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免疫检查点抑制剂治疗肝细胞癌患者的免疫相关不良事件与预后的相关性。

Correlation Between Immune-Related Adverse Events and Prognosis in Hepatocellular Carcinoma Patients Treated With Immune Checkpoint Inhibitors.

机构信息

Department of Rheumatology and Immunology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.

Department of Otolaryngology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.

出版信息

Front Immunol. 2021 Dec 7;12:794099. doi: 10.3389/fimmu.2021.794099. eCollection 2021.

Abstract

BACKGROUND

Immune-related adverse events (irAEs) caused by immune checkpoint inhibitors (ICIs) were associated with clinical benefit in cancer patients of melanoma, a lung cancer. In the present study, we investigated the correlation between irAE and ICI efficacy in hepatocellular carcinoma (HCC) patients.

METHODS

We divided the HCC patients who received the anti-PD-1 antibody into two groups as irAE group and non-irAE group according to the National Cancer Institute Common Terminology Criteria for Adverse Events ver. 4.03. The treatment efficacy of ICIs was evaluated with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).

RESULT

Of the 65 HCC patients who received the anti-PD-1 antibody (monotherapy or combined with targeted medicine), median PFS in the irAE group was superior to that in the non-irAE group (302 days vs. 148 days, = 0.004). Median OS in the irAE group was also better than that in the non-irAE group (374 days vs. 279 days, = 0.038). Although the statistical difference for DCR in the irAE group and non-irAE group was not reached, the DCR of the irAE displayed a trend better than that of the non-irAE group (41.20% vs. 20.80%, = 0.118). Multivariate analysis also demonstrated that the non-irAE group (HR = 6.410, 95% CI: 1.404 to 29.275) was associated independently with the poor prognosis.

CONCLUSIONS

Development of irAEs was associated with clinical benefit for HCC patients who were treated with immune checkpoint inhibitors; irAE, particularly low-grade irAE, was a predictable marker for better ICI treatment efficiency in HCC patients.

摘要

背景

免疫检查点抑制剂(ICIs)引起的免疫相关不良反应(irAEs)与黑色素瘤、肺癌等癌症患者的临床获益相关。在本研究中,我们探讨了 irAE 与 HCC 患者接受免疫检查点抑制剂(ICI)治疗疗效的相关性。

方法

根据美国国立癌症研究所不良事件通用术语标准 4.03 版,我们将接受抗 PD-1 抗体治疗的 HCC 患者分为 irAE 组和非 irAE 组。采用客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)和总生存期(OS)评估 ICIs 的治疗疗效。

结果

在 65 例接受抗 PD-1 抗体(单药或联合靶向药物)治疗的 HCC 患者中,irAE 组的中位 PFS 优于非 irAE 组(302 天比 148 天, = 0.004)。irAE 组的中位 OS 也优于非 irAE 组(374 天比 279 天, = 0.038)。尽管 irAE 组和非 irAE 组的 DCR 差异无统计学意义,但 irAE 组的 DCR 显示出优于非 irAE 组的趋势(41.20%比 20.80%, = 0.118)。多因素分析也表明,非 irAE 组(HR = 6.410,95%CI:1.404 至 29.275)与预后不良独立相关。

结论

irAE 的发生与 HCC 患者接受免疫检查点抑制剂治疗的临床获益相关;irAE,特别是低级别 irAE,是预测 HCC 患者接受 ICI 治疗效果更好的可预测标志物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/05f2/8691363/543713acd4e4/fimmu-12-794099-g001.jpg

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