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Originally published as JCO Early Release 10.1200/JCO.2005.07.119 on July 11 2005

Journal of Clinical Oncology, Vol 23, No 24 (August 20), 2005: pp. 5568-5577
© 2005 American Society of Clinical Oncology.
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Phase II Multicenter Study of the Antiepidermal Growth Factor Receptor Monoclonal Antibody Cetuximab in Combination With Platinum-Based Chemotherapy in Patients With Platinum-Refractory Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck

José Baselga, José M. Trigo, Jean Bourhis, Jacques Tortochaux, Hernán Cortés-Funes, Ricardo Hitt, Pere Gascón, Nadia Amellal, Andreas Harstrick, André Eckardt

From the Vall d'Hebron University Hospital; Hospital Clinic, Barcelona; Hospital Universitario 12 de Octubre, Madrid, Spain; Institut Gustave-Roussy, Villejuif; Centre Jean Perrin, Clermont-Ferrand, France; Merck KGaA, Darmstadt; and Medizinische Hochschule, Hannover, Germany

Address reprint requests to José Baselga, Vall d'Hebron University Hospital, Oncology Service, P Vall d'Hebron 119-129, Barcelona 08035, Spain; e-mail: jbaselga{at}vhebron.net

PURPOSE: To evaluate the efficacy and safety of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

PATIENTS AND METHODS: Ninety-six eligible patients received cetuximab (initial dose of 400 mg/m2 followed by subsequent weekly doses of 250 mg/m2) followed by platinum chemotherapy at the same dose and schedule at which progressive disease was documented before entry onto the study.

RESULTS: The response rate, based on an independently read assessment, in the intent-to-treat population was 10%, with a disease control rate (complete response, partial response [PR], and stable disease) of 53%. The median time to progression and overall survival were 85 and 183 days, respectively; both were longest in patients achieving a PR (median, 203.5 and 294 days, respectively). Treatment was well tolerated. The most common cetuximab-related adverse events were skin reactions, particularly an acne-like rash.

CONCLUSION: The combination of cetuximab and platinum chemotherapy is an active and well-tolerated approach to the treatment of this poor-prognosis patient population with platinum-refractory recurrent or metastatic SCCHN for whom there are no recommended standard therapeutic options.

Supported by Merck KGaA, Darmstadt, Germany.

Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18-21, 2002.

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


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