EXTREME
The regimen that defined first-line treatment for advanced head and neck cancer from 2008 until immunotherapy replaced it.
OS 10.1 vs 7.4 months (HR 0.80), NEJM 2008. The first survival gain in this setting in decades and the control arm for KEYNOTE-048.
Setting
Untreated recurrent or metastatic HNSCC: cetuximab + platinum/5-FU vs platinum/5-FU
Phase
Phase 3
Sponsor
Merck KGaA
Registry
Headline result
OS 10.1 vs 7.4 months; HR 0.80.
Reported
2008
Enrolled
442
Replication
TPExtreme (docetaxel-based) matched it; the regimen was robust until superseded.
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 10.1 vs 7.4 months with Cetuximab + chemotherapy compared with Chemotherapy; about 2.7 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 20 percent lower chance of the event at any given time (hazard ratio 0.8).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Untreated recurrent or metastatic HNSCC: cetuximab + platinum/5-FU vs platinum/5-FU. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
442 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Cetuximab + chemotherapy | — | 10.1 months | 0.8 | — | link |
| Chemotherapy | — | 7.4 months |
Replication
TPExtreme (docetaxel-based) matched it; the regimen was robust until superseded.