Therapeutic efficacy of transarterial chemo-embolization with a fine-powder formulation of cisplatin for hepatocellular carcinoma

Table 1 Baseline characteristics of the 262 patients

Characteristics
Enrolled patients		262
Age (yr)	Median (range)	70 (32-92)
Sex	Male/female	176/86
Etiology	HBV/HCV/NBNC	30/170/62
Child Pugh classification	A/B/C	147/93/22
Number of tumors	< 10/≥ 10	114/148
Maximum tumor size (mm)	Median (range)	32.5 (8.0-300.0)
Stage1	I/II/III/IV	17/45/136/64
PVTT grade	Vp0/Vp1-2/Vp3	202/27/33
Total bilirubin (mg/dL)	mean ± SD	1.0 ± 0.7
Albumin (g/dL)	mean ± SD	3.4 ± 0.6
Prothrombin time (%)	mean ± SD	91.1 ± 8.4
Platelet count (× 104/L)	mean ± SD	8.9 ± 5.0
AFP (ng/mL)	median (range)	31.6 (1.0-1  000  000)
AFP-L3 (ng/mL)	median (range)	4.0 (0-91.8)
DCP (mAU/mL)	median (range)	60 (0-928  900)
Previous treatment	Yes/no	107/155

Data are expressed as median values with ranges, mean ± SD, or number of patients.

¹According to the modified RECIST (mRECIST) criteria. HBV: Hepatitis B virus; HCV: Hepatitis C virus; NBNC: Negative for hepatitis B surface antigen and HCV antibody; PVTT: Portal vein tumor thrombosis; AFP: α-fetoprotein; AFP-L3: Lens culinaris agglutinin-reactive fraction of α-fetoprotein; DCP: Des-γ-carboxy prothrombin.

Table 2 Univariate and multivariate analysis of predictors of survival

Variable	Hazard ratio	95%CI	P value
Univariate analysis of predictors of survival
Age ( ≤ 65 vs > 65 yr)	1.085	0.772-1.525	0.638
Gender (M vs F)	0.861	0.607-1.222	0.403
Previous treatment (no vs yes)	1.258	0.911-1.738	0.164
HCV antibody (negative vs positive)	0.951	0.673-1.344	0.776
Stage (I, II, III vs IV)	2.705	1.919-3.814	< 0.001
Child Pugh classification (A vs B or C)	1.584	1.149-2.184	0.005
JIS score (0-2 vs 3-5)	2.285	1.638-3.189	< 0.001
Total bilirubin ( ≤ 1.5 mg/dL vs > 1.5 mg/dL)	1.578	1.044-2.385	0.031
Albumin (> 3.5 mg/dL vs ≤ 3.5 mg/dL)	1.527	1.100-2.119	0.012
Number of tumors (< 10 vs≥ 10)	1.920	1.378-2.675	< 0.001
Maximum tumor size ( ≤ 50 mm vs > 50 mm)	2.052	1.404-2.998	< 0.001
PVTT grade (Vp0, 1, 2 vs Vp3)	4.142	2.754-6.230	< 0.001
Tumor distribution (Unilateral vs Bilateral)	2.237	1.464-3.420	< 0.001
AFP ( ≤ 100 ng/mL vs > 100 ng/mL)	2.131	1.539-2.949	< 0.001
AFP-L3 ( ≤ 50% vs > 50%)	1.664	0.957-2.894	0.071
DCP ( ≤ 100 mAU/mL vs > 100 mAU/mL)	2.201	1.588-3.051	< 0.001
Therapeutic effect (CR + PR vs SD + PD)	3.419	2.382-4.909	< 0.001
Multivariate analysis of predictors of survival
PVTT grade (Vp0, 1, 2 vs Vp3)	2.310	1.217-4.384	0.010
AFP ( ≤ 100 ng/mL vs > 100 ng/mL)	1.856	1.265-2.724	0.002
Therapeutic effect (CR + PR vs SD + PD)	3.392	2.240-5.135	< 0.001

The JIS score is obtained by simply adding both scores for the tumor, lymph node, metastasis (TNM) stage and Child-Turcotte-Pugh stage. HCV: Hepatitis C virus; JIS: Japan integrated staging; PVTT: Portal vein tumor thrombosis; AFP: α-fetoprotein; DCP: Des-γ-carboxy prothrombin; CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease.

Table 3 Adverse effects among the 262 patients n (%)

Adverse effect	Grade 1	Grade 2	Grade 3	Grade 4
Nausea/vomiting	160 (61.1)	48 (18.3)	- (-)	- (-)
General fatigue	28 (10.7)	17 (6.5)	1 (0.4)	- (-)
Fever	168 (64.1)	27 (10.3)	- (-)	- (-)
Abdominal pain	121 (46.1)	54 (20.6)	- (-)	- (-)
Leucopenia	13 (4.9)	2 (0.7)	- (-)	- (-)
Thrombocytopenia	16 (6.1)	2 (0.7)	- (-)	- (-)
AST/ALT	154 (58.8)	46 (17.6)	- (-)	- (-)
Liver abscess	- (-)	2 (0.7)	2 (0.7)	- (-)
Hepatic/Renal failure	- (-)	- (-)	1 (0.4)	- (-)

Data are expressed as number of patients with percentages in parentheses. AST: Aspartate aminotransferase; ALT: Alanine aminotransferase.