Molecular biomarkers of sintilimab plus lenvatinib in hepatitis-B-virus-associated hepatocellular carcinoma

Table 1 Patients’ baseline characteristics evaluated by modified Response Evaluation Criteria in Solid Tumors, n (%)

Characteristic	Response group (CR + PR, n = 22)	Non-response group (SD + PD, n = 11)	P value
Median age (year)			0.488
< 60	13 (59)	5 (46)
≥ 60	9 (41)	6 (54)
Sex			0.033a
Male	21 (95)	7 (64)
Female	1 (5)	4 (36)
ECOG PS			0.017a
0	18 (82)	4 (36)
1	4 (18)	7 (64)
BCLC stage			1.000
B	11 (50)	5 (45)
C	11 (50)	6 (55)
Tumor number			1.000
1	12 (55)	6 (55)
2-3	6 (27)	3 (27)
≥ 4	4 (18)	2 (18)
Size of the largest tumor (cm)			0.593
< 5	3 (14)	2 (18)
5-10	10 (45)	3 (27)
≥ 10	9 (41)	6 (55)
Serum alpha-fetoprotein level			0.488
< 400 ng/mL	13 (59)	5 (45)
≥ 400 ng/mL	9 (41)	6 (55)
Conversion to surgery			0.132
Yes	11 (50)	2 (18)
No	11 (50)	9 (82)

^aP < 0.05. P values for differences between two groups were obtained by Fisher’s exact test.

CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; ECOG PS: Eastern Cooperative Oncology Group performance status; BCLC: Barcelona Clinic Liver Cancer.

Table 2 Univariate and multivariate Cox regression analysis of factors associated with progression-free survival (backward stepwise selection with Wald criteria)

	Number	Univariate HR	P value	Multivariate HR	P value
Tumor number (single/multiple)	18/15	0.33 (0.14-0.78)	0.01	0.31 (0.11-0.85)	0.02
AFP (< 400/≥ 400 ng/mL)	18/15	0.49 (0.22-1.11)	0.09	-	-
CUX1 (wild/mutant)	30/3	0.22 (0.06-0.79)	0.02	-	-
LINC01554 (high/Low)	15/15	0.32 (0.13-0.79)	0.01	0.16 (0.05-0.49)	0.01
WHRN (high/Low)	15/15	0.39 (0.16-0.94)	0.04	-	-
CD4+ Tcm (high/Low)	9/21	0.43 (0.16-1.19)	0.10	0.29 (0.08-0.98)	0.05

HR: Hazard ratio; AFP: Alpha-fetoprotein; CUX1: Cut-like homeobox 1; LINC01554: Long intergenic non-protein coding RNA 01554; WHRN: Whirlin; CD4+ Tcm: CD4+ central memory T cells.