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. 2023 Sep 6:10:1465-1477.
doi: 10.2147/JHC.S424616. eCollection 2023.

Adjuvant Lenvatinib Plus PD-1 Antibody for Hepatocellular Carcinoma with High Recurrence Risks After Hepatectomy: A Retrospective Landmark Analysis

Jingzhong Ouyang #  1 , Zhengzheng Wang #  1 , Kun Yuan #  2 , Yi Yang  3   4 , Yanzhao Zhou  1 , Qingjun Li  1 , Nanmu Yang  1 , Haitao Zhao  5 , Hong Zhao  3   4 , Jinxue Zhou  1
Affiliations

Adjuvant Lenvatinib Plus PD-1 Antibody for Hepatocellular Carcinoma with High Recurrence Risks After Hepatectomy: A Retrospective Landmark Analysis

Jingzhong Ouyang et al. J Hepatocell Carcinoma. .

Abstract

Purpose: To evaluate the efficacy and safety of lenvatinib plus programmed death-1 (PD-1) antibody as postoperative adjuvant therapy in patients with hepatocellular carcinoma (HCC) at high risks of recurrence.

Patients and methods: A series of 137 patients with HCC at high risks of recurrence who underwent hepatectomy at our hospital between October 2019 and January 2022 were retrospectively analyzed. Recurrence-free survival (RFS), overall survival (OS), and treatment-related adverse events (TRAEs) were assessed. Landmark analysis was used to compare short- and long-term RFS. Univariable and multivariable analyses were used to identify prognostic factors, and subgroup analyses were performed according to high risks of recurrence.

Results: A total of 85 patients underwent hepatectomy alone and 52 patients received postoperative adjuvant therapy. Compared with the hepatectomy group (HG), RFS was significantly improved in the adjuvant therapy group (ATG) (P < 0.001), but OS was not (P = 0.098). Landmark analysis revealed that RFS within 6 months of the HG was significantly different from that of the ATG (P < 0.001) but not after 6 months (P = 0.486). Multivariable analysis showed that without adjuvant therapy, high Child-Pugh classification, high alpha-fetoprotein levels, microvascular invasion, and satellite lesions were independent risk factors for recurrence within 6 months after hepatectomy. Subgroup analysis revealed that patients with MVI significantly benefited from adjuvant therapy in RFS. But for OS, adjuvant therapy was only significantly effective in patients with single tumor. The most common treatment-related adverse events during adjuvant therapy were hypertension (36.5%), rash or itching (28.8%), diarrhea (23.1%), and fatigue (21.2%).

Conclusion: Postoperative adjuvant lenvatinib plus PD-1 antibody significantly improved RFS in patients with HCC at high risks of recurrence with acceptable safeties.

Keywords: PD-1 antibody; efficacy; hepatocellular carcinoma; lenvatinib; postoperative adjuvant therapy; safety.

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Conflict of interest statement

All authors have no conflicts of interest to declare in this work.

Figures

Figure 1
Figure 1
Flowchart of patient enrollment. HCC, hepatocellular carcinoma; R0 surgical margin, no residual cancer cells by eyes or microscope; TRAEs, treatment-related adverse events; the HG, the hepatectomy group; the ATG, adjuvant therapy group.
Figure 2
Figure 2
Kaplan‒Meier survival curves based on recurrence-free survival (A) and overall survival (B) of the adjuvant therapy group (ATG) and the hepatectomy group (HG).
Figure 3
Figure 3
Landmark analysis based on recurrence-free survival of the adjuvant therapy group (ATG) and the hepatectomy group (HG).
Figure 4
Figure 4
Subgroup analysis of recurrence-free survival (A) and overall survival (B) stratified by age, AFP level, BCLC stage, number, max size, microvascular invasion (MVI), Edmonson tumor grade, and satellite lesion between adjuvant therapy group and the hepatectomy group.
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