Lack of treatment-related mortality definitions in clinical trials of children, adolescents and young adults with lymphomas, solid tumors and brain tumors: a systematic review

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• 作者：Thai Hoa Tran (18)
  Michelle Lee (19)
  Sarah Alexander (18)
  Paul Gibson (20)
  Ute Bartels (18)
  Donna L Johnston (21)
  Carol Portwine (22)
  Marianna Silva (23)
  Jason D Pole (24)
  Lillian Sung (18)
  
  18. Division of Haematology/Oncology ; The Hospital for Sick Children ; 555 University Ave ; Toronto ; Ontario ; M5G 1X8 ; Canada
  19. Child Health Evaluative Sciences ; The Hospital for Sick Children ; Peter Gilgan Centre for Research and Learning ; 686 Bay St ; Toronto ; Ontario ; M5G 0A4 ; Canada
  20. Haematology/Oncology ; Department of Pediatrics ; London Health Sciences Centre ; PO Box 5010800 ; Commissioners Rd E ; London ; N6A 5W9 ; Canada
  21. Division of Hematology/Oncology ; Children鈥檚 Hospital of Eastern Ontario ; 401 Smyth Rd ; Ottawa ; Ontario ; K1H 8L1 ; Canada
  22. Hematology/Oncology ; McMaster Children鈥檚 Hospital ; 1200 Main St W ; Hamilton ; Ontario ; L8N 3Z5 ; Canada
  23. Hematology/Oncology ; Cancer Centre of Southeastern Ontario ; 25 King St W ; Kingston ; Ontario ; K7L 5P9 ; Canada
  24. Pediatric Oncology Group of Ontario ; Dalla Lana School of Public Health ; University of Toronto ; 155 College St ; Toronto ; Ontario ; M5T 3M7 ; Canada
  
• 关键词：Treatment ; related mortality ; Toxic death ; Cancer ; Pediatric ; Adolescents ; Young adults ; Systematic review
• 刊名：BMC Cancer
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：14
• 期：1
• 全文大小：443 KB
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  13. The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2407/14/612/prepub
  
• 刊物主题：Cancer Research; Oncology; Stem Cells; Animal Models; Internal Medicine;
• 出版者：BioMed Central
• ISSN：1471-2407

文摘

Background There is a lack of standardized definition for treatment-related mortality (TRM), which represents an important endpoint in cancer. Our objective was to describe TRM definitions used in studies of children, adolescents and young adults with lymphomas, solid tumors and brain tumors. Methods We conducted a systematic review of studies enrolling children, adolescents and young adults with lymphomas, solid tumors and brain tumors in which an anti-cancer intervention was randomized, or all study designs in which TRM was a primary or secondary outcome. We searched Ovid MEDLINE, EMBASE and Evidence-Based Medicine Reviews from 1980 to June 2013. Two reviewers evaluated study eligibility and abstracted data. Results In total, 67 studies were included and consisted of 62 randomized therapeutic trials and 5 TRM studies. None of the studies (0/67) provided a definition for TRM. Only one randomized trial of rhabdomyosarcoma provided a definition of early death. Conclusions We were unable to identify any TRM definitions used in studies of children, adolescents and young adults with lymphomas, solid tumors and brain tumors. Given that a proportion of this patient population may receive intensive treatment, there is an urgent need for consensus-based definitions of TRM for use across clinical trials.