Table 1.
Baseline Characteristics of the Intention-to-Treat Population
| Characteristic | Total |
FU/RT (SOC) |
FU/RT + TNFerade |
P | |||
|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | ||
| No. of patients | 277 | 90 | 187 | ||||
| Age, years | .85 | ||||||
| Mean | 63.5 | 63.3 | 63.5 | ||||
| SD | 11.0 | 10.7 | 11.2 | ||||
| Median | 64.4 | 64.8 | 64.3 | ||||
| Range | 28.7-85.6 | 28.7-84.8 | 31.0-85.6 | ||||
| Sex | .30 | ||||||
| Male | 160 | 57.8 | 48 | 53.3 | 112 | 59.9 | |
| Female | 117 | 42.2 | 42 | 46.7 | 75 | 40.1 | |
| Race | .72 | ||||||
| White | 212 | 76.5 | 72 | 80 | 140 | 74.9 | |
| African American | 34 | 12.3 | 11 | 12.2 | 23 | 12.3 | |
| Hispanic | 14 | 5.1 | 3 | 3.3 | 11 | 5.9 | |
| Other | 17 | 6.1 | 4 | 4.5 | 13 | 6.9 | |
| Prior cancer history | .34 | ||||||
| Yes | 35 | 12.6 | 14 | 15.6 | 21 | 11.2 | |
| No | 242 | 87.4 | 76 | 84.4 | 166 | 88.8 | |
| Prior cancer treatment | .31 | ||||||
| Yes | 31 | 11.2 | 13 | 14.4 | 18 | 9.6 | |
| No | 246 | 88.8 | 77 | 85.6 | 169 | 90.4 | |
| KPS, % | .41 | ||||||
| 90 to 100 | 187 | 68.0 | 64 | 71.9 | 123 | 66.1 | |
| < 90 | 88 | 32.0 | 25 | 28.1 | 63 | 33.9 | |
| 80 to 100 | 264 | 96.0 | 87 | 97.8 | 177 | 95.2 | .51 |
| < 80 | 11 | 4.0 | 2 | 2.2 | 9 | 4.8 | |
| T stage | .42 | ||||||
| 1 | 1 | 0.36 | 1 | 1.1 | 0 | 0 | |
| 2 | 17 | 6.1 | 5 | 5.6 | 12 | 6.4 | |
| 3 | 68 | 24.6 | 25 | 27.8 | 43 | 23.0 | |
| 4 | 191 | 68.9 | 59 | 65.6 | 132 | 70.6 | |
| N stage | .097 | ||||||
| N0 | 116 | 41.9 | 37 | 41.1 | 79 | 42.3 | |
| N1 | 106 | 38.3 | 41 | 45.6 | 65 | 34.8 | |
| Nx | 55 | 19.9 | 12 | 13.3 | 43 | 23.0 | |
| M stage | .75 | ||||||
| M0 | 266 | 96.0 | 86 | 95.6 | 180 | 96.3 | |
| Mx | 11 | 4.0 | 4 | 4.4 | 7 | 3.7 | |
| CA19-9 | |||||||
| ≥ 1,000 | 72 | 26.3 | 19 | 21.4 | 53 | 28.6 | .24 |
| < 1,000 | 202 | 73.7 | 70 | 78.6 | 132 | 71.4 | |
Abbreviations: CA19-9, cancer antigen 19-9; FU, fluorouracil; KPS, Karnofsky performance status; RT, radiotherapy; SD, standard deviation; SOC, standard of care.