Comparative Safety, Efficacy and Survival Outcome of Anti-PD-1 Immunotherapy in Colorectal Cancer Patients With vs Without Hepatitis B Virus Infection: A Multicenter Cohort Study.

INTRODUCTION: Antiprogrammed cell death protein-1 (PD-1) immunotherapy has substantially broadened in scope for the treatment of colorectal cancer (CRC). However, comparative safety, efficacy and survival outcome of anti-PD-1 therapy in CRC patients with and without hepatitis B virus (HBV) infection remain unclear. METHODS: This multicenter, retrospective cohort study included 180 advanced-stage CRC patients with available serological markers for HBV infection treated with anti-PD-1 therapy at the Sixth Affiliated Hospital, Sun Yat-sen University and Sun Yat-sen University Cancer Center between December 2016 and December 2019. A propensity score-matched analysis was performed to compare the safety, efficacy, and survival outcome between HBV and non-HBV groups. RESULTS: The incidences of deficient mismatch repair and metastatic disease were significantly different between HBV and non-HBV groups (both P < 0.05). After propensity score-matched analysis, any grade immune-related adverse events and grade ≥ 3 immune-related adverse events were 47% vs 38% (P = 0.25) and 5% vs 6% (P = 1.0) between HBV and non-HBV groups, respectively. The overall response rate was 39% with 17 complete responses and 13 partial responses for the HBV infection cohort and 39% with 11 complete responses and 19 partial responses for the non-HBV infection cohort (P = 1.0). Two-year progression-free survival rates were 38% vs 40% (P = 0.596) and 2-year overall survival rates were 55% vs 63% (P = 0.401) for HBV vs non-HBV infection cohorts. DISCUSSION: The incidences of toxicity, efficacy and survival outcome were similar between patients with HBV infection and non-HBV patients receiving anti-PD-1 therapy, which supports to include CRC patients with HBV in clinical trials of anti-PD-1 therapy.