The symptom burden for children undergoing cancer treatment is high. But when a child experiences an adverse event during a cancer clinical trial, who’s responsible for reporting it, and whose report is the most useful?
A team of researchers sought to compare symptomatic adverse event reporting by children with cancer, their caregivers, and their clinicians. Their findings were published in the Journal of Clinical Oncology.
The researchers surveyed 438 child-clinician-caregiver triads. The recognized standard for reporting adverse outcomes in oncology trials is the Common Terminology Criteria for Adverse Events (CTCAE); however, it relies on clinician assessment. This study used the CTCAE-linked patient-reported outcome (PRO) measures to compare responses from children undergoing cancer treatment (Ped-PRO-CTCAE) with those of their clinicians (CTCAE) and caregivers (Ped-PRO-CTCAE [Caregiver]). Responses from 2 analysis points were compared: within 72 hours prior to initiation of a treatment course and approximately 1 to 4 weeks later.
Before starting a treatment course, the clinicians’ mean adverse event (AE) scores were lower than the children’s. The clinicians’ scores also remained lower at the second analysis point (posttreatment), except for nausea, anorexia, constipation, anxiety, and neuropathy. Additionally, the agreement between the clinicians’ AE scores and the children’s AE scores was poor-to-fair at both analysis points.
The caregivers’ scores hewed more closely to the children’s scores prior to treatment, but were significantly higher for nausea, vomiting, pain, fatigue, anxiety, anorexia, and depression after treatment.
The researchers suggested that both the clinician’s report and the child’s report need to be included when assessing symptomatic AEs to get the most complete version.
“Our finding that clinicians consistently underreport symptomatic AEs compared with children using CTCAE-based measures provides compelling evidence for routinely incorporating child report in formal toxicity monitoring on pediatric cancer clinical trials,” the researchers reported, noting that the child’s report complements but does not replace the clinician’s report.
A few study limitations could affect the applicability of these results. The study had a relative lack of patients who had undergone bone marrow transplantation and clinician and child reports may have been submitted on different days. The researchers also noted the sample was limited to English-speaking participants, with modest representation of the Hispanic population.
Disclosure: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Freyer DR, Lin L, Mack JW, et al. Lack of concordance in symptomatic adverse event reporting by children, clinicians, and caregivers: implications for cancer clinical trials. J Clin Oncol. 2022;40(15):1623-1634. doi:10.1200/JCO.21.02669