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Evaluating the endometabolic and bone health effects of Tyrosine Kinase Inhibitors in Chronic Myeloid Leukaemia: a systematic review protocol
  1. Janatani Balakumaran1,2,3,
  2. Tanisha Birk3,
  3. Breanne Golemiec3,
  4. Wryan Helmeczi3,
  5. Jeyanth Inkaran3,
  6. Yun-ya Kao1,
  7. Jennifer Leigh3,
  8. Sarah Saliba3,
  9. Rishi Sharma3,
  10. Laura Spatafora3,
  11. Kristin Wright3,
  12. William Yao3,
  13. Christopher Hillis4,
  14. Laura Banfield5,
  15. Lehana Thabane6,7,8,9,
  16. Uma Athale1,10,
  17. M Constantine Samaan1,2,3
  1. 1Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada
  2. 2Division of Pediatric Endocrinology, McMaster University, Hamilton, Ontario, Canada
  3. 3Michael G. De Groote School of Medicine, McMaster University, Hamilton, Ontario, Canada
  4. 4Division of Hematology Oncology, Juravinski Cancer Center, Hamilton, Ontario, Canada
  5. 5Health Sciences Library, McMaster University, Hamilton, Ontario, Canada
  6. 6Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
  7. 7Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada
  8. 8Centre for Evaluation of Medicines, McMaster University, Hamilton, Ontario, Canada
  9. 9Biostatistics Unit, St Joseph's Healthcare-Hamilton, Hamilton, Ontario, Canada
  10. 10Division of Hematology Oncology, McMaster Children's Hospital, Hamilton, Ontario, Canada
  1. Correspondence to Dr M Constantine Samaan, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada; samaanc{at}mcmaster.ca

Abstract

Introduction Chronic Myeloid Leukaemia (CML) constitutes 15% of new adult leukaemia cases as well as 2%–3% of leukaemia in children under 15% and 9% of leukaemias in adolescents 15–19 years of age annually. The introduction of Tyrosine Kinase Inhibitors (TKI) therapy has dramatically improved survival in these patients, yet the off-target effects of this treatment may have long-term health impacts on CML survivors. The risk of adverse health outcomes is especially important in children, where TKI exposure may occur during critical windows of growth and puberty, and patients require treatment for prolonged periods of time. The aim of this systematic review protocol is to report on the methods used to conduct a systematic review to investigate the endometabolic and bone health effects of TKI therapy in CML.

Methods and analysis Searches will be conducted in the Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE from inception on August 1st, 2019. Searches may be updated while performing the systematic review to ensure new evidence is included if applicable. Grey literature search will include ClinicalTrials.gov and ProQuest Dissertations and Theses A&I. We will perform a meta-analysis if there are at least two studies reporting similar populations, interventions, methods and tracking the same outcome measures. The studies should also have similar age and sex distributions.

Ethics and dissemination As this is a systematic review protocol, it does not include patient data; therefore, Research Ethics Board approval is not indicated. The systematic review will be published in a peer-reviewed journal and presented at international conferences.

PROSPERO registration number CRD42018091175.

  • systematic review
  • protocol
  • chronic myeloid leukemia
  • tyrosine kinase inhibitors
  • metabolic
  • endocrine
  • bone health

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors MCS is the guarantor. Research question was defined by JB, TB, BG, WH, JI, YK, JL, SS, RS, LS, KW, WY, LB, LT, UA, CH and MCS. Search strategy and eligibility criteria were developed by MCS, JB, LT, UA, CH and LB. Data abstraction form was designed by JB, TB, BG, WH, JI, YK, JL, SS, RS, LS, KW, WY, LB and MCS. MCS, LT, UA, CH and JB drafted the manuscript. All authors reviewed, edited and approved the final version of the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement There are no data in this work.

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