Adjuvant radiation and cetuximab improves local control in head and neck cutaneous squamous cell carcinoma: Phase II study

Background: Cutaneous squamous cell carcinoma of the head/neck (CSCCHN) is common due to chronic sun exposure. As CSCCHN highly expresses EGFR, we prospectively studied postoperative concurrent cetuximab with radiotherapy for locally advanced CSCCHN (LA-CSCCHN). Materials and methods: Single-institutional phase II trial of LA-CSCCHN (NCT XXXX). Adjuvant radiation was given with concurrent cetuximab. Primary endpoint of 2-year LRC and secondary objectives of 2-year disease-free survival (DFS) and 2-year OS were assessed by Kaplan–Meier analysis. Results: Twenty-four patients ages 47–88 (median 71 years) were treated from 2014 to 2017. Fourteen patients had T3/4 disease, 5 had N1 disease, and 7 were N2/3. At median follow-up of 42 months, median OS and DFS was not reached and 64 months. Two-year OS was 75%, 2-year DFS was 70.8%. LRC was 91.1% at 2 years. All grade 3 adverse events were related to skin toxicity (12.5% radiation-related dermatitis, 16.7% cetuximab-related rash). Conclusions: LRC compares favorably to historical data examining postoperative radiation alone but requires further investigation.