Cetuximab in locally advanced squamous cell carcinoma of the head and neck: generalizability of EMR 062202-006 trial results.

In a randomized controlled trial in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN), treatment with RT plus cetuximab resulted in improved survival compared to treatment with RT alone. Uncertainty exists about the generalizability of the trial results for the Dutch healthcare setting due to possible discrepancies in treatment allocation. Retrospective patient chart review was performed for 141 patients treated with first line RT plus cetuximab or RT alone, diagnosed in 2007-2010 in two head and neck treatment centers. Combined with aggregated population-based data from the Netherlands Cancer Registry and patient level clinical trial data, use of cetuximab in Dutch daily practice was assessed through comparison of patient characteristics, treatment characteristics and treatment outcomes between trial and daily practice. 61 daily practice patients fulfilled the selection criteria. In line with Dutch guidelines, RT plus cetuximab is prescribed in patients requiring combined therapy unfit to receive traditional platinum-based chemotherapeutics. These patients have unfavorable baseline characteristics, due to selection on--amongst others--high age of the patients. Beyond 1 year after treatment start, patients treated with RT plus cetuximab in daily practice died earlier than patients treated with RT plus cetuximab in the trial. Selective treatment allocation in daily practice limits generalizability of EMR 062202-006 trial results. Evidence is needed about the effectiveness of RT plus cetuximab compared to other treatments for patients with unfavorable clinical baseline characteristics.