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©The Author(s) 2020.
World J Gastroenterol. Aug 14, 2020; 26(30): 4465-4478
Published online Aug 14, 2020. doi: 10.3748/wjg.v26.i30.4465
Published online Aug 14, 2020. doi: 10.3748/wjg.v26.i30.4465
Table 1 Characteristics of patients with advanced hepatocellular carcinoma treated with lenvatinib
All (n = 54) | HBV-related HCC (n = 40) | |
Age, yr | 58.94 ± 12.10 | 57.49 ± 12.03 |
Gender (male:female) | 46:8 | 35:5 |
Height, cm | 172.04 ± 7.65 | 171.72 ± 7.24 |
Weight, kg | 70.47 ± 13.72 | 69.21 ± 12.35 |
Etiology (HBV:HCV:Others) | 40:5:9 | 40 |
Total bilirubin, mg/dL | 29.81 ± 31.35 | 32.40 ± 33.17 |
Albumin, g/dL | 38.53 ± 5.64 | 38.73 ± 5.01 |
Prothrombin time, positive, % | 14 (26%) | 10 (25%) |
Extrahepatic spread | 18 (33.3%) | 12 (30%) |
Lymphatic metastasis | 33 (61%) | 28 (70%) |
Liver occupation (< 50%: > 50%) | 38:15 | 27:13 |
Portal vein thrombus | 21 (39%) | 16 (40%) |
Baseline AFP (ng/mL)(≥ 200: < 200) | 32:22 | 22:18 |
Native: Recurrence | 28:26 | 19:21 |
History of treatment (TACE: RFA: Targeted therapy) | 37:21:17 | 29:14:14 |
History of Radiotherapy | 11 (20%) | 7 (18%) |
Initial dose of LEN (8 mg: 12 mg) | 26:28 | 21:19 |
Diagnostic method (Image: Pathology) | 25:29 | 21:19 |
Size of target lesion, cm | 6.93 ± 4.75 | 7.25 ± 4.36 |
Table 2 Combination characteristics of patients with advanced hepatocellular carcinoma treated with lenvatinib
All (n = 54) | HBV-related HCC (n = 40) | |
ECOG PS (0: 1: 2) | 11:38:5 | 9:28:3 |
Child-Pugh score (5: 6: 7: 8) | 29:15:7:3 | 21:13:4:2 |
ALBI grade (1: 2: 3) | 27:25:2 | 20:19:1 |
BCLC stage (B: C) | 18:36 | 12:28 |
TNM stage (IIIA: IIIB: IVA: IVB) | 8:7:18:21 | 3:6:16:15 |
Table 3 Efficacy of lenvatinib in patients with advanced hepatocellular carcinoma
Investigator review according to RECIST 1.1 | ALL (n = 54) | HBV-related HCC (n = 40) | P value |
Progression-free survival (d, 95%CI) | 168 (130-205) | 175 (124-226) | 0.250 |
Time to progression (d, 95%CI) | 153 (116-189) | 156 (126-186) | 0.520 |
Objective response | 22% | 25% | 0.753 |
Complete response | 0 | 0 | - |
Partial response | 12 | 10 | - |
Stable disease | 36 | 26 | 0.866 |
Progressive disease | 6 | 4 | - |
Disease control rate | 88% | 90% | 0.863 |
Decreased AFP predicts tumor reduction | |||
Se | 56.7% | 53.8% | - |
Sp | 83.3% | 85.7% | - |
Table 4 Lenvatinib-related adverse events in patients with hepatocellular carcinoma, n (%)
Event | Hepatocellular carcinoma (n = 56) | |
Any grade | Grade 3-4 | |
Any adverse event | 52 (92.9) | 11 (21.2) |
Hypertension | 25 (44.6) | 2 (3.8) |
Fatigue | 10 (17.9) | 0 |
Decreased appetite | 13 (23.2) | 1 (1.9) |
Diarrhea | 13 (23.2) | 2 (3.8) |
Proteinuria | 12 (21.4) | 5 (9.6) |
Decreased weight | 3 (5.4) | 0 |
Hand-foot skin reaction | 6 (10.7) | 0 |
Nausea | 5 (8.9) | 0 |
Abdominal pain | 4 (7.1) | 0 |
Rash | 4 (7.1) | 1 (1.9) |
Decreased platelet count | 3 (5.4) | 0 |
Vomiting | 1 (1.8) | 0 |
Hypothyroidism | 2 (3.6) | 0 |
Dysphonia | 1 (1.8) | 0 |
Table 5 Multivariate analysis of the objective response rate and progression-free survival in patients with advanced hepatocellular carcinoma treated with lenvatinib
Clinical factors | Category | Analysis of ORR | Analysis of PFS | ||
P value | OR, 95%CI | P value | HR, 95%CI | ||
Age (yr) | < 58.8 | 0.489 | 0.978 (0.919-1.041) | 0.010 | 0.959 (0.929-0.990) |
Gender | Male | 0.571 | 1.828 (0.227-14.724) | 0.606 | 1.137 (0.698-1.850) |
HBV infection | HBV | 0.371 | 2.300 (0.370-14.290) | 0.151 | 1.844 (0.799-4.257) |
First-line therapy | Sorafenib | 0.212 | 0.324 (0.055-1.901) | 0.167 | 1.724 (0.796-3.734) |
Extrahepatic spread | Without | 0.604 | 0.600 (0.088-4.118) | 0.443 | 0.675 (0.247-1.844) |
Tumor occupation | < 50% | 0.937 | 1.080 (0.162-7.178) | 0.169 | 2.043 (0.738-5.654) |
Portal vein thrombus | Without | 0.987 | 0.985 (0.167-5.817) | 0.037 | 0.381 (0.154-0.944) |
History of TACE | With | 0.396 | 2.229 (0.350-14.186) | 0.776 | 0.875 (0.348-2.197) |
Combination factors | |||||
ECOG-PS score | 0 | 0.066 | 3.571 (0.876-14.564) | 0.05 | 4.9 (0.998-24.193) |
ALBI stage | 1 | 0.651 | - | 0.462 | 0.574 (0.130-2.524) |
Child-Pugh class | A | 0.061 | - | 0.042 | 0.468 (0.225-0.973) |
BCLC stage | B | 0.487 | 1.593 (0.425-5.971) | 0.031 | 0.465 (0.232-0.931) |
- Citation: Wang DX, Yang X, Lin JZ, Bai Y, Long JY, Yang XB, Seery S, Zhao HT. Efficacy and safety of lenvatinib for patients with advanced hepatocellular carcinoma: A retrospective, real-world study conducted in China. World J Gastroenterol 2020; 26(30): 4465-4478
- URL: https://www.wjgnet.com/1007-9327/full/v26/i30/4465.htm
- DOI: https://dx.doi.org/10.3748/wjg.v26.i30.4465