Thalidomide-based multidisciplinary treatment for patients with advanced hepatocellular carcinoma: A retrospective analysis

Table 1 The clinical characteristics of 53 patients with hepatocellular carcinoma

Characteristic	n (%)
Age, yr (median)	61 (range, 29-88)
Sex
Male	44 (83.0)
Female	9 (17.0)
Type of hepatitis
Hepatitis B	30 (56.6)
Hepatitis C	20 (37.7)
Hepatitis B + C	1 (1.9)
Child-Pugh classification
A	30 (56.6)
B	12 (22.6)
C	1 (1.8)
TNM stage
I	0 (0)
II	6 (11.2)
IIIA	11 (20.8)
IIIB	3 (5.7)
IIIC	6 (11.2)
IV	24 (45.3)
Okuda stage
I	27 (51.9)
II	16 (30.8)
III	1 (1.9)
BCLC stage
A	2 (3.9)
B	7 (13.5)
C	37 (71.2)
D	1 (1.9)
Extrahepatic metastasis
Yes	25 (47.2)
No	28 (52.8)
Portal vein thrombosis
Yes	26 (49.1)
No	26 (49.1)
Unknown	1 (1.8%)
Site of extrahepatic metastasis
Lung	11 (21.2)
Bone	6 (11.5)
Brain	1 (1.9)
Others	7 (13.5)
Prior therapy
Surgery	12 (22.6)
TACE	16 (30.2)
TAE	13 (24.5)
Radiation therapy	10 (18.9)
RFA	10 (18.9)
No therapy	10 (18.9)
Duration of treatment, mo
Median	6.0 (range, 1.5-53.9)
AFP level
> 400 ng/mL	31 (58.5)
< 400 ng/mL	22 (41.5)

BCLC: Barcelona Clinic Liver Cancer; TACE: Transarterial chemoembolization; TAE: Transarterial embolization; RFA: Radiofrequency ablation; AFP: Alpha fetoprotein; TNM: Tumor node metastasis.

Table 2 Efficacy results of thalidomide

Overall objective response, n = 53, (%)
CR	1 (2.9)
PR	5 (9.4)
SD	9 (17.0)
PD	38 (44.1)
Objective response rate	6 (11.3), 95% CI: 4.3-23.0
Disease control rate	15 (28.3), 95% CI: 17.8-42.4
Overall survival, mo
Median	10.5, 95% CI: 6.9-23.3
1-year survival	(45)
2-year survival	(20)
A decrease in AFP > 50% after treatment
Yes	16 (30.2)
No	37 (69.8)

CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; AFP: Alpha fetoprotein.

Table 3 Prognostic factors for efficacy analysis in hepatocellular carcinoma patients receiving thalidomide

Variables		P value
Overall response rate n (%)
Child-Pugh classification
A	3/30 (10.0)	1.0001
B and C	3/23 (13.0)
Okuda staging
Stage 1	2/27 (7.4	0.3441
Stage 2	3/16 (18.8)
AFP level
> 400 ng/mL	1/31 (3.2)	0.0711
< 400 ng/mL	5/22 (22.7)
A decrease in AFP > 50% after treatment
Yes	5/16 (31.3)	0.0071
No	1/37 (2.7)
Disease control rate n (%)
Child-Pugh Classification
A	6/30 (20.0)	0.2181
B and C	9/23 (39.1)
Okuda staging
Stage 1	6/27 (22.2)	0.7191
Stage 2	5/16 (31.3)
AFP level
> 400 ng/mL	7/31 (22.6)	0.3571
< 400 ng/mL	8/22 (36.4)
A decrease in AFP > 50% after treatment
Yes	7/16 (43.8)	0.0711
No	8/37 (21.6)
Overall survival, mo
Child-Pugh Classification
A	8.8	0.9222
B and C	10.8
Okuda staging
Stage 1	22.2	0.0752
Stage 2	6.9
AFP level
> 400 ng/mL	10.8	0.6792
< 400 ng/mL	6.5
A decrease in AFP > 50% after treatment
Yes	20.7 (95% CI: 1.7-NA)	0.3072
No	7.1 (95% CI: 6.3-24.3)

¹P value was calculated by Fisher’s exact test;

²P value was calculated by Log-rank test. AFP: Alpha fetoprotein; NA: Not assessable.

Table 4 Comparison of patients who responded and patients with progressive disease

Characteristic	CR	PR	SD	PD	CR + PR + SD	P valuea
AFP level						0.357
> 400 ng/mL	0 (0)	1 (3.2)	6 (19.4)	24 (77.4)	7 (22.6)
< 400 ng/mL	1 (4.6)	4 (18.2)	3 (13.6)	14 (63.6)	8 (36.4)
A decrease in AFP > 50% after treatment	1 (6.3)	4 (25.0)	2 (12.5)	9 (56.3)	7 (43.8)	0.182
Overall survival, mo	66.8	NA	20.7 (95% CI: 20.7-33.3)	6.9 (95% CI: 6.3-10.8)	33.3 (95% CI: 20.7-NA)	0.003b

AFP: Alpha fetoprotein; CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; NA: Not assessable.

^aP < 0.05 between the two groups (CR + PR + SD vs PD);

^bP = 0.0003 (less than 0.005) between progress disease and CR + PR + SD.