Higher than reported adolescent and young adult clinical trial enrollment during the “Golden Age” of melanoma clinical trials

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.

Systematic review of barriers and facilitators to clinical trial enrollment among adolescents and young adults with cancer: Identifying opportunities for intervention

“…Three of the 13 AYA studies addressed barriers to patient eligibility . In their study, Shaw and Ritchey found that 6% of patients (8 of 139) aged 15 to 22 years were not enrolled in a study because of ineligibility.…”

“…Nine of the 13 AYA CCT studies addressed the extent to which a lack of AYA acceptance of a CCT was a barrier to enrollment . CCT enrollment discussions that occurred close to the diagnosis were overwhelming and impaired decision making .…”

“…CCT enrollment discussions that occurred close to the diagnosis were overwhelming and impaired decision making . The time of CCT randomization was seen as the point at which the most imperative decisions were made . Three studies indicated patient disinterest and parental preference as barriers .…”

Cutaneous melanoma in adolescents and young adults

“…Very few studies have specifically addressed the topic of melanoma in AYAs, an age group in which melanoma may present with a variety of histological subtypes and differences in biology and clinical history, consequently making any classification arbitrary. In this review, we discuss what is known about the characteristics of melanoma in such young people, comparing them with the ample experience gained on adult melanoma in an effort to shed more light on the issue presented by melanoma in AYAs.…”

“…The same patient recruitment problems affected the phase II study of ipilimumab on adolescents (i.e., age 12–18 years) with unresectable stage III or IV melanoma; the plan had been to enroll 40 patients, but the study was prematurely closed after only 12 patients had been recruited over a 3.5‐year period . There have nonetheless been reports of a positive trend in the enrollment of young patients in clinical trials in recent years, associated with a statistically insignificant trend towards a better 3‐year OS for AYA patients with advanced disease who were enrolled in clinical trials than for those who were not …”