Impact of sintilimab plus anlotinib on progression-free survival in advanced unresectable hepatocellular carcinoma

Table 1 Comparison of baseline data between the two groups of patients, n (%)

Index	Experimental group (n = 45)	Control group (n = 45)	χ2/t	P value
Gender			0.102	0.749
Man	34 (75.6)	33 (73.3)
Woman	11 (24.4)	12 (26.7)
Age (years, mean ± SD)	58.6 ± 8.2	59.3 ± 7.9	0.398	0.691
Child-Pugh classification of liver function			0.235	0.628
Class A	30 (66.7)	29 (64.4)
Class B	15 (33.3)	16 (35.6)
BCLC stage			0.189	0.664
B	17 (37.8)	16 (35.6)
C	28 (62.2)	29 (64.4)
ECOG score			0.124	0.725
0-1	37 (82.2)	36 (80.0)
2	8 (17.8)	9 (20.0)
Tumor size (cm, mean ± SD)	5.8 ± 1.6	6.0 ± 1.5	0.592	0.554
Pre-treatment AFP (ng/mL, mean ± SD)	386.5 ± 124.3	392.7 ± 118.9	0.236	0.814
Pre-treatment CA19-9 (ng/mL, mean ± SD)	89.6 ± 32.4	92.3 ± 30.7	0.408	0.684

AFP: Alpha-fetoprotein; CA19-9: Carbohydrate antigen 19-9; BCLC: Barcelona Clinical Stage of Liver Cancer; ECOG: Eastern Cooperative Oncology Group.

Table 2 Comparison of survival indicators between the two groups of patients (mean ± SD)

Survival indicators	Experimental group (n = 45)	Control group (n = 45)	χ2/t	P value
Median progression-free survival (months)	8.9 ± 0.4	4.7 ± 0.5	43.265	< 0.001
Median overall survival (months)	16.8 ± 1.2	10.3 ± 1.0	25.782	< 0.001

Table 3 Comparison of objective response rate and disease control rate between the two groups of patients, n (%)

Efficacy evaluation	Experimental group (n = 45)	Control group (n = 45)	χ2	P value
Complete remission	3 (6.7)	1 (2.2)
Partial remission	19 (42.20)	10 (22.2)
Stable disease	17 (37.8)	18 (40.0)
Progressive disease	6 (13.3)	16 (35.6)
Objective response rate (%)	48.9	24.4	6.895	0.008
Disease control rate (%)	86.7	64.4	6.172	0.013

Table 4 Comparison of changes in tumor markers before and after treatment in the two groups of patients (mean ± SD)

Tumor markers	Group	Before treatment	After treatment	Difference before and after treatment	t	P value
AFP (ng/mL)	Experimental group (n = 45)	386.5 ± 124.3	128.7 ± 49.5	257.8 ± 86.4	8.895	< 0.001
	Control group (n = 45)	392.7 ± 118.9	219.4 ± 78.6	173.3 ± 67.2
CA19-9 (U/mL)	Experimental group (n = 45)	89.6 ± 32.4	32.8 ± 15.7	56.8 ± 21.3	7.052	< 0.001
	Control group (n = 45)	92.3 ± 30.7	57.9 ± 22.4	34.4 ± 18.5

Compared with this group before treatment, all P < 0.05. AFP: Alpha-fetoprotein; CA19-9: Carbohydrate antigen 19-9.

Table 5 Comparison of adverse reaction incidence between the two groups of patients, n (%)

Type of adverse reaction	Experimental group (n = 45)	Control group (n = 45)	χ2	P value
Hypertension	12 (26.7)	9 (20.0)	0.632	0.427
Proteinuria	8 (17.8)	6 (13.3)	0.456	0.499
Diarrhea	10 (22.2)	8 (17.8)	0.358	0.549
Rash	9 (20.0)	7 (15.6)	0.369	0.544
Hypothyroidism	7 (15.6)	6 (13.3)	0.121	0.728
Grade 1-2 adverse reactions	38 (84.4)	36 (80.0)	0.342	0.559
Grade 3-4 adverse reactions	4 (8.9)	3 (6.7)	0.162	0.687
Total adverse reactions	40 (88.9)	37 (82.2)	0.815	0.367

Table 6 Independent risk factors affecting progression-free survival in patients

Risk factors	β	SE	Wald	HR	95%CI	P value
Treatment options (single drug = 1, combination = 0)	-0.876	0.324	7.582	0.416	0.209-0.828	0.006
BCLC stage (stage B = 1, stage C = 2)	0.923	0.351	7.156	2.517	1.215-5.212	0.007
ECOG score (score of 0-1 = 1, score of 2 = 2)	1.058	0.386	7.789	2.881	1.324-6.263	0.005

BCLC: Barcelona Clinical Stage of Liver Cancer; ECOG: Eastern Cooperative Oncology Group; HR: Hazard ratio.