Adjuvant heparanase inhibitor PI-88 therapy for hepatocellular carcinoma recurrence

Table 1 Intent-to-treat patient demographics and baseline characteristic in the follow-up study n (%)

	Group A untreated (n = 50)1	Group B 160 mg/d (n = 48)	Group C 250 mg/d (n = 45)	Overall (n = 143)	P-value2
Age (yr)
mean ± SD	55.9 ± 12.2	52.3 ± 12.6	54.3 ± 11.9	54.2 ± 12.2	0.3565
Age group (yr)
Age < 65	36 (72.0)	38 (79.2)	37 (82.2)	111 (77.6)	0.4667
Age ≥ 65	14 (28.0)	10 (20.8)	8 (17.8)	32 (22.4)
Sex
Female	13 (26.0)	10 (20.8)	9 (20.0)	32 (22.4)	0.7445
Male	37 (74.0)	38 (79.2)	36 (80.0)	111 (77.6)
Alcohol use
Never or rarely	43 (86)	35 (72.9)	36 (80.0)	114 (79.7)	0.7547
Monthly	1 (2.0)	1 (2.1)	1 (2.2)	3 (2.1)
Weekly	2 (4.0)	6 (12.5)	3 (6.7)	11 (7.7)
Daily	4 (8.0)	6 (12.5)	5 (11.1)	15 (10.5)
Clip stage
0	30 (60.0)	25 (52.1)	26 (57.8)	81 (56.6)	0.6169
1	13 (26.0)	12 (25.0)	10 (22.2)	35 (24.5)
2	4 (8.0)	6 (12.5)	7 (15.6)	17 (11.9)
3	1 (2.0)	5 (10.4)	2 (4.4)	8 (5.6)
4	2 (4.0)	0	0	2 (1.4)
Ecog performance status score
0	42 (84.0)	40 (83.3)	40 (88.9)	122 (85.3)	0.6496
1	7 (14.0)	8 (16.7)	5 (11.1)	20 (14.0)
2	1 (2.0)	0	0	1 (0.7)
Child-Pugh score
5/6	48 (96.0)	46 (95.8)	43 (95.6)	137 (95.8)	0.6702
7	1 (2.0)	2 (4.2)	2 (4.4)	5 (3.5)
8	1 (2.0)	0	0	1 (0.7)
New York Heart Association classification of functional capacity class activity
Class I	48 (96.0)	47 (97.9)	44 (97.8)	139 (97.2)	0.8144
Class II	2 (4.0)	1 (2.1)	1 (2.2)	4 (2.8)
Differentiation of tumor
Well differentiated	2 (4.0)	7 (14.6)	4 (8.9)	13 (9.1)	0.2487
Moderately differentiated	34 (68.0)	23 (47.9)	26 (57.8)	83 (58.0)
Poorly differentiated or anaplasia	14 (28.0)	18 (37.5)	15 (33.3)	47 (32.9)
Liver cirrhosis
Absence	19 (38.0)	20 (41.7)	12 (26.7)	51 (35.7)	0.6023
Presence	28 (56.0)	24 (50.0)	29 (64.4)	81 (56.6)
Not assessed	3 (6.0)	4 (8.3)	4 (8.9)	11 (7.7)
Hepatitis activity
Absence	7 (14.0)	4 (8.3)	5 (11.1)	16 (11.2)	0.8234
Presence	34 (68.0)	35 (72.9)	29 (64.4)	98 (68.5)
Not assessed	9 (18.0)	9 (18.8)	11 (24.4)	29 (20.3)
Vein invasion (microscopic)
Absence	42 (84.0)	36 (75.0)	36 (80.0)	114 (79.7)	0.7375
Presence	8 (16.0)	11 (22.9)	8 (17.8)	27 (18.9)
Not assessed	0 (0)	1 (2.1)	1 (2.2)	2 (1.4)
Macro vascular invasion
Absence	47 (94.0)	42 (87.5)	42 (93.3)	131 (91.6)	0.4493
Presence	3 (6.0)	6 (12.5)	3 (6.7)	12 (8.4)

¹Includes 1 patient who withdrew consent during follow-up study;

²P-value on Age is by using analyses of variance, on CLIP stage by using Cochran-Mantel-Haenszel modified ridit scores for mean scores difference, on others by using χ² test. Differences in patient demographics and baseline characteristics were not statistically significant.