新的抗癌疗法改善了患者的治疗效果，但相关的皮肤不良事件 (AE) 可能导致发病和治疗中断。目前缺乏对癌症药物与皮肤AE之间关联的全面评估。本研究利用FDA的不良事件报告系统（FAERS）数据库（2013年1月至2022年9月），有3,399,830份报告，涉及3,084种药物和16,348个AE。采用最近邻匹配模型为每个病例报告选择 10 个对照，利用人口统计学和 AE 严重程度因素的余弦相似性来最大限度地减少假阳性/阴性。皮肤 AE (n= 873）对，其中 676 对的报告比值比 (ROR) >1，包括 113 种药物和 144 种 AE。最小 ROR 为 1.25，50% 的关联显示 ROR >10。最常见的是皮疹（51 种药物）和皮肤干燥（28 种药物）。甲氨蝶呤诱发最明显的 AE (34)，然后是氮芥 (33) 和维莫非尼 (24)。靶向治疗占 49%，细胞毒性化疗占 35.9%，免疫治疗占 11%。113 种抗癌药物被确定与皮肤 AE 显着相关，最常见的是皮疹和皮肤干燥。数据可能被低估，但可以在上市后快速识别皮肤毒性信号。版权所有 © 2024。由 Elsevier Inc. 出版。

New anticancer therapies have improved patient outcomes but associated dermatologic adverse events (AEs) may cause morbidity and treatment discontinuation. A comprehensive estimation of associations between cancer drugs and skin AEs is lacking.This study utilized the FDA's Adverse Event Reporting System (FAERS) database (January 2013-September 2022), with 3,399,830 reports involving 3,084 drugs and 16,348 AEs. A nearest neighbor matching model was employed to select 10 controls for each case report, utilizing the cosine similarity of demographic and AE severity factors to minimize false positives/ negatives.There were 10,698 unique anticancer drugs (n=212) to skin AE (n=873) pairs, of which 676 had significant Reporting Odds Ratios (ROR) >1, comprising 113 drugs and 144 AEs. The minimum ROR was 1.25, and 50% of associations displayed a ROR >10. The most common were rash (51 agents) and dry skin (28 drugs). Methotrexate induced the most distinct AEs (34), then mechlorethamine (33), and vemurafenib (24). Targeted therapies accounted for 49% of pairs, cytotoxic chemotherapies for 35.9%, and immunotherapies for 11%.113 anticancer drugs were identified as significantly associated with skin AEs, most frequently rash and dry skin. Data are likely underreported but enable quick post-marketing identification of skin toxicity signals.Copyright © 2024. Published by Elsevier Inc.