Suspected Adverse Drug Reactions in Pediatric Cancer Patients in China: An Analysis of Henan Province Spontaneous Reporting System Database

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.

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Family history of cardiovascular disease and cardiovascular comorbidities risk in a pediatric cancer population.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.10518 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 10518-10518

Author(s):

Thomas Patrick Curtin ◽

Wendy Kohlmann ◽

Luke Devon Maese ◽

Zhe Yu ◽

Karen Curtin ◽

...

Keyword(s):

Cardiovascular Disease ◽

Family History ◽

Cancer Patients ◽

Pediatric Cancer ◽

Pediatric Patients ◽

Cvd Risk ◽

First Degree Relatives ◽

Pediatric Cancers ◽

Pediatric Cancer Patients ◽

History Of

10518 Background: Survival rates for childhood cancer patients have improved dramatically, but the growing survivor population suffers from increased treatment-related toxicity including high risk for cardiovascular disease (CVD). While the link between chemotherapy and radiation to cardiotoxicity is well established, few studies seek to determine if an underlying familial risk for cardiovascular disease contributes or predicts this risk. The Utah Population Database (UPDB) is a genealogical resource linked to statewide cancer diagnoses and electronic medical data in which family history is objectively determined. Methods: We calculated the risk of subsequent CVD (ICD-9 401-449) in relatives of 5602 pediatric cancer patients diagnosed at ages 0-19 in Utah from 1966-2013 with no congenital CVD-related anomalies (ICD-9 745-747, 758-759). We identified 964 patients with subsequent CVD diagnoses. Cox models provided recurrence-risk estimates in first-degree relatives of patients compared to relatives of 5:1 matched controls. Results: Pediatric cancer patients were at 5-fold risk of CVD compared to controls ( P< 10-15). In pediatric patients with subsequent CVD, first-degree relatives were at 30% increased CVD risk compared to relatives of cancer-free controls (HR = 1.31, 95%CI 1.16-1.47; P< 10-5). In pediatric patients without CVD, only parents exhibited slight CVD risk (HR = 1.08, 95%CI 1.03-1.14; P= 0.002). In 685,000 individuals with a non-congenital CVD history, pediatric cancers among their first-degree relatives were associated with a similar increased risk of subsequent CVD, compared to pediatric cancers among relatives of controls with no CVD events (HR = 1.39, 95%CI 1.18-1.64, P< 10-4). Conclusions: The UPDB is powerful for investigating comorbidities in cancer patients and their families without recall bias from self-reported family medical history. A family history of CVD may increase risk of CVD-related comorbidities among pediatric cancer patients by 30-40% beyond that observed in patients without a CVD family history. This finding suggests that in addition to a cancer family history, a CVD-related family history should be assessed in children diagnosed with cancer.

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