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TPExtreme compared a shorter, docetaxel-based version of the standard EXTREME chemotherapy for advanced head and neck cancer with the original; patients lived about as long on either, and the shorter regimen was easier to tolerate, so it became an accepted alternative.
The EXTREME regimen of platinum, fluorouracil and cetuximab was the first-line standard for recurrent or metastatic head and neck squamous cell carcinoma for a decade but requires six cycles of infusional fluorouracil. TPExtreme, a French randomised phase 2 trial of 541 patients, compared TPEx (docetaxel, cisplatin and cetuximab for four cycles with G-CSF support) against EXTREME, both followed by cetuximab maintenance. The primary endpoint was overall survival.
Overall survival was not superior with TPEx, so the primary endpoint was not met, but survival was similar, the regimen was shorter, and it caused fewer severe adverse events. TPEx is now an accepted first-line chemotherapy backbone, in particular for patients with rapidly progressing disease or after immunotherapy, since pembrolizumab-based regimens displaced EXTREME in first line after KEYNOTE-048.
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.
541 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | TPEx (docetaxel, cisplatin, cetuximab) | 269 | 14.5 months | 0.89 (0.74 to 1.08) | 0.23 | link |
| EXTREME (platinum, fluorouracil, cetuximab) | 270 | 13.4 months | ||||
| Grade 3 or worse adverse events during chemotherapy | TPEx (docetaxel, cisplatin, cetuximab) | 263 | 81% | - | <0.0001 | link |
| EXTREME (platinum, fluorouracil, cetuximab) | 265 | 93% |
Shares Fluorouracil (5-FU), Docetaxel, Cisplatin, Cytotoxic chemotherapy and the tag subtype-trials.
Shares Fluorouracil (5-FU), Docetaxel, Cytotoxic chemotherapy and the tag subtype-trials.
Shares Cisplatin, Cytotoxic chemotherapy and the tag subtype-trials.
Shares Cisplatin, Head and neck squamous cell carcinoma and the tag subtype-trials.
Shares Fluorouracil (5-FU), Cisplatin and the tag subtype-trials.
Shares Fluorouracil (5-FU), Cisplatin and the tag subtype-trials.
Shares Cisplatin, Cytotoxic chemotherapy and the tag subtype-trials.
Shares Fluorouracil (5-FU), Cytotoxic chemotherapy and the tag subtype-trials.