Yin Yue, Liu Bao Jiang, Zhang Yan Hua, Qiu Xin Ye
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Pharmacy, Peking University Cancer Hospital & Institute, Beijing 100142, China.
Key Laboratory of Carcinogenesis and Translational Research [Ministry of Education], Department of Interventional Therapy, Peking University Cancer Hospital & Institute, Beijing 100142, China.
Jpn J Clin Oncol. 2024 Dec 7;54(12):1288-1297. doi: 10.1093/jjco/hyae105.
Hepatitis B virus (HBV) reactivation is a recognized complication of cytotoxic chemotherapy in patients with chronic hepatitis B. However, the risk of HBV reactivation with immune checkpoint inhibitors (ICIs) remains uncertain due to their exclusion from clinical trials. This study aimed to assess the incidence of HBV reactivation in patients with cancer undergoing ICI therapy, exploring associated risk factors.
This retrospective study included patients with cancer who tested positive for hepatitis B surface antigen (HBsAg). The primary endpoint was incidence of HBV reactivation, whereas the secondary endpoint was occurrence of hepatic adverse events during ICI therapy.
Among the 162 eligible patients (median age 59 years; 85.8% men), HBV reactivation occurred in 4.3% at a median of 13 weeks post-treatment initiation. At baseline, HBV DNA was undetectable in 78 patients; 88 received antiviral prophylaxis, while 74 patients did not. Reactivation rates were 3.5% in HBsAg-positive and 10% in hepatitis B core antibody (HBcAb)-positive individuals, with an overall rate of 4.3%. These rates were 1.1% with prophylaxis and 8.1% without. Twenty-two patients had grade 3-4 hepatitis, and 25 tested HBsAg-negative but HBcAb-positive. No HBV-related fatalities occurred. The absence of antiviral treatment was a significant risk factor for HBV reactivation.
Our study underscores the risk of HBV reactivation in patients with cancer undergoing ICI therapy, especially among those lacking antiviral prophylaxis. Regular HBV DNA testing and antiviral prophylaxis are crucial preventive measures for HBV reactivation. These findings emphasize the importance of monitoring HBV status in patients receiving ICIs.
乙型肝炎病毒（HBV）再激活是慢性乙型肝炎患者接受细胞毒性化疗时公认的并发症。然而，由于免疫检查点抑制剂（ICI）被排除在临床试验之外，其导致HBV再激活的风险仍不确定。本研究旨在评估接受ICI治疗的癌症患者中HBV再激活的发生率，并探索相关危险因素。
这项回顾性研究纳入了乙型肝炎表面抗原（HBsAg）检测呈阳性的癌症患者。主要终点是HBV再激活的发生率，次要终点是ICI治疗期间肝脏不良事件的发生情况。
在162例符合条件的患者（中位年龄59岁；85.8%为男性）中，HBV再激活发生率为4.3%，中位发生时间为治疗开始后13周。基线时，78例患者HBV DNA检测不到；88例接受了抗病毒预防，74例未接受。HBsAg阳性个体的再激活率为3.5%，乙型肝炎核心抗体（HBcAb）阳性个体为10%，总体率为4.3%。接受预防的患者为1.1%，未接受预防的为8.1%。22例患者发生3-4级肝炎，25例HBsAg阴性但HBcAb阳性。未发生与HBV相关的死亡病例。未进行抗病毒治疗是HBV再激活的一个重要危险因素。
我们的研究强调了接受ICI治疗的癌症患者中HBV再激活的风险，尤其是那些未接受抗病毒预防的患者。定期进行HBV DNA检测和抗病毒预防是预防HBV再激活的关键措施。这些发现强调了在接受ICI治疗的患者中监测HBV状态的重要性。
