Table 1.
Patient Characteristics
| Characteristic | Trial |
|
|---|---|---|
| S9346 (HSPC) | S9916 (CRPC) | |
| No. of patients in analysis | 1,078 | 597 |
| Age, years | ||
| Median | 69 | 71 |
| Range | 38-94 | 44-88 |
| Baseline PSA, ng/mL | ||
| Median | 89.5 | 96.7 |
| Range | 5.0-48,670 | 0.1-10,820 |
| Ethnicity, % | ||
| White | 63 | 85 |
| Black | 15 | 13 |
| Other | 3 | 2 |
| Unknown* | 19 | 0 |
| Presence of bone pain, %† | 40 | 34 |
| Performance status of 2-3, % | 8 | 9 |
| Randomly assigned to D/E arm, % | — | 50 |
| Gleason score, % | ||
| < 7 | 17 | — |
| 7 | 31 | — |
| > 7 | 52 | — |
| Prior prostatectomy, %‡ | 20 | 34 |
| Follow-up, years | ||
| Median | 4.4 | 3.5 |
| Range | 0.4 to 12.3 | 0.3 to 6.1 |
| PSA value, total on study | ||
| Median | 12 | 10 |
| Range | 2 to 121 | 2 to 57 |
| PSA value, by landmark time§ | ||
| Median | 5 | 4 |
| Range | 2 to 18 | 1 to 16 |
Abbreviations: HSPC, hormone-sensitive prostate cancer; CRPC, castration-resistant prostate cancer; D/E, docetaxel and estramustine; PSA, prostate-specific antigen.
*
The European Organisation for Research and Treatment of Cancer does not collect data pertaining to patient race/ethnicity.
†
For S9346, any grade bone pain was included; for S9916, only grades ≥ 2 were included.
‡
N = 1,065, as prior prostatectomy status was missing for 13 patients.
§
For S9346, the landmark time was 7 months after starting androgen-deprivation therapy. For S9916, the landmark time was 3 months after starting chemotherapy.