The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Osimertinib was associated with higher rates of cardiotoxicities compared with other EGFR tyrosine kinase inhibitors (TKIs), according to an analysis of the US Food and Drug Administration adverse events reporting system (FAERS) presented at the 2019 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois.1

The analysis was initiated because rates of cardiotoxicity were higher in the osimertinib arm of the phase 3 FLAURA trial, in which osimertinib was compared with earlier-generation EGFR TKIs for the first-line treatment of advanced lung cancer.

In this retrospective analysis, FAERS, a pharmacovigilance database, was queried for terms associated with cardiotoxicity secondary to osimertinib, erlotinib, afatinib, or gefitinib between 2016 and 2018.

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Osimertinib was associated with higher rates of most types of cardiotoxicities compared with the full data base and other EGFR TKIs. For the entire FAERS database, osimertinib was associated with significantly higher odds of developing cardiac failure (reporting odds ratio [ROR], 6.4; 95% CI, 4.7-8.7), atrial fibrillation (ROR, 4.0; 95% CI, 2.8-5.8), QT prolongation (ROR, 11.2; 95% CI, 7.9-15.8), pericardial effusion (ROR, 8.2; 95% CI, 4.8-14), and congestive cardiac failure (ROR, 3.9; 95% CI, 2.4-6.3). There was no association with myocardial infarction.

Compared with other EGFR TKIs, osimertinib significantly increased the odds of developing cardiac failure (ROR, 2.1; 95% CI, 1.3-3.2), atrial fibrillation (ROR, 2.1; 95% CI, 1.3-3.5), QT prolongation (ROR, 6.6; 95% CI, 3.4-12.8), and congestive cardiac failure (ROR, 2.3; 95% CI, 1.2-4.6). There was no significant difference between osimertinib and other EGFR TKIs for odds of developing myocardial infarction or pericardial effusion.

The actual number of patients affected by osimertinib-induced cardiotoxicity in the FAERS database was 150 of 2454 osimertinib adverse events reported. Among patients who experienced cardiotoxicities with osimertinib, the median age ranged from 64 to 79, depending on the type of toxicity. The majority of cases were serious, with a large proportion resulting in hospitalization and/or death.

Based on these results, the authors recommended that, “Electrocardiogram monitoring for QT prolongation and monitoring for signs and symptoms of heart failure should be considered while using osimertinib.”

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Anand K, Ensor J, Trachtenberg B, Bernicker EH. Osimertinib induced cardio-toxicity: a retrospective review of FDA adverse events reporting system (FAERS). Presented at: 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 9044.