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Anticancer Drugs Associated With Tumor Lysis Syndrome: Insights From the US Food and Drug Administration Adverse
Wei Wang1, Zirui Dong2, Qi Miao1
1Department of Urology, Beijing Anzhen Hospital, Capital Medical University, Beijing, People's Republic of China.
Purpose:
Tumor lysis syndrome (TLS) is a life-threatening metabolic emergency caused by rapid tumor cell breakdown, either spontaneously or after therapy, leading to electrolyte imbalances that can result in acute kidney injury, arrhythmias, seizures, and multiorgan failure. Despite its clinical importance, the relationship between anticancer drugs and TLS, particularly newer targeted therapies, remains poorly understood.
Methods:
We analyzed the US Food and Drug Administration (FDA) Adverse Events Reporting System database, a repository of adverse events associated with medical products, to identify TLS cases reported from the first quarter of 2004 to the third quarter of 2024. For signal detection, we used disproportionality analysis with 4 algorithms-reported odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and empirical Bayes geometric mean. These algorithms assessed statistical correlations between anticancer drugs and TLS, based on a 2 × 2 contingency table framework.
Findings:
From the first quarter of 2004 to the third quarter of 2024, a total of 7340 TLS cases were documented in the FDA Adverse Events Reporting System database. Clinical characteristics, including age, sex, and outcomes, were analyzed. Among all reported TLS cases, 53.0% were men, and the mean age across all individuals was 56.9 ± 21.5 years. The incidence of TLS peaked in 2022, with a 42% increase from 2016 to 2017. A total of 118 antineoplastic drugs were identified as highly associated with TLS, of which only 18 had FDA-labeled TLS-related adverse reactions. Chemotherapy drugs were the most frequently associated with TLS. Venetoclax emerged as the top drug associated with TLS, comprising 10.72% of all TLS reports.
Implications:
Our findings highlight critical drug-induced TLS associations, particularly with emerging targeted therapies such as venetoclax. The study underscores the need for clinicians to monitor TLS closely in patients receiving certain anticancer treatments and to refine therapeutic strategies to mitigate TLS risk, ensuring safer cancer care outcomes. Further longitudinal studies are warranted to validate these findings and enhance pharmacovigilance efforts.
Insights
This study identified 118 anticancer drugs linked to tumor lysis syndrome (TLS), a dangerous complication of cancer treatment. Venetoclax was the most frequently reported drug associated with TLS, highlighting the need for careful patient monitoring.
Area of Science:
- Oncology
- Pharmacovigilance
- Clinical Pharmacology
Background:
- Tumor lysis syndrome (TLS) is a critical metabolic emergency arising from rapid cancer cell breakdown, potentially leading to severe complications like kidney failure and arrhythmias.
- Understanding the link between anticancer therapies and TLS is crucial, especially with the advent of novel targeted treatments.
Purpose of the Study:
- To investigate the association between anticancer drugs and the occurrence of tumor lysis syndrome (TLS).
- To identify specific antineoplastic agents, including newer targeted therapies, linked to TLS using real-world adverse event data.
Main Methods:
- Analysis of the US Food and Drug Administration (FDA) Adverse Events Reporting System (AERS) database from Q1 2004 to Q3 2024.
- Utilized disproportionality analysis with four algorithms (reported odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, empirical Bayes geometric mean) for signal detection.
Main Results:
- A total of 7340 TLS cases were reported, with a peak incidence in 2022 and a notable increase between 2016-2017.
- 118 antineoplastic drugs showed a strong association with TLS; only 18 had FDA-labeled TLS-related adverse reactions.
- Chemotherapy drugs were most frequently implicated, with venetoclax identified as the top drug associated with TLS, accounting for 10.72% of reports.
Conclusions:
- The study identifies significant associations between specific anticancer drugs, particularly targeted therapies like venetoclax, and drug-induced TLS.
- Highlights the necessity for enhanced clinical monitoring of TLS in patients undergoing specific cancer treatments.
- Emphasizes the need for refining treatment strategies to minimize TLS risks and improve patient safety in oncology care.
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