Hepatitis B virus infection does not affect the clinical outcome of anti-programmed death receptor-1 therapy in advanced solid malignancies: Real-world evidence from a retrospective study using propensity score matching

This study aimed to investigate the impact of hepatitis B virus (HBV) infection on the outcome of patients with advanced solid malignancies treated with programmed death receptor-1 (PD-1) inhibitors. We retrospectively included patients treated with PD-1 inhibitors between August 2018 and April 2020. Propensity score matching (PSM) was performed to match the characteristics of the HBV and non-HBV groups. Objective response rate (ORR) and disease control rate (DCR) were compared between HBV and non-HBV groups using χ(2) or Fisher exact tests. Kaplan-Meier and log-rank tests were used to analyze overall survival (OS) and progression-free survival (PFS). A total of 120 patients, including 43 (35.8%) with HBV and 77 (64.2%) without HBV, were enrolled. Cases of HBV reactivation were not observed. In the entire study population, ORR and DCR did not significantly differ between both groups. After PSM, the study population comprised 39 patients, 15 with and 24 without HBV. The HBV group had an ORR of 55.6%, whereas the ORR in the non-HBV group was 36.8% (P = .35). Similarly, the DCR was 77.8% in the HBV group, as compared to 68.4% in the non-HBV group (P = .61). Additionally, HBV infection did not significantly affect OS (P = .54) and PFS (P = .64) in the unmatched cohort. Moreover, statistically significant differences regarding OS (P = .15) and PFS (P = .23) were also not detected after PSM. In conclusion, the HBV infection status did not impact the therapy response or prognosis of patients treated with PD-1 inhibitors. Further prospective studies are needed to corroborate these findings.