According to the results of a Phase III clinical trial, the addition of Erbitux® (cetuximab) to chemotherapy with FOLFOX did not improve outcomes among patients with Stage III colon cancer. These results were reported by the National Cancer Institute and will be presented at an upcoming medical meeting.
Colorectal cancer is the second leading cause of cancer death in the United States. Stage III colon cancer refers to cancer that has spread to lymph nodes surrounding the colon but not to other parts of the body.
Erbitux is a targeted therapy that inhibits growth of the cancer by binding to a portion of the epidermal growth factor receptor (EGFR), a protein located on the surface of many cancer cells. Erbitux is currently approved for the treatment of selected patients with advanced head and neck cancer or advanced colorectal cancer. Response to Erbitux among patients with colorectal cancer appears to vary by whether or not the tumor contains a mutation in a gene known as KRAS. Tumors with KRAS mutations generally don’t respond to treatment with Erbitux.
The benefit of Erbitux among selected patients with metastatic colorectal cancer prompted interest in the role of Erbitux among patients with earlier-stage disease. The addition of Erbitux to FOLFOX chemotherapy was evaluated in a Phase III clinical trial among approximately 1,760 patients with Stage III colon cancer. All patients underwent complete surgical removal of their cancer before chemotherapy.
A review by the study’s Data Monitoring Committee concluded that no group of patients benefited from the addition of Erbitux to chemotherapy. Detailed results from the study will be presented at an upcoming medical meeting.
Reference: National Cancer Institute News Note: Addition of Cetuximab to Standard Chemotherapy in Early-Stage Colon Cancer Shows No Benefit in Phase 3 Clinical Trial. Available at: http://www.cancer.gov/newscenter/pressreleases/CetuximabClosure. Accessed December 2, 2009.