Reporting of tumor lysis syndrome with targeted therapy for hepatic cancer in the FDA adverse events reporting system

ABSTRACT

Background

Hepatic cancer is a common cancer in clinical practice. Current drug therapies for this condition include targeted therapy, chemotherapy, and immunotherapy. Tumor lysis syndrome (TLS) is the most serious complication of oncology treatment. According to the literature, several cases reported TLS occurred with targeted therapies for hepatic cancer.

Methods

Reporting odds ratio and information component were used to measure the disproportionate signals for TLS associated with targeted therapies, using data from the FDA’s Adverse Event Reporting System (FAERS). A stepwise sensitivity analysis was conducted to test the robustness of signals. Time-to-onset analysis was used to describe the latency of TLS events associated with targeted therapies. The Bradford Hill criteria were used to perform a global assessment of the evidence.

Results

Sorafenib, lenvatinib, cabozantinib, and bevacizumab showed higher disproportionate signals for TLS than chemotherapy. The median number of days to TLS occurrence after drug therapy was 5.5, 6.5, and 6.5 days for sorafenib, lenvatinib, and bevacizumab, respectively.

Conclusions

There is a significant association between tumor lysis syndrome and targeted therapies for hepatic carcinoma, with particularly strong signals for sorafenib and lenvatinib. Clinicians should be aware of the potential for tumor lysis syndrome in targeted therapies for hepatic carcinoma.

KEYWORDS:

• Pharmacovigilance
• FAERS
• hepatic cancer
• tumor lysis syndrome
• targeted therapy

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The datasets analyzed during the current study are available in the following resource in the public domain: https://research.cchmc.org/aers/.

Author contribution statement

Study concept and design: Zhichao Jiang, Miao Yan, and Ling Liu. Acquisition of the data: Chengyi Zhang, Huihui Liu, and Huan Luo. Analysis and interpretation of the data: Mingxuan Xiao, Pan Zou and Zhuzhu Xie. Drafting of the manuscript: Ling Liu and Chengyi Zhang. Statistical analysis: Rong Cao and Huan Luo. Technical support: Hui Gong and Rui Ma. All the authors read and approved the final manuscript.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2312147.

Additional information

Funding

This study was supported by the Natural Science Foundation of Hunan Province with funding number [2023JJ60351] and the National Natural Science Foundation of China with funding number [82274033].