Differences observed in child, clinician, caregiver reporting of cancer therapy toxicities
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Clinicians consistently underreported and caregivers overreported symptomatic adverse events that children undergoing cancer treatment in clinical trials experienced, according to study results published in Journal of Clinical Oncology.
The findings suggest that direct child self-reporting should be routinely incorporated into toxicity assessment in clinical trials, researchers noted.
Methods
More than 60% of the approximately 40,000 children and adolescents undergoing cancer treatment annually in the U.S. are enrolled in clinical trials. Regulatory agencies mandate that all cancer clinical trials collect and report adverse events, which are important to inform investigators, sponsors, regulatory agencies and patients about the safety and tolerability of treatments, according to study background.
David R. Freyer, DO, MS, director of the survivorship and supportive care program in the Cancer and Blood Disease Institute at Children’s Hospital Los Angeles, and colleagues sought to examine concordance in symptomatic adverse event grading among 438 children (mean age, 13 years; 53.7% male; 32.6% white; 56.4% with leukemia/lymphoma) with a first cancer diagnosis, their caregivers and clinicians. They used Common Terminology Criteria for Adverse Events for clinicians and its patient-reported outcome versions for children and caregivers to measure adverse events before and after initiating a course of treatment. For this study, researchers focused on 15 common symptoms during cancer treatment, including fatigue, nausea, vomiting, mouth sores, pain and sleep difficulties. They used multivariable mixed regression models to evaluate associations between clinical factors and adverse event reporting concordance.
Findings
Results showed clinicians reported significantly lower mean adverse event grades at treatment initiation compared with those children reported for all adverse events, which remained lower after the treatment course except for constipation, nausea, anorexia, neuropathy and anxiety.
Conversely, caregiver mean adverse event grades were similar to children at treatment initiation and significantly higher after completion of treatment for nausea, vomiting, anorexia, pain, fatigue, anxiety and depression.
Researchers also found poor-to-fair agreement for child and clinician grading at treatment initiation and after treatment completion, but fair-to-good agreement for children and caregivers at both time points.
Of note, researchers identified no factors consistently associated with reporter concordance across adverse events.
Implications
The findings are in line with earlier studies, but the current study’s size and design add significant weight, Freyer said in a press release.
“Our findings show that child self-reports should complement doctor adverse event reporting whenever possible,” Freyer said in the release. “Children are best able to identify and remember their own symptoms throughout their cancer treatment.
“We hope that future pediatric cancer clinical trials will incorporate direct child reporting using our measure or something similar,” Freyer added. “More accurate reporting will limit new treatment toxicity and help children and families decide which of two similar treatments is better tolerated.”
The results indicate a “critical need” to incorporate the child’s voice into pediatric oncology research and treatment, Abby R. Rosenberg, MD, MS, MA, associate professor in the division of hematology-oncology and division of bioethics and palliative care in the department of pediatrics at University of Washington School of Medicine, wrote in an accompanying editorial.
“As pediatric oncology strives to help children with cancer live their best lives for as long as possible, it is time we rigorously integrate the child’s voice into our science and clinical care,” Rosenberg wrote.
References :
- Children’s Hospital Los Angeles finds differences in how doctors, caregivers and patients report side effects of cancer therapy (press release). Available at: www.businesswire.com/news/home/20220809005408/en/Children’s-Hospital-Los-Angeles-Finds-Differences-in-How-Doctors-Caregivers-and-Patients-Report-Side-Effects-of-Cancer-Therapy. Published Aug. 9, 2022. Accessed Sept. 2, 2022.
- Freyer DR, et al. J Clin Oncol. 2022;doi:10.1200/JCO.21.02669.
- Rosenberg AR. J Clin Oncol. 2022;doi:10.1200/JCO.22.00196.
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