EVALUATION OF ANTICANCER THERAPY- RELATED DERMATOLOGIC ADVERSE EVENTS: INSIGHTS FROM FDA's FAERS DATASET.
Anticancer drugs
FAERS
adverse events
cutaneous toxicities
skin
Journal
Journal of the American Academy of Dermatology
ISSN: 1097-6787
Titre abrégé: J Am Acad Dermatol
Pays: United States
ID NLM: 7907132
Informations de publication
Date de publication:
20 Jul 2024
20 Jul 2024
Historique:
received:
03
04
2024
revised:
10
06
2024
accepted:
01
07
2024
medline:
23
7
2024
pubmed:
23
7
2024
entrez:
22
7
2024
Statut:
aheadofprint
Résumé
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.
Sections du résumé
BACKGROUND
BACKGROUND
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.
METHODS
METHODS
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.
RESULTS
RESULTS
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%.
CONCLUSIONS
CONCLUSIONS
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.
Identifiants
pubmed: 39038557
pii: S0190-9622(24)02532-5
doi: 10.1016/j.jaad.2024.07.1456
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024. Published by Elsevier Inc.