Li Zhuoyang, Zhu Ning, Liu Yuwei, Yu Yan, Wang Tianhong, Zou Congcong, Wang Siman, Ou Xiaofeng
School of Medicine, Wuhan University of Science and Technology, Wuhan, 430065, China.
Division of Head & Neck Tumor Multimodality Treatment, Cancer Center, West China Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, China.
BMC Pharmacol Toxicol. 2025 Mar 4;26(1):51. doi: 10.1186/s40360-025-00879-2.
An increasing number of clinical studies have highlighted the use of atezolizumab in tumor immunotherapy. However, There is still a lack of comprehensive research on its associated adverse events (AEs). To improve our understanding of its toxicological profile and to provide valuable clinical insights regarding into the effectiveness of immunotherapy, this study utilized data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) to conduct a retrospective analysis of AEs linked to atezolizumab.
We extracted the reports of AEs related to atezolizumab from the FAERS database from the first quarter of 2004 to the first quarter of 2024. We quantified them using the reporting odds ratio (ROR) and proportional reporting ratio (PRR), along with chi-square value (χ²), and conducted systematic classification of the AE signal mining results through SAS 9.4 software.
A total of 19,563 valid reports were incorporated, involving 20 distinct system organ class categories. The AEs related to atezolizumab, reported at the preferred term level, mainly encompassed anemia [ROR 2.33, 95% confidence interval (CI) lower limit 2.09, PRR 2.31, χ² 255.977], febrile neutropenia (ROR 2.81, 95% CI lower limit 2.50, PRR 2.79, χ² 333.586), neutrophil count decreased (ROR 2.14, 95% CI lower limit 1.89, PRR 2.13, χ² 150.688), white blood cell count decreased (ROR 2.35, 95% CI lower limit 2.03, PRR 2.34, χ² 136.673), sepsis (ROR 2.21, 95% CI lower limit 1.91, PRR 2.20, χ² 117.741), alanine aminotransferase increased (ALT) (ROR 2.86, 95% CI lower limit 2.44, PRR 2.85, χ² 180.031), and aspartate aminotransferase increased (AST) (ROR 2.79, 95% CI lower limit 2.38, PRR 2.78, χ² 170.955).
Apart from various degrees of hepatotoxicity, such as increased ALT and AST, the immune-related hematological toxicity of atezolizumab should also be noted. In clinical practice, healthcare providers should always be vigilant for the occurrence of such medication-related AEs and take measures to enhance the safety of clinical medication use.
越来越多的临床研究强调了阿替利珠单抗在肿瘤免疫治疗中的应用。然而，对于其相关不良事件（AE）仍缺乏全面研究。为了加深我们对其毒理学特征的理解，并提供有关免疫治疗有效性的有价值临床见解，本研究利用美国食品药品监督管理局不良事件报告系统（FAERS）的数据，对与阿替利珠单抗相关的不良事件进行回顾性分析。
我们从FAERS数据库中提取了2004年第一季度至2024年第一季度与阿替利珠单抗相关的不良事件报告。我们使用报告比值比（ROR）、比例报告比（PRR）以及卡方值（χ²）对其进行量化，并通过SAS 9.4软件对不良事件信号挖掘结果进行系统分类。
共纳入19563份有效报告，涉及20个不同的系统器官类别。在首选术语层面报告的与阿替利珠单抗相关的不良事件主要包括贫血[ROR 2.33，95%置信区间（CI）下限2.09，PRR 2.31，χ² 255.977]、发热性中性粒细胞减少（ROR 2.81，95% CI下限2.50，PRR 2.79，χ² 333.586）、中性粒细胞计数减少（ROR 2.14，95% CI下限1.89，PRR 2.13，χ² 150.688）、白细胞计数减少（ROR 2.35，95% CI下限2.03，PRR 2.34，χ² 136.673）、脓毒症（ROR 2.21，95% CI下限1.91，PRR 2.20，χ² 117.741）、丙氨酸氨基转移酶升高（ALT）（ROR 2.86，95% CI下限2.44，PRR 2.85，χ² 180.031）以及天冬氨酸氨基转移酶升高（AST）（ROR 2.79，95% CI下限2.38，PRR 2.78，χ² 170.955）。
除了ALT和AST升高等不同程度的肝毒性外，还应注意阿替利珠单抗的免疫相关血液学毒性。在临床实践中，医护人员应始终警惕此类药物相关不良事件的发生，并采取措施提高临床用药安全性。
