ABSTRACT
A meta-analysis of randomized controlled trials (RCTs) was performed to examine the risk of everolimus discontinuation due to related and unrelated adverse events (AE) in cancer patients. Fifteen RCTs were analyzed that compared everolimus to placebo and reported discontinuation due to AE with everolimus (related and unrelated to everolimus) and placebo (unrelated to everolimus). Incidence of discontinuation with everolimus due to AE and placebo was 12.3% and 4.7% respectively. Relative risk of everolimus discontinuation due to related AE was 2.60. Risk of discontinuation varied by tumor type, however everolimus dose or concomitant chemotherapy was not significant.
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Acknowledgment
Study concept and design: Dr. Wu
Acquisition of data: Dr. Rogers
Analysis and interpretation of data: Dr. Wu, Dr. Rogers
Drafting of the manuscript: Dr. Rogers, Dr. Garcia
Critical revision of the manuscript for important intellectual
content: Dr. Wu, Dr. Rogers and Dr. Garcia
Statistical analysis: Dr. Wu
Administrative, technical, or material support: none
Study supervision: Dr. Wu
Funding/Material Support: none
Dr. Wu has full access to all of the data in the study and takes
responsibility for the integrity of the data and the accuracy of the data analysis.
Declaration of interest
Dr. Wu reported being a speaker for Pfizer and Novartis. No other authors reported conflicts of interest.