| General information |
| Database: | DB00351 |
| Objective: | They 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 squamouscell carcinoma of the head and neck. |
| Authors: | Bonner JA, et al |
| Title: | Radiotherapy plus cetuximab for squamouscell carcinoma of the head and neck. |
| Journal: | N Engl J Med. |
| Year: | 2006 |
| PMID: | 16467544 |
| Trial Design |
| Clinical Trial Id: | NCT00004227 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | Radiotherapy plus cetuximab |
| Study Type: | multinational, randomized study internationalphase III study |
| Key Patients Feature: | Patients with stage III or IV, 31 nonmetastatic, measurable squamouscell carcinoma of the oropharynx, hypopharynx, or larynx medical suitability for definitive radiotherapy, a Karnofsky performancescore of at least 60, and normal hematopoietic, hepatic, and renal function. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | A: radiotherapy alone B: radiotherapy plus weekly cetuximab |
| Treatment Info: | patients were randomly assigned to treatment with highdose radiotherapy alone (213 patients) or highdose radiotherapy plus weekly cetuximab (211 patients) at an initial dose of 400 mg per square meter of bodysurface area, followed by 250 mg per square meter weekly for the duration of radiotherapy. |
| Primary End Point: | the duration of control of locoregional disease; |
| Secondary End Point: | overall survival, progression free survival, the response rate, and safety. |
| Patients Number: | 424 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 17.1 months among patients treated with radiotherapy plus cetuximab and 12.4 months among those treated with radiotherapy alone. |
| Median OS A vs. C: | 49.0 months among patients treated with combined therapy and 29.3 months among those given radiotherapy alone (P = 0.03). |
| Adverse Event(agent arm): | 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 highdose 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.) |