Intra-arterial cetuximab for the treatment of recurrent unresectable head and neck squamous cell carcinoma(†).

IMPORTANCE: Management of recurrent head and neck squamous cell carcinoma is a common and challenging clinical problem in head and neck oncology. OBJECTIVE: Here we present the first reported case of super-selective intra-arterial (SSIA) microcatheter based local delivery of cetuximab for head and neck cancer. This technical report describes the techniques used to deliver the SSIA dose of cetuximab, as well as the patient outcome. DESIGN: This technical report is part of an ongoing Phase I Clinical Trial. SETTING: The New York Head and Neck Institute (NYHNI) is a full-service otolaryngology and neurosurgery department at Lenox Hill Hospital, part of the Northwell Health System. The NYHNI serves a diverse patient population with a wide range of head and neck diseases in a tertiary hospital setting. INTERVENTION: SSIA Cetuximab. PARTICIPANT: A patient presents to our clinic with recurrent unresectable squamous cell carcinoma of the nasopharynx. He is recruited into the first cohort of a phase I clinical trial to assess the safety of SSIA cetuximab, dose starting at 100mg/m2. Adjuvant chemo-radiation therapy is also given. MEASURES: Safety, as measured by toxicity of SSIA cetuximab. RESULTS: SSIA Cetuximab has been demonstrated to be a safe and feasible procedure in this technical report. CONCLUSIONS: This case illustrates technical feasibility and a very preliminary assessment of the safety of a novel delivery of a biologic agent for squamous cell carcinoma of the head and neck, which is part of an ongoing phase I clinical trial. TRIAL REGISTRATION: NCT02438995.