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The monoclonal antibody cetuximab (Erbitux), which blocks the epidermal growth factor receptor (EGFR), has activity against colorectal cancer (CRC). However, benefits seem to be limited to patients who have KRAS wild-type tumors (JW Oncol Hematol Mar 3 2009).
Investigators conducted an industry-supported, multicenter phase III trial of cetuximab as part of first-line treatment for 1998 patients with metastatic, EGFR-positive CRC. Patients were randomized to receive fluorouracil, leucovorin, and irinotecan (FOLFIRI) alone or with cetuximab. Tumor KRAS status was evaluated retrospectively in 540 patients.
At median follow-up of 29.9 months for the cetuximab-FOLFIRI group and 29.4 months for the FOLFIRI-only group, patients who received cetuxima…