Table 1.
Baseline characteristics of patients eligible for analysis1
| TAX-327 study (n = 166) | CS-205 study (n = 99) | p value | |
|---|---|---|---|
| Patients receiving cycle 10, no. (%)2 | 166 (50.0) | 99 (45.0%) | 0.26 |
| Baseline characteristics | |||
| Mean age, yr (± SD) | 67.1 (8.3) | 68.1 (7.6) | 0.39 |
| Gleason score, no. (%) | 0.121 | ||
| ≤7 | 71 (42.8) | 35 (35.4) | |
| 8–10 | 53 (31.9) | 44 (44.4) | |
| NA | 42 (25.3) | 20 (20.2) | |
| Good performance status3, no. (%) | 152 (91.6) | 95 (96.0) | 0.21 |
| Stage, no. (%) | 0.14 | ||
| 1–2 | 24 (15.7) | 23 (23.7) | |
| 3–4 | 129 (84.3) | 74 (76.3) | |
| NA | 13 | 2 | |
| Prior radiotherapy, no. (%) | 89 (53.6) | 52 (52.5) | 0.90 |
| Extent of disease, no. (%) | |||
| Bone metastases | 148 (89.2) | 88 (88.9) | 1.00 |
| Visceral disease | 26 (15.7) | 25 (25.3) | 0.076 |
| Measurable lesions | 61 (36.7) | 17 (17.2) | <0.001 |
| Evidence of progression, no. (%) | |||
| Bone scan | 116 (69.9) | 48 (48.5) | <0.001 |
| Increased PSA | 126 (75.9) | 84 (84.8) | 0.088 |
| Median PSA, ng/ml (range) | 98.1 (0.7–40740) | 71.4 (1.2–13056) | 0.39 |
| PSA <20 ng/ml, no. (%) | 24 (14.5%) | 16 (16.2%) | |
| Patients with significant pain, no. (%) | 65 (39.2) | 34/96 (35.4) | 0.60 |
| Median alkaline phosphatase level, U/ml (range) | 183 (40–4517) | 119 (44–1553) | <0.001 |
| Patients with anemia, no. (%) | 86 (51.8) | 52/98 (53.1) | 0.90 |
| Risk factors, no. (%) | 0.75 | ||
| 0–1 (good risk) | 69 (41.6) | 42 (44.2) | |
| 2 (intermediate risk) | 59 (35.5) | 35 (36.8) | |
| 3–4 (poor risk) | 38 (22.9) | 18 (18.9) | |
| NA | 0 | 4 | |
| PCWG-2 subtypes, no. (%) | 0.16 | ||
| Visceral disease | 26 (15.9) | 25 (25.3) | |
| Bone metastasis with/without nodal involvement | 127 (77.4) | 67 (67.7) | |
| Nodal disease only | 11 (6.7) | 7 (7.1) | |
| NA | 2 | 0 | |
| Cycle 10 | |||
| Median PSA at cycle 10 (range) | 13.6 (0.07–1658) | 26.1 (0.0–9180) | 0.006 |
| PSA <20 ng/ml, no. (%) | 96 (57.8) | 46 (46.5) | |
| Median PSA change from baseline, % | −84.5 | −62.3 | <0.001 |
| Completed cycle 10, no. (%)4 | 154 (92.8) | 87 (87.9) | 0.19 |
DQ3W = Every 3-wk docetaxel plus prednisone therapy; SD = standard deviation; PSA = prostate-specific antigen; NA = not available; PCWG-2 = Prostate Cancer Clinical Trials Working Group 2.
1
All p values and percentages are calculated excluding patients with missing data except for Gleason score p value, which is calculated including all patient data.
2
Percentage of patients receiving any DQ3W study treatment.
3
Defined as Karnofsky 80–100% (TAX-327 study) or ECOG 0-1 (CS-205 study).
4
Defined as receiving cycle 11 treatment (CS-205 study) or completed treatment per study protocol (TAX-327 study).