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Cetuximab Provides Slight Survival Advantage in Advanced Colorectal Cancer Adapted from the NCI Cancer Bulletin, vol. 4/no. 30, November 15, 2007 (see the current issue).
Use of the targeted agent cetuximab (Erbitux®) provides a small, but statistically significant improvement in overall survival in patients with colorectal cancer for whom prior therapies are no longer effective, an international research team reported.
In a 572-patient phase III randomized clinical trial, patients treated with cetuximab had a slightly superior overall survival rate compared to with patients treated with the best supportive care, 6.1 months vs. 4.6 months (see the protocol summary). All patients in the trial had tumors that expressed the epidermal growth factor receptor, or EGFR, a known molecular target of cetuximab, the research team reported in the November 15, 2007, New England Journal of Medicine (see the journal abstract).
"This is the first time that single-agent biological therapy has shown a survival benefit in advanced colorectal cancer," the study's lead author, Dr. Derek Jonker from the National Cancer Institute of Canada Clinical Trials Group, said in April 2007, when the trial's results were first presented at the American Association of Cancer Research annual meeting.
Cetuximab was also associated with a small, statistically significant improvement in progression-free survival compared with the best supportive care, the authors reported. In addition, 31.4 percent of patients treated with cetuximab achieved stable disease, compared with 10.9 percent in the best supportive care group, and 23 patients on cetuximab (8 percent) had a partial response, that is, some tumor shrinkage, compared with no patients in the best supportive care group.
The research team also conducted an "exploratory analysis," Dr. Jonker explained, and found that the severity of rash seen in cetuximab-treated patients seemed to correlate with treatment response. The median survival for patients who survived at least 28 days who had a very low level rash, for example, was 2.6 months, whereas it was 4.8 months for those with a moderate rash (grade 1) and 8.4 months in those with a severe rash (grade 2).
The finding, the authors concluded, "suggests that [rash] may be a predictive marker, but this point has not been validated."
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