TPExtreme (GORTEC 2014-01): docetaxel, cisplatin and cetuximab versus the EXTREME regimen in recurrent or metastatic head and neck cancer
Replacing fluorouracil with docetaxel in the cetuximab-platinum regimen for advanced head and neck cancer did not lengthen survival but was less toxic and much easier to give, so TPEx is an accepted alternative.
Overview
Randomised phase 2 trial of 541 patients with recurrent or metastatic head and neck squamous cell carcinoma randomised to TPEx (docetaxel, cisplatin and cetuximab for four cycles then cetuximab maintenance) or the EXTREME regimen.
Median overall survival was 14.5 versus 13.4 months (not significant), with fewer grade 4 or higher adverse events (34 versus 50 percent) and shorter treatment duration in the TPEx arm.
- Median overall survival 14.5 vs 13.4 months (not significantly different).
- Grade 4 or higher adverse events 34 percent vs 50 percent.
TPEx is a less toxic, more convenient chemotherapy backbone for patients who need cetuximab-based first-line therapy, for instance when immunotherapy is unsuitable.
- Did not meet its superiority endpoint.
- Both arms performed better than historical EXTREME data, reflecting later-line immunotherapy.
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