Comparative effectiveness of traditional chemoembolization with or without sorafenib for hepatocellular carcinoma

Table 1 Child-Turcotte-Pugh scoring system and classification for patients with chronic liver disease

Measures	1 point	2 points	3 points
Serum total bilirubin (mg/dL)	≤ 2	2-3	> 3
Serum albumin (g/dL)	> 3.5	2.8-3.5	< 2.8
INR	< 1.7	1.71-2.30	> 2.30
Ascites	None	Mild	Moderate to severe
Hepatic encephalopathy	None	Grade I-II (or suppressed with medication)	Grade III- IV (or refractory)
CTP points	CTP class	One year predicted survival
5-6	A	100%
7-9	B	81%
10-15	C	45%

INR: International normalized ratio; CTP: Child-Turcotte-Pugh.

Table 2 Barcelona Clinic Liver Cancer staging system for hepatocellular carcinoma

Stage of HCC	Tumor features	Child-Pugh classification	Performance status test	Treatment
Stage 0	Single < 2 cm carcinoma in situ	Child-Pugh A	0	Resection
Stage A	Single < 5 cm or 3 nodules < 3 cm	Child-Pugh A-B	0	Liver transplant, percutaneous ethanol injection, radiofrequency ablation
Stage B	Single > 5 cm or multi-nodular	Child-Pugh A-B	0	TACE
Stage C	Portal vein invasion	Child-Pugh A-B	1-2	Sorafenib
Stage D	Distant metastasis	Child-Pugh A-B	3-4	Symptomatic

HCC: Hepatocellular carcinoma; TACE: Transarterial chemoembolization.

Table 3 Comparison of demographic and disease characteristics of patients with hepatocellular carcinoma in both treatment groups

Characteristic	TACE + sorafenib(n = 13)	TACE alone(n = 30)	P value
Age (yr)	61.4 ± 7.5	59.2 ± 7.4	0.39
Etiology			0.18
Alcohol	2 (15.4)	1 (3.4)
Hepatitis C	6 (46.1)	17 (56.6)
Hepatitis C and alcohol	3 (23.1)	11 (36.6)
Non-alcohol/non-hepatitis C	2 (15.4)	1 (3.4)
HCC histology			0.86
Poorly differentiated	1 (7.6)	3 (10.0)
Moderately differentiated	7 (53.8)	13 (43.3)
Well differentiated	5 (38.6)	14 (46.7)
CTP classification			0.69
A	11	23
B	2	7
BCLC staging for HCC			0.004
A	6	22
B	2	8
C	5	0
BCLC staging for HCC (excluding stage C)			0.98
A	6	22
B	2	8
MELD score	8.8 ± 2.3	9.8 ± 2.9	0.29
AFP (ng/mL)	6.6 (2.3-745)	8.1 (1.9-6000)	0.96
Tumor size seen on CT with the largest diameter (cm)	4 (1.5 -16.7)	3.1 (1.4 -5.8)	0.58

Data are summarized as the mean ± SD or median (range). HCC: Hepatocellular carcinoma; TACE: Transarterial chemoembolization; CTP: Child-Turcotte-Pugh; BCLC: Barcelona Clinic Liver Cancer; MELD: Model of end stage liver disease; AFP: Alpha fetoprotein; CT: Computed tomography.

Table 4 Statistical analysis for each covariate in univariate cox regression model predicting overall survival

Characteristic	HR (95%CI)	P value
Age (yr)	0.99 (0.95-1.04)	0.79
Etiology	1.04 (0.66-1.63)	0.86
Alcohol
Hepatitis C
Hepatitis C and alcohol
Non-alcohol/non-hepatitis C
HCC histology	0.73 (0.43-1.25)	0.26
Poorly differentiated
Moderately differentiated
Well differentiated
CTP classification	3.84 (1.74-8.51)	0.001
A
B
BCLC staging for HCC	1.58 (1.02-2.46)	0.04
A
B
C
BCLC staging for HCC (excluding stage C)	1.5 (0.66-3.43)	0.34
A
B
MELD score	1.1 (0.98-1.23)	0.08
AFP (ng/mL)	0.99 (0.82-1.20)	0.98
Tumor size seen on CT with the largest diameter (cm)	1.06 (0.93-1.20)	0.41

HCC: Hepatocellular carcinoma; CTP: Child-Turcotte-Pugh; BCLC: Barcelona Clinic Liver Cancer; MELD: Model of end stage liver disease; AFP: Alpha fetoprotein; CT: Computed tomography.

Table 5 Adverse events attributed to both treatment arms

Adverse events (CTCAE grades 1-3)	TACE alone	TACE + sorafenib	P value
Hand foot skin reaction	0	2	0.554
Diarrhea	0	1
Hypertension (mild)	0	1
Abdominal pain (mild)	6	1
Nausea, vomiting	3	0
Elevated liver enzymes (< 2 times of normal limits)	1	2

TACE: Transarterial chemoembolization; CTCAE: Common terminology criteria for adverse events.