Longitudinal Use of the Pediatric PRO-CTCAE in Heterogeneous Oncology Population is Feasible and Highlights Individuality of the Adverse Event Experience.

BACKGROUND

Documentation of the adverse events (AEs) experienced by pediatric oncology patients relies on input from patients, caregivers, and providers. Accurate AE reporting allows comparison of treatment options, preparation of supportive care guidance, as well as appropriate support of current patients.

OBJECTIVE

In this study, we aimed to assess the feasibility of collecting symptomatic AE information longitudinally from a diverse group of pediatric and adolescent oncology patients, to describe the most and least symptomatic parts of treatment, and to identify impactful AEs.

METHODS

Pediatric Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Event (PRO-CTCAE) items were administered to a heterogeneous sample of pediatric and adolescent oncology patients and their caregivers over 6 time points: the start of 3 cycles of chemotherapy, 1 to 2 weeks following the start of 2 cycles, and at the end of treatment.

RESULTS

Sixty-seven percent of participants completed all required surveys. The frequency of AEs peaked at the expected count nadir, after the first cycle of treatment, and decreased by the end of treatment/maintenance but did not reach zero. The most frequent AE reported was anorexia; the highest severity and interference ratings were for fatigue. The least common AEs were oral mucositis, constipation, diarrhea, and numbness. Age and diagnosis did not predict AE burden. Some AEs, for example, oral mucositis, had low frequency but high severity and interference reported.

CONCLUSION

It is feasible and clinically important to ask families to complete the Pediatric PRO-CTCAE items regularly throughout treatment.

IMPLICATION FOR PRACTICE: Families will complete the Pediatric PRO-CTCAE. Identifying common AEs aids resource planning and design of supportive care guidelines; identifying unique AEs allows personalized care.