Cardiovascular toxicities associated with anticancer drugs are a major problem for pediatric patients treated for cancer. Reliable data concerning the burden of acute cancer-therapy related cardiac dysfunction (CTRCD) are scarce in this specific population at high risk of myocardial toxicity. Using the World Health Organization individual case safety report database, VigiBase®, we aimed to determine the association between anticancer drugs and acute CTRCD in children.

A disproportionality analysis evaluating the multivariable adjusted reporting odd-ratios (aROR) for CTRCD reporting with their 95% confidence intervals (CI) was performed for 249 FDA- or EMA-labeled anticancer drugs in VigiBase® in 4 pediatric age classes (0–27 days, 28 days–23 months, 2–11 years, 12–17 years), followed by a descriptive analysis of the time to CTRCD onset for the anticancer drugs identified in VigiBase®.

A total of 796 CTRCD cases associated with at least one anticancer drug were identified in VigiBase® In the multivariate analysis on the whole pediatric population, 16 anticancer drugs were significantly associated with CTRCD reporting of which 10 (63%) are mainly used in hematologic malignancies and 2 represented new CTRCD associations not previously reported in literature including topo-isomerase 1 inhibitor (Topotecan) and cytotoxics antibiobics (Dactinomycine) (Fig. 1).

We identified in Vigibase® 16 anticancer drugs significantly associated with CTRCD reporting in pediatrics. Our analysis confirmed some of associations that were extensively previously reported in children (as for anthracyclines), and found new signals such as systemic exposure to Topotecan and Dactinomycin. Dedicated prospective clinical trials are now required to confirm these results.