National Cancer Institute (NCI) funded cooperative oncology group trials have improved overall survival for children with cancer from 10% to 85% over the past five decades, and have set standards of care for adults with malignancies. However, according to the Institute of Medicine: """"""""the clinical trial system is approaching a state of crisis"""""""". If [it] does not improve its efficiency and effectiveness, the introduction of new treatments for cancer will be delayed and patient lives will be lost unnecessarily. This application proposes to improve toxicity monitoring, estimate treatment associated resource utilization and costs, and serve as a platform for answering important clinical epidemiology questions by merging data from the Children's Oncology Group (COG) and the Pediatric Health Information Systems (PHIS) administrative data base for patients treated for de novo acute myeloid leukemia (AML) on recent Phase III clinical trials. Four hypotheses underpin this application: (1) We hypothesize that greater than 95% of patients enrolled on recent and current COG AML trials can be identified in PHIS;(2) COG-PHIS merged data will more accurately report adverse events than unmerged data;(3) COG-PHIS merged data can prospectively monitor a Phase III trial for adverse events;(4) COG-PHIS merged data will describe standardized costs of treatment by regimen arm and enable analyses of cost variation. This application has significance both as a methodological advancement and in the use of this methodology to improve toxicity monitoring and outcome analysis in cooperative group oncology trials. Furthermore, this application is highly innovative as the first merging of cooperative grou clinical trial data with administrative data. Finally, the approach taken in this application shoul be applicable not only to other pediatric malignancies, but also to adult cancers generally. Thus, the application is likely to have a high impact on the care of both children and adults with cancer.

Public Health Relevance

This application proposes to improve toxicity monitoring, estimate treatment associated resource utilization and costs, and serve as a platform for answering important clinical epidemiology questions by merging data from the Children's Oncology Group (COG) and the Pediatric Health Information Systems (PHIS) administrative data base for patients treated for de novo acute myeloid leukemia (AML) on recent Phase III clinical trials. This application has significance both as a methodological advancement and in the use of this methodology to improve toxicity monitoring and outcome analysis in cooperative group oncology trials. Furthermore, the approach taken in this application should be applicable not only to other pediatric malignancies, but also to adult cancers generally, and thus have broad public health impact.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA165277-03
Application #
8676741
Study Section
Epidemiology of Cancer Study Section (EPIC)
Program Officer
Witherspoon, Kim
Project Start
2012-08-03
Project End
2016-05-31
Budget Start
2014-06-01
Budget End
2015-05-31
Support Year
3
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Children's Hospital of Philadelphia
Department
Type
DUNS #
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Desai, Ami V; Seif, Alix E; Li, Yimei et al. (2016) Resource Utilization and Toxicities After Carboplatin/Etoposide/Melphalan and Busulfan/Melphalan for Autologous Stem Cell Rescue in High-Risk Neuroblastoma Using a National Administrative Database. Pediatr Blood Cancer 63:901-7
DiNofia, Amanda M; Salazar, Elizabeth; Seif, Alix E et al. (2016) Bortezomib Inpatient Prescribing Practices in Free-Standing Children's Hospitals in the United States. PLoS One 11:e0151362
Heneghan, Mallorie B; Rheingold, Susan R; Li, Yimei et al. (2016) Treatment of Osteonecrosis in Children and Adolescents With Acute Lymphoblastic Leukemia. Clin Lymphoma Myeloma Leuk 16:223-229.e2
Miller, Tamara P; Getz, Kelly D; Kavcic, Marko et al. (2016) A comparison of discharge strategies after chemotherapy completion in pediatric patients with acute myeloid leukemia: a report from the Children's Oncology Group. Leuk Lymphoma 57:1567-74
Miller, Tamara P; Li, Yimei; Kavcic, Marko et al. (2016) Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia. J Clin Oncol 34:1537-43
Miller, Tamara P; Troxel, Andrea B; Li, Yimei et al. (2015) Comparison of administrative/billing data to expected protocol-mandated chemotherapy exposure in children with acute myeloid leukemia: A report from the Children's Oncology Group. Pediatr Blood Cancer 62:1184-9
Lee, Grace E; Fisher, Brian T; Xiao, Rui et al. (2015) Burden of Influenza-Related Hospitalizations and Attributable Mortality in Pediatric Acute Lymphoblastic Leukemia. J Pediatric Infect Dis Soc 4:290-6
G Salazar, Elizabeth; Bernhardt, M Brooke; Li, Yimei et al. (2015) The impact of chemotherapy shortages on COG and local clinical trials: a report from the Children's Oncology Group. Pediatr Blood Cancer 62:940-4
Getz, Kelly D; Miller, Tamara P; Seif, Alix E et al. (2015) A comparison of resource utilization following chemotherapy for acute myeloid leukemia in children discharged versus children that remain hospitalized during neutropenia. Cancer Med 4:1356-64
Seif, Alix E; Walker, Dana M; Li, Yimei et al. (2015) Dexrazoxane exposure and risk of secondary acute myeloid leukemia in pediatric oncology patients. Pediatr Blood Cancer 62:704-9

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