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Cancer Epidemiol Biomarkers Prev. 2017 May;26(5):666-674. doi: 10.1158/1055-9965.EPI-16-0812. Epub 2016 Dec 29.

Approach for Classification and Severity Grading of Long-term and Late-Onset Health Events among Childhood Cancer Survivors in the St. Jude Lifetime Cohort.

Author information

1
Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee. melissa.hudson@stjude.org.
2
Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
3
Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.
4
Department of Global Medicine, St. Jude Children's Research Hospital, Memphis, Tennessee.
5
Department of Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, Tennessee.
6
Department of Psychology, St. Jude Children's Research Hospital, Memphis, Tennessee.
7
Department of Diagnostic Imaging, St. Jude Children's Research Hospital, Memphis, Tennessee.
8
Department of Rehabilitation Services, St. Jude Children's Research Hospital, Memphis, Tennessee.
9
Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee.
10
University of Tennessee College of Medicine, Memphis, Tennessee.

Abstract

Characterization of toxicity associated with cancer and its treatment is essential to quantify risk, inform optimization of therapeutic approaches for newly diagnosed patients, and guide health surveillance recommendations for long-term survivors. The NCI Common Terminology Criteria for Adverse Events (CTCAE) provides a common rubric for grading severity of adverse outcomes in cancer patients that is widely used in clinical trials. The CTCAE has also been used to assess late cancer treatment-related morbidity but is not fully representative of the spectrum of events experienced by pediatric and aging adult survivors of childhood cancer. Also, CTCAE characterization does not routinely integrate detailed patient-reported and medical outcomes data available from clinically assessed cohorts. To address these deficiencies, we standardized the severity grading of long-term and late-onset health events applicable to childhood cancer survivors across their lifespan by modifying the existing CTCAE v4.03 criteria and aligning grading rubrics from other sources for chronic conditions not included or optimally addressed in the CTCAE v4.03. This article describes the methods of late toxicity assessment used in the St. Jude Lifetime Cohort Study, a clinically assessed cohort in which data from multiple diagnostic modalities and patient-reported outcomes are ascertained. Cancer Epidemiol Biomarkers Prev; 26(5); 666-74. ©2016 AACR.

PMID:
28035022
PMCID:
PMC5413397
DOI:
10.1158/1055-9965.EPI-16-0812
[Indexed for MEDLINE]
Free PMC Article

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