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, Herna ´n Cortés-Funes, Ricardo Hitt, Pere Gasco ´n, Nadia Amellal, Andreas Harstrick, and André Eckardt A B S T R A C T 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/m 2 followed by subsequent weekly doses of 250 mg/m 2 ) 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. J Clin Oncol 23:5568-5577. © 2005 by American Society of Clinical Oncology INTRODUCTION Squamous cell carcinoma of the head and neck (SCCHN) is the sixth most common cancer in the world, with approximately 600,000 new cases per year. 1 Recurrent and/or metastatic SCCHN patients have a poor prognosis, which has not changed sig- nificantly for 30 years. 2,3 More than 50% of newly diagnosed patients with SCCHN are not cured and will relapse locally or at a distant site; 10% of newly diagnosed pa- tients with SCCHN present with distant me- tastases. Several therapeutic options are available for recurrent and/or metastatic SCCHN patients, including reirradiation 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, Darm- stadt; and Medizinische Hochschule, Hannover, Germany. Submitted July 21, 2004; accepted February 23, 2005. 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 con- flicts of interest are found at the end of this article. 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@vhebron.net. © 2005 by American Society of Clinical Oncology 0732-183X/05/2324-5568/$20.00 DOI: 10.1200/JCO.2005.07.119 JOURNAL OF CLINICAL ONCOLOGY O R I G I N A L R E P O R T VOLUME 23  NUMBER 24  AUGUST 20 2005 5568 Downloaded from ascopubs.org by 54.91.45.86 on June 10, 2022 from 054.091.045.086 Copyright © 2022 American Society of Clinical Oncology. All rights reserved.