Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Eur J Cancer. 2024 Aug;207:114148. doi: 10.1016/j.ejca.2024.114148. Epub 2024 May 31.
Cancer patients with autoimmune disease have been excluded from randomized trials of immune checkpoint blockers (ICBs). We conducted a systematic review of observational studies and uncontrolled trials including cancer patients with pre-existing autoimmune disease who received ICBs.
We searched 5 electronic databases through November 2023. Study selection, data collection, and quality assessment were performed independently by 2 investigators. We performed a meta-analysis to pool incidence of immune-related adverse events (irAEs), including de novo events and flares of existing autoimmune disease, hospitalizations due to irAEs, as well as deaths.
A total of 95 studies were included (23,897 patients with cancer and preexisting autoimmune disease). The most common cancer evaluated was lung cancer (30.7 %) followed by skin cancer (15.7 %). Patients with autoimmune disease were more likely to report irAEs compared to patients without autoimmune disease (relative risk 1.3, 95 % CI 1.0 to 1.6). The pooled occurrence rate of any irAEs (flares or de novo) was 61 % (95 % CI 54 % to 68 %); that of flares was 36 % (95 % CI 30 % to 43 %), and that of de novo irAEs was 23 % (95 % CI 16 % to 30 %). Flares were mild (grade <3) in half of cases and more commonly reported in patients with psoriasis/psoriatic arthritis (39 %), inflammatory bowel disease (37 %), and rheumatoid arthritis (36 %). 32 % of the patients with irAEs required hospitalization and treatment of irAEs included corticosteroids in 72 % of the cases. The irAEs mortality rate was 0.07 %. There were no statistically significant differences in cancer response to ICBs between patients with and without autoimmune disease.
Although more patients with pre-existing autoimmune disease had irAEs, these were mild and managed with corticosteroids in most cases, with no impact on cancer response. These results suggest that ICBs can be used in these patients, but careful monitoring is required, as over a third of the patients will experience a flare of their autoimmune disease and/or require hospitalization. These findings provide a crucial foundation for oncologists to refine their monitoring and management strategies, ensuring that the benefits of ICB therapy are maximized while minimizing its risks.
自身免疫性疾病的癌症患者已被排除在免疫检查点抑制剂 (ICB) 的随机试验之外。我们对包括患有预先存在的自身免疫性疾病的癌症患者接受 ICB 的观察性研究和非对照试验进行了系统评价。
我们通过 2023 年 11 月检索了 5 个电子数据库。两名研究人员独立进行了研究选择、数据收集和质量评估。我们进行了荟萃分析，以汇总免疫相关不良事件 (irAE) 的发生率，包括新发事件和现有自身免疫性疾病的发作、因 irAE 住院以及死亡。
共纳入 95 项研究（23897 例患有癌症和预先存在的自身免疫性疾病的患者）。评估的最常见癌症是肺癌（30.7%），其次是皮肤癌（15.7%）。与没有自身免疫性疾病的患者相比，患有自身免疫性疾病的患者更有可能报告 irAE（相对风险 1.3，95%CI 1.0 至 1.6）。任何 irAE（发作或新发）的总发生率为 61%（95%CI 54%至 68%）；发作率为 36%（95%CI 30%至 43%），新发 irAE 发生率为 23%（95%CI 16%至 30%）。发作的一半为轻度（<3 级），更常见于银屑病/银屑病关节炎（39%）、炎症性肠病（37%）和类风湿关节炎（36%）患者。32%的 irAE 患者需要住院治疗，irAE 的治疗包括皮质类固醇，在 72%的病例中。irAE 的死亡率为 0.07%。自身免疫性疾病患者与无自身免疫性疾病患者对 ICB 的癌症反应无统计学差异。
尽管患有预先存在的自身免疫性疾病的患者发生 irAE 的比例较高，但这些反应通常为轻度，且大多数患者用皮质类固醇治疗即可控制，对癌症反应无影响。这些结果表明，ICB 可用于这些患者，但需要密切监测，因为超过三分之一的患者会出现自身免疫性疾病发作和/或需要住院治疗。这些发现为肿瘤学家完善监测和管理策略提供了重要基础，确保最大限度地发挥 ICB 治疗的益处，同时将风险最小化。
