Table 1.
The patient characteristics of the TJ-14 and placebo groups
| Treatment | TJ-14 (N=88) |
Placebo (N=93) |
P-value | |
|---|---|---|---|---|
| Type of cancer | 0.822 | |||
| Colon cancer | 43(48.9%) | 47(50.5%) | ||
| Gastric cancer | 45(51.1%) | 46(49.5%) | ||
| Sex | 0.296 | |||
| Male | 55(62.5) | 51(54.8) | ||
| Female | 33(37.5) | 42(45.2) | ||
| Age | 0.341 | |||
| Mean (SD) | 67.2(9.9) | 65.8(9.7) | ||
| Performance status | 0.754 | |||
| 0 | 73(83.0) | 80(86.0) | ||
| 1 | 13(14.8) | 10(10.8) | ||
| 2 | 2(2.3) | 3(3.2) | ||
| Chemotherapy status | 0.985 | |||
| Adjuvant setting | 33(37.5) | 35(37.9) | ||
| Advanced setting | 55(62.5) | 58(62.4) | ||
| Platinum containing chemotherapy | 0.494 | |||
| Yes | 59(67%) | 66(71.7%) | ||
| No | 29(33%) | 26(28.3%) | ||
| Chemotherapy at the time of registration | 0.867 | |||
| 5-fluorouracile based | 67(76.1%) | 67(72.8%) | ||
| Taxanes based | 3(3.4%) | 4(4.3%) | ||
| CPT-11 based | 18(20.5%) | 21(22.8%) | ||
| Dose reduction of the chemotherapy before the experimental cycles | 0.455 | |||
| Yes | 19(21.6%) | 16(17.2%) | ||
| No | 69(78.4%) | 77(82.8%) | ||