Objective:

To provide a head-to-head comparison of the hepatic safety profiles of Sintilimab and Pembrolizumab in patients with advanced non-small cell lung cancer (NSCLC).

Approach:

• Study Design: A retrospective observational cohort study was conducted to evaluate liver function damage between Sintilimab and Pembrolizumab in patients with advanced NSCLC.
• Patient Selection: Patients treated with Sintilimab or Pembrolizumab at Southwest Hospital were included, with propensity score matching performed to balance between-group differences.
• Statistical Analysis: Cox proportional hazards models and Kaplan-Meier curves were used to assess differences in hepatotoxicity, with Benjamini-Hochberg correction applied for multiple comparisons.

Key Findings:

• 222 patients with advanced NSCLC were included in the study.
• The overall incidence of hepatic-related adverse events was 17.1% in the Sintilimab group and 18.1% in the Pembrolizumab group.
• No significant differences were observed in liver function indicators (AST, ALT, ALP, GGT, TBIL) between the two groups.
• Kaplan-Meier analysis revealed similar risks of hepatotoxicity for both treatment regimens.
• No Grade 3 or higher hepatotoxicity events were observed in either group.

Interpretation:

Sintilimab and Pembrolizumab demonstrated comparable hepatic safety profiles, with no significant difference in the incidence of hepatotoxicity.

Limitations:

• The study is retrospective and conducted at a single center, which may limit generalizability.
• The sample size may not be sufficient to detect rare adverse events.

Conclusion:

Further prospective, multi-center studies with larger and multi-ethnic cohorts are warranted to validate these findings.