# EXTREME

Source: https://onco.cc/trials/extreme/  
OnCo record `extreme` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The regimen that defined first-line treatment for advanced head and neck cancer from 2008 until immunotherapy replaced it.

## Summary

EXTREME, trial NCT00122460 sponsored by Merck KGaA and reported in 2008, produced the regimen that defined first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma from 2008 until immunotherapy replaced it. It randomised 442 patients to cetuximab plus platinum and fluorouracil or chemotherapy alone and met its primary overall survival endpoint, the first survival gain in this setting in decades, and it became the control arm for KEYNOTE-048. OnCo links it to head and neck cancer, monoclonal antibodies, platinum agents, EGFR as a target, Jan B. Vermorken and KEYNOTE-048, and the docetaxel-based TPExtreme regimen matched it. Whether cetuximab retains any first-line role now that pembrolizumab-based regimens are standard is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT00122460
- Phase: 3
- Setting: Untreated recurrent or metastatic HNSCC: cetuximab + platinum/5-FU vs platinum/5-FU
- Sponsor: Merck KGaA
- Enrolled: 442
- Result: OS 10.1 vs 7.4 months; HR 0.80.
- Outcomes: Overall survival: Cetuximab + chemotherapy 10.1 months vs Chemotherapy 7.4 months, HR 0.8
- Replication: TPExtreme (docetaxel-based) matched it; the regimen was robust until superseded.

## Sources

- ClinicalTrials.gov NCT00122460: https://clinicaltrials.gov/study/NCT00122460
- NEJM 2008: https://www.nejm.org/doi/full/10.1056/NEJMoa0802656

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer)](https://onco.cc/cancers/hpv-negative-head-and-neck-cancer/), [Recurrent or metastatic head and neck squamous cell carcinoma](https://onco.cc/cancers/recurrent-metastatic-hnscc/)
- technologies: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/), [Platinum agents](https://onco.cc/technologies/platinum/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- companies: [Merck KGaA (EMD Serono)](https://onco.cc/companies/merck-kgaa/)
- people: [Jan B. Vermorken](https://onco.cc/people/jan-vermorken/)
- trials: [KEYNOTE-048](https://onco.cc/trials/keynote-048/)
- key papers: [EXTREME: platinum-based chemotherapy plus cetuximab in recurrent or metastatic head and neck cancer](https://onco.cc/key-papers/paper-extreme-vermorken-nejm-2008/)

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