Classification of treatment-related mortality in children with cancer: a systematic assessment

Sarah Alexander; Jason D Pole; Paul Gibson; Michelle Lee; Tanya Hesser; Susan N Chi; Christopher C Dvorak; Brian Fisher; Henrik Hasle; Jukka Kanerva; Anja Möricke; Bob Phillips; Elizabeth Raetz; Carlos Rodriguez-Galindo; Sujith Samarasinghe; Kjeld Schmiegelow; Wim Tissing; Thomas Lehrnbecher; Lillian Sung; International Pediatric Oncology Mortality Classification Group

doi:10.1016/S1470-2045(15)00197-7

Classification of treatment-related mortality in children with cancer: a systematic assessment

Lancet Oncol. 2015 Dec;16(16):e604-10. doi: 10.1016/S1470-2045(15)00197-7.

Authors

Sarah Alexander¹, Jason D Pole², Paul Gibson³, Michelle Lee⁴, Tanya Hesser⁴, Susan N Chi⁵, Christopher C Dvorak⁶, Brian Fisher⁷, Henrik Hasle⁸, Jukka Kanerva⁹, Anja Möricke¹⁰, Bob Phillips¹¹, Elizabeth Raetz¹², Carlos Rodriguez-Galindo⁵, Sujith Samarasinghe¹³, Kjeld Schmiegelow¹⁴, Wim Tissing¹⁵, Thomas Lehrnbecher¹⁶, Lillian Sung¹⁷; International Pediatric Oncology Mortality Classification Group

Affiliations

¹ Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, ON, Canada.
² Pediatric Oncology Group of Ontario, Toronto, ON, Canada.
³ Division of Haematology/Oncology, Children's Hospital, London Health Sciences Centre, London, ON, Canada.
⁴ Program in Child Health Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, Toronto, ON, Canada.
⁵ Department of Hematology/Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
⁶ Division of Pediatric Allergy, Immunology, and Bone Marrow Transplantation, University of California, San Francisco Medical Center-Mission Bay, San Francisco, CA, USA.
⁷ Division of Infectious Diseases, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
⁸ Department of Paediatrics, Aarhus University Hospital, Aarhus, Denmark.
⁹ Hospital for Children and Adolescents, Helsinki University Central Hospital, Helsinki, Finland.
¹⁰ Department of Paediatrics, University Medical Centre Schleswig-Holstein, Kiel, Germany.
¹¹ Centre for Reviews and Dissemination, University of York, York, UK.
¹² Division of Pediatric Hematology/Oncology, University of Utah, Salt Lake City, UT, USA.
¹³ Department of Paediatric Haematology, Great Ormond Street Hospital, London, UK.
¹⁴ Department of Pediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark; Institute for Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
¹⁵ Department of Paediatric Oncology, University Medical Center Groningen, Groningen, Netherlands.
¹⁶ Department of Paediatric Haematology and Oncology, Johann Wolfgang Goethe University, Frankfurt, Germany.
¹⁷ Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, ON, Canada. Electronic address: lillian.sung@sickkids.ca.

PMID: 26678213
DOI: 10.1016/S1470-2045(15)00197-7

Abstract

Treatment-related mortality is an important outcome in paediatric cancer clinical trials. An international group of experts in supportive care in paediatric cancer developed a consensus-based definition of treatment-related mortality and a cause-of-death attribution system. The reliability and validity of the system was tested in 30 deaths, which were independently assessed by two clinical research associates and two paediatric oncologists. We defined treatment-related mortality as death occurring in the absence of progressive cancer. Of the 30 reviewed deaths, the reliability of classification for treatment-related mortality was noted as excellent by clinical research associates (κ=0·83, 95% CI 0·60-1·00) and paediatric oncologists (0·84, 0·63-1·00). Criterion validity was established because agreement between the consensus classifications by clinical research associates and paediatric oncologists was almost perfect (0·92, 0·78-1·00). Our approach should allow comparison of treatment-related mortality across trials and across time.

Publication types

Consensus Development Conference
Research Support, Non-U.S. Gov't
Review

MeSH terms

Adolescent
Age Factors
Antineoplastic Combined Chemotherapy Protocols / adverse effects*
Antineoplastic Combined Chemotherapy Protocols / classification
Cause of Death
Child
Child Mortality*
Child, Preschool
Consensus
Drug-Related Side Effects and Adverse Reactions / classification
Drug-Related Side Effects and Adverse Reactions / diagnosis
Drug-Related Side Effects and Adverse Reactions / mortality*
Hematopoietic Stem Cell Transplantation / adverse effects
Hematopoietic Stem Cell Transplantation / classification
Hematopoietic Stem Cell Transplantation / mortality*
Humans
Infant
Infant Mortality*
Infant, Newborn
Neoplasms / mortality*
Neoplasms / therapy*
Risk Assessment
Risk Factors
Terminology as Topic*
Time Factors
Treatment Outcome

Grants and funding

G0800472/MRC_/Medical Research Council/United Kingdom