Comparative study between Embosphere® and Marine gel® as embolic agents for chemoembolization of hepatocellular carcinoma

Table 1 Baseline characteristics of the study population

	Total (n = 70)	Embosphere (n = 33)	Marine gel (n = 37)	P value
Age	67.4 ± 10.5	68.4 ± 8.5	66.4 ± 12.1	0.44
Sex				0.53
Male	55	27	28
Female	15	6	9
Etiology				0.99
HBV	48	24	24
HCV	2	1	1
HBV + HCV	5	1	4
Non-viral	15	7	8
Platelet (103/mm3)	126.1 ± 58.9	119.4 ± 65.7	132.1 ± 52.3	0.37
Serum albumin(g/dL)	4.05 ± 0.47	3.97 ± 0.52	4.12 ± 0.41	0.20
Total bilirubin (mg/dL)	0.77 ± 0.60	0.74 ± 0.54	0.80 ± 0.64	0.70
PT (INR)	1.08 ± 0.14	1.10 ± 0.13	1.07 ± 0.15	0.32
Creatinine (mg/dL)	1.09 ± 0.92	1.14 ± 1.03	1.04 ± 0.82	0.67
ALT	27.7 ± 14.7	30.5 ± 16.8	25.1 ± 12.2	0.13
AST	34.1 ± 16.7	38.0 ± 19.6	30.7 ± 12.9	0.07
Child-Pugh class				0.49
A	67	31	36
B	3	2	1
Previous Tx				0.55
RFA	18	11	7
Resection	5	1	4
AFP (≤ 100 ng/mL/> 100 ng/mL)	62/8	30/3	32/5	0.56
PIVKA (≤ 100 mAU/mL/> 100 mAU/mL)	59/11	30/3	29/8	0.15
Tumor size (cm)				0.50
mean ± SD		1.7 ± 0.6	1.8 ± 0.7
Median		1.5	1.5
Range		1.0-3.2	1.0-3.6

HCV: Hepatitis C virus; HBV: Hepatitis B virus; PT: Prothrombin time; INR: International normalized ratio; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; RFA: Radiofrequency ablation; AFP: Alpha-fetoprotein; PIVKA: Prothrombin induced by vitamin K deficiency or antagonist.

Table 2 Univariate and multivariate analysis of prognostic factors for local progression-free survival

Parameter	Univariable analysis			Multivariable analysis
	HR	95%CI	P value	HR	95%CI	P value
Group (embosphere vs marine gel)	1.121	0.339-3.707	0.851
Age (> 65 vs ≤ 65)	1.444	0.383-5.448	0.58
Sex (male vs female)	2.628	0.336-20.55	0.34
HBV (positive vs negative)	1.911	0.558-6.540	0.29
Platelet (≤ 120 vs > 120) (103/mm3)	1.939	0.567-6.630	0.28
Serum albumin (≤ 3.5 vs > 3.5) (g/dL)	25.03	0.012-5251.5	0.20
Total bilirubin (> 1.0 vs ≤ 1.0) (mg/dL)	26.63	0.026-2756.8	0.14
PT (> 1.2 vs ≤ 1.2) (INR)	26.33	0.024-2905.2	0.15
ALT (> 40 vs ≤ 40) (IU/L)	1.088	0.235-5.040	0.91
AST (> 40 vs ≤ 40) (IU/L)	3.528	0.451-27.62	0.20
AFP (> 100 ng/mL vs ≤ 100 ng/mL)	5.407	1.572-18.60	0.003	5.130	1.479-17.79	0.01
PIVKA (> 100 mAU/mL vs 100 mAU/mL)	1.233	0.266-5.719	0.79
Tumor size (> 2 cm vs ≤ 2 cm)	1.040	0.275-3.935	0.953

HR: Hazard ratio; CI: Confidence interval; HBV: Hepatitis B virus; PT: Prothrombin time; INR: International normalized ratio; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; AFP: Alpha-fetoprotein; PIVKA: Prothrombin induced by vitamin K deficiency or antagonist.

Table 3 Adverse events and toxicities according to the treatment group

	Total (n = 70)	Embosphere (n = 33)	Marine gel (n = 37)	P value
Postembolization syndrome	25	12 (36.4)	13 (35.1)	0.915
Fever	1	1	0	0.286
Nausea/vomiting	6	2	4	0.479
Pain	23	11	12	0.448
Unscheduled hospital visit	2	1	1	0.935
Laboratory toxicity (90 d)
PT-INR (grade 0/1/2)	69/1/0	32/1/0	37/0/0	0.286
Albumin (grade 0/1/2)	67/3/0	32/1/0	35/2/0	0.624
Total bilirubin (grade 0/1/2)	63/5/2	30/2/1	33/3/1	0.811
AST (grade 0/1/2/3)	58/11/0/1	26/7/0/0	32/4/0/1	0.394
ALT (grade 0/1/2/3)	63/5/1/1	30/2/1/0	33/3/0/1	0.811
Alkaline phosphatase (grade 0/1/2)	67/3/0	33/0/0	34/3/0	0.095
Biloma	0	0	0	1.0
Liver abscess	0	0	0	1.0
Biliary duct dilation	0	0	0	1.0
Focal hepatic parenchymal infarct	1	1	0	0.286

PT: Prothrombin time; INR: International normalized ratio; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase. Number in parentheses is percentage.