Baseline characteristics of patients and by treatment arm
| Characteristic | All (n = 42) | TCV (n = 24) | DCV (N = 18) | P-value |
|---|---|---|---|---|
| Age ≥ 60 years | 20 (48%) | 12 (50%) | 8 (44%) | 0.72 |
| # Male | 27 (64%) | 16 (67%) | 11 (61%) | 0.71 |
| # from out of state | 16 (38%) | 9 (38%) | 7 (39%) | 0.93 |
| KPS = 100% | 21 (50%) | 12 (50%) | 9 (50%) | 1.00 |
| ↑LDH at randomization | 11 (26%) | 4 (17%) | 7 (39%) | 0.16 |
| Highest stage =4 | 33 (79%) | 17 (71%) | 16 (89%) | 0.16 |
| Prior brain metastases | 10 (24%) | 6 (25%) | 4 (22%) | 1.00 |
| Prior visceral metastases (non-CNS) | 22 (52%) | 14 (58%) | 8 (44%) | 0.45 |
| Measurable Disease | 17 (40%) | 9 (38%) | 8 (44%) | 0.65 |
| Detectable (not measurable) | 10 (24%) | 4 (17%) | 6 (33%) | 0.28 |
| NED at randomization | 15 (36%) | 11 (46%) | 4 (22%) | 0.19 |
| Stage 4 M1a at randomization | 3 (7%) | 1 (4%) | 2 (11%) | 0.57 |
| Stage 4 M1b at randomization | 9 (21%) | 6 (25%) | 3 (17%) | 0.71 |
| Stage 4 M1c at randomization | 15 (36%) | 6 (25%) | 9 (50%) | 0.094 |
TCV tumor cell vaccine, DCV dendritic cell vaccine, KPS Karnofsky Performance Status, LDH serum lactate dehydrogenase, CNS central nervous system, NED no evidence of disease, M1a metastatic disease soft tissue metastases only and normal LDH, M1b metastatic lung with or without soft tissue metastases, but no other visceral metastases and normal LDH, M1c metastases to visceral organs and/or elevated LDH