Key result
PD-1/PD-L1 inhibitors were associated with 11,538 reports of cardiotoxicity, with myocardial and pericardial disorders typically occurring within the first 1-2 months of therapy.
Why the study?
PD-1 and PD-L1 inhibitors improve cancer prognosis, but can cause rare events that may prove fatal.
What are the characteristics and signals of cardiac adverse events associated with PD-1/PD-L1 inhibitors in the FAERS database?
Observational (n=11,538)
What are the characteristics and signals of cardiac adverse events associated with PD-1/PD-L1 inhibitors in the FAERS database?
PD-1/PD-L1 inhibitors are associated with rare but potentially fatal cardiac adverse events, particularly myocardial and pericardial disorders occurring within the first 1-2 months of therapy.
Signals for cardiac irAEs with PD-1/PD-L1 inhibitors support vigilance; leaves open causal confirmation in prospective cohorts.
BACKGROUND: Programmed cell death protein-1 (PD-1) and programmed cell death ligand-1 (PD-L1) inhibitors have reformed the treatment landscape for various malignancies and improved prognosis of patients. However, they also lead to events that although rare may prove to be fatal. RESEARCH DESIGN AND METHODS: Data from July 2014 to June 2022 based on FDA Adverse Event Reporting System (FAERS) were analyzed. The signal index reporting odds ratio (ROR) was used to evaluate the correlation between cardiac AEs and given medications. The indications and the median time to onset (TTO) of different PD-1/PD-L1 inhibitors were compared. RESULTS: Cardiac AEs are rare but may be fatal with particular profiles in primary tumor, onset time, and especially gender. We identified 11,538 reports that were related to cardiotoxicity of PD-1/PD-L1 inhibitors, in which 178 different preferred terms (PTs) were distinguished, and nivolumab reported the most PTs with signal. All targeted medications showed signals in myocardial disorders and pericardial disorders, which tend to occur in the first 1-2 months. Non-small cell neoplasm was the top and common indication during anti-PD-1 or anti-PD-L1 therapy with cardiotoxicity. CONCLUSIONS: This study could help early diagnosis and surveillance of ICIs-related cardiotoxicity.
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Wang et al. (2023) conducted an observational in Malignancies treated with PD-1/PD-L1 inhibitors (n=11,538). PD-1/PD-L1 inhibitors was evaluated on Correlation between cardiac AEs and given medications (reporting odds ratio). PD-1/PD-L1 inhibitors were associated with 11,538 reports of cardiotoxicity, with myocardial and pericardial disorders typically occurring within the first 1-2 months of therapy.
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