Table 1.
Patient Demographics and Clinical Characteristics, by Treatment Group
| Characteristics | Abiraterone (N = 1067) | Enzalutamide (N = 592) | Bicalutamide (N = 5524) | Chemotherapya (N = 256) |
|---|---|---|---|---|
| Age, mean ± SD (median) | 73.7 ± 10.1 (74.0) | 73.1 ± 10.0 (74.0) | 71.4 ± 10.5 (71.0) | 68.1 ± 9.4 (67.0) |
| Age category, N (%) | ||||
| 35–44 yrs | 2 (0.2) | 0 (0.0) | 11 (0.2) | 0 (0.0) |
| 45–54 yrs | 23 (2.2) | 18 (3.0) | 223 (4.0) | 16 (6.3) |
| 55–64 yrs | 204 (19.1) | 120 (20.3) | 1458 (26.4) | 94 (36.7) |
| 65–74 yrs | 313 (29.3) | 166 (28.0) | 1617 (29.3) | 70 (27.3) |
| ≥75 yrs | 525 (49.2) | 288 (48.6) | 2215 (40.1) | 76 (29.7) |
| Region, N (%) | ||||
| Northeast | 258 (24.2) | 130 (22.0) | 1362 (24.7) | 39 (15.2) |
| North Central | 288 (27.0) | 154 (26.0) | 1405 (25.4) | 74 (28.9) |
| South | 318 (29.8) | 189 (31.9) | 1588 (28.7) | 97 (37.9) |
| West | 198 (18.6) | 113 (19.1) | 1107 (20.0) | 43 (16.8) |
| Unknown | 5 (0.5) | 6 (1.0) | 62 (1.1) | 3 (1.2) |
| Year of index date, N (%) | ||||
| 2012 | 210 (19.7) | 218 (36.8) | 986 (17.8) | 106 (41.4) |
| 2013 | 615 (57.6) | 230 (38.9) | 2520 (45.6) | 94 (36.7) |
| 2014 | 242 (22.7) | 144 (24.3) | 2018 (36.5) | 56 (21.9) |
| Insurance type, N (%) | ||||
| Commercial | 244 (22.9) | 146 (24.7) | 1778 (32.2) | 113 (44.1) |
| Medicare | 823 (77.1) | 446 (75.3) | 3746 (67.8) | 143 (55.9) |
| Quan-Charlson comorbidity index,b mean ± SD (median) | 5.4 ± 2.3 (6.0) | 5.6 ± 2.1 (6.0) | 3.2 ± 2.1 (3.0) | 5.9 ± 1.9 (6.0) |
| Patients with metastases,b N (%) | 707 (66.3) | 440 (74.3) | 904 (16.4) | 212 (82.8) |
| Brain metastases | 18 (1.7) | 14 (2.4) | 13 (0.2) | 4 (1.6) |
| Other metastases | 706 (66.2) | 439 (74.2) | 901 (16.3) | 212 (82.8) |
| Comorbidities,b N (%) | ||||
| Hypertension | 469 (44.0) | 254 (42.9) | 2762 (50.0) | 116 (45.3) |
| Cardiovascular disease | 319 (29.9) | 163 (27.5) | 1583 (28.7) | 66 (25.8) |
| Diabetes | 228 (21.4) | 122 (20.6) | 1239 (22.4) | 50 (19.5) |
| Liver disease | 61 (5.7) | 29 (4.9) | 299 (5.4) | 17 (6.6) |
| Treatments during the baseline period, N (%) | ||||
| Abiraterone | 0 (0.0) | 226 (38.2) | 1 (0.0) | 18 (7.0) |
| Enzalutamide | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Bicalutamide | 394 (36.9) | 90 (15.2) | 0 (0.0) | 82 (32.0) |
| Chemotherapy | 81 (7.6) | 108 (18.2) | 4 (0.1) | 0 (0.0) |
| Other chemotherapy treatments | 20 (1.9) | 21 (3.5) | 83 (1.5) | 9 (3.5) |
| Hormone treatmentsc (except bicalutamide) | 829 (77.7) | 421 (71.1) | 1182 (21.4) | 201 (78.5) |
| Sipuleucel-T | 77 (7.2) | 29 (4.9) | 8 (0.1) | 23 (9.0) |
| Radium 223 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Opioids | 382 (35.8) | 267 (45.1) | 1468 (26.6) | 131 (51.2) |
| Corticosteroids | 536 (50.2) | 384 (64.9) | 821 (14.9) | 169 (66.0) |
| Prednisone | 421 (39.5) | 317 (53.5) | 309 (5.6) | 111 (43.4) |
| Dexamethasone | 109 (10.2) | 129 (21.8) | 151 (2.7) | 95 (37.1) |
| Other corticosteroids | 132 (12.4) | 66 (11.1) | 483 (8.7) | 32 (12.5) |
| Hormone treatments before the index date,c,d N (%) | 1022 (95.8) | 557 (94.1) | 1787 (32.3) | 237 (92.6) |
| LhRH/GnRH | 914 (85.7) | 503 (85.0) | 1575 (28.5) | 224 (87.5) |
| Estrogen | 6 (0.6) | 8 (1.4) | 1 (0.0) | 3 (1.2) |
| Antiandrogens | 840 (78.7) | 420 (70.9) | 37 (0.7) | 178 (69.5) |
| Adrenal androgen blockers | 188 (17.6) | 136 (23.0) | 276 (5.0) | 42 (16.4) |
| Hormonal treatment excluding bicalutamide | 961 (90.1) | 526 (88.9) | 1787 (32.3) | 231 (90.2) |
| Orchiectomy,d,e N (%) | 23 (2.2) | 9 (1.5) | 22 (0.4) | 11 (4.3) |
| Time from insurance eligibility start to index date, mo, mean ± SD (median) | 67 ± 34 (66) | 64 ± 35 (60) | 62 ± 37 (58) | 62 ± 34 (60) |
| Any CNS events before baseline period,f N (%) | 544 (51.0) | 322 (54.4) | 2279 (41.3) | 101 (39.5) |
| Time between last CNS event and index date, mo, mean ± SD (median) | 26 ± 21 (19) | 25 ± 19 (20) | 27 ± 22 (20) | 27 ± 21 (18) |
| Use of opioids in the follow-up period, N (%) | 558 (52.3) | 359 (60.6) | 2,122 (38.4) | 160 (62.5) |
| Length of exposure to index treatment, days, mean ± SD (median)g | 246 ± 186 (200) | 184 ± 165 (120) | 141 ± 167 (74) | 121 ± 90 (106) |
Chemotherapy includes cabazitaxel, docetaxel, mitoxantrone hydrochloride, and estramustine.
Evaluated during the 6-month baseline period.
Hormone therapy includes LhRH/GnRH (leuprolide, histrelin, triptorelin, goserelin, buserelin, nafarelin, and degarelix), estrogen (estrogen and diethylstilbestrol), antiandrogens (flutamide, nilutamide, cyproterone, and bicalutamide), and adrenal androgen blockers (ketoconazole and aminoglutethimide).
Identified at any time before the index date.
Identified with CPT codes 54520, 54522, 54530, 54535, and 54690, and with ICD-9-CM procedure codes 62.3 and 62.4.
Identified at any time before the 6-month baseline period.
Exposure spans from index date through the earliest of (1) end of data availability, (2) end of insurance coverage, or (3) treatment nonpersistence (ie, the end of the days of supply of the first fill for which the next fill of the index treatment, if any, is >90 days later). Exposure was not adjusted for early refills.
CNS indicates central nervous system; CPT, Current Procedural Terminology; GnRH, gonadotropin-releasing hormone; ICD-9-CM, International Classification of Diseases, Ninth Revision, Clinical Modification; LhRH, luteinizing hormone-releasing hormone; SD, standard deviation.