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免疫检查点抑制剂毒性的临床特征及其对实体癌疗效的影响:摩洛哥患者真实世界数据的分析

Clinical Characteristics of Toxicities of Immune Checkpoint Inhibitors and Their Impact on Efficacy in Solid Cancers: An Analysis of Real-World Data in Moroccan Patients.

作者信息

Batlamous Badiaa, Lkhoyaali Sihame, Omri Loubna, Nguema-Mipaka Magaly-Gwen-Farnely, Khalis Mohamed, Inrhaoun Hanane, Naciri Sarah, El Ghissassi Ibrahim, Mrabti Hind, Boutayeb Saber, Errihani Hassan

机构信息

Translational Oncology Research Team, Faculty of Medicine and Pharmacy, Mohammed V University, Rabat, Morocco.

Medical Oncology Department, National Institute of Oncology, Rabat, Morocco.

出版信息

JCO Glob Oncol. 2025 Feb;11:e2400312. doi: 10.1200/GO-24-00312. Epub 2025 Feb 27.

DOI:10.1200/GO-24-00312
PMID:40014840
Abstract

PURPOSE

Patients receiving immune checkpoint inhibitors (ICIs) may induce immune-related adverse events (irAEs). This study aimed to evaluate the toxicity induced by ICIs and explore the correlation between efficacy and toxicity in a Moroccan population.

METHODS

We conducted a prospective study of patients with solid tumors who received pembrolizumab or atezolizumab at the from July 2018 to December 2023. We identified irAEs according to ASCO 2021 guidelines and graded them according to the Common Terminology Criteria for Adverse Events Version 4.0. Efficacy with respect to progression-free survival (PFS) and overall survival (OS) was determined. A Cox regression model was used to determine the association between irAEs and survival.

RESULTS

Eighty-six patients with solid tumors who received ICIs were included. The primary tumor types were lung (40.7%), skin (29.1%), and GI cancer (14%). The ICIs most commonly used included pembrolizumab (67.4%) and atezolizumab (32.6%). ICIs were used as monotherapy (77.9%) or in combination (22.1%). A total of 58 (67.4%) patients presented any kind of irAEs. The most common toxicities in both the monotherapy and combination groups were GI, with rates of 25.3% and 31.5%, respectively. Patients with irAEs showed significantly longer median PFS compared with those without irAEs (9 3.6 months; hazard ratio [HR], 0.5 [95% CI, 0.32 to 0.99]; = .04). The median OS was longer in patients with irAEs than in those without irAEs but was not statistically significant (19 10.3 months; HR, 0.8 [95% CI, 0.39 to 1.7]; = .5).

CONCLUSION

Our results indicated that ICIs have the potential to induce irAEs in patients with solid tumors. These adverse effects were commonly GI. The development of irAEs was associated with improved effectiveness of ICI treatment across different malignancies.

摘要

目的

接受免疫检查点抑制剂(ICI)治疗的患者可能会引发免疫相关不良事件(irAE)。本研究旨在评估ICI在摩洛哥人群中诱导的毒性,并探讨疗效与毒性之间的相关性。

方法

我们对2018年7月至2023年12月期间接受帕博利珠单抗或阿替利珠单抗治疗的实体瘤患者进行了一项前瞻性研究。我们根据美国临床肿瘤学会(ASCO)2021年指南识别irAE,并根据《不良事件通用术语标准》第4.0版对其进行分级。确定了无进展生存期(PFS)和总生存期(OS)方面的疗效。使用Cox回归模型确定irAE与生存之间的关联。

结果

纳入了86例接受ICI治疗的实体瘤患者。主要肿瘤类型为肺癌(40.7%)、皮肤癌(29.1%)和胃肠道癌(14%)。最常用的ICI包括帕博利珠单抗(67.4%)和阿替利珠单抗(32.6%)。ICI用作单药治疗(77.9%)或联合治疗(22.1%)。共有58例(67.4%)患者出现了任何类型的irAE。单药治疗组和联合治疗组中最常见的毒性均为胃肠道毒性,发生率分别为25.3%和31.5%。与未发生irAE的患者相比,发生irAE的患者中位PFS显著更长(9对3.6个月;风险比[HR],0.5[95%置信区间,0.32至0.99];P = 0.04)。发生irAE的患者中位OS比未发生irAE的患者更长,但差异无统计学意义(19对10.3个月;HR,0.8[95%置信区间,0.39至1.7];P = 0.5)。

结论

我们的结果表明,ICI有潜力在实体瘤患者中诱导irAE。这些不良反应常见于胃肠道。irAE的发生与ICI在不同恶性肿瘤治疗中的疗效改善相关。

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