Lenvatinib Plus Camrelizumab versus Lenvatinib Monotherapy as Post-Progression Treatment for Advanced Hepatocellular Carcinoma: A Short-Term Prognostic Study

Figures & data

Table 1 Baseline Characteristics of Patients

	Lenvatinib Group (n=27)	Lenvatinib Plus Camrelizumab Group (n=21)	P
Age,years
>45	19	17	0.401
≤45	8	4
Gender
Male	24	19	0.858
Female	3	2
ECOG-PS
0	18	17	0.269
1	9	4
AFP (ng/mL)
<400	11	12	0.259
≥400	16	9
HBsAg
-	2	4	0.226
+	25	17
TBil (mean±SD (umol/L))	19.90 (16.39–23.88)	15.47 (12.35–18.42)	0.363
ALB (mean±SD (g/L))	39.37 (37.91–41.26)	39.90 (37.58–42.07)	0.328
PT (mean±SD (s))	13.52 (13.04–14.01)	13.02 (12.3–13.83)	0.522
Child-pugh score
5~6	25	19	0.792
7	2	2
Cirrhosis
No	3	2	0.858
Yes	24	19
Tumor type
Primary	11	8
Relapse	16	13	0.853
Portal vein thrombus
No	15	10	0.225
I/II	1	4
III/IV	11	7
Extrahepatic metastasis
No	10	11	0.288
Yes	17	10
Previous treatment
First-line	6	3	0.547
Second-lines	10	11
Third-lines or more	11	7

Abbreviations: ECOG-PS, Eastern Cooperative Oncology Group Performance Status; AFP, α‐fetoprotein; ALB, albumin, PT, prothrombin time.

Figure 1 Survival curves of all patients with advanced hepatocellular carcinoma who underwent lenvatinib plus camrelizumab treatment and lenvatinib monotherapy. (A) cumulative overall survival (OS) curves and, (B) cumulative progression-free survival (rPFS) curves.

Table 2 Univariate and Multivariate Analyses of the Prognostic Factors for OS

Variables	Univariate Analysis			Multivariate Analysis
	Hazard Ratio	95% CI	P value	Hazard Ratio	95% CI	P value
Age, years (>45 vs ≤45)	1.029	0.278–3.804	0.996	0.030	0.001–1.017	0.051
Gender (male vs female)	0.728	0.094–5.639	0.761
ECOG-PS (0 vs 1)	5.801	1.798–18.712	0.003*	13.403	1.766–30.171	0.027*
AFP (≥400 vs <400ng/mL)	3.503	0.937–13.099	0.062	2.432	0.509–11.613	0.265
HBsAg (- VS +)	0.804	0.174–3.719	0.780
TBil (umol/L)	1.047	0.991–1.017	0.098
ALB (g/L)	0.908	0.791–1.042	0.169
PT (s)	1.212	0.902–1.627	0.202
Child-Pugh score (5~6 vs 7)	4.927	1.302–18.642	0.019*	5.981	1.208–29.609	0.040*
Cirrhosis (no vs yes)	1.230	0.159–9.534	0.843
Tumor type (primary vs relapse)	0.370	0.115–1.197	0.097	0.069	0.001–4.951	0.220
Portal vein thrombus (no vs I/II vs III/IV)	1.924	1.008–3.671	0.047*	0.147	0.007–3.133	0.219
Extrahepatic metastasis (no vs yes)	1.112	0.353–3.506	0.856	5.159	0.612–43.454	0.131
Previous treatment (first-line vs second-lines vs third-lines or more)	0.334	0.148–0.756	0.008*
Treatment (lenvatinib group vs lenvatinib plus camrelizumab group)	0.625	0.188–2.077	0.443	5.785	0.221–8.998	0.292

Note: *P<0.05.

Abbreviations: ECOG-PS, Eastern Cooperative Oncology Group Performance Status; AFP, α‐fetoprotein; ALB, albumin, PT, prothrombin time.

Table 3 Univariate and Multivariate Analyses of the Prognostic Factors for PFS

Variables	Univariate Analysis			Multivariate Analysis
	Hazard Ratio	95% CI	P value	Hazard Ratio	95% CI	P value
Age, years (>45 vs ≤45)	1.013	0.984–1.044	0.379
Gender (male vs female)	1.401	0.490–4.008	0.529
ECOG (0 vs 1)	3.236	1.535–6.821	0.002*	10.685	2.888–39.529	<0.001*
AFP (≥400 vs <400ng/mL)	1.300	0.667–2.532	0.441	1.464	0.569–3.765	0.429
HBsAg (- VS +)	0.345	1.336–3.181	0.035*	0.378	0.090–1.582	0.183
TBil (umol/L)	1.026	0.991–1.063	0.152
ALB (g/L)	1.032	0.961–1.108	0.387
PT (s)	1.112	0.899–1.376	0.329
Child-Pugh score (5~6 vs 7)	1.031	0.310–3.423	0.960	2.757	0.631–12.040	0.178
Cirrhosis (no vs yes)	0.643	0.190–2.182	0.479
Tumor type (primary vs relapse)	1.058	0.533–2.099	0.873	0.637	0.170–2.391	0.504
Portal vein thrombus (no vs I/II vs III/IV)	1.015	0.781–1.434	0.934	0.449	0.194–1.038	0.061
Extrahepatic metastasis (no vs yes)	0.832	0.433–1.596	0.579	0.435	0.148–1.278	0.130
Previous treatment (first-line vs second-lines vs third-lines or more)	0.812	0.528–1.249	0.344	0.755	0.387–1.471	0.409
Treatment (lenvatinib group vs Lenvatinib plus camrelizumab group)	0.434	0.217–0.867	0.018*	0.365	0.148–0.897	0.028*

Note: *P<0.05.

Abbreviations: ECOG-PS, Eastern Cooperative Oncology Group Performance Status; AFP, α‐fetoprotein; ALB, albumin, PT, prothrombin time.

Table 4 Best Anti-Tumor Response According to the mRECIST

	Lenvatinib Group (n=27)	Lenvatinib Plus Camrelizumab Group(n=21)
Complete response	0 (0%)	0 (0%)
Partial response	2 (7.41%)	6 (28.57%)
Stable disease	12 (44.44%)	9 (42.86%)
Progressive disease	13 (38.15%)	6 (28.57%)
Objective Response Rate	7.41%	28.57%
Disease Control Rate	51.85%	71.43%

Note: Responses were evaluated according to modified Response Evaluation Criteria in Solid Tumors version by investigators.

Table 5 Treatment-Related Adverse Events

	Lenvatinib Group (n=27)		Lenvatinib Plus Camrelizumab Group (n=21)
	All Grade	Grade3/4	All Grade	Grade3/4
Hand-foot skin reaction	2 (7.41%)	1 (3.70%)	5 (23.81%)	1 (4.76%)
Hypertension	6 (22.22%)	4 (14.81%)	7 (33.33%)	3 (14.29%)
RECCP	0	0	3 (14.29%)	0
Weight loss	0	0	0	0
Decreased appetite	1 (3.70%)	0	0	0
Nausea	4 (14.81%)	0	0	0
Diarrhea	2 (7.41%)	1 (3.70%)	2 (9.52%)	0
Alopecia	2 (7.41%)	0	1 (4.76%)	0
Weakness	1 (3.70%)	0	0	0
Rash	2 (7.41%)	0	0	0
Hemorrhage	2 (7.41%)	0	0	0
Hoarseness	0	0	1 (4.76%)	0
Mucositis	1 (3.70%)	0	0	0
Pain	3 (11.11%)	0	1 (4.76%)	0
Myelosuppression
Decreased white blood cell	1 (3.70%)	1 (3.70%)	1 (4.76%)	0
Decreased red blood cell	1 (3.70%)	0	0	0
Decreased platelet count	1 (3.70%)	0	2 (9.52%)	1 (4.76%)
Abnormal hepatic function
Increased blood bilirubin	4 (14.81%)	0	1 (4.76%)	0
Increased alanine aminotransferase	6 (22.22%)	0	2 (9.52%)	0
Increased aspartate aminotransferase	7 (25.93%)	0	5 (23.81%)	0
Abnormal renal function
Proteinuria	4 (14.81%)	0	3 (14.29%)	0
Increased creatinine	0	0	0	0
Increased urea nitrogen	0	0	0	0
Abnormal cardiac function
Increased creatine kinase	0	0	4 (19.05%)	0
Increased creatine kinase isoenzyme	0	0	3 (14.29%)	0
Hypothyroidism	0	0	2 (9.52%)	0

Abbreviation: RECCP, reactive cutaneous capillary endothelial proliferation.