Evaluation of anticancer therapy-related dermatologic adverse events: Insights from Food and Drug Administration's Adverse Event Reporting System dataset.

Autor: Salah S; La Roche-Posay Laboratoire Dermatologique, Levallois Perret, France. Electronic address: samir.salah@loreal.com., Kerob D; La Roche-Posay Laboratoire Dermatologique, Levallois Perret, France., Pages Laurent C; Departments of Oncodermatology and Clinical Research, Institut Universitaire du Cancer, Toulouse Oncopole, France., Lacouture M; Department of Medicine, New York University Langone, New York, New York., Sibaud V; Departments of Oncodermatology and Clinical Research, Institut Universitaire du Cancer, Toulouse Oncopole, France.
Jazyk: angličtina
Zdroj: Journal of the American Academy of Dermatology [J Am Acad Dermatol] 2024 Nov; Vol. 91 (5), pp. 863-871. Date of Electronic Publication: 2024 Jul 20.
DOI: 10.1016/j.jaad.2024.07.1456
Abstrakt: 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: This study utilized the Food and Drug Administartion (FDA)'s Adverse Event Reporting System database (January 2013-September 2022), with 3,399,830 reports involving 3084 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: 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: A total of 113 anticancer drugs were identified as significantly associated with skin AEs, most frequently rash and dry skin. Data are likely under-reported but enable quick postmarketing identification of skin toxicity signals.
Competing Interests: Conflicts of interest Dr Sibaud has served as a consultant for L'Oreal. Dr Kerob and Mr Salah are employees of La Roche-Posay. Dr Lacouture has a consultant role with Johnson and Johnson, Novocure, Janssen, Novartis, Deciphera, Kintara, RBC/La Roche Posay, Tmunity, Repare, Kinnate, Trifecta, Genentech, Loxo, Seattle Genetics, Lutris, OnQuality, Roche, Oncoderm, and Apricity.
(Published by Elsevier Inc.)
Databáze: MEDLINE
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