Characteristics of adverse reactions of three anti-glioma drugs in WHO-VigiAccess.

Abstract

Antitumor medications such as Avastin, Berubicin, and Temozolomide have fundamentally transformed the treatment landscape for gliomas by exhibiting potent pharmacological effects on both high-grade and low-grade gliomas. This study aims to determine which anti-glioma medication presents the lowest risk for personalized use in clinical patients by assessing the adverse drug reactions (ADRs) associated with these medications as reported in the World Health Organization (WHO) VigiAcess database, and by comparing the characteristics of adverse responses among the three drugs. This investigation employs a retrospective descriptive analysis method. We compiled ADR reports for three commercially available anti-glioma medications from WHO-VigiAccess, gathering data on the disease systems and symptoms associated with ADRs, as well as the age, gender, and geographic characteristics of the patients represented in the reports. To provide a reference for clinical treatment, we analyzed the similarities and differences in the adverse reactions of the three medications by calculating the proportion of adverse reactions recorded for each drug. A total of 132,471 adverse events (AEs) associated with three anti-glioma drugs were reported in VigiAccess. The analysis revealed that the ten most frequently reported AEs included bone marrow suppression, myalgia, leukopenia, thrombocytopenia, nausea, vomiting, death, rhabdomyolysis, disease progression, and a decrease in neutrophil count. The five most common categories of AEs related to anti-glioma drugs were blood and lymphatic system diseases (20,233 cases, 15.2%), general disorders and administration site conditions (26,973 cases, 20.3%), gastrointestinal dysfunction (22,061 cases, 16.7%), necessitating further investigations (18,285 cases, 13.8%), and musculoskeletal and connective tissue diseases (30,695 cases, 23.1%). Notably, the adverse events associated with Avastin were more pronounced in the category of musculoskeletal and connective tissue diseases compared to the other two drugs. Furthermore, Berubicin exhibited a particularly high proportion of blood and lymphatic system disease AEs, reaching 45.6%, which was significantly greater than those observed for the other two drugs. There is limited correlation between antineoplastic medications and ADRs. Current comparative observational studies indicate that these inhibitors are associated with both common and specific adverse effects documented in the ADR reports submitted to the World Health Organization (WHO).