PO.PS01.04 · 人群科学

免疫检查点抑制剂免疫相关不良事件的种族差异：一项系统评价与荟萃分析

Racial disparities in immune‑related adverse events with immune checkpoint inhibitors: A systematic review and meta‑analysis

编号 914 展板 27 时间 4/19 02:00–05:00 区域 Section 35 主讲 Toshiaki Takahashi, MD

分会场 Survivorship Research Addressing Cancer Disparities

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作者与单位 Authors & Affiliations

Toshiaki Takahashi¹, Yu Fujiwara², Ahmad Bouhuwaish³, Kohei Chida², Rodrigo Paredes⁴, Sarbajit Mukherjee⁵

¹Department of Medicine, John A. Burns Sch. of Med. Univ. of Hawaii at Manoa, Honolulu, HI,²Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY,³Department of Public Health, Sechenov University, Moscow, Russian Federation,⁴Department of Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai West/Morningside, New York, NY,⁵Miami Cancer Institute | Baptist Health South Florida, Miami, FL

摘要 Abstract

中文摘要

背景：关于免疫检查点抑制剂（ICI）所致免疫相关不良事件（irAE）是否因种族/族裔而异，数据尚不充分。本研究的目的是系统评价按种族划分的irAE发生率，以为公平的治疗策略提供依据。方法：我们检索了PubMed/MEDLINE和Embase从建库至2024年12月16日的成人接受ICI的随机试验和队列研究。使用广义线性混合效应比例荟萃分析汇总种族特异性发生率。使用随机效应逆方差模型汇总研究内相对白人的比值比（OR）；用I²总结异质性，并通过留一法分析进行检查。基于ICI类别（PD-1单药治疗和PD-1/CTLA-4双药治疗）、肿瘤类型（肺癌）和研究设计（排除器官特异性irAE报告和排除基于登记数据库的研究）进行亚组分析。结果：在筛选的3,397条记录中，510篇全文文章经过资格评估，最终24项研究、共109,902名患者纳入分析。在总体人群中，irAE的汇总发生率在亚裔中为13.7%（95% CI，2.7-47.5），黑人中为20.6%（8.6-41.7），西班牙裔中为16.0%（5.1-40.5），白人中为20.5%（11.1-34.8），异质性显著（I²=85.7-99.8%）。相对白人的汇总OR无统计学显著性：非白人1.28（95% CI 0.82-1.98），亚裔1.67（0.76-3.70），黑人1.37（0.83-2.27），西班牙裔0.89（0.55-1.42）；所有p>0.05。结果在各ICI类别亚组、肺癌亚组以及排除基于登记研究的亚组中显示出一致的趋势。结论：各种族间未观察到irAE的显著差异。这些发现支持公平获得ICI治疗以及文化敏感的毒性监测。按种族划分的irAE汇总发生率和比值比（OR）。缩写：NA，不适用。总体人群敏感性分析，排除仅报告器官特异性irAE的研究种族发生率%（95% CI）I²（%）OR vs 白人（95% CI）p I²（%）发生率%（95% CI）I²（%）OR vs 白人（95% CI）p I²（%）亚裔（n=3516）13.7（2.7-47.5）98.1 1.67（0.76-3.70）0.20 80.7 63.0（57.6-68.3）0.0 0.97（0.40-2.37）0.95 75.4 黑人（n=8864）20.6（8.6-41.7）98.3 1.37（0.83-2.27）0.45 94.8 43.4（34.0-53.3）94.0 1.37（0.57-3.30）0.47 94.8 西班牙裔（n=638）16.0（5.1-40.5）85.7 0.89（0.55-1.42）0.61 66.5 43.5（39.1-47.9）33.2 0.41（0.18-0.93）0.03 NA 白人（n=86676）20.5（11.1-34.8）99.8 NA NA NA 40.0（29.8-51.2）98.7 NA NA NA 非白人（n=14565）NA NA 1.28（0.82-1.98）0.27 94.6 NA NA 1.15（0.66-2.01）0.62 93.1

查看英文原文 English abstract

Background: There is insufficient data on whether immune‑related adverse events (irAEs) from immune checkpoint inhibitors (ICIs) differ by race/ethnicity. The objective of our study was to systematically evaluate the incidence of irAEs by race to inform equitable treatment approaches. Methods: We searched PubMed/MEDLINE and Embase from inception through December 16, 2024 for randomized trials and cohort studies in adults receiving ICIs. Race‑specific incidence was pooled using a generalized linear mixed‑effects proportional meta‑analysis. Within‑study odds ratios (ORs) versus White were pooled with random‑effects inverse‑variance models; heterogeneity was summarized with I² and inspected with leave‑one‑out analyses. Subgroup analyses were conducted based on ICI class (PD‑1 monotherapy and dual PD-1/CTLA-4 therapy), tumor type (lung cancer), and study design (excluding organ-specific irAE reports and excluding registry-based database studies). Results: Of the 3,397 records screened, 510 full-text articles were assessed for eligibility, and 24 studies comprising 109,902 patients were included in the analysis. In the overall population, the pooled incidence of irAEs was 13.7% (95% CI, 2.7-47.5) in Asian, 20.6% (8.6-41.7) in Black, 16.0% (5.1-40.5) in Hispanic, and 20.5% (11.1-34.8) in White patients, with substantial heterogeneity (I²=85.7-99.8%). Pooled ORs versus White were not statistically significant: non‑White 1.28 (95% CI 0.82-1.98), Asian 1.67 (0.76-3.70), Black 1.37 (0.83-2.27), and Hispanic 0.89 (0.55-1.42); all p>0.05. Findings showed a consistent trend across the ICI-class subgroups, the lung-cancer subgroup, and the subgroup excluding registry-based studies. Conclusion: No significant differences in irAEs were observed among races. These findings support equitable access to ICI therapy and culturally competent toxicity monitoring. Pooled incidence of irAEs and odds ratios (ORs) by race. Abbreviation: NA, not applicable Overall population Sensitivity analysis, excluding studies reporting only organ-specific irAEs Race Incidence % (95% CI) I² (%) OR vs White (95% CI) p I² (%) Incidence % (95% CI) I² (%) OR vs White (95% CI) p I² (%) Asian (n=3516) 13.7 (2.7-47.5) 98.1 1.67 (0.76-3.70) 0.20 80.7 63.0 (57.6-68.3) 0.0 0.97 (0.40-2.37) 0.95 75.4 Black (n=8864) 20.6 (8.6-41.7) 98.3 1.37 (0.83-2.27) 0.45 94.8 43.4 (34.0-53.3) 94.0 1.37 (0.57-3.30) 0.47 94.8 Hispanic (n=638) 16.0 (5.1-40.5) 85.7 0.89 (0.55-1.42) 0.61 66.5 43.5 (39.1-47.9) 33.2 0.41 (0.18-0.93) 0.03 NA White (n=86676) 20.5 (11.1-34.8) 99.8 NA NA NA 40.0 (29.8-51.2) 98.7 NA NA NA Non-White (n=14565) NA NA 1.28 (0.82-1.98) 0.27 94.6 NA NA 1.15 (0.66-2.01) 0.62 93.1

利益披露 Disclosure

T. Takahashi, None.. Y. Fujiwara, None.. A. Bouhuwaish, None.. K. Chida, None.. R. Paredes, None. S. Mukherjee, National Comprehensive Cancer Network (NCCN) ). Ipsen Biopharmaceuticals / North American Neuroendocrine Tumor Society (NANETS) ). Merck & Co.; Eisai; Bristol-Myers Squibb (BMS); Boehringer Ingelheim; Gilead; BeiGene / BeOne Ltd. Independent Contractor. Total Health Oncology Other, Speaker honoraria. Binaytara Foundation Other, Speaker honoraria. Esophageal Cancer Action Network Other, Board Member. Binaytara Foundation Other, Educational Committee, Member. North American Neuroendocrine Tumor Society (NANETS) Other, Scientific Review Committee. NCCN; ASCO Other, Guidelines Panel Member.

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