Safety and efficacy of tyrosine kinase inhibitors in pediatric chronic myeloid leukemia: A protocol for systematic review and meta-analysis

Introduction

Current evidence regarding the efficacy and safety of tyrosine kinase inhibitors in the pediatrics with chronic myeloid leukemia (CML) is limited. The safety of TKI beyond 15years of use has not been studied even in the adult population. This systematic review and meta-analysis’s main objectives are (a) to combine the existing knowledge of efficacy and safety profile of TKI in pediatric CML and (b) to compare the side effects of long-term TKI therapy in the pediatric population versus stem cell transplantation.

Methods

A systematic review with meta-analysis will be performed. Multiple online databases will be explored via pre-decided searching strategy to find eligible studies. All studies reporting on the efficacy and safety of TKI in pediatrics. We will include case reports and series, retrospective and prospective observational studies, studies with experimental designs and gray literature including abstracts from various hematology conferences. The quality of articles will be analyzed by 2 independent reviewers following Reporting Guidelines for Meta-analyses of Observational Studies and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. CMA and STATA will be utilized to perform the meta-analysis.

Discussion

This study will be among the initial ones to explore and combine the evidence available on the safety and efficacy of TKI in pediatric CML patients in the form of systematic review and meta-analysis. By acquiring and summarizing data about the use of TKI therapy in pediatric CML patients, the results from this study will give insights for future prospective studies and will provide a better understanding of the efficacy and safety of TKI in pediatric CML.

Other Information

Published in: Medicine: Case Reports and Study Protocols
License: https://creativecommons.org/licenses/by/4.0/
See article on publisher's website: https://dx.doi.org/10.1097/md9.0000000000000223