Randomized phase 2 study of first-line TPEx versus EXTREME for R/M HNSCC

Prof. Joël Guigay

The multinational randomized phase 2 study GORTEC 2014-01 TPExtreme compared TPEx chemotherapy (docetaxel-platinum-cetuximab) versus the standard of care EXTREME (platinum-fluorouracil-cetuximab) as first-line treatment for recurrent of metastatic head and neck squamous cell carcinoma. Overall survival did not differ significantly between the groups (median 14.5 months with TPEx versus 13.4 months with EXTREME; p=0.23) but the TPEx regimen had a favorable safety profile (grade 3 or worse AEs in 81% versus 93% of patients; pxtagstartz0.0001).