News Note: Addition of Cetuximab to Standard Chemotherapy in Early-Stage Colon Cancer Shows No Benefit in Phase 3 Clinical Trial

A Data Monitoring Committee (DMC) determined that in a phase 3 clinical trial for early-stage colon cancer, no group of patients benefited from the addition of the monoclonal antibody cetuximab (Erbitux ™) to a standard chemotherapy regimen known as FOLFOX. Monoclonal antibodies are a type of protein designed in the laboratory that can locate and bind to substances in the body, including tumor cells. There was some initial evidence that the addition of cetuximab to FOLFOX may have been harmful, particularly in patients age 70 or older. Approximately 1,760 patients with stage III colon cancer (cancer that has spread to the lymph nodes surrounding the colon but not to other parts of the body) after compete surgical removal of the cancerous portions of the colon were randomized between the two treatment arms. All patients had their tumors tested and only those patients with tumors that did not contain mutations in the KRASgene (called KRAS wild-type) were included in the analysis. Detailed results from the study will be presented at a future scientific meeting.

This study (N0147: A Randomized Phase III Trial of Oxaliplatin Plus 5-Fluorouracil/Leucovorin With or Without Cetuximab After Curative Resection for Patients with Stage III Colon Cancer) was conducted by a network of researchers led by the North Central Cancer Treatment Group (NCCTG) and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, under a Cooperative Research and Development Agreement with Sanofi-Aventis and in collaboration with Imclone Systems, a wholly owned subsidiary of Eli Lilly and Company and Bristol- Myers Squibb under a Clinical Supply Agreement. Current recommendations limit cetuximab therapy to patients with metastatic colorectal tumors that do not contain mutations in the KRAS gene.