Assessment of efficacy and safety by CalliSpheres versus HepaSpheres for drug-eluting bead transarterial chemoembolization in unresectable large hepatocellular carcinoma patients

Figures & data

Table 1. Characteristics of HCC patients.

Items	HepaSpheres group (N = 60)	CalliSpheres group (N = 67)	p Value
Age (years), mean ± SD	65.5 ± 8.7	64.3 ± 9.0	.431
Gender, no. (%)			.238
Male	42 (70.0)	53 (79.1)
Female	18 (30.0)	14 (20.9)
History of liver disease, no. (%)			.994
Hepatitis B	48 (80.0)	53 (79.1)
Hepatitis C	6 (10.0)	7 (10.4)
ALD	3 (5.0)	3 (4.5)
Others	3 (5.0)	4 (6.0)
ECOG PS score, no. (%)			.946
0	37 (61.7)	42 (62.7)
1	20 (33.3)	21 (31.3)
2	3 (5.0)	4 (6.0)
MELD score, mean ± SD	9.5 ± 2.2	9.3 ± 2.0	.592
Child-Pugh stage, no. (%)			.729
A	34 (56.7)	40 (59.7)
B	26 (43.3)	27 (40.3)
Tumor size (cm), mean ± SD	7.9 ± 2.5	7.5 ± 2.3	.350
Number of tumors, no. (%)			.821
≤3	37 (61.7)	40 (59.7)
>3	23 (38.3)	27 (40.3)
Vascular invasion, no. (%)			.767
Yes	13 (21.7)	16 (23.9)
No	47 (78.3)	51 (76.1)
Extrahepatic metastasis, no. (%)			.590
Yes	7 (11.7)	10 (14.9)
No	53 (88.3)	57 (85.1)
BCLC stage, no. (%)			.755
B	27 (45.0)	32 (47.8)
C	33 (55.0)	35 (52.2)
AFP level, no. (%)			.883
≤400 ng/mL	15 (25.0)	16 (23.9)
>400 ng/mL	45 (75.0)	51 (76.1)
Times of TACE treatment, mean ± SD	3.7 ± 3.3	3.4 ± 2.7	.574

HCC: hepatocellular carcinoma; SD: standard deviation; ALD: alcoholic liver disease; ECOG PS: Eastern Cooperative Oncology Group performance status; MELD: model for end-stage liver disease; BCLC: Barcelona Clinic Liver Cancer; AFP: alpha-fetoprotein; TACE: transarterial chemoembolization.

Figure 1. ORR and DCR in CalliSpheres group and HepaSpheres group. The comparison of ORR and DCR at 1 month (A), 3 months (B), and 6 months (C) after treatment between CalliSpheres group and HepaSpheres group. ORR: objective response rate; DCR: disease control rate.

Table 2. Treatment response.

Items	CR	PR	SD	PD	p Value
1 month after treatment
CalliSpheres group (n = 52)	11 (21.2)	32 (61.5)	9 (17.3)	0 (0.0)	.026
HepaSpheres group (n = 47)	6 (12.8)	24 (51.1)	13 (27.8)	4 (8.5)
3 months after treatment
CalliSpheres group (n = 38)	8 (21.0)	23 (60.5)	3 (8.0)	4 (10.5)	.863
HepaSpheres group (n = 34)	7 (20.6)	20 (58.8)	3 (8.8)	4 (11.8)
6 months after treatment
CalliSpheres group (n = 33)	6 (18.2)	18 (54.5)	4 (12.1)	5 (15.2)	.853
HepaSpheres group (n = 31)	6 (19.4)	17 (54.8)	4 (12.9)	4 (12.9)

CR: complete response; PR: partial response; SD: stable disease; PD: progressive disease.

Figure 2. KPS score in CalliSpheres group and HepaSpheres group. The comparison of KPS score at 1 month, 3 months, and 6 months post treatment between CalliSpheres group and HepaSpheres group. KPS: Karnofsky performance status.

Table 3. Liver function indexes.

Items	Before treatment	7 days after treatment	30 days after treatment
ALT (U/L), mean ± SD
CalliSpheres group	42.7 ± 14.2	79.3 ± 23.5	39.3 ± 12.4
HepaSpheres group	41.9 ± 13.7	80.0 ± 24.2	40.1 ± 13.3
p Value	.748	.869	.726
AST (U/L), mean ± SD
CalliSpheres group	49.0 ± 15.3	67.8 ± 21.9	53.4 ± 14.3
HepaSpheres group	48.9 ± 14.9	68.6 ± 20.9	54.0 ± 16.0
p Value	.970	.834	.824
ALB (g/L), mean ± SD
CalliSpheres group	36.1 ± 9.9	34.2 ± 8.8	37.0 ± 11.4
HepaSpheres group	35.0 ± 8.9	34.8 ± 9.0	36.2 ± 10.6
p Value	.513	.705	.684
TBIL (mmol/L), mean ± SD
CalliSpheres group	24.5 ± 10.1	27.0 ± 8.5	22.2 ± 6.9
HepaSpheres group	22.8 ± 7.3	24.6 ± 8.1	21.7 ± 7.1
p Value	.284	.107	.688

ALT: alanine aminotransferase; AST: aspartate aminotransferase; ALB: albumin; TBIL: total bilirubin.

Table 4. Adverse events.

Parameters	Total adverse events			Grade I–II			Grade III–IV
	CalliSpheres group	HepaSpheres group	p Value	CalliSpheres group	HepaSpheres group	p Value	CalliSpheres group	HepaSpheres group	p Value
Nausea/vomiting, no. (%)	42 (62.7)	37 (61.7)	.906	39 (58.2)	35 (58.3)	.989	3 (4.5)	2 (3.3)	1.000
Pain, no. (%)	27 (40.3)	24 (40.0)	.973	25 (37.3)	22 (36.7)	.940	2 (3.0)	2 (3.3)	1.000
Fever, no. (%)	21 (31.3)	18 (30.0)	.870	19 (28.4)	17 (28.3)	.998	2 (3.0)	1 (1.7)	1.000
Myelosuppression, no. (%)	3 (4.5)	2 (3.3)	1.000	3 (4.5)	2 (3.3)	1.000	0 (0.0)	0 (0.0)	–
Biloma, no. (%)	1 (1.5)	1 (1.7)	1.000	1 (1.5)	1 (1.7)	1.000	0 (0.0)	0 (0.0)	–
Abscess, no. (%)	0 (0.0)	1 (1.7)	.472	0 (0.0)	1 (1.7)	.472	0 (0.0)	0 (0.0)	–

Figure 3. TTP and OS in CalliSpheres group and HepaSpheres group. The comparison of TTP (A) and OS (B) between CalliSpheres group and HepaSpheres group. TTP: time to progression; OS: overall survival; 95%CI: 95% confidence interval.