Sorafenib-Related Dermatologic Toxicity: A Comprehensive Evaluation Based on Disproportionality Analysis and Clinical Characteristics

IF 3.4 4区医学 Q1 DERMATOLOGY

Dermatologic Therapy Pub Date : 2025-10-12 DOI:10.1155/dth/1667726

Yiling Ding, Zhen Wang, Yamin Shu, Ying Tang, Qilin Zhang

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引用次数: 0

Abstract

Objective

Recognized as the primary treatment for unresectable hepatocellular carcinoma (HCC) and as an approved therapeutic agent for renal cell carcinoma (RCC) and differentiated thyroid carcinoma (DTC), sorafenib is often limited in long-term clinical application due to dermatologic toxicity, which may necessitate dose modifications or even treatment discontinuation. The present study sought to comprehensively characterize these toxicities through mining of the Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods

Using FAERS reports collected between the first quarter (Q1) of 2018 and Q1 of 2023, we applied disproportionality analysis, calculating reporting odds ratios (RORs) to compare sorafenib-related dermatologic toxicity with the overall database. Comparisons were made between serious and nonserious reports, followed by signal prioritization using a predefined scoring system. To evaluate the consistency of these findings, stratification analyses were undertaken. Moreover, univariate logistic regression was applied to investigate potential determinants of sorafenib-related dermatologic AEs.

Results

Reports of dermatologic toxicity accounted for 32.36% of the overall sorafenib reports during the study period, and 72 adverse events (AEs) were defined as sorafenib-related dermatologic toxicity. Reports of sorafenib-associated dermatologic toxicity indicated a median patient age of 64 years (interquartile range [IQR] 56–72) and a median time-to-onset (TTO) of 11 days (IQR: 0.5–37.5), with serious outcomes accounting for 89.07% of cases. Besides, 1, 15, and 16 AEs were identified as signals with strong, moderate, and weak clinical priority, respectively, all displaying an early failure pattern. Sex and reporter types were significant influencing factors for sorafenib-associated dermatic AEs (male: OR = 0.667 [0.577–0.772], p < 0.01; healthcare professional: OR = 0.760 [0.661–0.874], p < 0.01).

Conclusions

This study characterized the clinical features, TTO, severity profiles, clinical prioritization, and influencing factors of sorafenib-associated dermatologic toxicities. The findings offer supportive evidence to aid clinicians in managing AEs, thereby enhancing patient adherence and therapeutic outcomes.

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索拉非尼相关皮肤毒性：基于歧化分析和临床特征的综合评价

目的索拉非尼是不可切除的肝癌（HCC）的主要治疗药物，也是肾细胞癌（RCC）和分化型甲状腺癌（DTC）的治疗药物，但由于皮肤毒性，索拉非尼的长期临床应用往往受到限制，可能需要调整剂量甚至停药。本研究试图通过挖掘食品和药物管理局不良事件报告系统（FAERS）来全面描述这些毒性。方法利用2018年第一季度至2023年第一季度收集的FAERS报告，应用歧化分析，计算报告优势比（RORs），将索拉非尼相关皮肤毒性与整个数据库进行比较。比较严重和不严重的报告，然后使用预定义的评分系统进行信号优先级排序。为了评估这些发现的一致性，进行了分层分析。此外，单变量逻辑回归应用于研究索拉非尼相关皮肤ae的潜在决定因素。结果在研究期间，皮肤毒性报告占索拉非尼报告总数的32.36%，72例不良事件（ae）被定义为索拉非尼相关皮肤毒性。索拉非尼相关皮肤毒性报告显示，患者中位年龄为64岁（四分位数范围[IQR] 56-72），中位发病时间（TTO）为11天（IQR: 0.5-37.5），严重后果占病例的89.07%。此外，1例、15例和16例ae分别被确定为临床优先级为强、中、弱的信号，均表现为早期衰竭模式。性别和报告者类型是索拉非尼相关皮肤ae的显著影响因素（男性：OR = 0.667 [0.577-0.772], p < 0.01；医护人员：OR = 0.760 [0.661-0.874], p < 0.01）。结论本研究描述了索拉非尼相关皮肤毒性的临床特征、TTO、严重程度、临床优先级和影响因素。研究结果为临床医生管理不良事件提供了支持性证据，从而提高了患者的依从性和治疗效果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Dermatologic Therapy 医学-皮肤病学

CiteScore

7.00

自引率

8.30%

发文量

711

审稿时长

3 months

期刊介绍： Dermatologic Therapy has been created to fill an important void in the dermatologic literature: the lack of a readily available source of up-to-date information on the treatment of specific cutaneous diseases and the practical application of specific treatment modalities. Each issue of the journal consists of a series of scholarly review articles written by leaders in dermatology in which they describe, in very specific terms, how they treat particular cutaneous diseases and how they use specific therapeutic agents. The information contained in each issue is so practical and detailed that the reader should be able to directly apply various treatment approaches to daily clinical situations. Because of the specific and practical nature of this publication, Dermatologic Therapy not only serves as a readily available resource for the day-to-day treatment of patients, but also as an evolving therapeutic textbook for the treatment of dermatologic diseases.