Bevacizumab—Insights from EudraVigilance Database on the Assessments of the Safety Profile of Monoclonal Antibodies Used as Targeted Cancer Treatment
<b>Background/Objectives:</b> Worldwide, colon cancer is a major cause of cancer-related mortality, with an increasing incidence influenced by genetic, environmental, and lifestyle factors. Despite advances in diagnosis and personalized treatments, challenges remain in improving patient prognosis, particularly in metastatic colorectal cancer (mCRC). Bevacizumab (BEV), a monoclonal antibody, is widely used in colorectal cancer treatment. This study aimed to analyze adverse events associated with BEV compared with other therapies based on data from the EudraVigilance (EV) database. <b>Methods:</b> A descriptive and disproportionality analysis was conducted on signals reported in the EV database related to BEV. The study included comparisons with other antineoplastic treatments, such as chemotherapy, targeted therapy, and immunotherapy. Patient demographics, severity of adverse drug reactions (ADRs), and distribution patterns were analyzed to assess the safety profile of BEV in colorectal cancer treatment. <b>Results:</b> The majority of the signals for BEV were from patients aged 18-64 years (39.42%) and 65-85 years (34.08%). Hypertension, thromboembolism, proteinuria, and gastrointestinal disorders have been the most frequently reported. Serious ADRs, including gastrointestinal perforations, hemorrhage, and arterial thromboembolism, were observed in 93.74% of Individual Case Safety Reports. BEV was associated with a higher likelihood of vascular and endocrine disorders compared with chemotherapy and other targeted therapies. Immunotherapy was linked to increased immunological ADRs, while BEV demonstrated fewer immune-related toxicities. <b>Conclusions:</b> Continuous monitoring is necessary to optimize patient management, particularly in elderly patients or those with cardiovascular comorbidities. Understanding BEV's safety profile allows for better personalization of treatment strategies, minimizing risks while enhancing therapeutic outcomes.
Authors
- Felicia Gabriela Gligor (ORCID: https://orcid.org/0000-0003-3167-9864)
- Andreea Loredana Vonica-Țincu (ORCID: https://orcid.org/0000-0001-6362-4302)
- Claudiu Morgovan (ORCID: https://orcid.org/0000-0003-2730-8729)
- Adina Frum (ORCID: https://orcid.org/0000-0003-4874-0430)
- Stéliana Ghibu (ORCID: https://orcid.org/0000-0003-2247-4613)
- Anca Butucă (ORCID: https://orcid.org/0000-0003-1540-641X)
- Remus Călin Cipăian
- Carmen Maximiliana Dobrea (ORCID: https://orcid.org/0000-0002-9913-1750)
- Florina Batâr (ORCID: https://orcid.org/0000-0002-1147-9251)
- Manuela Pumnea
- Razvan Constantin Vonica
- Aliteia-Maria Pacnejer
Institutions
- Lucian Blaga University of Sibiu (RO)
- Iuliu Hațieganu University of Medicine and Pharmacy (RO)
- Victor Babeș University of Medicine and Pharmacy Timișoara (RO)
Publication Details
- Journal
- Pharmaceuticals
- Published
- 2025-03-30
- DOI
- https://doi.org/10.3390/ph18040501
- Citations
- 5
- Primary Topic
- Colorectal Cancer Treatments and Studies
- Type
- article
- Field-Weighted Citation Impact
- 5.23
Funders
- Universitatea "Lucian Blaga" din Sibiu