Objective:

To evaluate drug-related interstitial lung disease (ILD) reporting signals in patients with head and neck squamous cell carcinoma (HNSCC) using the FAERS database.

Approach:

• Data Source: Utilized the FDA Adverse Event Reporting System (FAERS) database from Q1 2004 to Q1 2025 to analyze adverse event reports related to ILD in HNSCC patients.
• Analysis Methods: Conducted disproportionality analysis using reporting odds ratio (ROR) and information component (IC), along with descriptive statistics and Weibull distribution modeling for time to onset.

Key Findings:

• 513 patients with ILD related to HNSCC treatment were included.
• Three drugs showed definite positive ILD signals: cetuximab (ROR = 1.46, IC = 0.36), nivolumab (ROR = 1.67, IC = 0.61), and pembrolizumab (ROR = 2.39, IC = 1.06).
• Etoposide showed a positive ROR (ROR = 4.51) but a negative IC (IC = 2.11).
• Anti-EGFR monoclonal antibodies (ROR = 1.45, IC = 0.35) and PD-1/PD-L1 inhibitors (ROR = 2.14, IC = 0.72) had positive safety signals for ILD.
• The median time to onset of ILD was 32 days.

Interpretation:

The study identifies an association of ILD with specific drug classes in HNSCC treatment.

Limitations:

• Causality cannot be confirmed due to the nature of spontaneous reporting data.
• The study is limited to data available in the FAERS database.

Conclusion:

Monitoring for ILD in patients receiving anti-EGFR monoclonal antibodies and PD-1/PD-L1 inhibitors is important, particularly in early treatment stages.