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

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