Abstract 4367292: Meta-Analysis of Phase III Randomized Controlled Trials to Evaluate the Risk of Cardiac Adverse Events in Patients with Non-small Cell Lung Cancer Treated with Osimertinib Compared to Control
Abstract
Introduction:
Osimertinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that is crucial in the treatment of EGFR-mutant non-small cell lung cancer (NSCLC). It exerts its effect by selectively binding to mutant EGFR and inhibiting downstream signaling pathways involved in cell proliferation and survival. However, emerging evidence has raised concerns about its potential cardiovascular toxicity. This meta-analysis evaluates the incidence and relative risk of cardiac adverse events in NSCLC patients treated with Osimertinib.
Methods:
We conducted a comprehensive literature search using MEDLINE and EMBASE databases from inception through May 31st, 2025. Phase III randomized controlled trials (RCTs) utilizing Osimertinib in NSCLC reporting cardiac adverse events were included. The Mantel-Haenszel method was used to calculate the estimated pooled risk ratio (RR) with a 95% confidence interval (CI). Heterogeneity was assessed with Cochran’s Q-statistic. The random effects model was applied.
Results:
A total of 2,863 patients from six phase III RCTs (MARIPOSA n=849, LAURA n=216, AURA3 n=415, FLAURA n=556, ADAURA n=680, NCT02959749 n=147) were included in the analysis. QT prolongation of any grade occurred in 4.83% of patients receiving Osimertinib versus 1.50 % in controls (RR 3.32; 95% CI: 2.06-5.34; P<0.00001). High-grade QT prolongation was reported in 1.24% of the Osimertinib group compared to 0.30% of the control group (RR 3.25; 95% CI: 1.16-9.12;…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 2,863 participants or records.
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