Real world safety of bevacizumab in cancer patients: A systematic literature review of case reports
| العنوان: | Real world safety of bevacizumab in cancer patients: A systematic literature review of case reports |
|---|---|
| المؤلفون: | Amit Dang, P Jagan Mohan Venkateshwara Rao, B N Vallish, Ravi Kishore |
| المصدر: | International Journal of Risk & Safety in Medicine. 32:163-173 |
| بيانات النشر: | IOS Press, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Adult, medicine.medical_specialty, Adolescent, Drug-Related Side Effects and Adverse Reactions, Bevacizumab, Off-label use, Young Adult, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Gastrointestinal perforation, Neoplasms, Internal medicine, medicine, Prescribing information, Humans, 030212 general & internal medicine, Drug reaction, Child, Aged, United States Food and Drug Administration, business.industry, Health Policy, Public Health, Environmental and Occupational Health, Cancer, General Medicine, Middle Aged, medicine.disease, United States, Clinical trial, Systematic review, business, medicine.drug |
| الوصف: | BACKGROUND: Real-world safety of bevacizumab in cancer patients is limited. OBJECTIVE: To review the adverse drug reactions (ADRs) due to bevacizumab in cancer patients, in published case reports. METHODS: PubMed was searched; case reports of patients with any type of cancer, administered with bevacizumab (monotherapy/combination) and reported ADRs were included. Causality of ADRs was presented as reported in individual papers. ADRs were classified using the information in the USFDA-approved prescribing information (PI) of bevacizumab as ‘Serious’, ‘Common’, and ‘Post-marketing surveillance’ ADRs; ADRs not mentioned in the bevacizumab PI were termed as ‘Non-label ADRs’. RESULTS: A total of 130 published papers comprising 154 cases from 22 different countries were included. Most papers (102/130; 78.46%) had moderate methodological quality. Age range of patients was 9-77 years. Off-label use of bevacizumab was found in 34/154 cases (22.08%). Ninety-six unique ADRs were found among 154 ADRs; most reported ADRs affected circulatory, digestive, and respiratory systems (33, 32, and 26 cases respectively). Most commonly reported ADRs were posterior leukoencephalopathy, fistulae, and gastrointestinal perforation (17, 17, and 16 cases respectively). Twenty-eight unique non-label ADRs (29.17%) were found. CONCLUSION: Bevacizumab is associated with more ADRs in the real world among cancer patients than those reported during clinical trials. |
| تدمد: | 1878-6847 0924-6479 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9df0e531988ee802e965c80523e2339dTest https://doi.org/10.3233/jrs-194051Test |
| رقم الانضمام: | edsair.doi.dedup.....9df0e531988ee802e965c80523e2339d |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 18786847 09246479 |
|---|