EXTREME

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.