | |
| Missing | 16 (3.2) | 497 (3.3) | |
| PSA, ng/mL | 0.0256 | ||
| ≤50 | 10 (2.0) | 501 (3.3) | |
| >50 | 450 (90.2) | 13,006 (86.0) | |
| Missing | 39 (7.8) | 1620 (10.7) | |
| Risk groups | <0.0001 | ||
| Low–intermediate | 38 (7.6) | 1698 (11.2) | |
| High–very high | 121 (24.3) | 5314 (35.1) | |
| Regional or metastatic | 340 (68.1) | 8115 (53.7) | |
| CCI | < 0.0001 | ||
| 0 | 90 (18.0) | 4266 (28.2) | |
| 1 | 142 (28.5) | 4273 (28.3) | |
| 2 | 117 (23.5) | 2590 (17.1) | |
| 3+ | 150 (30.1) | 3998 (26.4) | |
| Concomitant medication | |||
| Antiandrogen | 90 (18.0) | 7489 (49.5) | <0.0001 |
| Abiraterone | 21 (4.2) | 1058 (7.0) | 0.0009 |
| Bicalutamide | 165 (33.1) | 10,023 (66.3) | <0.0001 |
| Cyproterone | 56 (11.2) | 4489 (29.7) | <0.0001 |
| Enzalutamide | 17 (3.4) | 746 (4.9) | 0.0542 |
| Flutamide | 12 (2.4) | 1490 (9.9) | <0.0001 |
| Pre-existing cardiovascular disease factors | |||
| Ischemic heart disease | 35 (7.1) | 882 (5.8) | 0.2685 |
| Congestive heart failure | 10 (2.0) | 155 (1.0) | 0.0352 |
| Stroke | 11 (2.2) | 245 (1.6) | 0.3113 |
| Hyperlipidemia | 87 (17.4) | 1694 (11.2) | <0.0001 |
| Hypertension | 128 (25.7) | 3557 (23.5) | 0.2685 |
| Diabetes | 58 (11.6) | 1486 (9.8) | 0.1850 |
| Use of cardiac therapy | 92 (18.4) | 1580 (10.4) | <0.0001 |
| Pre-existing CVD | <0.0001 | ||
| Yesa | 167 (33.5) | 3348 (22.1) | |
| No | 332 (66.5) | 11,779 (77.9) | |
Risk groups defined by National Comprehensive Cancer Network guidelines were as follows:
Low risk: T1–T2a, GS ≤ 6, and PSA of 10 ng/mL; favorable intermediate risk: T2b–T2c or GS ≤ 7 or PSA of 10–20 ng/mL and a primary GS of 3; unfavorable intermediate risk: T2c or GS ≤ 7 or PSA of 10–20 ng/mL and primary GS of 4; high risk: T3a or GS of 8–10 or PSA >20 ng/mL; very high risk for locally advanced prostate cancer: T3b–T4 or primary GS component scores of ≥5 scores with overall GS of 8–10; metastatic risk: N1 or M1 with any T stage [29].
CCI Charlson comorbidity index, CVD cardiovascular disease(s), GnRH gonadotropin-releasing hormone, PSA prostate specific antigen, TNM where T = tumor, N = nodes and M = metastasis.
aYes: receiving cardiac therapy, diagnosis of ischemic heart diseases, stroke, or congestive heart failure 1 year before androgen deprivation therapy initiation.