ABSTRACT Background Phase 1 trials may expose pediatric oncology patients to potential adverse effects beyond drug‐related toxicity, including delays in advance care planning and suboptimal quality of end‐of‐life (EoL) care. Pediatric palliative care (PPC) can provide symptom management support and assist with EoL planning and care for patients and families enrolling in Phase 1 trials; however, little is known about children with cancer who enroll in Phase 1 studies. Methods A retrospective medical record review of pediatric oncology patients enrolled on a Phase 1 clinical trial over a 9‐year period was completed at an academic cancer hospital. Data collected included sociodemographic, clinical, and EoL‐related variables. Descriptive analyses were performed. Results A total 539 patient charts met the inclusion criteria for review; 53% ( n = 285) were male, 76% ( n = 411) were Caucasian, and 82% ( n = 442) were deceased. Central nervous system (CNS) tumors were the most common diagnosis (44%, n = 237), followed by leukemias (33%, n = 179), solid tumors (20%, n = 108), and lymphomas (3%, n = 15). All patients enrolled in at least one Phase 1 study, with 15% ( n = 83) enrolling in two or more. The median length of time on study was 62 days, with time on study decreasing for subsequent Phase 1 trial participation. Two‐thirds of patients (68%, n = 368) had PPC consultation; however, only 21% ( n = 76) had PPC consulted prior to Phase 1 trial enrollment. Conclusions Although most patients enrolled in Phase 1 studies have PPC involvement, referrals are typically made far beyond trial enrollment. Earlier and systematic PPC integration in this high‐risk patient population may offer the potential benefit of maximal EoL support, care, and planning.
Cuviello et al. (Sat,) studied this question.