Transcatheter arterial chemoembolization with a fine-powder formulation of cisplatin for hepatocellular carcinoma

Table 1 Patient characteristics

Characteristics	DDPH group	ADM group	P value
No. of patients	76	88
Age (yr) [median, (range)]	67 (32-87)	69 (21-90)	0.093
Gender (male/female)	57/19	52/36	0.031
Etiology (HBV/HCV/NBNC)	11/50/15	8/64/16	0.508
Child-Pugh classification (A/B/C)	47/26/3	45/36/7	0.303
TNM classification (I-II/III-IV)	10/66	24/64	0.026
Tumor size ( ≤ 3.0/> 3.0 cm)	21/55	30/58	0.373
Number of tumors (1-3/≥ 4)	35/41	46/42	0.427
PVTT (Vp0-2 /Vp3)	62/14	80/8	0.080
Total bilirubin ( ≤ 1.5/> 1.5 mg/dL)	66/10	75/13	0.906
Albumin ( ≤ 3.5/> 3.5 g/dL)	38/38	45/42	0.822
AFP ( ≤ 1000/> 1000 ng/mL)	68/8	79/8	0.776
DCP ( ≤ 1000/> 1000 mAU/mL)	59/14	73/14	0.609

Data are expressed as median with range values, or the number of patients. The stages of HCC by TNM classification are clustered into two groups (I-II and III-IV). The tumor characteristics and other parameters are classified as follows: tumor size: ≤ 3.0, > 3.0 cm; tumor number: 1-3, > 4; extent of PVTT: Vp 0-2, and Vp 3; serum bilirubin: ≤ 1.5, > 1.5 mg/dL; serum albumin: ≤ 3.5, > 3.5 g/dL; serum AFP levels: ≤ 1000, > 1000 ng/mL. Serum DCP levels: ≤ 1000, > 1000 mAU/mL. 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; DCP: Des-γ-carboxy prothrombin; DDPH group: Using a suspension of DDPH in lipiodol (LPD); ADM group: With an emulsion of doxorubicin (ADM) with LPD.

Table 2 Early tumor response n (%)

	DDPH (n = 76)	ADM (n = 88)	P value
CR	2 (3)	5 (6)
PR	39 (51)	16 (18)
SD	23 (30)	5 (6)
PD	12 (16)	62 (70)
CR + PR	41 (54)	21 (24)	< 0.001

Data are expressed as number of patients and percentages. DDPH group: Using a suspension of DDPH in lipiodol (LPD); ADM group: With an emulsion of doxorubicin (ADM) with LPD; CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease.

Table 3 Univariate analysis for identifying the predictors of survival

Variable	Hazard ratio	95% CI	P value
Treatment regimen (ADM vs DDPH)	0.580	0.325-1.035	0.065
Age ( ≤ 65 yr vs > 65 yr)	1.286	0.741-2.231	0.372
Gender (female vs male)	1.651	0.944-2.888	0.079
Etiology (NBNC vs HBV/HCV)	0.734	0.432-1.246	0.252
Child Pugh classification (A vs B/C)	1.142	0.689-1.891	0.607
TNM classification (I-II vs III-IV)	2.765	1.252-6.106	0.012
Tumor size ( ≤ 3.0 cm vs > 3.0 cm)	2.094	1.161-3.776	0.014
Number of tumors (1-3 vs≥ 4)	2.612	1.535-4.444	0.001
PVTT (Vp0-2 vs Vp3)	4.714	2.520-8.819	< 0.001
Total bilirubin ( ≤ 1.5 mg/dL vs > 1.5 mg/dL)	1.730	0.874-3.422	0.116
Albumin ( ≤ 3.5 g/dL vs > 3.5 g/dL)	0.996	0.603-1.647	0.989
AFP ( ≤ 1000 ng/mL vs > 1000 ng/mL)	1.323	0.528-3.315	0.551
DCP ( ≤ 1000 mAU/mL vs > 1000 mAU/mL)	2.396	1.288-4.459	0.005

DDPH group: Using a suspension of DDPH in lipiodol (LPD); ADM group: With an emulsion of doxorubicin (ADM) with LPD; 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; DCP: Des-γ-carboxy prothrombin.

Table 4 Multivariate analysis for identifying predictors of survival

Variable	Hazard ratio	95% CI	P value
Treatment regimen (ADM vs DDPH)	0.329	0.149-0.726	0.006
Gender (female vs male)	2.291	1.174-4.470	0.015
Number of tumors (1-3 vs≥ 4)	6.541	3.201-13.363	< 0.001
PVTT (Vp0-2 vs Vp3)	6.704	2.581-17.418	< 0.001
Albumin ( ≤ 3.5 g/dL vs > 3.5 g/dL)	0.311	0.157-0.612	0.001

DDPH group: Using a suspension of DDPH in lipiodol (LPD); ADM group: With an emulsion of doxorubicin (ADM) with LPD; PVTT: Portal vein tumor thrombosis.

Table 5 Adverse events n (%)

Adverse effect	Treatment group (%)		P value
	DDPH group (n = 76)	ADM group (n = 88)
Nausea/vomiting	64 (84)	48 (55)	< 0.001
Fever	61 (80)	73 (83)	0.571
Abdominal pain	53 (69)	63 (72)	0.958
Elevation of transaminase levels	55 (72)	62 (71)	0.993
Liver abscess	1 (1)	2 (2)	0.765
Hepatic arterial damage	1 (1)	16 (18)	< 0.001
Renal or liver failure	0 (0)	2 (2)	0.229
Leucopenia	3 (4)	12 (14)	0.002
Thrombocytopenia	4 (5)	6 (7)	0.650
Fatigue	21(28)	27 (31)	0.839

DDPH group: Using a suspension of DDPH in lipiodol (LPD); ADM group: With an emulsion of doxorubicin (ADM) with LPD; Data are expressed as number of patients, with the percentages indicated in parentheses.