| General information |
| Database: | DB00021 |
| Objective: | Cetuximab, an IgG1 chimeric monoclonal antibody against epidermal growth factor receptor (EGFR), has activity against colorectal cancers that express EGFR. |
| Authors: | Jonker DJ, et al |
| Title: | Cetuximab for the treatment of colorectal cancer. |
| Journal: | N Engl J Med |
| Year: | 2007 |
| PMID: | 18003960 |
| Trial Design |
| Clinical Trial Id: | NCT00079066 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | colorectal cancer expressing EGFR |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase III trial |
| Key Patients Feature: | patients who had colorectal cancer expressing immunohistochemically detectable EGFR and who had been previously treated with a fluoropyrimidine, irinotecan, and oxaliplatin or had contraindications to treatment with these drugs |
| Biomarker: | immunohistochemically detectable EGFR |
| Biomark Analysis: | as in the conclusion |
| Control Group Info: | best supportive care alone |
| Treatment Info: | pts underwent randomization to an initial dose of 400 mg of cetuximab per square meter of bodysurface area follotheyd by a weekly infusion of 250 mg per square meter plus best supportive care (287 patients) or best supportive care alone (285 patients). |
| Primary End Point: | overall survival. |
| Secondary End Point: | progression free survival;response rates; and quality of life;the safety profile of cetuximab. |
| Patients Number: | 572 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Partial responses occurred in 23 patients (8.0%) in the cetuximab group but in none in the group assigned to supportive care alone (P<0.001); the disease was stable in an additional 31.4% of patients assigned to cetuximab and in 10.9% of patients assigned to supportive care alone (P<0.001). Quality of life was better preserved in the cetuximab group, with less deterioration in physical function and global health status scores (both P<0.05). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | cetuximab treatment was associated with a significant improvement in progression free survival (hazard ratio for disease progression or death, 0.68; 95% CI, 0.57 to 0.80; P<0.001). |
| Median OS A vs. C: | cetuximab treatment was associated with a significant improvement in overall survival (hazard ratio for death, 0.77; 95% confidence interval [CI], 0.64 to 0.92; P=0.005) ;6.1 ms vs 4.6 ms ; |
| Adverse Event(agent arm): | Cetuximab treatment was associated with a characteristic rash; a rash of grade 2 or higher was strongly associated with improved survival (hazard ratio for death, 0.33; 95% CI, 0.22 to 0.50; P<0.001). The incidence of any adverse event of grade 3 or higher was 78.5% in the cetuximab group and 59.1% in the group assigned to supportive care alone (P<0.001). |
| Conclusions: | Cetuximab improves overall survival and progression free survival and preserves qualityoflife measures in patients with colorectal cancer in whom other treatments have failed. |