Comparative analysis of adverse events among intravesical drugs in bladder cancer: a real-world study on FAERS database

ABSTRACT

Background

Intravesical therapy is a commonly utilized treatment for non-muscle invasive bladder cancer (NMIBC). This study focuses on summarizing the signals of all intravesical drugs and aims to highlight the comprehensive differences in adverse events (AEs) between these drugs.

Research design and methods

We conducted pharmacovigilance data analysis based on the real-world big data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Results

We elucidated all signals compared with the overall FAERS database or other administration routes for Bacillus Calmette-Guerin (BCG), mitomycin, gemcitabine, valrubicin, and epirubicin. Notably, the distribution of reported AEs associated with intravesical therapy exhibited a noticeable inclination toward male patients. Furthermore, all five drugs demonstrated a disproportionate distribution in local AEs, particularly in renal and urinary disorders. Additionally, specific signals and findings were summarized for each individual drug. Finally, we highlighted the AEs that resulted in serious outcomes for each drug.

Conclusion

We have compiled an overview of the AEs tied to intravesical drugs whilst considering their individual distinctions. These insightful findings serve to enrich our comprehension of the safety profiles and potential risks linked to intravesical therapy.

KEYWORDS:

• Bladder cancer
• intravesical therapy
• adverse effects
• disproportionality analysis
• real world

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

One reviewer received consulting fees for AstraZeneca and CG Oncology, Stock options for CG Oncology. Creator of intellectual property owned by UT/MDACC related to the use of genetic alterations as a predictive biomarker for response to nadofaragene firadenovec. Cancer Center Support Grant funding from NIH/NCI (award number P30CA016672). MD Anderson CCSG program (P30 016672). The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Data availability statement

The data generated in this study are publicly available in https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html Additionally, the code used in our study has been deposited in the following GitHub repository: https://github.com/Yunuuuu/faers

Author contribution statement

Yun Peng, and Yuxuan Song conceived the project. Yun Peng, and Yuxuan Song performed the analysis, wrote the paper and participated in the revision. Tao Xu, Caipeng Qin and Yiqing Du supervised the study. All authors have read and approved the final manuscript.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2374921

Additional information

Funding

This paper was funded by National Key Research and Development Program of China [2018YFA0902802], National natural science foundation of China [82371840], Peking University People’s Hospital Basic Special Fund [RDJ2022-03], Beijing Natural science foundation of China [7202219], National natural science foundation of China [81802533], Beijing Municipal Science and Technology Commission of China [Z191100006619010], and Capital’s Funds for Health Improvement and Research of China [2022-4-4087].