| General information |
| Database: | DB00341 |
| Objective: | Here they report the 5year survival data, and investigate the relation between cetuximabinduced rash and survival. |
| Authors: | Bonner JA, et al |
| Title: | Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5year survival data from a phase 3 randomised trial, and relation between cetuximabinduced rash and survival. |
| Journal: | Lancet Oncol. |
| Year: | 2010 |
| PMID: | 19897418 |
| Trial Design |
| Clinical Trial Id: | NCT00004227 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced cancer of oropharynx, hypopharynx, or larynx |
| Therapy Type: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | Radiotherapy plus cetuximab |
| Study Type: | phase III randomised trial |
| Key Patients Feature: | patients with stage III or IVnonmetastatic, measurable cancers of the oropharynx, hypopharynx, or larynx were randomly assigned to eitherradiotherapy alone or radiotherapy with cetuximab. Onlythose patients judged to be medically suitable fordefinitive radiotherapy, and who had a Karnofskyperformance score (KPS) of at least 60 with normalhaematopoietic, hepatic, and renal function were eligiblefor inclusion |
| Biomarker: | NA |
| Biomark Analysis: | none |
| Control Group Info: | A: radiotherapy with cetuximab(n=211) B: radiotherapy without (n=213) cetuximab |
| Treatment Info: | pts were randomly allocated in a 1:1 ratio to receive either comprehensive head and neck radiotherapy alone for 67 weeks or radiotherapy plus weekly doses of cetuximab: 400 mg/m(2) initial dose, followed by seven weekly doses at 250 mg/m(2). |
| Primary End Point: | locoregional control |
| Secondary End Point: | survival. |
| Patients Number: | 424 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Updated median overall survival for patients treated with cetuximab andradiotherapy was 49.0 months (95% CI 32.8-69.5) versus 29.3 months (20.6-41.4) in the radiotherapyalone group(hazard ratio [HR] 0.73, 95% CI 0.56-0.95; p=0.018). 5year overall survival was 45.6% in thecetuximabplusradiotherapy group and 36.4% in the radiotherapyalone group |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | patients treated with cetuximab and radiotherapy was 49.0 months (95% CI 32.8-69.5) versus 29.3 months (20.6-41.4) in the radiotherapyalone group (hazard ratio [HR] 0.73, 95% CI 0.56-0.95; p=0.018). 5year overall survival was 45.6% in the cetuximabplusradiotherapy group and 36.4% in the radiotherapyalone group. |
| Adverse Event(agent arm): | NA |
| Conclusions: | For patients with LASCCHN, cetuximab plus radiotherapy significantly improves overall survival at 5 years compared with radiotherapy alone, confirming cetuximab plus radiotherapy as an important treatment option in this group of patients. Cetuximabtreated patients with prominent cetuximabinduced rash (grade 2 or above) have better survival than patients with no or grade 1 rash. |