Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Jan 19:11:801199.
doi: 10.3389/fonc.2021.801199. eCollection 2021.

Cutaneous Toxicity Associated With Enfortumab Vedotin: A Real-Word Study Leveraging U.S. Food and Drug Administration Adverse Event Reporting System

Hui Yang  1 , Xiaojia Yu  1 , Zhuoling An  1
Affiliations

Cutaneous Toxicity Associated With Enfortumab Vedotin: A Real-Word Study Leveraging U.S. Food and Drug Administration Adverse Event Reporting System

Hui Yang et al. Front Oncol. .

Abstract

Introduction: Enfortumab vedotin (EV) has been demonstrated to have a significant response rate in early phase trials and is known for its tolerable side-effect profile. Emerging case reports have raised awareness of cutaneous toxicities, which may be a potentially fatal complication.

Objective: To assess the potential relevance between EV and cutaneous toxicities reports through data mining of the U.S. Food and Drug Administration (FDA) adverse event reporting system (FAERS).

Methods: Data from January 1, 2019, to November 4, 2021, in the FAERS database were retrieved. Information component (IC) and reporting odds ratio (ROR) were used to evaluate the association between EV and cutaneous toxicities events.

Results: EV was significantly associated with cutaneous toxicities in the database compared with both all other drugs (ROR 12.90 [10.62-15.66], IC 2.76 [2.52-3.01], middle signal) and platinum-based therapy (ROR 15.11 [12.43-18.37], IC 2.91 [2.66-3.15], middle signal) in the FAERS database. A significant association was detected between EV and all the cutaneous adverse effects (AEs) except erythema, palmar-plantar erythrodysesthesia syndrome, and dermatitis allergic. Both Stevens-Johnson syndrome and toxic epidermal necrolysis occurred 15 times as frequently for EV compared with all other drugs (ROR = 15.20; ROR = 15.52), while Stevens-Johnson syndrome occurred 18 times and toxic epidermal necrolysis occurred 7 times as frequently for EV compared with platinum-based therapy in the database (ROR = 18.74; ROR = 7.80). All groups that limited the gender and age showed a significant association between EV and cutaneous toxicities.

Conclusions: A significant signal was detected between EV use and cutaneous toxicities. It is worth noting that Stevens-Johnson syndrome and toxic epidermal necrolysis were significantly associated with EV use.

Keywords: EV; Food and Drug Administration Adverse Event Reporting System; cutaneous toxicity; disproportionality analysis; real-word study.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

References

    1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin (2018) 68:394–424. doi: 10.3322/caac.21492 - DOI - PubMed
    1. Alt M, Stecca C, Tobin S, Jiang DM, Sridhar SS. Enfortumab Vedotin in Urothelial Cancer. Ther Adv Urol (2020) 12:1756287220980192. doi: 10.1177/1756287220980192 - DOI - PMC - PubMed
    1. von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, Moore MJ, et al. . Gemcitabine and Cisplatin Versus Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Advanced or Metastatic Bladder Cancer: Results of a Large, Randomized, Multinational, Multicenter, Phase III Study. J Clin Oncol (2000) 18:3068–77. doi: 10.1200/JCO.2000.18.17.3068 - DOI - PubMed
    1. Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee JL, Fong L, et al. . Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma. N Engl J Med (2017) 376:1015–26. doi: 10.1056/NEJMoa1613683 - DOI - PMC - PubMed
    1. Sidaway P. Sacituzumab Govitecan is Safe and Effective. Nat Rev Clin Oncol (2021) 18(7):400. doi: 10.1038/s41571-021-00523-y - DOI - PubMed

LinkOut - more resources