Open Access Research article

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

Thai Hoa Tran1, Michelle Lee2, Sarah Alexander1, Paul Gibson3, Ute Bartels1, Donna L Johnston4, Carol Portwine5, Marianna Silva6, Jason D Pole7 and Lillian Sung1*

Author Affiliations

1 Division of Haematology/Oncology, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario M5G 1X8, Canada

2 Child Health Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, 686 Bay St, Toronto, Ontario M5G 0A4, Canada

3 Haematology/Oncology, Department of Pediatrics, London Health Sciences Centre, PO Box 5010800 Commissioners Rd E, London N6A 5W9, Canada

4 Division of Hematology/Oncology, Children’s Hospital of Eastern Ontario, 401 Smyth Rd, Ottawa, Ontario K1H 8L1, Canada

5 Hematology/Oncology, McMaster Children’s Hospital, 1200 Main St W, Hamilton, Ontario L8N 3Z5, Canada

6 Hematology/Oncology, Cancer Centre of Southeastern Ontario, 25 King St W, Kingston, Ontario K7L 5P9, Canada

7 Pediatric Oncology Group of Ontario, Dalla Lana School of Public Health, University of Toronto, 155 College St, Toronto, Ontario M5T 3M7, Canada

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BMC Cancer 2014, 14:612  doi:10.1186/1471-2407-14-612

Published: 26 August 2014

Abstract

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.

Keywords:
Treatment-related mortality; Toxic death; Cancer; Pediatric; Adolescents; Young adults; Systematic review