# EXTREME: platinum-based chemotherapy plus cetuximab in recurrent or metastatic head and neck cancer

Source: https://onco.cc/key-papers/paper-extreme-vermorken-nejm-2008/  
OnCo record `paper-extreme-vermorken-nejm-2008` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding cetuximab to platinum and fluorouracil lengthened survival in recurrent or metastatic head and neck cancer from 7.4 to 10.1 months, the first improvement in first-line treatment in decades.

## Summary

Phase 3 trial of 442 patients with untreated recurrent or metastatic head and neck squamous cell carcinoma randomised to cisplatin or carboplatin plus fluorouracil for up to six cycles, with or without cetuximab continued as maintenance.

Median overall survival was 10.1 versus 7.4 months (hazard ratio 0.80), progression-free survival 5.6 versus 3.3 months and response 36 versus 20 percent, with skin reactions and infusion reactions as the added toxicities.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2008
- DOI: 10.1056/NEJMoa0802656
- Authors: Vermorken JB, Mesia R, Rivera F, et al.
- Findings: Median overall survival 10.1 vs 7.4 months; hazard ratio 0.80.; Objective response 36 percent vs 20 percent.
- What it means: EXTREME was the first-line standard for a decade and remains the option for patients unsuitable for pembrolizumab; it was the comparator that KEYNOTE-048 improved upon.
- Caveats: Fluorouracil infusion is burdensome; TPExtreme showed docetaxel can replace it.

## Sources

- N Engl J Med 2008: https://doi.org/10.1056/NEJMoa0802656
- PubMed: https://pubmed.ncbi.nlm.nih.gov/18784101/

## Connected records

- cancers: [Recurrent or metastatic head and neck squamous cell carcinoma](https://onco.cc/cancers/recurrent-metastatic-hnscc/)
- drugs: [Cetuximab](https://onco.cc/drugs/cetuximab/)
- trials: [EXTREME](https://onco.cc/trials/extreme/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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