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Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival
The Lancet Oncology - Online First, 11/11/09

Bonner JA et al. – For patients with LASCCHN, cetuximab plus radiotherapy significantly improves overall survival at 5 years compared with radiotherapy alone, confirming cetuximab plus radiotherapy as an important treatment option in this group of patients. Cetuximab-treated patients with prominent cetuximab-induced rash (grade 2 or above) have better survival than patients with no or grade 1 rash.

Methods

Patients with LASCCHN of oropharynx, hypopharynx, or larynx with measurable disease randomly allocated in 1:1 ratio to receive either comprehensive head and neck radiotherapy alone for 6—7 weeks or radiotherapy plus weekly doses of cetuximab: 400 mg/m2 initial dose, followed by seven weekly doses at 250 mg/m2
Randomization was done with adaptive minimization technique to balance assignments across stratification factors of Karnofsky performance score, T stage, N stage, and radiation fractionation
Un-blinded trial
Primary endpoint locoregional control, with secondary endpoint of survival
Following discussions with US Food and Drug Administration, the dataset locked, except for queries to sites about overall survival, before our previous report in 2006, so that an independent review could be done
Following completion of treatment, patients underwent physical examination and radiographic imaging every 4 months for 2 years, and then every 6 months thereafter

Results

Patients randomly assigned to receive radiotherapy with (n=211) or without (n=213) cetuximab, and all patients followed for survival
Updated median overall survival for patients treated with cetuximab and radiotherapy was 49·0 months (95% CI 32·8—69·5) versus 29·3 months (20·6—41·4) in the radiotherapy-alone group (hazard ratio [HR] 0·73, 95% CI 0·56—0·95)
5-year overall survival 45·6% in cetuximab-plus-radiotherapy group and 36·4% in radiotherapy-alone group
Patients treated with cetuximab had overall survival significantly improved in those who experienced an acneiform rash of at least grade 2 severity compared with patients with no rash or grade 1 rash