Qu Zhizhao, Zhao Jiajia, Yang Liu, Fu Yuanwei, Bai Rui, Li Jinchuan, Wang Hongqin
Department of Neurosurgery, First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Graduate School, Shanxi Medical University, Taiyuan, Shanxi, China.
Front Pharmacol. 2025 May 15;16:1595642. doi: 10.3389/fphar.2025.1595642. eCollection 2025.
Alkylating agents and bevacizumab are both first-line chemotherapeutic options for the treatment of glioblastoma; however, their mechanisms of action differ substantially. This study aimed to compare the safety profiles of these two drug classes in the treatment of glioblastoma to inform clinical decision-making.
Adverse events reported between the first quarter of 2004 and the fourth quarter of 2023 were analyzed using data from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality analysis was employed to assess and compare the AE signals associated with bevacizumab and alkylating agents.
In the context of glioblastoma treatment, 3,323 adverse reports were associated with bevacizumab, 5,283 with temozolomide, and 427 with lomustine. The most frequently reported AEs for bevacizumab were fatigue (n = 276), hypertension (n = 220), and headache (n = 199). Compared to temozolomide, bevacizumab was more strongly associated with "vascular disorders," "renal and urinary disorders," and "hypertension." Notably, bevacizumab appeared to offer a potential safety advantage with respect to hematological adverse events.
Our analysis indicates that bevacizumab exhibits a distinct safety profile compared to alkylating agents, particularly demonstrating a lower incidence of hematological adverse events. Further prospective studies are warranted to validate these findings and to elucidate the underlying mechanisms responsible for the observed adverse events.
烷化剂和贝伐单抗均为胶质母细胞瘤治疗的一线化疗选择；然而，它们的作用机制有很大差异。本研究旨在比较这两类药物在胶质母细胞瘤治疗中的安全性，以为临床决策提供参考。
使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库的数据，分析2004年第一季度至2023年第四季度期间报告的不良事件。采用不成比例分析来评估和比较与贝伐单抗和烷化剂相关的不良事件信号。
在胶质母细胞瘤治疗方面，3323份不良报告与贝伐单抗有关，5283份与替莫唑胺有关，427份与洛莫司汀有关。贝伐单抗最常报告的不良事件为疲劳（n = 276）、高血压（n = 220）和头痛（n = 199）。与替莫唑胺相比，贝伐单抗与“血管疾病”、“肾脏和泌尿系统疾病”以及“高血压”的关联更强。值得注意的是，贝伐单抗在血液学不良事件方面似乎具有潜在的安全优势。
我们的分析表明，与烷化剂相比，贝伐单抗具有独特的安全性，尤其是血液学不良事件的发生率较低。有必要进行进一步的前瞻性研究来验证这些发现，并阐明导致观察到的不良事件的潜在机制。
