Table 1.
Summary of individual trial characteristics.
| TRIAL | PATIENT GROUPS (N) | MEDIAN FOLLOW-UPa | TREATMENT ARMS (N) | OSa | TIME TO PSA PROGRESSIONa | RADIOGRAPHIC PFSa | PSA RRb | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|
| |||||||||||
| MEDIAN | HR (95% CI) |
MEDIAN | HR (95% CI) |
MEDIAN | HR (95% CI) |
RR | OR (95% CI) |
||||
| AFFIRM15 | Progressive CRPC post-docetaxel (N = 1199) |
14.4 | Enzalutamidec (n = 800) |
18.4 | 0.63 (0.53–0.75) | 8.3 | 0.25 (0.20–0.30) | 8.3 | 0.40 (0.35–0.47) | 54.0%e | 76.41 (31.22–187.04) |
| Placeboc (n = 399) |
13.6 | 3.0 | 2.9 | 1.5%e | |||||||
|
| |||||||||||
| COU-AA-30117 | Metastatic CRPC post-docetaxel (N = 1195) |
20.2 | Abiraterone acetated (n = 797) |
15.8 | 0.74 (0.64–0.86) | 8.5 | 0.63 (0.52–0.78) | 5.6 | 0.66 (0.58–0.76) | 29.5% | 7.15 (4.53–11.28) |
| Placebod (n = 398) |
11.2 | 6.6 | 3.6 | 5.5% | |||||||
Notes:
a
Reported in units of months.
b
RR defined as PSA decline ≥50%.
c
Concomitant administration with prednisone was allowed but not needed.
d
Concomitant administration with prednisone.
e
Denominator – enzalutamide – was 731; denominator – placebo – was 330.