Real-Life Clinical Data of Lenvatinib versus Sorafenib for Unresectable Hepatocellular Carcinoma in Italy

Figures & data

Figure 1 CONSORT diagram of the study.

Table 1 Patient Characteristics Before and After Propensity Score Matching

	Before Propensity Score Matching			After Propensity Score Matching
	Sorafenib	Lenvatinib	P value	Sorafenib	Lenvatinib	P value
	%	%		%	%
	N = 289 Patients	N = 144 Patients		N = 144 Patients	N = 144 Patients
Gender
Male	85.5	77.1		82.6	77.1	0.24
Female	14.5	22.9	0.48	17.4	22.9
Age
<70	54.0	52.8		52.7	52.8	1.00
>70	46.0	47.2	0.83	68	47.2
Etiology
HCV	48.8	46.5		48.6	46.5	0.34
HBV	20.8	15.2		21.5	15.2
NASH	11.1	13.9		12.5	13.9
Others	19.3	24.4	0.33	17.4	24.4
TACE before
Yes	44.3	41.0		41.0	41.0	1.00
No	55.7	59.0	0.53	59.0	59.0
Child-Pugh
A	88.6	94.9		93.0	94.9	0.61
B	11.4	5.1	0.03	7.0	5.1
BCLC
C	81.3	75.0		75.0	75.0	1.00
B	18.7	25.0	0.12	25.0	25.0
ECOG
0	58.5	78.9		78.9	78.9	1.00
>0	41.5	21.1	0.000025	21.1	21.1
AFP
<400	69.2	64.6		69.3	64.6	0.43
>400	30.8	35.4	0.07	30.7	35.4
NLR
<3	60.4	65.1		65.4	65.1	1.00
>3	39.6	34.9	0.38	34.6	34.9
Bilirubin
<NV	80.1	64.0		66.9	64.0	0.70
>NV	19.9	36.0	0.006	33.1	36.0
Albumin
<35	24.2	13.5		21.3	13.5	0.13
>35	75.8	86.5	0.53	78.7	86.5

Table 2 Univariate and Multivariate Cox Analysis of Factors Associated with Mortality

	Univariate Analysis		Multivariate Analysis
Treatment
Sorafenib	1		1	0.0115
Lenvatinib	0.52 (0.34–0.81)	0.0034	0.54 (0.27–0.73)
Alpha-fetoprotein
<400	1		1	0.0030
>400	1.71 (1.14–2.55)	0.0083	1.79 (1.22–2.63)
BCLC
B	1		1	0.0153
C	1.60 (1.10–2.33)	0.0127	1.78 (1.11–2.85)
Child Pugh
A	1		1	<0.0001
B	18.08 (6.39–51.1)	<0.0001	4.49 (2.49–8.09)
Etiology
HCV	1
HBV	1.23 (0.80–1.91)
NASH	0.90 (0.39–2.03)
Others	1.54 (0.94–2.52)	0.21
NLR
<3	1
>3	1.09 (0.74–1.60)	0.65
Portal vein thrombosis
No	1
Yes	1.99 (1.35–2.90)	0.0004
ECOG
0	1
>0	1.39 (0.87–2.20)	0.1610

Figure 2 Kaplan-Meier curves for OS in sorafenib and lenvatinib cohorts (A), and Kaplan-Meier curves for PFS in sorafenib and lenvatinib cohorts (B).

Table 3 Adverse Events in Sorafenib and Lenvatinib Arms

	Lenvatinib Arm	Sorafenib Arm	P
	%	%
All toxicity
No	2.8	2.1	1.00
Yes	97.2	97.9
GRADE
1–2	67.8	72.3	0.43
>2	29.4	25.6
HFSR
No	89.5	61.8	<0.000001
Yes	10.5	38.2
GRADE
1–2	5.5	29.9	0.17
>2	5.0	8.3
Diarrhea
No	72.9	69.5	0.60
Yes	37.1	30.5
GRADE
1–2	37.1	26.4	0.02
>2	0.0	4.1
Hypertension
No	64.6	75.7	0.053
Yes	35.4	24.3
GRADE
1–2	9.0	19.4	0.000001
>2	26.4	4.9
Fatigue
No	59.0	70.8	0.04
Yes	41.0	29.2
GRADE
1–2	25.0	24.3	0.01
>2	16.0	4.9
Decrease appetite
No	67.4	NR
Yes	32.6	NR
GRADE
1–2	20.1	NR
>2	12.5	NR
Proteinuria
No	93.0	NR
Yes	7.0	NR
GRADE
1–2	4.2	NR
>2	2.8	NR
Hypothyroidism
No	73.6	NR
Yes	26.4	NR
GRADE	GRADE
1–2	9.7	NR
>2	16.7	NR
Other toxicity
No	68.7	54.9	0.01
Yes	31.3	45.1
GRADE
1–2	17.4	38.9	0.001
>2	13.9	6.2

Note: In bold font positive results.

Figure 3 Different response rates between sorafenib and lenvatinib.

Figure 4 Forest plot for overall survival (A) and progression free survival (B).