Affiliations: [a] MarksMan Healthcare Communications and KYT Adhere, India E-mail: [email protected] | [b] MarksMan Healthcare Communications, India E-mail: [email protected] | [c] MarksMan Healthcare Communications, India E-mail: [email protected] | [d] Medical Writing and Biostatistics, MarksMan Healthcare Communications, India E-mail: [email protected]
Correspondence:
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Address for correspondence: Dr. Amit Dang, Founder and CEO, MarksMan Healthcare Communications and KYT Adhere, H. No 9-1-67, Plot no. 67, TNGO’s Colony, Behind Q City, Financial District, Hyderabad, Telangana 500032, India. Tel.: +91 77383 89300; E-mail: [email protected]
Abstract: 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.
Keywords: Bevacizumab, safety, cancer patients, off-label use, real world
