title: Approach for Classification and Severity Grading of Long-term and Late-Onset Health Events among Childhood Cancer Survivors in the St. Jude Lifetime Cohort.
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.
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee. melissa.hudson@stjude.org.|Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Melissa M
authors.initials: MM
authors.lastname: Hudson
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Ehrhardt
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Global Medicine, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Nickhill
authors.initials: N
authors.lastname: Bhakta
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Malek
authors.initials: M
authors.lastname: Baassiri
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Hesham
authors.initials: H
authors.lastname: Eissa
authors.affiliation: Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Wassim
authors.initials: W
authors.lastname: Chemaitilly
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Green
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Mulrooney
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Gregory T
authors.initials: GT
authors.lastname: Armstrong
authors.affiliation: Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Psychology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Tara M
authors.initials: TM
authors.lastname: Brinkman
authors.affiliation: Department of Psychology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: James L
authors.initials: JL
authors.lastname: Klosky
authors.affiliation: Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Psychology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Kevin R
authors.initials: KR
authors.lastname: Krull
authors.affiliation: Department of Diagnostic Imaging, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Noah D
authors.initials: ND
authors.lastname: Sabin
authors.affiliation: Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Carmen L
authors.initials: CL
authors.lastname: Wilson
authors.affiliation: Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: I-Chan
authors.initials: IC
authors.lastname: Huang
authors.affiliation: Department of Rehabilitation Services, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Johnnie K
authors.initials: JK
authors.lastname: Bass
authors.affiliation: Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Karen
authors.initials: K
authors.lastname: Hale
authors.affiliation: Department of Diagnostic Imaging, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Sue
authors.initials: S
authors.lastname: Kaste
authors.affiliation: Department of Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Raja B
authors.initials: RB
authors.lastname: Khan
authors.affiliation: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Deo Kumar
authors.initials: DK
authors.lastname: Srivastava
authors.affiliation: Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Yasui
authors.affiliation: University of Tennessee College of Medicine, Memphis, Tennessee.
authors.forename: Vijaya M
authors.initials: VM
authors.lastname: Joshi
authors.affiliation: University of Tennessee College of Medicine, Memphis, Tennessee.
authors.forename: Saumini
authors.initials: S
authors.lastname: Srinivasan
authors.affiliation: University of Tennessee College of Medicine, Memphis, Tennessee.
authors.forename: Dennis
authors.initials: D
authors.lastname: Stokes
authors.affiliation: University of Tennessee College of Medicine, Memphis, Tennessee.
authors.forename: Mary Ellen
authors.initials: ME
authors.lastname: Hoehn
authors.affiliation: University of Tennessee College of Medicine, Memphis, Tennessee.
authors.forename: Matthew
authors.initials: M
authors.lastname: Wilson
authors.affiliation: Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Kirsten K
authors.initials: KK
authors.lastname: Ness
authors.affiliation: Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Leslie L
authors.initials: LL
authors.lastname: Robison
mesh_terms: D000293:Adolescent; D000970:Antineoplastic Agents / Q000009:adverse effects; D000073116:Cancer Survivors / Q000145:classification*; D002648:Child; D015331:Cohort Studies; D006801:Humans; D009369:Neoplasms / Q000150:complications* / Q000628:therapy*; D011878:Radiotherapy / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents