Table 5.
Prostate-specific antigen (PSA) response, time to PSA progression, and time to radiographic progression
| Efficacy endpointa | Chemotherapy-naive (n = 65) | Postchemotherapy (n = 75) | Total (n = 140) |
|---|---|---|---|
| PSA at baseline and at least one further time point (n) | 64 | 74 | 138 |
| Reduction in PSA response from baseline, n (%)b | |||
| ≥50% reduction | 40 (63) | 39 (53) | 79 (57) |
| ≥90% reduction | 22 (34) | 9 (12) | 31 (23) |
| Time to PSA progression (wk)c | |||
| Median | Not reached | 45.1 | 106.1 |
| 95% confidence interval | 106–NA | 33–85 | 82–NA |
| Time to radiographic progression (wk) | |||
| Median | 56 | 25 | 36 |
| 95% confidence interval | 25–95 | 12–46 | 23–59 |
NA = not applicable.
a
PSA response and time to PSA progression were based on the final study analysis conducted in September 2010; time to radiographic progression was based on data collected up to December 2010.
b
Percentages were based on patients with PSA values at baseline and at least one further time point.
c
PSA progression was defined as a ≥25% increase in PSA level from baseline that represented a ≥5-ng/ml increase. A second confirmatory PSA measurement meeting the above criterion was also required.