Table 1. Baseline characteristics of the entire study cohort and the subsets with and without visceral disease.
| Baseline characteristics |
All patients |
Patients with visceral disease |
Patients without visceral disease |
|||
|---|---|---|---|---|---|---|
| AA+P (n=797) | P (n=398) | AA+P (n=253) | P (n=99) | AA+P (n=544) | P (n=299) | |
| Age (years): median (range) | 69 (42–95) | 69 (39–90) | 69 (42–88) | 69 (50–88) | 69.5 (45–95) | 69 (39–90) |
| Extent of disease, n (%) | ||||||
| Bone | 710 (89) | 358 (90) | 218 (86) | 87 (88) | 492 (91) | 271 (92) |
| Node | 361 (45) | 164 (41) | 124 (49) | 44 (44) | 237 (44) | 120 (41) |
| Liver | 89 (11) | 29 (8) | 89 (35) | 29 (29) | 0 | 0 |
| Lung | 105 (13) | 45 (11) | 105 (42) | 45 (46) | 0 | 0 |
| Significant pain present, n (%)a,b | 357 (45) | 179 (45) | 123 (49) | 50 (51) | 234 (43) | 129 (43) |
| ECOG PS 2, n (%) | 82 (10) | 45 (11) | 31 (12) | 16 (16) | 51 (9) | 29 (10) |
| 2 prior chemotherapy regimens, n (%)a | 240 (30) | 123 (31) | 79 (31) | 34 (34) | 161 (30) | 89 (30) |
| Radiographic progression, n (%)a | 559 (70) | 273 (69) | 196 (78) | 68 (69) | 363 (67) | 205 (69) |
| Gleason score at initial diagnosis, n (%) | (n=697) | (n=350) | (n=217) | (n=86) | (n=480) | (n=264) |
| ⩽7 | 341 (49) | 161 (46) | 103 (47) | 39 (45) | 238 (50) | 122 (46) |
| ⩾8 | 356 (51) | 189 (54) | 114 (53) | 47 (55) | 242 (50) | 142 (54) |
| PSA (ng ml−1), median (range) | (n=788) | (n=393) | (n =248) | (n=98) | (n=540) | (n=295) |
| 128.8 | 137.7 | 153.30 | 178.50 | 123.80 | 129.20 | |
| (0.4–9253) | (0.6–10 114) | (0.7–9253) | (0.6–5310) | (0.4–5906) | (3.2–100 114) | |
| Median hemoglobin, g dl−1 (range) | 11.8 | 11.8 | 11.5 | 11.5 | 11.9 | 11.9 |
| (7.3–16.1) | (7.2–16.5) | (7.3–15.1) | (7.2–16.4) | (8.1–16.1) | (8.1–16.5) | |
| Median LDH, IU l−1 (range) | 223 | 238 | 250 | 281 | 215 | 227 |
| (84–3373) | (123–5125) | (98–3373) | (127–1400) | (84–2145) | (123–5125) | |
| Baseline CTC, median (range) | 5 (0–2055) | 6 (0–979) | 5 (0–202) | 9 (0–979) | 5 (0–2055) | 6 (0–253) |
Abbreviations: AA, abiraterone acetate; CTC, circulating tumor cells; ECOG PS, Eastern Cooperative Oncology Group performance status; LDH, lactate dehydrogenase; P, prednisone.
a
Includes two patients with outliers subsequently removed from analysis.
b
Brief Pain Inventory-Short Form score of 4–10 for worst pain over the previous 24 h.