Wednesday, April 1, 2009
WEDNESDAY, April 1 (HealthDay News) -- Adding cetuximab to the combination treatment of fluorouracil and leucovorin (FOLFIRI) for the first-line treatment of metastasized colorectal cancer can retard disease progression, according to a report in the April 2 issue of the New England Journal of Medicine.
Eric Van Cutsem, M.D., of the University Hospital Gasthuisberg in Leuven, Belgium, and colleagues conducted a randomized multicenter study in which 1,198 colorectal cancer patients with unresectable metastases received FOLFIRI alone (599 patients) or FOLFIRI with cetuximab (599 patients) in 14-day cycles. The study endpoint was disease progression-free survival time or death within 60 days of randomization. Progression was assessed by computed tomography scan or MRI.
Disease progression was observed in 298 patients receiving cetuximab-FOLFIRI and 322 patients receiving FOLFIRI alone, showing a 15 percent reduction of progression risk for the cetuximab-FOLFIRI group, the researchers report. Overall, median survival time was 19.9 months for cetuximab-FOLFIRI and 18.6 months for FOLFIRI alone. Grade 3 or 4 adverse events occurred in 79.3 percent of the cetuximab-FOLFIRI group and 61 percent of the FOLFIRI-alone group, the study found.
"First-line treatment with cetuximab plus FOLFIRI, as compared with FOLFIRI alone, reduced the risk of progression of metastatic colorectal cancer. The benefit of cetuximab was limited to patients with KRAS wild-type tumors," the authors write.
Merck provided support for the study. Several of the study authors report financial relationships with the pharmaceutical industry, including Merck.
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