Table 1.
Between-Arm Comparison of Baseline Patient Characteristics
| Characteristic | PROSTVAC-VF (n = 82) |
Placebo (n = 40) |
||
|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | |
| Age, years | ||||
| Median | 71.5 | 79 | ||
| Mean | 72 | 76 | ||
| IQR | 67-79 | 72-83 | ||
| Range | 52-94 | 55-90 | ||
| Race | ||||
| Caucasian | 71 | 86.6 | 33 | 82.5 |
| African American | 10 | 12.2 | 4 | 10 |
| Hispanic | 1 | 1.2 | 1 | 2.5 |
| Other | 0 | 2 | 5 | |
| Bisphosphonate use | ||||
| Yes | 35 | 42.7 | 16 | 40 |
| No | 47 | 57.3 | 24 | 60 |
| Gleason score | ||||
| 2-4 | 3 | 3.7 | 3 | 7.5 |
| 5 | 6 | 7.3 | 3 | 7.5 |
| 6 | 20 | 24.4 | 8 | 20 |
| 7 | 53 | 64.6 | 26 | 65 |
| ECOG performance status | ||||
| 0 | 56 | 68.3 | 27 | 67.5 |
| 1 | 26 | 31.7 | 13 | 32.5 |
| PSA | ||||
| Median | 36 | 45 | ||
| Mean | 131 | 183 | ||
| IQR | 17-107 | 20-85 | ||
| Range | 3-2,524 | 5-2,729 | ||
| Lactate dehydrogenase | ||||
| Median | 194 | 205 | ||
| Mean | 217 | 229 | ||
| IQR | 163-220 | 185-240 | ||
| Range | 124-1,380 | 107-480 | ||
| Alkaline phosphatase | ||||
| Median | 100 | 115 | ||
| Mean | 137 | 168 | ||
| IQR | 80-142 | 93-206 | ||
| Range | 52-828 | 67-555 | ||
| Hemoglobin | ||||
| Median | 13.0 | 12.65 | ||
| Mean | 12.97 | 12.77 | ||
| IQR | 12-13.8 | 11.5-13.9 | ||
| Range | 9.8-15.9 | 9.2-15.9 | ||
| Halabi-predicted survival, estimated No. of months | ||||
| Median | 22.5 | 20.4 | ||
| Mean | 21.4 | 20.4 | ||
| IQR | 18-24.5 | 16.2-24.5 | ||
| Range | 6.6-32.4 | 10.8-32.4 | ||
| Bone scan | ||||
| Median | 6 | 7 | ||
| Mean | 6.2 | 7.1 | ||
| IQR | 2-10 | 3-11 | ||
| Range | 0-20 | 1-19 | ||
| 0 | 8 | 9.8 | 0 | 0 |
| 1-4 | 31 | 37.8 | 15 | 37.5 |
| 5-9 | 17 | 20.7 | 11 | 27.5 |
| > 10 | 26 | 31.7 | 14 | 35 |
| Disease location | ||||
| Lymph node only | 8 | 9.8 | 0 | |
| Bone only | 37 | 45 | 21 | 52 |
| Bone and lymph node | 37 | 45 | 19 | 48 |
Abbreviations: PROSTVAC-VF, a vaccine containing two recombinant viral vectors (vaccinia and fowlpox) and three immune costimulatory molecules (B7.1, ICAM-1, and LFA3); IQR, interquartile range; ECOG, Eastern Cooperative Oncology Group; PSA, prostate-specific antigen.