Is there a role for adjuvant cetuximab after radiotherapy (RT) plus cetuximab in patients (pts) with locally advanced squamous cell carcinoma of the oropharynx? A phase II randomized trial.

5534 Background: Cetuximab combined with RT is a treatment option for locally advanced head and neck cancer, especially for oropharyngeal tumors. The objectives of this prospective, randomized, multicenter, phase II trial were to evaluate the efficacy and safety of cetuximab maintenance therapy following definitive RT with concomitant cetuximab in pts with locally advanced oropharyngeal cancer. Methods: Main eligibility criteria: >18 yrs old, stage III-IVM0 squamous tumors. Group A received concomitant boost RT (69.9Gy in 28 days) + cetuximab (400 mg/m2 1 wk before RT and 250 mg/m2/wk during RT). Group B received an additional 12 consecutive wks of cetuximab maintenance therapy. The primary endpoint was locoregional control (LRC) at 1 yr, secondary endpoints included LRC-2yrs, event-free survival, overall survival, safety and a molecular analysis (reported at meeting). Results: Demographics of the 91 enrolled pts (45 [A]; 46 [B]) were (A/B): median age (range), 60(42-75)/61(45-80); males, 80%/91%; Stage I...