# Radiotherapy plus cetuximab for locoregionally advanced squamous cell carcinoma of the head and neck

Source: https://onco.cc/key-papers/paper-bonner-cetuximab-radiotherapy-nejm-2006/  
OnCo record `paper-bonner-cetuximab-radiotherapy-nejm-2006` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding the EGFR antibody cetuximab to radiotherapy lengthened survival in locally advanced head and neck cancer by about 20 months without increasing the mucosal toxicity of radiotherapy, giving patients unfit for cisplatin an alternative.

## Summary

Phase 3 trial of 424 patients with stage III to IV squamous cell carcinoma of the oropharynx, hypopharynx or larynx randomised to high-dose radiotherapy alone or with weekly cetuximab.

Median overall survival was 49.0 versus 29.3 months (hazard ratio 0.74) and locoregional control 24.4 versus 14.9 months; apart from acneiform rash and infusion reactions, toxicity was not increased. Later analyses suggested the benefit was concentrated in oropharyngeal cancer.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2006
- DOI: 10.1056/NEJMoa053422
- Authors: Bonner JA, Harari PM, Giralt J, et al.
- Findings: Median overall survival 49.0 vs 29.3 months; hazard ratio 0.74.; Median locoregional control 24.4 vs 14.9 months.
- What it means: Cetuximab-radiotherapy is the standard for patients who cannot receive cisplatin; head-to-head trials in HPV-positive disease (RTOG 1016, De-ESCALaTE) later showed it inferior to cisplatin where cisplatin is possible.
- Caveats: Never compared directly with cisplatin chemoradiation in this trial.; HPV status was not known.

## Sources

- N Engl J Med 2006: https://doi.org/10.1056/NEJMoa053422
- PubMed: https://pubmed.ncbi.nlm.nih.gov/16467544/

## Connected records

- cancers: [HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)](https://onco.cc/cancers/hpv-negative-head-and-neck-cancer/), [Hypopharyngeal cancer](https://onco.cc/cancers/hypopharyngeal-cancer/), [Lip cancer](https://onco.cc/cancers/lip-cancer/)
- drugs: [Cetuximab](https://onco.cc/drugs/cetuximab/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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