Table 1.
Baseline patient characteristics and covariates (intent-to-treat population)
| Characteristic | Abiraterone (n = 546) | Prednisone (n = 542) | ||
|---|---|---|---|---|
| BTT (n = 184) | No BTT (n = 362) | BTT (n = 169) | No BTT (n = 373) | |
| Median age, yr (IQR) | 70.0 (64.0–76.0) | 71.0 (65.0–78.0) | 70.0 (65.0–76.0) | 70.0 (63.0–76.0) |
| Gleason score ≥8 at initial diagnosis, n/N (%) | 95/167 (57) | 168/321 (52) | 89/157 (57) | 165/351 (47) |
| Median PSA at study entry, ng/ml (IQR) | 42.5 (16.4–128.2) | 41.5 (16.1–110.4) | 34.2 (11.3–91.9)a | 39.1 (18.2–98.1)b |
| ECOG PS at study entry, n (%) | ||||
| 0 or 1 | 184 (100) | 361 (100) | 169 (100) | 373 (100) |
| 2 | 0 | 1 (0.3) | 0 | 0 |
| Extent of disease, n (%) | ||||
| Bone | 172 (94) | 280 (78) | 157 (93) | 275 (74) |
| Soft tissue or nodec | 76 (41) | 191 (53) | 58 (34) | 213 (57) |
| Other | 2 (1) | 2 (0.6) | 1 (0.6) | 6 (2) |
| Bone metastasis only at study entry, n (%) | 100 (54) | 138 (38) | 95 (56) | 147 (39) |
| Median alkaline phosphatase, IU/l (IQR) | 91.5 (66.0–140.5) | 94.0 (72.0–133.0) | 91.0 (65.5–137.0)d | 89.0 (69.0–139.0)e |
| Median lactate dehydrogenase, U/l (IQR) | 192.0 (164.0–223.0)f | 184.5 (160.0–207.5)g | 187.0 (161.0–222.0)h | 183.0 (165.0–210.0)i |
| BTT use, n (%) | ||||
| At baseline | 170 (31) | NA | 157(29) | NA |
| New starts during study | 14 (3) | NA | 12 (2) | NA |
| Type of BTT, n (%)j | ||||
| Zoledronic acid | 172 (32) | NA | 158 (29) | NA |
| Other bisphosphonates | 7 (1) | NA | 8 (2) | NA |
| Denosumab | 16 (3) | NA | 6 (1) | NA |
| Otherk | 2 (0.4) | NA | 3 (0.6) | NA |
BTT = bone-targeted therapy; ECOG PS = Eastern Cooperative Oncology Group performance status; IQR = interquartile range; NA = not applicable; PSA = prostate-specific antigen.
a
n = 167;
b
n = 372.
c
Metastatic lesions other than liver or visceral metastases on computed tomography or magnetic resonance imaging. If lymph node metastasis was the only evidence of metastasis, it must be ?2 cm in diameter. Patients with visceral metastases were excluded.
d
n = 168;
e
n = 371;
f
n = 183;
g
n = 360;
h
n = 166;
i
n = 370.
j
Patients could receive more than one BTT at the same time.
k
Methylsulfonylmethane, strontium ranelate.