PDF(Pubmed)
Abstract：
Background: Immune checkpoint inhibitor (ICI) therapy is now administered to patients with advanced cancers. However, the safety and efficacy of ICIs in cancer patients with hepatitis B virus (HBV) infection is unknown. Therefore, we performed this systematic review to examine the safety and efficacy of ICIs in patients with HBV infection, with particular focus on HBV reactivation. Methods: Studies examining ICI treatment in patients with advanced cancer and HBV infection in PubMed from database inception to April 2022 were retrieved in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. In addition, reports of individuals diagnosed with HBV reactivation were supplemented through the Food and Drug Administration Adverse Event Reporting System. Results: We identified 20 articles (8 case reports, 10 retrospective case series, and 2 prospective clinical trials) and 2 meeting abstracts including 633 patients with advanced cancer and HBV infection treated with ICIs. The overall rate of HBV reactivation was 4.1% (26/633), and no HBV-related fatal events were reported. Among patients with HBV reactivation with known baseline data (20/26), HBV-DNA returned to undetectable status in 15 of 17 patients (88.2%) after a median 5.5 weeks (range, 1-14 weeks). Therapeutic responses to ICIs were observed in 14 of 88 patients (15.91%) with hepatocellular carcinoma, 6 of 45 patients (13.33%) with non-small cell lung cancer, and 3 of 13 patients (23.08%) with melanoma. Conclusion: ICIs may be safe and effective in patients with advanced cancer and HBV infection. However, there is still a need for clinical monitoring of liver enzymes and HBV-DNA during ICI therapy. Prospective trials are necessary to elucidate the appropriate antiviral therapy in these patients.
摘要：
背景：免疫检查点抑制剂（ICI）疗法现已用于晚期癌症患者。然而,ICIs在乙型肝炎病毒(HBV)感染癌症患者中的安全性和有效性尚不清楚.因此,我们进行了这项系统评价，以检查ICIs在HBV感染患者中的安全性和有效性，特别关注HBV再激活。方法：从数据库开始到2022年4月，在PubMed中检查晚期癌症和HBV感染患者的ICI治疗的研究按照系统评价和荟萃分析指南的首选报告项目进行检索。此外,通过食品和药物管理局不良事件报告系统补充了诊断为HBV再激活的个体的报告。结果：我们确定了20篇文章(8例病例报告，10个回顾性病例系列，和2个前瞻性临床试验）和2个会议摘要，包括633例晚期癌症和HBV感染患者，接受ICIs治疗。HBV再激活的总体率为4.1％（26/633），未报告HBV相关致死性事件.在已知基线数据（20/26）的HBV再激活患者中，在中位5.5周后，17例患者中的15例（88.2%）HBV-DNA恢复到检测不到的状态（范围，1-14周）。在88例肝细胞癌患者中有14例（15.91％）观察到对ICIs的治疗反应，45例非小细胞肺癌患者中有6例（13.33%），13例黑色素瘤患者中有3例（23.08%）。结论：ICIs在晚期癌症合并HBV感染患者中可能是安全有效的。然而,在ICI治疗期间仍需要临床监测肝酶和HBV-DNA.前瞻性试验是必要的，以阐明在这些患者适当的抗病毒治疗。
