Abstract
Purpose: Adolescent and young adult (AYA) oncology patients are less likely to enroll in clinical trials than pediatric patients. After two decades of effort to improve enrollments, challenges remain. We sought to explore where phase II and phase III trials are available for an AYA cohort.Methods: Based on the epidemiology of AYA cancers and outcomes, we assembled a simulated data set of 1000 patients (AYAsims). Available phase II and phase III trials were matched to diseases and treatment setting (relapsed or newly diagnosed) and characterized by sponsor (industry, National Clinical Trials Network [NCTN], investigator initiated) and location (Moffitt Cancer Center [MCC], community or pediatric).Results: The majority of AYAsims had potential first line (64.4%) and/or relapsed (68.1%) trials. The majority of these opportunities were industry-sponsored trials available at MCC. Phase II trials for relapsed cancer were most often at the MCC and more likely to be investigator-initiated trials. Trial availability for histologies varied widely, likely reflective of the overall epidemiology of cancers beyond the AYA age range. Pediatric hospitals offered trials for select cancers but had a trial portfolio that matched the fewest number of AYAsims.Conclusions: In general, newly diagnosed AYA patients have trial enrollment opportunities in both the community and comprehensive cancer center setting with select diagnoses having more trials in pediatric hospitals. Relapsed AYA patients have the most trial opportunities at a comprehensive cancer center. A facile system that navigates patients across health systems would maximize potential AYA trial enrollments.
Highlights
A dolescent and young adult (AYA) cancer patients, aged 15–39 years, have the lowest participation rates in clinical trials of all cancer patients.[1,2,3,4,5] This same group comprises 7% of new cancer diagnoses across many different diagnoses and some studies suggest trial enrollment is declining.[6]
The majority of trials were available at MCC at 101 (66.4%), followed by 53 at community oncology practices, and 9 at pediatric hospitals (Fig. 1E)
We found that the majority (n = 803/1000) of AYAsims in a 50-mile radius of a comprehensive cancer center had an available trial in either the frontline (n = 644/1000) and/or relapse (681/1000) setting
Summary
A dolescent and young adult (AYA) cancer patients, aged 15–39 years, have the lowest participation rates in clinical trials of all cancer patients.[1,2,3,4,5] This same group comprises 7% of new cancer diagnoses across many different diagnoses and some studies suggest trial enrollment is declining.[6] Clinical trials are the best means to improve outcomes and are often considered the standard of care in cancer.[7] For example, AYA clinical trial participation has been found to correlate with higher 5-year survival rates in AYA patients with soft tissue and bone sarcomas.[7] Lack of clinical trial participation in the AYA population results in less collection of tumor specimens and fewer oppor- Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA
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