New recommendations advise against use of cetuximab in colon cancer therapy
The new recommendations were issued after officials stopped enrollment in a phase III clinical trial in patients with the spread of colon cancer into regional lymph nodes whose tumors had been surgically removed. The researchers issued a recommendation that cetuximab should not be used in patients with stage III colon cancer.
According to background information provided by the report's authors, based on earlier studies, cetuximab is now indicated for treatment of patients with advanced colorectal cancer whose tumors do not have a mutation in the V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) gene.
Based on the results of cetuximab use in advanced disease, researchers of the phase III trial hoped to see similar benefits when cetuximab was added to a standard chemotherapy regimen in earlier stages of colon cancer. However, ongoing analysis during the clinical trial found that patients receiving the combination therapy had no significant improvement in survival compared to standard therapy.
“We expected that patients with the genetic mutation would not respond to cetuximab, and that is what we found,” said Richard Goldberg, MD, chief of the division of hematology/oncology at The University of North Carolina at Chapel Hill School of Medicine, who presented the results for this group of patients. “However, even the patients in the study whose tumors did not harbor the KRAS mutation did not benefit significantly from the combination therapy and the standard treatment proved to have the best results.”
Researchers also reported that the combination therapy was more toxic and the side effects of treatment, especially in older patients, negatively impacted their ability to complete the standard treatment.