[Efficacy and safety of combined immunotherapy and targeted therapy as adjuvant treatment for hepatocellular carcinoma with microvascular invasion after surgery].

Objective

To compare and analyze the efficacy and safety of immune checkpoint inhibitors (ICIs) combined with tyrosine kinase inhibitors (TKIs) as adjuvant therapy after surgery for hepatocellular carcinoma (HCC) with microvascular invasion (MVI).

Methods

Patients with HCC accompanied with MVI who underwent R0 liver resection at the First Medical Center of the PLA General Hospital between January 2016 and December 2024 were retrospectively enrolled. The clinicopathological data, surgical details, and follow-up data were recorded. Adverse events after medication were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Recurrence-free survival (RFS) and overall survival (OS) curves were plotted using the Kaplan-Meier method and compared with the Log-rank test. The Cox proportional hazards regression model was used to analyze factors influencing recurrence.

Results

The study included 39 patients in the adjuvant therapy group and 41 patients in the follow-up observation group. There were no significant differences in baseline characteristics between the two groups (all P>0.05). The follow-up time [M(Q1, Q3)] was 21.8 (10.9, 50.7) months. The RFS rates at 6, 12, 24, and 36 months in the adjuvant therapy group were 92.3%, 76.0%, 71.2%, and 51.8%, respectively, all higher than those in the follow-up observation group (75.1%, 56.3%, 44.3%, and 16.9%). The median RFS in the adjuvant therapy group was 46.7 months (95%CI:15.19-78.22), significantly better than the 19.33 months (95%CI: 3.22-35.44) in the follow-up observation group (P=0.004). The median OS was not reached in either group(P=0.480). Multivariate Cox analysis showed that postoperative adjuvant therapy (HR=0.46, 95%CI: 0.24-0.89, P=0.020) and liver cirrhosis (HR=2.22, 95%CI: 1.00-4.92, P=0.050) were influencing factors for RFS. In terms of safety, 43.59% (17/39) of patients in the adjuvant therapy group experienced grade 1-4 adverse events, and 15.38% (6/39) experienced grade 3 or higher adverse events, primarily manifested as abnormal liver and kidney function, rash, etc. No treatment-related deaths occurred, and the safety profile was manageable.

Conclusion

For patients with HCC accompanied by MVI, postoperative adjuvant therapy with immunotherapy combined with targeted therapy significantly prolongs recurrence-free survival, reduces the risk of recurrence, and demonstrates a manageable safety profile.