Table 2.
Patient characteristics (safety population)
| Characteristics | All patients (n=61) | Prior use of abiraterone | p value | |
|---|---|---|---|---|
|
| ||||
| No (n=35) | Yes (n=25†) | |||
| Age, yr, median (range) | 65 (42–81) | 64 (42–78) | 69 (47–81) | 0.0253* |
| Age, n (%) | ||||
| < 65 years | 27 (44.3) | 18 (51.4) | 9 (36.0) | |
| 65 years to <75 years | 23 (37.7) | 15 (42.9) | 8 (32.0) | 0.0310** |
| ≥75 years | 11 (18.0) | 2 (5.7) | 8 (32.0) | |
| ECOG performance status, n (%) | ||||
| 0 | 18 (29.5) | 11 (31.4) | 6 (24.0) | |
| 1 | 38 (62.3) | 20 (57.1) | 18 (72.0) | 1.0000** |
| 2 | 5 (8.2) | 4 (11.4) | 1 (4.0) | |
| Time since diagnosis, years, median (range) | ||||
| Initial | 6.3 (0.8–21.5) | 5.7 (0.8–18.8) | 6.6 (1.6–21.3) | 0.1850* |
| mCRPC | 2.2 (0.4–18.0) | 2.1 (0.4–6.6) | 2.6 (1.0–18.0) | 0.2769* |
| Number of metastatic sites, n (%) | ||||
| 1 | 26 (42.6) | 16 (45.7) | 10 (40.0) | 0.6623** |
| ≥2 | 35 (57.4) | 19 (54.3) | 15 (60.0) | |
| Location of metastatic sites≠, n (%) | ||||
| Bones | 54 (88.5) | 29 (82.9) | 24 (96.0) | 0.1211** |
| Visceral | 15 (24.6) | 8 (22.9) | 7 (28.0) | 0.6529** |
| Lymph nodes | 23 (37.7) | 15 (42.9) | 7 (28.0) | 0.2430** |
| Other | 6 (9.8) | 4 (11.4) | 2 (8.0) | 0.6652 |
| Time between last docetaxel dose and progression, n (%) | ||||
| <0 months | 7 (11.5) | 6 (17.1) | 1 (4.0) | |
| 0 to <3 months | 15 (24.6) | 10 (28.6) | 4 (16.0) | 0.054** |
| 3 to <6 months | 11 (18.0) | 5 (14.3) | 6 (24.0) | |
| At least 6 months | 28 (45.9) | 14 (40.0) | 14 (56.0) | |
| Type of progression, n (%) | ||||
| Bone scan and measurable lesions | 29 (47.5) | 19 (54.3) | 10 (40.0) | 0.2790** |
| Clinical progression | 15 (24.6) | 6 (17.1) | 9 (36.0) | 0.0991** |
| Increased PSA | 52 (85.2) | 29 (82.9) | 22 (88.0) | 0.5855** |
| Type of castration, n (%) | ||||
| Medical | 56 (91.8) | 33 (94.3) | 22 (88.0) | |
| Surgical | 5 (8.2) | 2 (5.7) | 3 (12.0) | 0.3891** |
| Cumulative docetaxel dose (mg/m2) by category, n (%)+ | ||||
| <225 | 1 (1.7) | 0 (0.0) | 1 (4.3) | |
| ≥225–450 | 10 (16.9) | 5 (14.3) | 5 (21.7) | |
| ≥450–675 | 11 (18.6) | 4 (11.4) | 7 (30.4) | 0.0486** |
| ≥675–900 | 19 (32.2) | 14 (40.0) | 5 (21.7) | |
| ≥900 | 18 (30.5) | 12 (34.3) | 5 (21.7) | |
| Median (range) | 750 (136–3406) | 750 (254–2250) | 602 (136–3406) | 0.2415** |
†
One patient was withdrawn from the study analysis due to lack of information on his prior use of abiraterone.
≠
Prevalence of >5%.
+
The dose of docetaxel for two patients was missing.
*
p value based on Student t-est.
**
p value based on Cochran Mantel Haenszel statistic. ECOG: Eastern Cooperative Oncology Group; mCRPC: metastatic castration-resistant prostate cancer; PSA: prostate-specific antigen.