Balloon-occluded chemoembolization for hepatocellular carcinoma: a prospective study of safety, feasibility and outcomes

Figures & data

Figure 1. Microballoon catheter.

The figure shows an entire inflated microballoon catheter (A) and the inflated balloon (B).

Reproduced with permission from Terumo Europe NV, Leuven, Belgium.

Table 1. Baseline and transarterial chemoembolization characteristics.

Baseline characteristics	n = 24
Age mean ± SD (years old)	66 ± 10.1
Male gender, n (%)	23/24 (95.8)
Cirrhosis, n (%):	24/24 (100)
– Alcohol	16/24 (66.7)
– HBV	2/24 (8.3)
– HCV	2/24 (8.3)
– NAFLD	2/24 (8.3)
Other (combining factors):
– Alcohol + HBV	1/24 (4.2)
– HCV + HBV + delta	1/24 (4.2)
– HBV + delta	0/24(0)
Child-Pugh, n (%):
– A	23/24(95.8)
– B	1/24 (4.2)
MELD score (mean ± SD)	10.1 ± 3.3
Previous treatment, n (%)	3/24 (12.5)
No previous treatment	21/24 (87.5)
At least one previous treatment:	3/24 (12.5)
– TACE	1/24 (4.2)
– Surgery	1/24 (4.2)
– Radiofrequency ablation + surgery	1/24 (4.2)
HCC-tumor load, n (%):
– Unilobar	19/24 (79.2)
– Bilobar	5/24(20.8)
– Unifocal	12/24 (50.0)
– Multifocal	12/24 (50.0)
Number of nodules, median (min–max)	1 (1–3)
Mean ± SD diameter of biggest nodule (mm)	32.7 ± 11.8
AFP score, n (%):
– <100	19/23 (82.6)
– ≥100	4/23 (17.4)
BCLC, n (%):
– 0	1/24 (4.2)
– A	15/24 (62.5)
– B	8/24 (33.3)
– C	0/24 (0)
– D	0/24 (0)
Milano, n (%):
– In	18/24 (75.0)
– Out	6/24 (25.0)
UCSF, n (%):
– In	20/24 (83.3)
– Out	4/24 (16.7)
TACE indication, n (%):
– Surgery	4/24 (16.7)
– Transplantation	12/24 (50)
– Disease control	8/24 (33.3)
No of procedures:	n = 35
– TACE 1	24
– TACE 2	9
– TACE 3	2
Selectivity, n (%):
– Lobar	3/35 (8.6)
– Selective	20/35 (57.1)
– Superselective	12/35 (34.3)
Size of LifePearl®, n (%):
– 100 μm	19/35 (54.3)
– 200 μm	16/35 (45.7)
Bead Block® use, n (%):
– Bead Block (yes)	2/35 (5.7)
– Bead Block diameter
– 100–300 μm	2/2 (100)
Mean dose of doxorubicin (mg)/procedure (mean ± SD):
– TACE (n = 35)	73.5 ± 16.5

AFP: Alpha-fetoprotein; BCLC: Barcelona Clinic of Liver Cancer; HBV: Hepatitis B virus; HCC: Hepatocellular carcinoma; HCV: Hepatitis C virus; MELD: Model for end-stage liver disease; NAFLD: Nonalcoholic fatty liver disease; SD: Standard deviation; TACE: Transarterial chemoembolization; UCSF: University of California San Francisco.

Figure 2. Flow-chart showing the 24 patients included in the study that underwent 35 procedures for 40 hepatocellular carcinoma nodules.

Available responses are shown in the right side of the image.

B-DEM-TACE: Balloon-occluded transarterial chemoembolization using drug-eluting microspheres; LT: Liver transplantation; SIRT: Selective internal radiation therapy.

Table 2. Early and late laboratory toxicities (grade 1 according to Common Terminology Criteria of Adverse Events version 5).

Parameters, n (%)	TACE 1 (24)	TACE 2 + 3 (11)	TACE total (35)
Laboratory toxicities baseline to 24–48 h weeks
AST (IU/l)	8/22 (36.4)	2/10 (20)	10/32 (31.3)
ALT (IU/l)	2/22 (9.1)	1/10 (10)	3/32 (9.4)
Bilirubin (mg/dl)	1/22 (4.5)	1/10 (10)	2/32 (6.3)
INR	0/22 (0)	1/10 (10)	1/32 (3.1)
Albumin (g/l)	2/20 (10)	1/10 (10)	3/30 (10)
Laboratory toxicities baseline to 4–6 weeks
AST (IU/l)	3/23 (13)	0/11 (0)	3/34 (8.8)
ALT (IU/l)	1/23 (4.3)	1/11 (9.1)	2/34 (5.9)
Bilirubin (mg/dl)	2/23 (8.7)	2/11 (18.2)	4/34 (11.8)
INR	1/23 (4.3)	2/11 (18.2)	3/34 (8.8)
Albumin (g/l)	1/21 (4.8)	0/11 (0)	1/32 (3.1)

ALT: Alanine aminotransaminase; AST: Aspartate aminotransaminase; INR: International normalized ratio; TACE: Transarterial chemoembolization.

Table 3. Evolution of biological parameters at different time points after the balloon-occluded transarterial chemoembolization using drug-eluting microspheres 1 (mean ± standard deviation, variables with normal distribution).

Characteristics	Baseline	24-h TACE	1-month TACE	p-value
Hgb (g/dl)	13.12 ± 0.47	12.26 ± 0.5 ^† ^, ^‡	13.15 ± 0.37	p < 0.0001
WBC (x 10^3/mm^3)	5.46 ± 0.4	8.09 ± 0.67 ^† ^, ^‡	5.21 ± 0.45	p < 0.0001
Neutrophils (x 10^3/mm^3)	3.38 ± 0.39	6.71 ± 0.58 ^† ^, ^‡	3.13 ± 0.35	p < 0.0001
Lymphocytes (x 10^3/mm^3)	1.21 ± 0.1	1.17 ± 0.26	1.24 ± 0.13	p = 0,979
Platelets (x 10^3/mm^3)	129 ± 11	114 ± 13 ^† ^, ^‡	139 ± 14	p = 0.001
AST (IU/l)	39.52 ± 3.59	53.23 ± 7.99	40.79 ± 3.28	p = 0.242
ALT (IU/l)	33.54 ± 4.9	42.41 ± 6.07	34.25 ± 4.84	p = 0.158
Bilirubin (mg/dl)	0.87 ± 0.09	6.4 ± 5.64	0.77 ± 0.07	p = 0.322
Albumin (g/l)	39.71 ± 1	35.75 ± 1.12 ^† ^, ^‡	38.21 ± 1.1	p < 0.0001
INR	1.22 ± 0.03	1.25 ± 0.03	1.2 ± 0.32	p = 0.048

No significant difference between baseline and 1 month. Statistical significance was defined as p-value < 0.05 and is indicated by bold font. The Bonferroni correction was applied in order to adjust comparison between several dependent values. Most significant differences occurred between baseline and 24-h postprocedure and 24-h postprocedure and 1 month. No significant differences were seen between baseline and 1-month evaluation.

† Significant difference between baseline and 24-h postprocedure.

‡ Significant difference between 24-h postprocedure and 1 month.

ALT: Alanine aminotransaminase; AST: Aspartate aminotransaminase; Hgb: Hemoglobin; INR: International normalized ratio; TACE: Transarterial chemoembolization; WBC: White blood cells.

Table 4. Modified response evaluation criteria in solid tumors-best overall response.

Response, n (%)	TACE 1 (24)	TACE 2 + 3 (10/11)	BOR
CR	9/24 (37.5)	4/10 (40)	10/24 (41.7)
PR	7/24 (29.2)	3/10 (30)	7/24 (29.2)
SD	8/24 (33.3)	3/10 (30)	7/24 (29.2)
PD	0/24 (0)	0/10 (0)	0/24 (0)

BOR: Best overall response; CR: Complete response; mRECIST: Modified response evaluation criteria in solid tumors; PD: Progressive disease; PR: Partial response; SD: Stable disease; TACE: Transarterial chemoembolization.

Table 5. Modified response evaluation criteria in solid tumors-response on 1-month follow-up per nodule.

Response, n (%)	TACE 1 (34)	TACE 2 (13)	TACE 3 (2)	TACE global ^† (39)
CR	14/34 (41.2)	6/13 (46.2)	1/2 (50)	19/39 (48.7)
PR	10/34 (29.4)	4/13 (30.8)	0/2 (0)	14/39 (25.6)
SD	10/34 (29.4)	3/13 (23.1)	1/2 (50)	14/39 (25.6)
PD	0/34 (0)	0/13 (0)	0/2 (0)	0/39 (0)

† The best response by nodule was reported in TACE global.

CR: Complete response; mRECIST: Modified response evaluation criteria in solid tumors; PD: Progressive disease; PR: Partial response; SD: Stable disease; TACE: Transarterial chemoembolization.

Figure 3. Kaplan–Meier curves.

Kaplan–Meier estimates of overall survival (A), transplantation-free survival (B) and progression-free-survival (C).