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...
Saved in:
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-03-01
|
| Series: | Pharmaceuticals |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1424-8247/18/4/501 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850180067016048640 |
|---|---|
| author | Razvan Constantin Vonica Anca Butuca Claudiu Morgovan Manuela Pumnea Remus Calin Cipaian Adina Frum Carmen Maximiliana Dobrea Andreea Loredana Vonica-Tincu Aliteia-Maria Pacnejer Steliana Ghibu Florina Batar Felicia Gabriela Gligor |
| author_facet | Razvan Constantin Vonica Anca Butuca Claudiu Morgovan Manuela Pumnea Remus Calin Cipaian Adina Frum Carmen Maximiliana Dobrea Andreea Loredana Vonica-Tincu Aliteia-Maria Pacnejer Steliana Ghibu Florina Batar Felicia Gabriela Gligor |
| author_sort | Razvan Constantin Vonica |
| collection | DOAJ |
| description | <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. |
| format | Article |
| id | doaj-art-8c55dbf8419c4ddd9c945c0239c88253 |
| institution | OA Journals |
| issn | 1424-8247 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj-art-8c55dbf8419c4ddd9c945c0239c882532025-08-20T02:18:20ZengMDPI AGPharmaceuticals1424-82472025-03-0118450110.3390/ph18040501Bevacizumab—Insights from EudraVigilance Database on the Assessments of the Safety Profile of Monoclonal Antibodies Used as Targeted Cancer TreatmentRazvan Constantin Vonica0Anca Butuca1Claudiu Morgovan2Manuela Pumnea3Remus Calin Cipaian4Adina Frum5Carmen Maximiliana Dobrea6Andreea Loredana Vonica-Tincu7Aliteia-Maria Pacnejer8Steliana Ghibu9Florina Batar10Felicia Gabriela Gligor11Preclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, RomaniaPreclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, RomaniaPreclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, RomaniaPreclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, RomaniaClinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, RomaniaPreclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, RomaniaPreclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, RomaniaPreclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, RomaniaPreclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, RomaniaDepartment of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy, “Iuliu Haţieganu” University of Medicine and Pharmacy, 400349 Cluj-Napoca, RomaniaPreclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, RomaniaPreclinical Department, Faculty of Medicine, “Lucian Blaga” University of Sibiu, 550169 Sibiu, Romania<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.https://www.mdpi.com/1424-8247/18/4/501colon cancerbevacizumabmonoclonal antibodiespharmacovigilancepersonalized therapy |
| spellingShingle | Razvan Constantin Vonica Anca Butuca Claudiu Morgovan Manuela Pumnea Remus Calin Cipaian Adina Frum Carmen Maximiliana Dobrea Andreea Loredana Vonica-Tincu Aliteia-Maria Pacnejer Steliana Ghibu Florina Batar Felicia Gabriela Gligor Bevacizumab—Insights from EudraVigilance Database on the Assessments of the Safety Profile of Monoclonal Antibodies Used as Targeted Cancer Treatment Pharmaceuticals colon cancer bevacizumab monoclonal antibodies pharmacovigilance personalized therapy |
| title | Bevacizumab—Insights from EudraVigilance Database on the Assessments of the Safety Profile of Monoclonal Antibodies Used as Targeted Cancer Treatment |
| title_full | Bevacizumab—Insights from EudraVigilance Database on the Assessments of the Safety Profile of Monoclonal Antibodies Used as Targeted Cancer Treatment |
| title_fullStr | Bevacizumab—Insights from EudraVigilance Database on the Assessments of the Safety Profile of Monoclonal Antibodies Used as Targeted Cancer Treatment |
| title_full_unstemmed | Bevacizumab—Insights from EudraVigilance Database on the Assessments of the Safety Profile of Monoclonal Antibodies Used as Targeted Cancer Treatment |
| title_short | Bevacizumab—Insights from EudraVigilance Database on the Assessments of the Safety Profile of Monoclonal Antibodies Used as Targeted Cancer Treatment |
| title_sort | bevacizumab insights from eudravigilance database on the assessments of the safety profile of monoclonal antibodies used as targeted cancer treatment |
| topic | colon cancer bevacizumab monoclonal antibodies pharmacovigilance personalized therapy |
| url | https://www.mdpi.com/1424-8247/18/4/501 |
| work_keys_str_mv | AT razvanconstantinvonica bevacizumabinsightsfromeudravigilancedatabaseontheassessmentsofthesafetyprofileofmonoclonalantibodiesusedastargetedcancertreatment AT ancabutuca bevacizumabinsightsfromeudravigilancedatabaseontheassessmentsofthesafetyprofileofmonoclonalantibodiesusedastargetedcancertreatment AT claudiumorgovan bevacizumabinsightsfromeudravigilancedatabaseontheassessmentsofthesafetyprofileofmonoclonalantibodiesusedastargetedcancertreatment AT manuelapumnea bevacizumabinsightsfromeudravigilancedatabaseontheassessmentsofthesafetyprofileofmonoclonalantibodiesusedastargetedcancertreatment AT remuscalincipaian bevacizumabinsightsfromeudravigilancedatabaseontheassessmentsofthesafetyprofileofmonoclonalantibodiesusedastargetedcancertreatment AT adinafrum bevacizumabinsightsfromeudravigilancedatabaseontheassessmentsofthesafetyprofileofmonoclonalantibodiesusedastargetedcancertreatment AT carmenmaximilianadobrea bevacizumabinsightsfromeudravigilancedatabaseontheassessmentsofthesafetyprofileofmonoclonalantibodiesusedastargetedcancertreatment AT andreealoredanavonicatincu bevacizumabinsightsfromeudravigilancedatabaseontheassessmentsofthesafetyprofileofmonoclonalantibodiesusedastargetedcancertreatment AT aliteiamariapacnejer bevacizumabinsightsfromeudravigilancedatabaseontheassessmentsofthesafetyprofileofmonoclonalantibodiesusedastargetedcancertreatment AT stelianaghibu bevacizumabinsightsfromeudravigilancedatabaseontheassessmentsofthesafetyprofileofmonoclonalantibodiesusedastargetedcancertreatment AT florinabatar bevacizumabinsightsfromeudravigilancedatabaseontheassessmentsofthesafetyprofileofmonoclonalantibodiesusedastargetedcancertreatment AT feliciagabrielagligor bevacizumabinsightsfromeudravigilancedatabaseontheassessmentsofthesafetyprofileofmonoclonalantibodiesusedastargetedcancertreatment |