Weekly Paclitaxel, Carboplatin, Cetuximab (Pcc), And Cetuximab, Docetaxel, Cisplatin, And Fluorouracil (C-Tpf), Followed By Risk-Based Local Therapy In Previously Untreated, Locally Advanced Head And Neck Squamous Cell Carcinoma (Lahnscc).

6001 Background: We designed a randomized phase II trial to determine the efficacy of two induction chemotherapy (ICT) cetuximab (C) containing regimens with demonstrated efficacy and acceptable toxicity in previously untreated LAHNSCC. ICT was followed by risk-based definitive local therapy, where risk was defined by Human Papillomavirus (HPV) status and stage and stratification by smoking status (low vs intermediate/high). Primary endpoint was 2-year progression free survival (2yr PFS). Methods: 136 patients (pts) median age 58 years, 84% males, 89% caucasian, 66% ECOG PS 0, 40% never smokers, with stage IV (40% T3-4, 98% N2b-c/N3), 77% HPV-positive, HNSCC (oropharynx 79%, others 21%) were randomized 1:1 to receive PCC [paclitaxel 135 mg/m2, carboplatin AUC 2 weekly (wy) and C 400 mg/m2 week (w) 1 then 250 mg/m2 wy] for 6 weeks or C-TPF [docetaxel 75 mg/m2, cisplatin 100 mg/m2 day (d) 1, fluorouracil 700 mg/m2 24-hr infusion d 1-4 every 3 w and C 400 mg/m2 w 1 then 250 mg/m2 wy] for 9 weeks. Results: As...