PMID- 35127510
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220501
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 11
DP  - 2021
TI  - Cutaneous Toxicity Associated With Enfortumab Vedotin: A Real-Word Study 
      Leveraging U.S. Food and Drug Administration Adverse Event Reporting System.
PG  - 801199
LID - 10.3389/fonc.2021.801199 [doi]
LID - 801199
AB  - 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.
CI  - Copyright (c) 2022 Yang, Yu and An.
FAU - Yang, Hui
AU  - Yang H
AD  - Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, 
      Beijing, China.
FAU - Yu, Xiaojia
AU  - Yu X
AD  - Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, 
      Beijing, China.
FAU - An, Zhuoling
AU  - An Z
AD  - Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, 
      Beijing, China.
LA  - eng
PT  - Journal Article
DEP - 20220119
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC8807512
OTO - NOTNLM
OT  - EV
OT  - Food and Drug Administration Adverse Event Reporting System
OT  - cutaneous toxicity
OT  - disproportionality analysis
OT  - real-word study
COIS- 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.
EDAT- 2022/02/08 06:00
MHDA- 2022/02/08 06:01
PMCR- 2021/01/01
CRDT- 2022/02/07 05:34
PHST- 2021/10/25 00:00 [received]
PHST- 2021/12/22 00:00 [accepted]
PHST- 2022/02/07 05:34 [entrez]
PHST- 2022/02/08 06:00 [pubmed]
PHST- 2022/02/08 06:01 [medline]
PHST- 2021/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2021.801199 [doi]
PST - epublish
SO  - Front Oncol. 2022 Jan 19;11:801199. doi: 10.3389/fonc.2021.801199. eCollection 
      2021.