Serious Cutaneous Toxicities with Immune Checkpoint Inhibitors in the US Food and Drug Administration Adverse Event Reporting System

被引:33
|
作者
Raschi, Emanuel [1 ,2 ]
Antonazzo, Ippazio Cosimo [1 ,2 ]
La Placa, Michelangelo [3 ]
Ardizzoni, Andrea [4 ]
Poluzzi, Elisabetta [1 ,2 ]
De Ponti, Fabrizio [1 ,2 ]
机构
[1] Univ Bologna, Pharmacol Unit, Dept Med, Bologna, Italy
[2] Univ Bologna, Pharmacol Unit, Dept Surg Sci, Bologna, Italy
[3] Univ Bologna, Dept Expt Diagnost & Specialty Med, Policlin S Orsola Malpighi, Dermatol Div, Bologna, Italy
[4] Univ Bologna, Dept Expt Diagnost & Specialty Med, Policlin S Orsola Malpighi, Med Oncol Unit, Bologna, Italy
来源
ONCOLOGIST | 2019年 / 24卷 / 11期
关键词
D O I
10.1634/theoncologist.2019-0250
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Cutaneous toxicities frequently occurred with immune checkpoint inhibitors (ICIs), although clinical and pharmacological features are incompletely characterized. The U.S. Food and Drug Administration Adverse Event Reporting System was queried to describe ICI-related cutaneous toxicities, focusing on severe cutaneous adverse reactions (SCARs): Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome. As compared with other anticancer drugs, a higher proportion of death (11.3% vs. 8.7%) and serious reports (42.7% vs. 34.6%) emerged for ICIs (p < .05). A higher frequency of coreported allopurinol and antiepileptics was recorded among 2,525 total SCARs (17% vs. 10%, ICIs and anticancer agents, respectively; p < .05). Mean times to onset were 47, 48, and 40 days (SJS, TEN, and DRESS, respectively), with comparable mean latency between monotherapy and combination regimens (41 days). This immune-related pattern advocates for long-lasting monitoring by oncologists and dermatologists.
引用
收藏
页码:E1228 / E1231
页数:4
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