Development And Validation Of A Simple Model For Detection Of Early Hepatocellular Carcinoma In A Liver Cirrhosis Cohort

Figures & data

Table 1 Baseline Characteristics Of The Study Population

Variables	All Patients	Analysis Group	Validation Group	P value
Sex F/M	113/298	68/166	45/132	0.44
Age (years)	54.34±10.83	54.37±10.55	54.32±11.23	0.43
ALT	32 (4–1138)	33.5 (6–1138)	31 (4–547)	0.58
AST	36 (10–1217)	35 (10–1217)	38 (13–427)	0.15
GGT	34 (7–1082)	32 (7–1082)	37 (11–304)	0.14
TBiL	22.3 (6.3–573.5)	22.42 (6.3–133)	22.2 (8–573.5)	0.87
ALB	35.64±6.28	35.55±6.06	35.76±6.57	0.11
D-Dimer	0.7 (0.05–28.26)	0.8 (0.1–27.4)	0.6 (0.05–28.26)	0.26
PTA	73.1±16.67	71.88±17.09	74.7±16.02	0.16
PLT (x10^9/L)	112.12±82.37	107.99±75.02	117.59±91.13	0.15
AFP	3.3 (0.5–19,549.10)	2.95 (0.60–19,549.10)	3.9 (0.50–7679.70)	0.11
PIVKA-II	25.87 (3.49–30,766.38)	25.18 (3.49–30,766.38)	27.96 (4.40–26,785.97)	0.52
Child–Pugh grade
A	290	173	117	0.09
B	121	61	60
Tumor number
Solitary	156	88	68
Multifocal	13	7	6	0.86
BCLC stage
0	25	15	10	0.68
A	144	80	64

Table 2 Baseline Characteristics Of Analysis Group

Variables	Analysis Group	Early HCC	Liver Cirrhosis	P value
Sex F/M	68/166	18/77	50/89	0.005
Age (years)	54.37±10.55	57.01±9.87	52.56±10.64	0.001
ALT	33.5 (6–1138)	35 (7–728)	33 (6–1138)	0.13
AST	35 (10–1217)	36 (10–1217)	33 (10–598)	0.13
GGT	32 (7–1082)	36 (7–817)	30 (10–1082)	0.12
TBiL	22.42 (6.30–133)	23.50 (6.30–75.10)	21.80 (6.35–133)	0.72
ALB	35.55±6.06	38.08±5.52	33.82±5.81	0.83
D-Dimer (mg/L)	0.80 (0.10–27.4)	0.48 (0.1–20)	0.92 (0.11–27.40)	0.44
PTA	71.88±17.09	80.73±14.96	65.84±15.8	0.51
PLT (x10^9/L)	107.99±75.02	113.09±66.97	104.50±80.10	0.47
AFP (ng/mL)	2.95 (0.60–19,549.10)	15 (0.90–19,549.1)	2 (0.60–121.8)	<0.01
PIVKA-II (mAU/mL)	25.18 (3.49–30,766.38)	90.97 (9.7–30,766.38)	18 (3.49–626.34)	<0.01
Child–Pugh class
A	173	71	102	0.82
B	61	24	37

Figure 1 Difference of PIVKA and AFP plasma levels after logarithmic transformation between early HCC patients and liver cirrhosis in the analysis group. (A) Serum level of PIVKA-II among early HCC patients was 90.97 (9.7–30,766.38) mAU/mL, significantly higher than that of LC patients at 18 (3.49–626.34) mAU/mL (P < 0.01) in analysis group. (B) Serum level of AFP among early HCC patients was 15 (0.9–19,549.1) ng/mL, significantly higher than that of LC patients at 2.00 (0.6–121.8) ng/mL (P < 0.01) in analysis group.

Figure 2 Diagnostic values of AFP (green), PIVKA-II (purple), the logistic regression model (blue), and the simple model (red) for early HCC detection among lLC patients in the analysis group.

Table 3 Univariate And Multivariate Analyses Of All Characteristics In Analysis Group

Characteristic	Univariate Analysis		Multivariate Analysis
OR (95% CI)	P value	OR (95% CI)	P value
Sex F/M	2.11(1.15, 3.85)	0.02	2.70 (1.01, 7.16)	0.047
Age (years)	1.04 (1.01, 1.06)	< 0.01	1.04 (1.00, 1.08)	0.031
ALT	1.00 (0.99, 1.01)	0.13	–
AST	0.99 (0.98, 1.02)	0.17	–
GGT	1.00 (0.99, 1.01)	0.28	–
TBiL	0.99 (0.98, 1.00)	0.33	–
ALB	0.89 (0.76, 1.14)	0.27	–
D-Dimer (mg/L)	1.04 (0.98, 1.11)	0.21	–
PTA	0.96 (0.91, 1.05)	0.14	–
PLT (x10^9/L)	1.00 (0.99, 1.01)	0.39	–
AFP (ng/mL)	1.04 (1.02, 1.06)	< 0.01	1.03 (1.01, 1.05)	0.001
PIVKA-II (mAU/mL)	1.02 (1.01, 1.03)	< 0.01	1.02 (1.01, 1.03)	< 0.01
Child–Pugh class	0.88 (0.76, 1.10)	0.37	–	–

Table 4 Baseline Characteristics Of Validation Group

Variables	Validation Group	Early HCC	Liver Cirrhosis	P value
Sex F/M	45/132	9/65	36/67	0.001
Age (years)	54.32±11.23	56.24±10.70	52.94±11.46	0.04
ALT	31 (4–547)	34.05 (4–547)	28 (6–252)	0.19
AST	38 (13–427)	39.5 (13–252)	36 (13–427)	0.84
GGT	37 (11–304)	42.5 (14–96)	34 (11–304)	0.06
TBiL	22.2 (8–573.5)	20.68 (8.67–67.70)	22.80 (8.00–573.5)	0.23
ALB	35.76±6.57	35.13±5.73	36.22±7.11	0.26
D-Dimer (mg/L)	0.6 (0.05–28.26)	0.41 (0.07–11.44)	0.69 (0.05–28.26)	0.17
PTA	74.7±16.02	72.64±13.29	76.19±17.64	0.15
PLT (x10^9/L)	117.59±91.13	127.01±59.67	110.82±108.03	0.20
AFP (ng/mL)	3.9 (0.50–7679.70)	20 (1.2–7679.7)	2.5 (0.50–16.8)	<0.01
PIVKA-II (mAU/mL)	27.96 (4.40–26,785.97)	108.32 (4.4–26,785.97)	20.14 (5.00–237.00)	<0.01
Child–Pugh class
A	110	47	63	0.88
B	67	27	40

Figure 3 Diagnostic values of the logistic regression model and the simple model for early HCC detection among LC patients in the validation group.

Figure 4 Validity of the predictive performance of the logistic model (A) and the simple model (B) in estimating the probabilities of early HCC in the validation group (n= 177).