Department of Medical Oncology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan.
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osaka-Sayama, Osaka, 589-8511, Japan.
Invest New Drugs. 2017 Aug;35(4):529-536. doi: 10.1007/s10637-017-0453-0. Epub 2017 Mar 20.
Background Nivolumab demonstrates promising efficacy for the treatment of non-small cell lung cancer and other malignancies. The clinical benefit of nivolumab, however, may be hampered by specific immune-related adverse events (irAEs), and little is known regarding nivolumab-related cholangitis. Methods A computerized search of our clinical database identified 3 metastatic non-small cell lung cancer patients with nivolumab-related cholangitis. All patients were treated with intravenous nivolumab monotherapy (3.0 mg/kg) every 2 weeks until disease progression or irAEs occurred. Clinical data regarding the duration of nivolumab treatment, symptoms, laboratory abnormalities, pathological findings of liver parenchyma biopsy specimens, and management of nivolumab-related cholangitis were analyzed. Results Our analysis revealed that nivolumab-related cholangitis was characterized by (1) localized extrahepatic bile duct dilation without obstruction; (2) diffuse hypertrophy of the extrahepatic bile duct wall; (3) a dominant increase in the biliary tract enzymes alkaline phosphatase and gamma-glutamyl transpeptidase relative to the hepatic enzymes aspartate and alanine aminotransferase; (4) normal or reduced levels of the serum immunological markers antinuclear antibody, antimitochondrial antibody, smooth muscle antibody, and immunoglobulin G4; (5) the pathological finding of biliary tract cluster of differentiation 8-positive T cell infiltration from liver biopsy; and (6) a moderate to poor response to steroid therapy. Conclusions Nivolumab-related cholangitis is associated with distinct imaging and clinicopathological features that distinguish it from acute cholangitis of common etiologies and other immune-related cholangitis. Further studies are warranted to establish the optimal management of patients with this irAE.
纳武利尤单抗在治疗非小细胞肺癌和其他恶性肿瘤方面显示出良好的疗效。然而,纳武利尤单抗的临床获益可能会受到特定的免疫相关不良反应(irAE)的影响,而关于纳武利尤单抗相关胆管炎知之甚少。
通过计算机检索我们的临床数据库,确定了 3 例转移性非小细胞肺癌患者发生纳武利尤单抗相关胆管炎。所有患者均接受静脉注射纳武利尤单抗单药治疗(3.0mg/kg),每 2 周一次,直至疾病进展或发生 irAE。分析了纳武利尤单抗治疗持续时间、症状、实验室异常、肝实质活检标本的病理发现以及纳武利尤单抗相关胆管炎的管理等临床数据。
我们的分析显示,纳武利尤单抗相关胆管炎的特征为:(1)局部肝外胆管扩张而无梗阻;(2)肝外胆管壁弥漫性肥大;(3)胆管酶碱性磷酸酶和γ-谷氨酰转肽酶相对于肝酶天冬氨酸和丙氨酸氨基转移酶明显升高;(4)血清免疫学标志物抗核抗体、抗线粒体抗体、平滑肌抗体和免疫球蛋白 G4 水平正常或降低;(5)肝活检显示胆管 CD8 阳性 T 细胞浸润的病理发现;(6)对类固醇治疗的反应中等至不佳。
纳武利尤单抗相关胆管炎具有独特的影像学和临床病理特征,可将其与常见病因引起的急性胆管炎和其他免疫相关胆管炎区分开来。需要进一步研究以确定这种 irAE 患者的最佳管理方法。