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Updated: May 11, 2026

Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia
Published on: September 18, 2013
Assessing the risk of tumor lysis syndrome associated with the use of antineoplastic agents: a real-world
Dongxuan Li1, Chunmeng Qin1,2, Hongli Wang3
1Department of Pharmacy, The Third Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Background:
The use of antineoplastic agents is one of the important triggers of tumor lysis syndrome (TLS), but there is still a lack of comprehensive understanding of antineoplastic agents that may trigger TLS and the TLS risk differences between different antineoplastic agents.
Objectives:
This study aims to investigate the TLS risk of different antineoplastic agents and provide reference information for clinical practice.
Design:
Real-world adverse events data in the FDA Adverse Event Reporting System (FAERS) database were used as the basis for the disproportionality analysis.
Methods:
We reviewed the TLS reports in the FAERS database from 2004 to 2022 to summarize an antineoplastic agent list that was reported to trigger TLS, based on which we conducted disproportionality analysis to assess the TLS risk of each antineoplastic agent.
Results:
In all, 164 antineoplastic agents were reported to trigger TLS. On the whole, rituximab was the most reported antineoplastic agent in TLS reports, followed by cyclophosphamide, venetoclax, doxorubicin, and etoposide, while tagraxofusp was the antineoplastic agent with the highest adverse drug reaction (ADR) signal strength in signal detection, followed by floxuridine, pentostatin, tebentafusp, and venetoclax. Integrating ADR signal detection results, 129 of 164 antineoplastic agents showed at least one positive ADR signal, and six antineoplastic agents (bevacizumab, carboplatin, cisplatin, fluorouracil, lenvatinib, and paclitaxel) have the highest total number of positive signals. Further classifying the 164 antineoplastic agents into 46 chemical subgroups to conduct ADR signal detection, nitrogen mustard analogs were the most reported antineoplastic agent subclasses, followed by clusters of differentiation 20 inhibitors, and pyrimidine analogs, while clusters of differentiation 22 inhibitors were the antineoplastic agent subclass with the highest ADR signal strength, followed by podophyllotoxin derivatives and actinomycines.
Conclusion:
Our study showed the TLS risk characteristics of 164 antineoplastic agents by detecting and integrating ADR signals, which may help to optimize clinical practice.
Insights
Antineoplastic agents can trigger tumor lysis syndrome (TLS). This study analyzed 164 agents, identifying rituximab and tagraxofusp as having high reporting and signal strength for TLS risk, aiding clinical practice.
Area of Science:
- Oncology
- Pharmacovigilance
- Clinical Pharmacology
Background:
- Antineoplastic agents are known triggers of tumor lysis syndrome (TLS).
- A comprehensive understanding of TLS-triggering agents and their varying risks is lacking.
- This knowledge gap necessitates further investigation into agent-specific TLS risks.
Purpose of the Study:
- To investigate the tumor lysis syndrome (TLS) risk associated with different antineoplastic agents.
- To provide essential reference information for optimizing clinical management of TLS.
- To enhance the safety profile of cancer therapies by identifying high-risk agents.
Main Methods:
- Utilized real-world adverse event data from the FDA Adverse Event Reporting System (FAERS) database (2004-2022).
- Conducted disproportionality analysis on reported TLS events to assess agent-specific risks.
- Summarized a comprehensive list of antineoplastic agents implicated in TLS.
Main Results:
- 164 antineoplastic agents were identified as TLS triggers.
- Rituximab was most frequently reported; tagraxofusp exhibited the highest adverse drug reaction (ADR) signal strength.
- Analysis revealed specific chemical subclasses, including nitrogen mustards and CD20 inhibitors, with notable TLS associations.
Conclusions:
- Characterized the TLS risk profiles of 164 antineoplastic agents through ADR signal detection.
- Findings offer valuable insights for refining clinical practices and mitigating TLS risks.
- This research supports safer and more effective use of antineoplastic therapies.
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