Table 1.
Characteristics of patients enrolled on study
| S-IL-2 (n = 18) | M-IL-2 (n = 18) | Placebo (n = 7) | P-value | |
|---|---|---|---|---|
| Age | ||||
| Median (range) | 60 (50 – 78) | 63 (50 – 75) | 67 (60 – 73) | 0.30a |
| Mean (s.d.) | 62 (8.8) | 62 (8.6) | 67 (5.2) | |
| PSA at diagnosis | ||||
| Median (range) | 14.5 (3.8 – 206) | 9.6 (4 – 187) | 8.9 (5.5 – 23) | 0.63a |
| Mean (s.d.) | 38 (54.0) | 28 (46.0) | 11.8 (6.6) | |
| Clinical T stage | ||||
| T1 | 33% | 44% | 43% | 0.63a |
| T2 | 50% | 39% | 14% | |
| T3 | 17% | 17% | 43% | |
| Gleason score | ||||
| 5 | 11% | 0% | 0% | 0.47a |
| 6 | 22% | 22% | 29% | |
| 7 | 28% | 39% | 71% | |
| 8 | 17% | 22% | 0% | |
| 9 | 22% | 17% | 0% | |
| NCCN risk group | ||||
| Low | 17% | 17% | 14% | 0.92a |
| Intermediate | 22% | 28% | 29% | |
| High | 61% | 55% | 57% | |
| Node-positive | 17% | 28% | 0% | 0.34 |
| Received ADT | 83% | 83% | 86% | 1.00 |
| Median EBRT dose Gy (range)b | 73 (68 – 76) | 74 (70 – 76) | 74 (73 – 76.4) | 0.80a |
| Treated with brachytherapy | 0% | 22% | 14% | 0.12 |
Abbreviations: ADT, androgen-deprivation therapy; EBRT, external beam radiation therapy; IL, interleukin; M-IL-2, metronomic dose IL-2; NCCN, National Comprehensive Cancer Network; S-IL-2, standard dose IL-2; T, tumor size.
a
Compared among groups by Kruskal - Wallis test; others were by Mehta’s modification to Fisher’s exact test.
b
Excludes four patients treated with EBRT plus high-dose-rate brachytherapy boost.