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. 2025 May 15:16:1595642.
doi: 10.3389/fphar.2025.1595642. eCollection 2025.

Comparative safety analysis of bevacizumab and alkylating agent in glioblastoma management - What have we learned recently?

Zhizhao Qu  1   2 , Jiajia Zhao  3 , Liu Yang  1 , Yuanwei Fu  1 , Rui Bai  1 , Jinchuan Li  4 , Hongqin Wang  1
Affiliations

Comparative safety analysis of bevacizumab and alkylating agent in glioblastoma management - What have we learned recently?

Zhizhao Qu et al. Front Pharmacol. .

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: FAERS; alkylating agent; bevacizumab; glioblastoma; safety profile; temozolomide.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Workflow of the de-duplication process.
FIGURE 2
FIGURE 2
Annual number of reported adverse events associated with bevacizumab and alkylating agents from Q1 2004 to Q4 2023.
FIGURE 3
FIGURE 3
Comparative safety profiles across System Organ Classes (SOCs) for bevacizumab versus temozolomide.
FIGURE 4
FIGURE 4
Comparative safety profiles at the Preferred Term (PT) level: safety signals of bevacizumab compared with temozolomide.
See this image and copyright information in PMC

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