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

doi:10.1056/NEJMoa053422

Volume 354:567-578		February 9, 2006		Number 6

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

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., Merrill S. 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.

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ABSTRACT

Background We conducted a multinational, randomized study tocompare radiotherapy alone with radiotherapy plus cetuximab,a monoclonal antibody against the epidermal growth factor receptor,in the treatment of locoregionally advanced squamous-cell carcinomaof the head and neck.

Methods Patients with locoregionally advanced head and neckcancer were randomly assigned to treatment with high-dose radiotherapyalone (213 patients) or high-dose radiotherapy plus weekly cetuximab(211 patients) at an initial dose of 400 mg per square meterof body-surface area, followed by 250 mg per square meter weeklyfor the duration of radiotherapy. The primary end point wasthe duration of control of locoregional disease; secondary endpoints were overall survival, progression-free survival, theresponse rate, and safety.

Results The median duration of locoregional control was 24.4months among patients treated with cetuximab plus radiotherapyand 14.9 months among those given radiotherapy alone (hazardratio for locoregional progression or death, 0.68; P=0.005).With a median follow-up of 54.0 months, the median durationof overall survival was 49.0 months among patients treated withcombined therapy and 29.3 months among those treated with radiotherapyalone (hazard ratio for death, 0.74; P=0.03). Radiotherapy pluscetuximab significantly prolonged progression-free survival(hazard ratio for disease progression or death, 0.70; P=0.006).With the exception of acneiform rash and infusion reactions,the incidence of grade 3 or greater toxic effects, includingmucositis, did not differ significantly between the two groups.

Conclusions Treatment of locoregionally advanced head and neckcancer with concomitant high-dose radiotherapy plus cetuximabimproves locoregional control and reduces mortality withoutincreasing the common toxic effects associated with radiotherapyto 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.).

Address reprint requests to Dr. Rowinsky at ImClone Systems, 33 ImClone Dr., Branchburg, NJ 08876, or at eric.rowinsky{at}imclone.com.

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