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Open-Label, Uncontrolled, Multicenter Phase II Study to Evaluate the Efficacy and Toxicity of Cetuximab As a Single Agent in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Failed to Respond to Platinum-Based Therapy

Jan B. Vermorken, José Trigo, Ricardo Hitt, Piotr Koralewski, Eduardo Diaz-Rubio, Frédéric Rolland, Rainald Knecht, Nadia Amellal, Armin Schueler, José Baselga

From the Department of Medical Oncology, University Hospital Antwerp, Edegem, Belgium; Oncología Médica, Hospital la Vall d'Hebron, Barcelona; Servicio de Oncologia, Hospital Universitario 12 de Octubre; Servicio de Oncologia, Hospital Universitario, Clinico San Carlos, Madrid, Spain; Klinika Chemioterapii, Szpital im. L. Rydygiera, Krakow, Poland; Centre René Gauducheau, Nantes, France; Zentrum der Hals-, Nasen- und Ohrenheilkunde, Klinikum der Johann-Wolfgang-von-Goethe-Universität, Frankfurt; and Merck KGaA, Darmstadt, Germany

Address reprint requests to Jan B. Vermorken, MD, PhD, Department of Medical Oncology, University Hospital Antwerpen, Wilrijkstraat 10, B-2650 Edegem, Belgium; e-mail: Jan.B.Vermorken{at}uza.be

Purpose: To evaluate the efficacy and safety of the epidermal growth factor receptor–directed monoclonal antibody cetuximab administered as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) who experience disease progression on platinum therapy.

Patients and Methods: An open-label multicenter study in which patients with disease progression on two to six cycles of platinum therapy received single-agent cetuximab (initial dose 400 mg/m² followed by subsequent weekly doses of 250 mg/m²) for 6 weeks (single-agent phase). Patients who experienced disease progression could receive salvage therapy with cetuximab plus platinum (combination-therapy phase). From June 2001 to December 2002, 103 patients were enrolled and treated with cetuximab, 53 of whom subsequently received combination therapy.

Results: In the single-agent phase, response rate was 13%, disease control rate (complete response/partial response/stable disease) was 46%, and median time to progression (TTP) was 70 days. During the combination-therapy phase, the objective response rate was zero, disease control rate was 26%, and TTP was 50 days. Median overall survival was 178 days. Treatment was well tolerated. The most common cetuximab-related adverse events in the single-agent phase were skin reactions, particularly rash (49% of patients, mainly grade 1 or 2). There was one treatment-related death due to an infusion-related reaction.

Conclusion: Single-agent cetuximab was active and generally well tolerated in the treatment of recurrent and/or metastatic SCCHN that progressed on platinum therapy. Response was comparable to that seen with cetuximab plus platinum combination regimens in the same setting.

Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, June 5-8, 2004, New Orleans, LA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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