The MetroHealth System Campus of Case Western Reserve University, Cleveland, Ohio, USA.
Oncologist. 2021 May;26(5):e827-e830. doi: 10.1002/onco.13739. Epub 2021 Mar 20.
The safety of immune checkpoint inhibitors (ICIs) in patients with hepatitis C virus (HCV) infection has not been studied in many cancers, as these patients were excluded from most ICI trials. This poses a degree of uncertainty when a patient with HCV is being considered for ICIs in the absence of data to inform potential adverse events (AEs).
This was a single-institution retrospective chart review of patients with active or resolved HCV who were treated with ICIs for cancer of any type and stage from January 2012 to December 2019, with emphasis on AE rates.
We identified 40 patients, 30 men and 10 women. Median age was 64 years. Cancer types were non-small cell lung cancer (18; 45%), hepatocellular carcinoma (12; 30%), head and neck cancer (4; 10%), small cell lung cancer (3; 7.5%), renal cell carcinoma (1; 2.5%), colon cancer (1; 2.5%), and melanoma (12.5%). Hepatitis C was untreated in 17 patients (42.5%), treated in 14 (35%), and spontaneously resolved in 9 (22.5%). AEs observed were grade 3 pneumonitis in one patient (2.5%) on pembrolizumab; grade 3 colitis in one patient (2.5%) on nivolumab; hepatotoxicity in two patients (5%) on nivolumab: one patient with grade 1 and the other with grade 2; grade 1-2 fatigue in three patients (7.5%); and hypothyroidism in one patient (2.5%).
Adverse events rates in patients with untreated and resolved HCV treated with ICI for a variety of cancers were comparable with AEs rates reported in clinical trials for patients without HCV.
The safety of immune checkpoint inhibitors (ICIs) in patients with cancer with hepatitis C virus (HCV) infection is a major concern because of the lack of prospective safety data for most cancers. HCV is prevalent worldwide, and the occurrence of cancer where ICI is indicated is not uncommon. This study was a retrospective review of all patients with HCV who received ICI for a variety of cancers in the authors' institution over 8 years, and the results are presented in this article. The results may help inform clinical decisions and the design of future clinical trials.
由于大多数免疫检查点抑制剂 (ICI) 试验都排除了 HCV 感染患者，因此在许多癌症中尚未研究这些患者使用 ICI 的安全性。在缺乏潜在不良反应 (AE) 数据的情况下，当考虑对 HCV 患者使用 ICI 时，这会带来一定程度的不确定性。
这是一项单机构回顾性图表审查，纳入了 2012 年 1 月至 2019 年 12 月期间接受任何类型和分期癌症 ICI 治疗的活动期或已解决 HCV 患者，重点关注 AE 发生率。
我们共确定了 40 例患者，其中 30 例为男性，10 例为女性。中位年龄为 64 岁。癌症类型为非小细胞肺癌（18 例；45%）、肝细胞癌（12 例；30%）、头颈部癌（4 例；10%）、小细胞肺癌（3 例；7.5%）、肾细胞癌（1 例；2.5%）、结肠癌（1 例；2.5%）和黑色素瘤（12.5%）。17 例（42.5%）患者未治疗 HCV，14 例（35%）患者接受了 HCV 治疗，9 例（22.5%）患者 HCV 自发解决。观察到的 AE 为：1 例（2.5%）在接受 pembrolizumab 治疗的患者中出现 3 级肺炎；1 例（2.5%）在接受 nivolumab 治疗的患者中出现 3 级结肠炎；2 例（5%）在接受 nivolumab 治疗的患者中出现肝毒性：1 例为 1 级，另 1 例为 2 级；3 例（7.5%）患者出现 1-2 级疲劳；1 例（2.5%）患者出现甲状腺功能减退。
未治疗和已解决 HCV 患者接受各种癌症的 ICI 治疗后的不良反应发生率与 HCV 患者临床试验中报告的不良反应发生率相当。
由于大多数癌症缺乏前瞻性安全性数据，因此 HCV 感染癌症患者使用免疫检查点抑制剂（ICI）的安全性是一个主要关注点。HCV 在全球广泛流行，而在需要使用 ICI 的癌症患者中，HCV 的发生并不罕见。本研究回顾了 8 年来作者所在机构所有接受 ICI 治疗各种癌症的 HCV 患者，结果在本文中进行了报告。这些结果可能有助于为临床决策和未来临床试验的设计提供信息。
