Immune checkpoint inhibitors use and the incidence of hepatitis B virus reactivation or immune-related hepatitis in non-small cell lung cancer patients with chronic hepatitis B.

Abstract

9086 Background: The safety and efficacy of immune-checkpoint inhibitors (ICIs) has not been thoroughly investigated in non-small cell lung cancer (NSCLC) patients with chronic hepatitis B (CHB) or occult hepatitis B infection (OBI). We analyzed incidence of hepatitis B virus (HBV) reactivation, immune-related hepatitis and jaundice in NSCLC patients treated with ICIs according to HBV DNA and hepatitis B serologic markers in real-world setting. Methods: A total of 1,277, consecutive NSCLC patients treated with ICIs from January 2015 to December 2020 at the Samsung Medical Center, Seoul, Korea were analyzed. Among them, 52 patients were hepatitis B surface antigen (+) (Group A, CHB), 759 patients were HBsAg (-)/anti-HBc IgG (+) (Group B, OBI), and 466 patients were HBsAg (-)/anti-HBc IgG (-) (Group C). Among 52 patients with CHB, 38 patients (73.1%) were receiving antiviral therapy. Primary endpoint was HBV reactivation, immune-related hepatitis and jaundice. Secondary endpoints include other immune-related adverse events, objective response rate, progression free survival (PFS) and overall survival (OS). Results: HBV reactivation was observed in two patients (0.2%) which was exclusively observed in Group A (CHB). Among CHB patients who were not receiving antiviral therapy, HBV reactivation was observed for 14.3% (2/14 patients). Incidence of immune-related hepatitis were 21.2%, 30.3% and 30.5% for Group A, Group B and Group C (p > 0.05), respectively, and incidence of immune-related of jaundice was 3.8%, 4.0% and 2.8% for Group A, Group B and Group C (p > 0.05), respectively. Incidence of ≥ grade 3 other immune-related adverse events, objective response rate, PFS, and OS were comparable among three group (p > 0.05 for all comparison). Conclusions: In this large, real-world cohort study, safety and efficacy of ICIs were comparable in patients with CHB or OBI, suggesting similar outcomes can be expected with ICIs in patients with CHB or OBI. HBV reactivation was observed in patients with CHB without antiviral therapy indicating antiviral prophylaxis might be required for them. For patients with OBI, risk of HBV reactivation was null.