Table 1 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 |