Abstract
Clinical trial enrollments in adolescents and young adults (AYA) with cancer have historically been lower than those in pediatric and older adult populations. We sought to examine therapeutic trial enrollment rates at our cancer center. We performed a retrospective evaluation of AYA patients treated before and after the first checkpoint inhibitor trial opened at our cancer center in 2007. We examined gender, stage at presentation and insurance status in terms of trial enrollment. We compared the trial participation rate of AYA patients with that of older adults. In this adult facility, 12.7% (1,831) of total patients were between age 15 and 39. Overall therapeutic clinical trial rate was 17.6% which increased to 19.8% since 2007. Both nodal disease or metastatic disease at presentation was associated with increasing odds of trial enrollment (OR = 5.36 and P < 0.001 for nodal disease and OR = 7.96 and P < 0.001 for metastatic disease). There was a nonstatistically significant trend toward improved 3‐year overall survival in the AYA patients with advanced presentation that enrolled on clinical trials compared with those not enrolled on trials since 2007. AYA clinical trial enrollment at a comprehensive care center melanoma program was higher than reported in the literature overall for AYA patients. This 1,831 patient cohort may provide a foundation for more detailed investigation toward quantifying the effects of clinical trial enrollment in terms of age‐specific benefits and toxicities for AYA patients with malignancies that have their peak incidence in older adults.
Highlights
Adolescent and young adult oncology (AYA) comprises the diagnosis and treatment of 15-to 39-year-old cancer patients
The overall therapeutic clinical trial enrollment rate found at this Comprehensive Cancer Center of 17.6% is higher than the reported national overall AYA clinical trial enrollment [1], but lower than enrollment at NCORP centers [9], or enrollments in 15-to 22-year-o ld patients in centers with an AYA program that has worked to increase trial enrollment [10]
Among patients most likely to be eligible for therapeutic trial enrollment, 36% of metastatic patients and 34% of patients with unresectable or regional disease were treated on one of 83 available research protocols, approaching current pediatric oncology participation rates
Summary
Adolescent and young adult oncology (AYA) comprises the diagnosis and treatment of 15-to 39-year-old cancer patients. Among the myriad causes of this disparity are lower clinical trial participation rates than both pediatric and older adult patient cohorts; initially reported to be as low as 1–2% on cooperative group trials [1]. The reasons for this being the lowest of any age range are likely multifactorial including suboptimal availability of trials at their location of care, trial awareness among providers and patients, regulatory factors, and a lack of recognition of this unique population of patients when developing therapies and trials [2,3,4,5,6,7,8] When isolated to populations included in pediatric cooperative group trials at National Community Oncology. There is less existing literature focusing on the young adult range of 18–39, with trial rates being typically reported in the 5–10% range [2, 11, 12, 14, 15]
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