Pertejo-Fernandez Ana, Ricciuti Biagio, Hammond Sarah P, Marty Francisco M, Recondo Gonzalo, Rangachari Deepa, Costa Daniel B, Awad Mark M
Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, United States.
Division of Infectious Disease, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.
Lung Cancer. 2020 Jul;145:181-185. doi: 10.1016/j.lungcan.2020.02.013. Epub 2020 Feb 24.
The safety and efficacy of immunotherapy among patients with history of hepatitis B (HBV) or hepatitis C virus (HCV) infection and non-small cell lung cancer (NSCLC) remains unclear as this population has traditionally been excluded from clinical trials with immune checkpoint inhibitors (ICIs).
We retrospectively evaluated treatment toxicities and clinical outcomes in nineteen patients with NSCLC and history of past or chronic HBV (16 cases, two of these had HCV co-infection) or chronic HCV infection (five cases), who received a programmed death-1 (PD-1) pathway inhibitor.
The overall response rate to immunotherapy was 35 %, and the median progression-free survival was 4.5 months. After ICI initiation, increases in liver function tests (LFTs) from baseline were infrequent and mild, and no patients experienced grade 3 or 4 hepatic immune-related adverse events or required ICI discontinuation or corticosteroid administration for management of hepatic toxicity. There were no significant changes in viral load or cases of HBV reactivation or HCV flare while on ICI therapy.
In this case series, treatment with immunotherapy in patients with NSCLC and past or chronic viral hepatitis appears to be safe, and responses to ICIs can be durable in this population. Additional studies are needed in larger cohorts of patients to determine the safety of immunotherapy in patients with chronic viral infections.
由于免疫检查点抑制剂（ICI）的临床试验传统上排除了有乙型肝炎（HBV）或丙型肝炎病毒（HCV）感染史的患者，因此免疫疗法在这类非小细胞肺癌（NSCLC）患者中的安全性和有效性仍不明确。
我们回顾性评估了19例有既往或慢性HBV感染史（16例，其中2例合并HCV感染）或慢性HCV感染史（5例）的NSCLC患者接受程序性死亡-1（PD-1）通路抑制剂治疗后的毒性反应和临床结局。
免疫疗法的总体缓解率为35%，中位无进展生存期为4.5个月。开始使用ICI后，肝功能检查（LFT）较基线升高的情况不常见且程度较轻，没有患者出现3级或4级肝脏免疫相关不良事件，也没有患者因肝脏毒性需要停用ICI或给予皮质类固醇治疗。在接受ICI治疗期间，病毒载量没有显著变化，也没有HBV再激活或HCV复发的病例。
在这个病例系列中，NSCLC合并既往或慢性病毒性肝炎患者接受免疫疗法治疗似乎是安全的，并且该人群对ICI的反应可能持久。需要在更大规模的患者队列中进行进一步研究，以确定免疫疗法在慢性病毒感染患者中的安全性。
