IDDF2020-ABS-0103 Efficacy and safety of programmed cell death protein 1 inhibitor and the associated prognostic factors in patients with hepatitis b virus-related advanced hepatocellular carcinoma

Background Programmed cell death protein 1 (PD1) inhibitor is safe and effective for hepatocellular carcinoma (HCC) treatment; however, the correlation between previous hepatitis B virus (HBV) infection and the clinical outcomes of PD1 treatment remain unclear. This study evaluated the safety and efficacy of PD-1 inhibitor treatment for HBV-related advanced HCC and determined the associated prognostic factors. Methods Fifty HBV-infected HCC patients treated with PD-1 inhibitor in a clinical trial were retrospectively investigated. Treatment responses as per the response evaluation criteria in solid tumors 1.1 (RECIST 1.1) and immune-modified RECIST criteria (imRECIST). Overall survival (OS) and time to progression (TTP) were evaluated, and any adverse events (AEs) were recorded. Results According to RECIST 1.1 criteria, no patient achieved a complete response (CR) while four (8%) achieved partial response (PR); thus, the objective response rate (ORR) was 8%. Nineteen (38%) and 26 (52%) patients exhibited stable disease (SD) and progressive disease (PD), respectively, at the first radiological assessment. The disease control rate (DCR) was 46% (table 1). The median OS was 9.5 months (95% confidence interval [CI], 7.6–11.3), while the median TTP was 2.77 months (95% CI, 2.1–3.5). In multivariate analysis, portal vein tumor thrombosis (PVTT) was an independent predictor of poor OS. Kaplan-Meier analysis revealed significantly shorter OS in the PVTT group than in the no PVTT group (median 6.0 vs. 10.1 months, p = 0.018, (figure 1). HBV reactivation occurred in six patients (12%), and the overall AEs rate was 92%. Conclusions PD-1 inhibitor may be safe and effective for HBV-related advanced HCC, with PVTT being a predictor of a poor prognosis.