ORIGINAL RESEARCH article
Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1646038
This article is part of the Research TopicCommunity Series in Reducing Adverse Effects of Cancer Immunotherapy: Volume IIView all 21 articles
Emerging Causes of Anticancer Therapies-Induced Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Evidence from Disproportionality Analysis of the FDA Adverse Event Reporting System
Provisionally accepted
- 1Department of Pharmacy, Shanghai Cancer Center, Fudan University, Shanghai, China
- 2Shanghai Jiao Tong University School of Medicine, Shanghai, China
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Background: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are potentially fatal cutaneous adverse events of drug treatment. Evidence for SJS/TEN risk from current anticancer therapies in population-based studies is scarce.Objective: The present study aims to characterize the profiles and risk factors of SJS/TEN related to contemporary anticancer regimens.Methods: Reported odds ratios (ROR) were employed to identify anticancer drugs associated with SJS/TEN development using FAERS data from January 2004 to September 2024. Single factor, LASSO, and multivariable logistic regression analysis were performed to explore the risk factors of SJS/TEN related to anticancer therapies. Weibull shape parameter analysis was applied to the onset time of reported SJS/TEN.Results: A total of 3471 unique SJS/TEN events were identified for 159 anticancer drug pairs, of which 31 drugs were identified as significantly disproportionate. Targeted therapies accounted for 35.93% of pairs, chemotherapies for 35.52%, and immunotherapies for 21.52%. The median onset time of SJS/TEN with anticancer therapies was 17 days. Moreover, multivariable logistic regression showed that age exceeding 65, female gender, and 10 anticancer drugs were significant risk factors for anticancer therapyrelated SJS/TEN.This study provides real-world evidence on SJS/TEN burden from anticancer therapies.Addressing this knowledge gap will facilitate clinical management optimization for SJS/TEN. Further research to establish causality and inform clinical decision-making regarding SJS/TEN related to anticancer therapies are urgent needed.
Keywords: Cancer, Stevens-Johnson Syndrome, toxic epidermal necrolysis, Pharmacovigilance, Disproportionality analysis, FAERS
Received: 07 Jul 2025; Accepted: 11 Aug 2025.
Copyright: © 2025 Liu, Song, Du and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Wensheng Liu, Department of Pharmacy, Shanghai Cancer Center, Fudan University, Shanghai, China
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