Departments of Medicine, Section of Hematology and Oncology.
Center for Innovations in Quality, Effectiveness, and Safety.
J Immunother. 2018 Oct;41(8):379-383. doi: 10.1097/CJI.0000000000000240.
Nivolumab is a standard treatment option in several advanced malignancies, but safety and efficacy are still unknown in patients with human immunodeficiency virus (HIV) infection. We describe a case series of people living with HIV (PLWH) receiving nivolumab in the Veterans Health Administration (VA) and report responses and toxicities. We identified all PLWH who received nivolumab at any VA facility since 2000 in the Corporate Data Warehouse (CDW), which provides nationwide research access to VA electronic medical records. We identified 16 HIV-infected nivolumab recipients. The median number of nivolumab doses received was 6 (range, 1-32). Changes in CD4 count during therapy were variable, with 70% (7/10) of patients experiencing increases. Half of PLWH were treated for non-small-cell lung cancer; 2 for Hodgkin lymphoma (HL), 2 for renal cell carcinoma, and 4 for off-label cancers. For non-small-cell lung cancer, 7 patients had evaluable responses. Although 5 of 7 patients immediately progressed, 1 had a partial response and 1 had stable disease, which were both durable. Two of 16 (14%) PLWH had complete responses; both with HL (2/2 HL, 100%). The prevalence of immune-related adverse effects was 40% overall (6/15); 27% (4/15) had pneumonitis. To our knowledge, this is the largest case series reporting outcomes with nivolumab in PLWH. Outcomes were comparable with those seen in studies of HIV-uninfected patients, and particularly interesting for HL. The reason for the high proportions of immune-related adverse effects is unclear, but needs to be confirmed in larger studies.
纳武利尤单抗是几种晚期恶性肿瘤的标准治疗选择，但在人类免疫缺陷病毒（HIV）感染患者中的安全性和疗效仍不清楚。我们描述了一组在退伍军人事务部（VA）接受纳武利尤单抗治疗的 HIV 感染者（PLWH）的病例系列，并报告了他们的反应和毒性。我们在企业数据仓库（CDW）中确定了自 2000 年以来在任何 VA 机构接受纳武利尤单抗治疗的所有 HIV 感染者，该仓库为 VA 电子病历提供全国范围内的研究访问。我们确定了 16 名接受纳武利尤单抗治疗的 HIV 感染者。接受纳武利尤单抗治疗的中位数剂量为 6（范围 1-32）。治疗期间 CD4 计数的变化是多样的，70%（7/10）的患者增加。一半的 PLWH 接受非小细胞肺癌治疗；2 例为霍奇金淋巴瘤（HL），2 例为肾细胞癌，4 例为标签外癌症。非小细胞肺癌的 7 名患者有可评估的反应。尽管 7 名患者中有 5 名立即进展，但 1 名患者有部分缓解，1 名患者有稳定的疾病，这两种情况都是持久的。16 名 PLWH 中有 2 名（14%）有完全缓解；2 名均为 HL（2/2 HL，100%）。总的来说，免疫相关不良事件的发生率为 40%（6/15）；27%（4/15）有肺炎。据我们所知，这是报告 HIV 感染者接受纳武利尤单抗治疗的最大病例系列。结果与 HIV 未感染者研究中的结果相当，特别是对 HL 患者。免疫相关不良事件比例高的原因尚不清楚，但需要在更大的研究中证实。
