Press Releases

Radiotherapy plus Cetuximab for Squamous Cell Carcinoma of the Head and Neck

February 9, 2006

James A. Bonner, M.D., Paul M. Harari, M.D., Jordi Giralt, M.D., Nozar Azarnia, Ph.D., Dong M. Shin,M.D., Roger B. Cohen, M.D., Christopher U. Jones, M.D., Ranjan Sur, M.D., Ph.D., David Raben, M.D., Jacek Jassem, M.D., Ph.D., Roger Ove, M.D., Ph.D., MerrillS. Kies, M.D., Jose Baselga, M.D., Hagop Youssoufian, M.D., Nadia Amellal, M.D., Eric K. Rowinsky, M.D., and K. Kian Ang, M.D., Ph.D.

New England Journal of Medicine 2006; 354:567-578, Feb 9,2006

ABSTRACT

Background: We conducted a multinational, randomized study to compare radiotherapy alone with radiotherapy plus cetuximab, a monoclonal antibody against the epidermal growth factor receptor, in the treatment of loco regionally advanced squamous cell carcinoma of the head and neck.

Methods: Patients with loco regionally advanced head and neck cancer were randomly assigned to treatment with high-dose radiotherapy alone (213 patients) or high-dose radiotherapy plus weekly cetuximab (211 patients) at an initial dose of 400 mg per square meter of body-surface area, followed by 250 mg per square meter weekly for the duration of radiotherapy. The primary end point was the duration of control of loco regional disease; secondary end points were overall survival, progression-free survival, the response rate, and safety.

Results: The median duration of loco regional control was 24.4 months among patients treated with cetuximab plus radiotherapy and 14.9 months among those given radio therapy alone (hazard ratio for loco regional progression or death, 0.68; P=0.005). With a median follow-up of 54.0 months, the median duration of overall survival was49.0 months among patients treated with combined therapy and 29.3 months among those treated with radiotherapy alone (hazard ratio for death, 0.74; P=0.03).Radiotherapy plus cetuximab significantly prolonged progression-free survival(hazard ratio for disease progression or death, 0.70; P=0.006). With the exception of acne i form rash and infusion reactions, the incidence of grade 3 or greater toxic effects, including mucositis, did not differ significantly between the two groups.

Conclusions: Treatment of loco regionally advanced head and neck cancer with concomitant high-dose radiotherapy plus cetuximab improves loco regional control and reduces mortality without increasing the common toxic effects associated with radiotherapy to the head and neck. (ClinicalTrials.gov number, NCT00004227[ClinicalTrials.gov] .)

Source Information

From the Department of Medicine, University of Alabama, Birmingham (J.A.B., R.O.); the Department of Human Oncology, University of Wisconsin, Madison (P.M.H.); the Services of Radiation Oncology (J.G.) and Oncology (J.B.), Vall d'Hebron University Hospital, Barcelona; ImClone Systems, New York (N.A., H.Y., E.K.R.); the Divisions of Cancer Medicine (D.M.S.,M.S.K.) and Radiation Oncology (K.K.A.), University of Texas M.D. Anderson Cancer Center, Houston; the Department of Medicine, University of Virginia, Charlottesville (R.B.C.); Radiological Associates of Sacramento, Sacramento, Calif. (C.U.J.); the Department of Radiation Oncology; University of Witwatersrand, Johannesburg (R.S.); the Department of Radiation Oncology, University of Colorado, Aurora (D.R.); the Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland (J.J.); and Merck, Darmstadt, Germany (N.A.).