Evaluation of anticancer therapy-related dermatologic adverse events: Insights from Food and Drug Administration's...

Area of Science:

• Oncology
• Dermatology
• Pharmacovigilance

Background:

• Anticancer therapies offer improved outcomes but can cause significant dermatologic adverse events (AEs).
• These AEs may lead to patient morbidity and necessitate treatment discontinuation.
• A comprehensive analysis of cancer drug-skin AE associations was previously lacking.

Purpose of the Study:

• To systematically estimate associations between anticancer drugs and skin AEs.
• To identify specific anticancer agents and skin toxicities of concern.
• To facilitate early postmarketing detection of dermatologic toxicities.

Main Methods:

• Utilized the FDA Adverse Event Reporting System database (2013-2022) with over 3.3 million reports.
• Employed a nearest neighbor matching model with 10 controls per case to minimize reporting errors.
• Analyzed drug-AE pairs using reporting odds ratios (ROR) to determine significant associations.

Main Results:

• Identified 113 anticancer drugs significantly associated with 144 distinct skin AEs (ROR > 1).
• Rash and dry skin were the most frequently reported AEs.
• Targeted therapies, cytotoxic chemotherapies, and immunotherapies comprised the majority of associated drug classes.

Conclusions:

• 113 anticancer drugs are significantly linked to skin AEs, primarily rash and dry skin.
• While under-reporting is likely, these findings enable rapid postmarketing identification of skin toxicity signals.
• This study provides valuable insights for oncologists and dermatologists managing cancer treatment side effects.