| General information |
| Database: | DB00020 |
| Objective: | The epidermal growth factor receptor (EGFR), which participates in signaling pathways that are deregulated in cancer cells, commonly appears on colorectalcancer cells. Cetuximab is a monoclonal antibody that specifically blocks the EGFR. They compared the efficacy of cetuximab in combination with irinotecan with that of cetuximab alone in metastatic colorectal cancer that was refractory to treatment with irinotecan. |
| Authors: | Cunningham D, et al |
| Title: | Cetuximab monotherapy and cetuximab plus irinotecan in irinotecanrefractory metastatic colorectal cancer. |
| Journal: | N Engl J Med |
| Year: | 2004 |
| PMID: | 15269313 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cetuximab +irinotecan vs cetuximab alone |
| Study Type: | an openlabel, randomized trial |
| Key Patients Feature: | patients with irinotecanrefractory metastatic colorectal cancer in 56 centers in 11 European countries |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | cetuximab monotherapy |
| Treatment Info: | patients were randomly assigned to receive either cetuximab and irinotecan (at the same dose and schedule as in a prestudy regimen [218 patients]) or cetuximab monotherapy (111 patients). In cases of disease progression, the addition of irinotecan to cetuximab monotherapy was permitted. |
| Primary End Point: | radiologically for tumor response, time to tumor progression, survival, and side effects of treatment |
| Secondary End Point: | NA |
| Patients Number: | 329 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The rate of response in the combinationtherapy group was significantly higher than that in the monotherapy group (22.9 percent [95 percent confidence interval, 17.5 to 29.1 percent] vs. 10.8 percent [95 percent confidence interval, 5.7 to 18.1 percent], P=0.007). |
| Disease Control Rate: | Disease control (complete response plus partial response plus stable disease) was achieved in 55.5 percent of patients receiving combination treatment and in 32.4 percent of patients treated with cetuximab alone (P<0.001). |
| Median Time to Progression: | median time to progression was significantly greater in the combinationtherapy group (4.1 vs. 1.5 months, P<0.001 by the logrank test). |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | The median survival time was 8.6 months in the combinationtherapy group and 6.9 months in the monotherapy group (P=0.48). |
| Adverse Event(agent arm): | Toxic effects were more frequent in the combinationtherapy group, but their severity and incidence were similar to those that would be expected with irinotecan alone |
| Conclusions: | Cetuximab has clinically significant activity when given alone or in combination with irinotecan in patients with irinotecanrefractory colorectal cancer. |