Abstract
IntroductionAdverse drug reactions (ADRs) in pediatric cancer patients have not yet received due attention in the world. Antineoplastic drugs are frequently related to ADRs. Few studies focus on the ADR and the intervention measures in pediatric cancer patients.MethodsADR reports submitted to Henan Adverse Drug Reaction Monitoring Center from 2016 to 2020 for individuals aged from birth to 17 years (including 17 years) were included. Data were analyzed with respect to gender, age, disease types, past history of ADR, occurrence time of ADR, polypharmacy, route of administration, off-label drug use, name of suspected drugs per ADR report, and severity of ADR reports.ResultsA total of 431 ADR reports related to antineoplastic drugs in pediatric patients were collected, 31.55% were serious ADRs (SADRs). The median age of patients was six years (inter quartile range, IQR: 3-11), the age groups with higher reporting rates were concentrated in 1-3-year-olds (130). Past history of ADR, occurrence time of ADR and polypharmacy were statistically associated with SADR. Myelosuppression was the most frequent ADR (15.55%), cytarabine was the most frequent drug (26.22%). The signal mining method produced 14 signals, three signals were off-label ADRs.ConclusionsThis study described the characteristics of ADRs in pediatric cancer patients. By conducting signal mining method, three off-label ADRs need further study. We should pay more attention to these ADRs and develop relative management strategies. More researches are needed to achieve a better understanding of the characteristics of ADRs in pediatric cancer patients of China.
Highlights
Adverse drug reactions (ADRs) in pediatric cancer patients have not yet received due attention in the world
A total of 15,910 ADR reports related to antineoplastic drugs were collected in Henan Provincial Adverse Drug Reaction Monitoring Center from 2016 to 2020, of which 431 (2.71%) occurred in pediatric patients
No significant difference in the severity of ADRs was found between genders
Summary
Adverse drug reactions (ADRs) in pediatric cancer patients have not yet received due attention in the world. As a leading cause of death, cancer is a growing public health problem worldwide [1]. More than 1,000 children are diagnosed with cancer every day globally, and the disease remains the leading cause of death in children and adolescents [3]. 84% of childhood cancers occur in low-income and middle-income countries [4]. As the developing country with the highest population in the world, China has a tough condition of cancer in childhood and adolescents [5]. A growing body of literature has investigated childhood and adolescent cancer in China. The first national childhood cancer profile in China was reported in 2015 [6]. A recent study assessed the childhood cancer incidence patterns from 2000 to 2015 and showed that cancer incidence has increased significantly in children and adolescents in China [5]
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