Chemoembolization alone vs combined chemoembolization and hepatic arterial infusion chemotherapy in inoperable hepatocellular carcinoma patients

Table 1 Baseline clinical characteristics of patients enrolled n (%)

	Chemoembolization group (n = 39)	Chemoembolization + HAIC group (n = 45)	P-value
Age (yr)	59.69 ± 13.13	57.16 ± 10.34	0.325
Gender			0.832
Male	35 (89.7)	41 (91.1)
Female	4 (10.3)	4 (8.9)
Hepatitis condition			0.309
Hepatitis B	32 (82.1)	39 (86.7)
Hepatitis C	3 (7.7)	3 (6.7)
Hepatitis B + hepatitis C	1 (2.6)	3 (6.7)
Non-hepatitis	3 (7.7)	0
Grading of physical condition			0.393
PS = 0	18 (46.2)	24 (53.3)
PS = 1	21 (53.8)	21 (46.7)
Ascites			0.900
Yes	10 (25.6)	11 (24.4)
No	29 (82.4)	34 (75.6)
Liver function Child-Pugh			0.075
Grade A	36 (92.3)	41 (91.1)
Grade B	3 (7.7)	4 (8.9)
Diameter of tumor target lesion (cm)			0.347
≤ 10	19 (48.7)	29 (64.4)
> 10	20 (51.3)	16 (35.6)
Number of tumor			0.149
> 3	22 (56.4)	31 (68.9)
≤ 3	17 (43.6)	14 (31.1)
Blood vessel invasion			1.000
No	26 (66.7)	30 (66.7)
Yes	13 (33.3)	15 (33.3)
BCLC stage			0.860
Stage A	4 (10.3)	3 (6.7)
Stage B	9 (23.1)	15 (33.3)
Stage C	22 (56.4)	21 (44.1)
Relapse after surgical resection	4 (10.3)	6 (13.3)
Follow-up time, median (mo)	7.2 (1.3-15.2)	9.3 (3.8-14.6)	0.169

Table 2 Overall curative effect based on mRECIST criteria n

	Chemoembolizationgroup (n = 39)	Chemoembolization + HAICgroup (n = 45)	P-value
CR	5	12
PR	12	19
SD	9	8
PD	11	6
Not evaluated	2 (lost)	0
ORR	17/37 (45.9%)	31/45 (68.9%)	0.036
DCR	26/37 (70.3%)	39/45 (86.7%)	0.068

DCR = CR + PR + SD; ORR = CR + PR; P value: Pearson method, χ² test. DCR: Disease control rate; PR: Partial response; SD: Partial response; ORR: Objective response rate.

Table 3 Univariate and multivariate prognostic analyses of the patients (n = 79)

Correlative factor	Number of cases	Kaplan-Meier univariate analysis			Cox multivariate analysis
		mPFS (mo)	95%CI	P-value	Sig	EXP(B)	95%CI
Interventional therapy				0.00049	0.00048	0.26	0.174-0.612
Chemoembolization	37	4.5	3.3-5.7
Chemoembolization combined with HAIC	42	8.0	7.2-8.8
Grading of physical condition				0.00014	0.312	1.525	0.674-3.452
PS = 0	40	8.9	6.2-11.5
PS = 1	39	4.5	3.7-5.2
Vascular invasion1				0.00047	0.050	1.963	0.989-3.898
No	52	7.9	7.3-8.5
Yes	27	3.8	2.7-4.8
BCLC Stage2				0.00051	0.003	3.083	1.479-6.426
Stage C	30	3.8	3.0-4.6
Stage A or B	39	9.3	6.7-11.9
AFP (ng/mL)				0.03	0.488	1.255	0.660-2.386
< 400	52	7.3	5.8-8.8
≥ 400	27	4.5	2.1-7.0
Sum of tumor target lesion diameter (cm)				0.00011	0.326	1.449	0.691-3.338
≤ 10	45	7.8	6.1-9.5
> 10	34	4.3	3.2-5.3
Serum albumin (g/L)				0.027	0.27	0.628	0.275-1.434
< 35	7	4.3	3.0-5.6
≥ 35	72	7.3	5.9-8.6

¹Venous invasion refers to portal vein or hepatic vein tumor thrombosis, APVS;

²BCLC staging did not include patients who relapsed after surgery. PFS: Progression free survival; mPFS: Median progression free survival; AFP: Alpha-fetoprotein; HAIC: Hepatic arterial infusion chemotherapy; BCLC: Barcelona Clinic Liver Cancer staging.

Table 4 Adverse reactions of patients enrolled in our study n (%)

Adverse reaction	Chemoembolization (n = 92)		Chemoembolization + HAIC (n = 137)
	I + II	III + IV	I + II	III + IV	P1	P2
Hematologic toxicity
Reduction of white cells	13 (14.1)	0	21 (15.3)	2 (1.4)	0.803	-
Reduction of hemoglobin	17 (18.5)	3 (3.3)	21 (15.3)	2 (1.4)	0.530	0.393
Reduction of thrombocyte	19 (20.7)	7 (7.6)	57 (41.6)	5 (3.6)	0.001	0.231
Non-hematologic toxicity
Increase of total bilirubin	38 (41.3)	4 (4.3)	74 (54.0)	5 (3.6)	0.059	0.744
Increase of glutamate pyruvate transaminase	55 (59.8)	5 (5.4)	78 (56.9)	11 (8.0)	0.668	0.450
Increase of glutamic-oxaloacetic transaminase	50 (54.3)	8 (8.7)	82 (59.8)	9 (6.5)	0.408	0.547
Fever	55 (59.8)	11 (12.0)	64 (46.7)	12 (8.8)	0.052	0.430
Pain1	40 (43.5)	3 (3.3)	63 (46.0)	19 (13.9)	0.708	0.008
Nausea	47 (51.1)	3 (3.3)	91 (66.4)	5 (3.6)	0.030	0.875
Vomit	19 (20.7)	0	47 (34.3)	3 (2.2)	0.025	-
Diarrhea	1 (1.1)	0	4 (3.0)	0	0.768	-
Constipation	18 (19.6)	1 (1.1)	29 (21.2)	0	0.6513	-
Neurotoxicity2	-	-	13 (6.8)	0	-	-

¹Pain was evaluated according to the grading standards for acute and subacute toxicity reactions for anti-cancer drugs issued by the WHO;

²Neurotoxicity was evaluated according to the Levi special grading standard for sensory nerve toxicity;

³Fisher’s exact testing method, χ² test (P₁ value: comparison of grades I + II adverse reactions between the two groups; P₂ value: comparison of grades III + IV adverse reactions between the two groups). Statistics for adverse events: Evaluation based on the NCI - CTCAE v3.0 criteria. P-values: Pearson method, χ² test.