With more than 3,000 patients enrolled, the study was one of the largest clinical trials yet performed testing cetuximab with the commonly-used FOLFOX chemotherapy following surgery in patients with colon cancer. It was expected that adding cetuximab to FOLFOX would provide benefit in stage III colon cancer patients, and would lead to Food and Drug Administration (FDA)-approval for that indication, Dr. Alberts says. Currently, the FDA has only approved cetuximab for metastatic colon cancer and the drug should continue to be used in that setting as clinically appropriate, he says.
"Based on what we found, any use of cetuximab in stage III colon cancer is not supported by the results of our trial," he says.
According to Dr. Alberts, this is the only U.S. study to have looked at the use of chemotherapy and cetuximab in phase III colon cancer patients, but a European clinical trial is ongoing and first results are expected next year.
The randomized clinical trial had multiple arms, but the most important were the two that tested FOLFOX with or without cetuximab. This particular analysis looked only at the 1,864 enrolled patients with a normal KRAS gene (909 treated with chemotherapy alone and 955 patients treated with both drugs).
Based on a statistical analysis of the outcomes at the three-year mark post-treatment, the researchers found that those treated with chemotherapy alone (without cetuximab) had a 76 percent disease-free survival (alive and with no disease rec
|Contact: Karl Oestreich|