Comparative efficacy and safety of immune checkpoint inhibitors combined with antiangiogenic agents for unresectable hepatocellular carcinoma in patients with Child-Pugh A versus B cirrhosis: a single-center, retrospective study.
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BACKGROUND: Immune checkpoint inhibitors (ICIs) combined with antiangiogenic agents (AAs) have been recommended as the first-line systemic treatment for unresectable hepatocellular carcinoma (uHCC). However, most Phase III clinical trials have excluded patients with Child-Pugh B (CP B) cirrhosis. This study aimed to evaluate the efficacy and safety of ICIs combined with AAs in uHCC patients with CP B cirrhosis and compare the outcomes with those in patients with Child-Pugh A (CP A) cirrhosis. METHODS: The uHCC patients who received ICIs plus AAs between September 2020 and November 2024 at Beijing You 'an Hospital were retrospectively analyzed. Tumor response and treatment related adverse events (TRAEs) were compared between the patients with CP A and CP B cirrhosis to assess the efficacy and safety of the treatment. RESULTS: A total of 94 patients were included in the study, including 63 patients with CP A cirrhosis and 31 with CP B cirrhosis. For the entire cohort, the objective response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS) and median overall survival (mOS) were 44.7%, 72.3%, 6.3 months, and 28.3 months. The four indicators mentioned above were 50.8% vs. 32.3% (P = 0.089), 76.2% vs. 64.5% (P = 0.234), 6.6 months vs. 5.8 months (P = 0.524) and 39.2 months vs. 15.9 months (P = 0.035) in the CP A group and CP B group, respectively, with only mOS showing a statistically significant difference between the two groups. The Eastern Cooperative Oncology Group performance status score (ECOG PS) 2, prior treatment and non-simultaneous locoregional therapies (LRTs) were identified as independent predictors of worse ORR. The CP B and Barcelona Clinic Liver Cancer (BCLC) stage C/D were identified as independent predictors of poorer OS. A total of 93.6% of patients experienced at least one TRAE of any grade, with 27.7% experiencing grade ≥ 3 TRAEs. The incidence and severity of TRAEs were similar between the patients with CP A and CP B cirrhosis. Additionally, Child-Pugh score improved in 32.3% of patients with CP B cirrhosis after systemic treatment. CONCLUSION: The combination of ICIs and AAs showed favorable clinical benefits, safety and tolerability in uHCC patients with CP B cirrhosis, with some patients experiencing improvements in Child-Pugh score. More well-designed studies with larger sample sizes are warranted to further determine the efficacy and safety of systemic therapy in this population.