THER-13. PEDIATRIC NEURO-ONCOLOGY CLINICAL TRIAL ENROLLMENTS: A 30 YEARS’ EXPERIENCE IN THE STATE OF FLORIDA

摘要

BACKGROUND: Currently about 200 newly diagnosed pediatric central nervous system (CNS) cases are reported in the state of Florida each year. In addition to the Florida Cancer Data System (FCDS), Florida has collected data on pediatric cancer cases diagnosed in the state since 1986 through the Statewide Pediatric Incidence Reporting System (SPIRS). SPIRS collects statewide data on pediatric cancer diagnosis, treatment, and clinical trial participation. Follow-up is performed annually at local sites for each case. METHODS: The SPIRS dataset was queried to find the total number of CNS cases diagnosed over a 30-year period in Florida and the annual enrollment on upfront cooperative group study each year. RESULTS: A total of 3,856 pediatric CNS cases were reported from 1986–2016. A range of 3–25 patients were reported as enrolled onto upfront cooperative group studies each year for a total of 419 enrollments over the 30-year period. From 1986–1995, 14.89% of patients enrolled on an upfront trial, from 1996–2005, 14.14% of patients enrolled on an upfront trial, and from 2006–2015, 8.5% of patients enrolled on an upfront trial. CONCLUSIONS: Enrollment onto upfront CNS trials in our state appears to have decreased over the past decade. Factors that may be an influence are an increase in non-cooperative group trials, the prodigious amount of time it takes from study conception to data analysis, increasingly narrow eligibility criteria, underreporting at sites, and perhaps a natural life-cycle of clinical research. Some patients may have been treated on a study out of state. The utility of our current approaches to pediatric oncology clinical trials collaboration might be a relevant topic for discussion if we are to bring forward meaningful advances for this group of rare pediatric diseases. Findings and solutions may be transferable to similar challenges at a national level.