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-doseradiotherapy 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.) Copyright 2006 Massachusetts Medical Society.
RCT Entities:
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.) Copyright 2006 Massachusetts Medical Society.
Authors: Phuc Felix Nguyen-Tan; Qiang Zhang; K Kian Ang; Randal S Weber; David I Rosenthal; Denis Soulieres; Harold Kim; Craig Silverman; Adam Raben; Thomas J Galloway; André Fortin; Elizabeth Gore; William H Westra; Christine H Chung; Richard C Jordan; Maura L Gillison; Marcie List; Quynh-Thu Le Journal: J Clin Oncol Date: 2014-11-03 Impact factor: 44.544
Authors: V Budach; E-T Becker; D Boehmer; H Badakhshi; U Jahn; K-D Wernecke; C Stromberger Journal: Strahlenther Onkol Date: 2013-12-11 Impact factor: 3.621
Authors: Marta Moral; Carmen Segrelles; M Fernanda Lara; Ana Belén Martínez-Cruz; Corina Lorz; Mirentxu Santos; Ramón García-Escudero; Jerry Lu; Kaoru Kiguchi; Agueda Buitrago; Clotilde Costa; Cristina Saiz; Jose L Rodriguez-Peralto; Francisco J Martinez-Tello; Maria Rodriguez-Pinilla; Montserrat Sanchez-Cespedes; Marina Garín; Teresa Grande; Ana Bravo; John DiGiovanni; Jesús M Paramio Journal: Cancer Res Date: 2009-01-27 Impact factor: 12.701
Authors: J L Lefebvre; F Rolland; M Tesselaar; E Bardet; C R Leemans; L Geoffrois; P Hupperets; L Barzan; D de Raucourt; D Chevalier; L Licitra; F Lunghi; R Stupp; D Lacombe; J Bogaerts; J C Horiot; J Bernier; J B Vermorken Journal: J Natl Cancer Inst Date: 2009-01-27 Impact factor: 13.506
Authors: Elizabeth A Hopper-Borge; Rochelle E Nasto; Vladimir Ratushny; Louis M Weiner; Erica A Golemis; Igor Astsaturov Journal: Expert Opin Ther Targets Date: 2009-03 Impact factor: 6.902