Clinical Report: Analysis of Drug-Related Interstitial Lung Disease in HNSCC Patients

Overview

This study identifies drug-related interstitial lung disease (ILD) signals in patients with head and neck squamous cell carcinoma (HNSCC) using the FDA Adverse Event Reporting System (FAERS). Cetuximab, nivolumab, and pembrolizumab were associated with positive ILD signals.

Background

Head and neck squamous cell carcinoma (HNSCC) is a prevalent malignancy with increasing use of targeted therapies and immunotherapies, which have been linked to drug-induced interstitial lung disease (ILD). ILD can lead to severe respiratory complications and has a high mortality rate.

Data Highlights

Key Findings

• 513 patients with ILD related to HNSCC treatment were analyzed from the FAERS database.
• The median age of patients was 68 years, with a median weight of 56 kg.
• Cetuximab, nivolumab, and pembrolizumab showed definite positive ILD signals based on ROR and IC analyses.
• Anti-EGFR monoclonal antibodies and PD-1/PD-L1 inhibitors were identified as drug classes with positive safety signals for ILD.
• The median time to onset of ILD was 32 days, indicating early onset as a significant characteristic.

Clinical Implications

Healthcare providers should be aware of the potential for ILD in patients receiving anti-EGFR monoclonal antibodies and PD-1/PD-L1 inhibitors.

Conclusion

The findings indicate the necessity for further verification of causality regarding ILD in HNSCC patients treated with specific therapeutic agents.

Related Resources & Content

1. Frontiers in Immunology, 2026 -- Antineoplastic agent-associated interstitial lung disease in breast, ovarian, and prostate cancers: a pharmacovigilance study using the FDA adverse event reporting system
2. The ASCO Post, 2025 -- Patients With Interstitial Lung Disease Face Elevated Lung Cancer Risk, Study Finds
3. Drugs - Real World Outcomes, 2021 -- Evaluation of Health Insurance Claims Versus Electronic Health Records for Patient Profiles and Treatment Approaches in Metastatic Non-small-cell Lung Cancer: A Retrospective Cohort Analysis
4. PubMed -- Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study
5. NCCN GUIDELINES® INSIGHTS -- Management of Immunotherapy-Related Toxicities
6. The ASCO Post — Clinical Trials Actively Recruiting Patients With Lung Cancer
7. FDA Adverse Event Reporting System (FAERS) Essentials
8. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study - PubMed
9. CE NCCN GUIDELINES® INSIGHTS Management of Immunot