Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck.

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 locoregionally advanced squamous-cell carcinoma of the head and neck.

METHODS:

Patients with locoregionally 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 locoregional disease; secondary end points were overall survival, progression-free survival, the response rate, and safety.

RESULTS:

The median duration of locoregional control was 24.4 months among patients treated with cetuximab plus radiotherapy and 14.9 months among those given radiotherapy alone (hazard ratio for locoregional progression or death, 0.68; P=0.005). With a median follow-up of 54.0 months, the median duration of overall survival was 49.0 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 acneiform 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 locoregionally advanced head and neck cancer with concomitant high-dose radiotherapy plus cetuximab improves locoregional control and reduces mortality without increasing the common toxic effects associated with radiotherapy to the head and neck. (ClinicalTrials.gov number, NCT00004227.)

• Authors: James A Bonner, Paul M Harari, Jordi Giralt, Nozar Azarnia, Dong M Shin, Roger B Cohen, Christopher U Jones, Ranjan Sur, David Raben, Jacek Jassem, Roger Ove, Merrill S Kies, Jose Baselga, Hagop Youssoufian, Nadia Amellal, Eric K Rowinsky, K Kian Ang
• Journal: The New England journal of medicine (N Engl J Med) Vol. 354 Issue 6 Pg. 567-78 (Feb 09 2006) ISSN: 1533-4406 [Electronic] United States
• PMID: 16467544 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2006 Massachusetts Medical Society.

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents
• ErbB Receptors
• Cetuximab

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents (adverse effects, therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, mortality, radiotherapy)
• Cetuximab
• Combined Modality Therapy
• Disease Progression
• ErbB Receptors (immunology)
• Female
• Head and Neck Neoplasms (drug therapy, mortality, radiotherapy)
• Humans
• Male
• Middle Aged
• Survival Analysis