Effect and safety of sorafenib in patients with intermediate hepatocellular carcinoma who received transarterial chemoembolization: A retrospective comparative study

Table 1 Baseline characteristics of the study population

Characteristics	Sorafenib + TACE (n = 38)	TACE (n = 29)	P value
Gender, Male/Female	24 (63.2%)/14 (36.8%)	18 (62.1%)/11 (37.9%)	> 0.05
Age (mean ± SD, yr)	52 ± 5	51 ± 6	> 0.05
ECOG PS 0/1/2/3/4 (%)	38 (100%)/0 (0%)/0/(0%) 0/(0%)	29 (100%)/0 (0%)/0/(0%) 0/(0%)	> 0.05
Child-Pugh A/B	25 (65.8%)/13 (34.2%)	19 (65.5%)/10 (34.5%)	> 0.05
Tumor diameter (cm) ≥ 6/< 6	14 (36.8%)/24 (63.2%)	10 (34.5%)/19 (65.5%)	> 0.05
Serum albumin (g/L) ≥ 35/< 35	20 (52.6%)/18 (47.4%)	16 (55.2%)/13 (44.8%)	> 0.05
Serum bilirubin (umol/L) ≥ 20/< 20	11 (28.9%)/27 (71.1%)	8 (27.6%)/21 (72.4%)	> 0.05
LDH (U/L) ≥ 245/< 245	23 (60.5%)/15 (39.5%)	16 (55.2%)/13 (44.8%)	> 0.05
AFP (ng/mL) ≥ 200/< 200	25 (65.8%)/13 (34.2%)	19 (65.5%)/10 (34.5%)	> 0.05
Number of TACE ≥ 2/< 2	19 (50.0%)/19 (50.0%)	14 (48.3%)/15 (51.7%)	> 0.05

TACE: Transarterial chemoembolization; SD: Standard deviation; ECOG PS: Eastern Coorperative Oncology Group performance status; LDH: Lactatedehydrogenase; AFP: α-fetoprotein.

Table 2 Univariate analysis of all patients for overall survival

Characteristic	n (%)	mOS (mo)	95%CI	P value	χ2
Gender
Male	42 (62.7)	33.4	28.03-38.77	0.659	0.195
Female	25 (37.3)	35.2	30.40-40.00
Age (yr)
≥ 57	26 (38.8)	33.0	29.34-36.66	0.178	1.818
< 57	41 (61.2)	35.2	32.58-37.82
Child-Pugh
A	44 (65.7)	35.2	31.00-39.40	0.000	17.805
B	23 (34.3)	21.0	16.22-25.78
Tumor diameter (cm)
≥ 6	24 (35.8)	20.0	14.51-25.49	0.016	5.815
< 6	43 (64.2)	35.2	32.63-37.77
Serum albumin (g/L)
≥ 35	36 (53.7)	36.0	33.34-38.66	0.066	3.39
< 35	31 (46.3)	23.0	18.25-27.75
Serum bilirubin (umol/L)
≥ 20	19 (28.4)	24.0	18.27-29.73	0.006	7.612
< 20	48 (71.6)	35.0	32.52-37.48
LDH (U/L)
≥ 245	39 (58.2)	28.0	24.83-31.17	0.143	2.143
< 245	28 (41.8)	33.0	31.19-34.81
AFP (ng/mL)
≥ 200	44 (65.7)	28.0	20.50-35.50	0.011	6.448
< 200	23 (34.3)	32.0	25.86-38.14
Number of TACE
≥ 2	33 (49.3)	29.8	23.14-36.46	0.079	3.809
< 2	34 (50.7)	36.6	35.12-38.08
Sorafenib + TACE	38 (56.7)	35.2	30.02-40.38	0.000	12.645
TACE	29 (43.3)	22.0	21.23-22.77

OS: Overall survival; LDH: Lactatedehydrogenase; AFP: α-fetoprotein; TACE: Transarterial chemoembolization; CI: Confidence interval.

Table 3 Multivariate Cox regression model analysis for overall survival

	HR	95%CI	P value
Child-pugh class	4.453	1.550-12.796	0.006
Tumor diameter	16.551	1.625-168.546	0.018
AFP	2.495	0.828-7.522	0.104
Serum bilirubin	0.894	0.292-2.731	0.843
SOR or no SOR	8.876	2.860-27.543	0.000

HR: Hazard ratio; AFP: α-fetoprotein; SOR: Sorafenib.

Table 4 Comparison of overall survival in patients with hepatocellular carcinoma treated with sorafenib and those treated with sorafenib plus transarterial chemoembolization

	Annual survival rate (%)			mOS (mo)	P value
	1 yr	2 yr	3 yr
Sorafenib + TACE	94.7	63.2	34.6	35.2	< 0.001
TACE	96.6	42	NA	22

None of the patients collected in the TACE treatment group achieved a 3-year survival time. mOS: Median overall survival; TACE: Transarterial chemoembolization.

Table 5 Comparison of treatment responses between the two groups of patients

	CR	PR	SD	PD	ORR	DCR	χ2	P value
Sorafenib + TACE (38)	12	11	10	5	60.5%	86.8%	21.586	0.000
TACE (29)	4	8	7	10	41.4%	65.5%

TACE: Transarterial chemoembolization; CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; ORR: Objective response rate; DCR: Disease control rate.

Table 6 Adverse events of sorafenib plus transarterial chemoembolization treatment and transarterial chemoembolization treatment alone

	Fatigue	Diarrhea	Rash	Nausea	HFS	Hypertensive	Vomiting	Bone marrow suppression
Sorafenib + TACE (38)	17	13	12	10	15	12	9	11
TACE (29)	10	4	2	3	0	3	3	5
χ2	0.066	3.062	6.062	4.019	14.749	4.268	3.378	1.24
P value	0.793	0.061	0.014	0.056	0.000	0.039	0.066	0.265

HFS: Hand-foot syndrome; TACE: Transarterial chemoembolization.