Erbitux effective for advanced colorectal cancer that has progressed on all standard treatments

Compared to best supportive care, Erbitux® (cetuximab) improved both progression-free survival and overall survival for patients with advanced colon or rectal cancer where all previous treatments had failed according to a study published in the New England Journal of Medicine this month.

In addition, patients who received Erbitux had a better quality of life with fewer problems with physical functioning.

In the study conducted in Canada and Australia, 570 patients were randomly assigned to receive weekly Erbitux infusions or supportive care alone.  Previously all had been treated with a fluoropyrimidine (5FU or Xeloda®), Eloxatin® (oxaliplatin), and Camptosar® (irinotecan).

Patients had already been heavily treated with chemotherapy.  Two-thirds had three or four previous treatment regimens.  Fifteen percent had more than five.

Results included:

• 23 percent increase in overall survival in the Erbitux group compared to supportive care.
• 32 percent improvement in progression-free survival for Erbitux
• Median overall survival:  6.1 months with Erbitux vs 4.6 months with supportive care alone
• 8 percent of Erbitux patients had partial shrinkage of their cancer compared to none of those on supportive care
• At six months half of patients who were taking Erbitux were alive compared to one third of those on supportive care.
• After one year, 21 percent of the Erbitux arm were alive compared to 16 percent of those on supportive care alone.

While other clinical studies of Erbitux have shown improvements in response rate and progression-free survival, this is the first trial to show a survival advantage.

Based on this research, the FDA has approved the use of Erbitux for patients whose colorectal cancer has progressed on other treatments.

Derek Jonker, MD and his colleagues concluded,

Cetuximab improves overall survival and progression-free survival and preserves quality-of-life measures in patients with colorectal cancer in whom other treatments have failed.

SOURCE:  Jonker et al. New England Journal of Medicine, Volume 357, Number 20, November 15, 2007.

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