Clinical outcomes of lenvatinib plus transarterial chemoembolization with or without programmed death receptor-1 inhibitors in unresectable hepatocellular carcinoma

doi:10.3748/wjg.v29.i10.1614

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Mar 14, 2023 (publication date) through Aug 23, 2024

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Retrospective Study

World J Gastroenterol. Mar 14, 2023; 29(10): 1614-1626
Published online Mar 14, 2023. doi: 10.3748/wjg.v29.i10.1614

Table 1 The baseline characteristics of included patients (n, %)

	Overall	Lenvatinib + TACE + PD-1	Lenvatinib + TACE	P value
Patient characteristics
Number (n)	65	45	20
Age, median (range), yr	57 (18-79)	54 (18-79)	62 (26-75)	0.066¹
< 65	50 (76.92)	38 (84.44)	12 (60.00)
≥ 65	15 (23.08)	7 (15.56)	8 (40.00)
Gender				0.095¹
Female	8 (12.31)	3 (6.67)	5 (25.00)
Male	57 (87.69)	42 (93.33)	15 (75.00)
ECOG-PS				0.154¹
0	33 (50.77)	26 (57.78)	7 (35.00)
1	32 (49.23)	19 (42.22)	13 (65.00)
Etiology				0.002¹
HBV	54 (83.08)	42 (93.33)	12 (60.00)
HCV	4 (6.15)	2 (4.44)	2 (10.00)
Non-HBV, non-HCV	7 (10.77)	1 (2.22)	6 (30.00)
Hepatic cirrhosis				0.879¹
Yes	43 (66.15)	29 (64.44)	14 (70.00)
No	22 (33.85)	16 (35.56)	6 (30.00)
AFP				0.551¹
< 400	21 (32.31)	13 (28.89)	8 (40.00)
≥ 400	44 (67.69)	32 (71.11)	12 (60.00)
Child-Pugh score				0.095¹
A5	48 (73.85)	30 (66.67)	18 (90.00)
A6 or B7	17 (26.15)	15 (33.33)	2 (10.00)
BCLC stage				1.000¹
A or B	16 (24.62)	11 (24.44)	5 (25.00)
C	49 (75.38)	34 (75.56)	15 (75.00)
Tumor characteristics
Tumor size				0.035¹
< 7 cm	25 (38.46)	13 (28.89)	12 (60.00)
≥ 7 cm	40 (61.54)	32 (71.11)	8 (40.00)
Tumor number				0.260¹
Single	21 (32.31)	17 (37.78)	4 (20.00)
Multiple	44 (67.69)	28 (62.22)	16 (80.00)
TBS group				0.173¹
L	23 (35.38)	13 (28.89)	10 (50.00)
H	42 (64.62)	32 (71.11)	10 (50.00)
Portal vein tumor thrombus				0.108¹
Presence	24 (36.92)	20 (44.44)	4 (20.00)
Absence	41 (63.08)	25 (55.56)	16 (80.00)
Extrahepatic metastasis				0.376¹
Yes	23 (35.38)	18 (40.00)	5 (25.00)
No	42 (64.62)	27 (60.00)	15 (75.00)
TACE times				0.260¹
< 3	44 (67.69)	28 (62.22)	16 (80.00)
≥ 3	21 (32.31)	17 (37.78)	4 (20.00)

¹χ² test.

AFP: Alpha-fetoprotein; BCLC: Barcelona Clinic Liver Cancer; ECOG-PS: Eastern Cooperative Oncology Group performance status; HBV: Hepatitis B virus; HCV: Hepatitis C virus; PD-1: Programmed death receptor-1; TACE: Transarterial chemoembolization; TBS: Tumor burden score.

Table 2 Therapeutic efficacy in all patients, n (%)

	Lenvatinib + TACE + PD-1 (n = 45)	Lenvatinib + TACE (n = 20)	P value
CR	0 (0)	0 (0)
PR	20 (44.4)	4 (20)
SD	22 (48.9)	9 (45)
PD	3 (6.7)	7 (35)
ORR	20 (44.4)	4 (20)	0.059¹
DCR	42 (93.3)	13 (64)	0.003¹

¹χ² test.

²Fisher’s exact test.

BCLC: Barcelona Clinic Liver Cancer; DCR: Disease control rate; ORR: Objective response rate; PD: Progressive disease; PR: Partial response; SD: Stable disease; PD-1: Programmed death receptor-1; TACE: Transarterial chemoembolization.

Table 3 Therapeutic efficacy in patients with stage A or B and stage C, n (%)

	BCLC A or B			BCLC C
	Lenvatinib + TACE + PD-1 (n = 11)	Lenvatinib + TACE (n = 5)	P value	Lenvatinib + TACE + PD-1 (n = 34)	Lenvatinib + TACE (n = 15)	P value
CR	0 (0)	0 (0)		0 (0)	0 (0)
PR	8 (72.7)	1 (20)		12 (35.3)	3 (20.0)
SD	3 (27.3)	2 (40)		19 (55.9)	7 (46.7)
PD	0 (0)	2 (40)		3 (8.8)	5 (33.3)
ORR	8 (72.7)	1 (20)	0.077²	12 (35.3)	3 (20)	0.235²
DCR	11(100)	3 (60)	0.083²	31 (91.2)	10 (66.7)	0.047²

¹χ² test.

²Fisher’s exact test.

Table 4 Adverse events, n (%)

AEs	Lenvatinib + TACE + PD-1		Lenvatinib + TACE
AEs	All grades	Grade 3/4	All grades	Grade 3/4
Decreased appetite	19 (42.2)	3 (6.7)	7 (35.0)	2 (10.0)
Elevated AST	18 (40)	3 (6.7)	5 (25.0)	0 (0)
Decreased albumin	18 (40)	2 (4.4)	6 (30.0)	1 (5.0)
Fatigue	17 (37.8)	3 (6.7)	8 (40.0)	1 (5.0)
Diarrhoea	13 (28.9)	5 (11.1)	4 (20.0)	1 (5.0)
Hypertension	13 (28.9)	3 (6.7)	3 (15.0)	0 (0)
Elevated blood bilirubin	13 (28.9)	2 (4.4)	5 (25.0)	0 (0)
Decreased platelet count	13 (28.9)	2 (4.4)	5 (25.0)	1 (5.0)
Hypothyroidism	12 (26.7)	2 (4.4)	3 (15.0)	0 (0)
Abdominal pain	11 (24.4)	2 (4.4)	4 (20.0)	1 (5.0)
Elevated ALT	11 (24.4)	2 (4.4)	4 (20.0)	0 (0)
Rash	8 (17.8)	2 (4.4)	2 (10.0)	0 (0)
Decreased WBC	7 (15.6)	0 (0)	4 (20.0)	0 (0)
Vomiting	7 (15.6)	0 (0)	3 (15.0)	0 (0)
Hypocalcemia	6 (13.3)	0 (0)	5 (25.0)	0 (0)
Palmar-plantar erythrodysaesthesia	5 (11.1)	0 (0)	1 (5.0)	0 (0)
Nausea	4 (8.9)	0 (0)	4 (20.0)	0 (0)
Elevated WBC	4 (8.9)	0 (0)	3 (15.0)	0 (0)
Gingival bleeding	4 (8.9)	0 (0)	1 (5.0)	0 (0)
Gastrointestinal hemorrhage	4 (8.9)	1 (2.2)	0 (0)	0 (0)
Decreased weight	3 (6.7)	0 (0)	2 (10.0)	0 (0)
Dysphonia	3 (6.7)	0 (0)	2 (10.0)	0 (0)
Proteinuria	1 (2.2)	1 (2.2)	1 (5.0)	0 (0)

AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; WBC: White blood cell; AEs: Adverse events; PD-1: Programmed death receptor-1; TACE: Transarterial chemoembolization.

Citation: Wang YY, Yang X, Wang YC, Long JY, Sun HS, Li YR, Xun ZY, Zhang N, Xue JN, Ning C, Zhang JW, Zhu CP, Zhang LH, Yang XB, Zhao HT. Clinical outcomes of lenvatinib plus transarterial chemoembolization with or without programmed death receptor-1 inhibitors in unresectable hepatocellular carcinoma. World J Gastroenterol 2023; 29(10): 1614-1626
URL: https://www.wjgnet.com/1007-9327/full/v29/i10/1614.htm
DOI: https://dx.doi.org/10.3748/wjg.v29.i10.1614