Abstract 217P
Background
Several studies have shown that adjuvant immune checkpoint inhibitor (ICI) therapy can improve recurrence-free survival of patients with hepatocellular carcinoma (HCC) after curative resection. This study evaluates the efficacy and safety of adjuvant tislelizumab in HCC with high-risk of recurrence after curative resection.
Methods
This is a prospective, observational, multicenter, single-arm study. Pts with high risk factor of HCC recurrence, including tumor size > 5 cm, multinodular, macrovascular invasion or microvascular invasion, were included. Within 4 to 8 weeks after curative resection, pts received tislelizumab (200mg/kg, IV, D1, Q3W) with or without tyrosine kinase inhibitor (TKI) as adjuvant therapy until disease recurrence or unacceptable toxicity or up to 1 year. The primary endpoint was recurrence-free survival (RFS). The seconded endpoints were overall survival (OS), 12-month RFS rate, 24-month RFS rate, 12-month OS rate and adverse events.
Results
Between June 10, 2020 and January 2, 2024, a total of 82 pts were enrolled. During median follow-up of 16.6 months, the median RFS was 26.6 months, and 6-month, 12-month and 24-month rate were 86% (95% CI: 79-94), 70% (95% CI: 59-82) and 49% (95% CI: 35-69), respectively. The 12-month and 24-month OS rate were 96% and 81%, while the median OS was not reached. 36 pts (44%) received tislelizumab alone and 46 pts (56%) received adjuvant tislelizumab and TKIs, with no significant difference in the mRFS (p=0.49). After excluding pts who relapsed within 6 months, patients with duration of adjuvant therapy at least 6 months had significantly longer RFS than less than 6 months (22 months vs. NA, HR 0.28, 95%CI 0.10-0.76, P = 0.0078). Most adverse events (AEs) were grade 1/2 AEs, including blood platelet decreased, aspartate aminotransferase increased, and hypothyroidism. The grade 3 AEs in one pts was rash.
Conclusions
These results indicated that adjuvant therapy with tislelizumab with or without TKIs may be efficient to reduce recurrence for pts with HCC at high-risk recurrence, particularly with duration of adjuvant therapy more than 6 months.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
the Ethics Committee of Guangxi Medical University Cancer Hospital.
Funding
This work was supported by the Specific Research Project of Guangxi for Research Bases and Talents (GuiKe AD22035057), Guangxi Key Research and Development Plan Project (GuiKe AB24010082), First-class Discipline Innovation-Driven Talent Program of Guangxi Medical University.
Disclosure
All authors have declared no conflicts of interest.