Cetuximab is a monoclonal antibody that specifically blocks the EGFR. The efficacy of cetuximab in combination with CPT-11 or alone was evaluated in a randomised trial in metastatic colorectal cancer refractory to treatment with CPT-11. Three hundred and twenty-nine patients whose disease had progressed during or within three months after treatment with a CPT-11-based regimen were randomly assigned to receive either cetuximab and CPT-11 (at the same dose and schedule as in a pre-study regimen) or cetuximab monotherapy. The rate of response in the combination therapy was significantly higher than that in the monotherapy (22.9% vs. 10.8%, p=0.007). The median time to progression was significantly greater in the combination therapy (4.1 vs. 1.5 months, p<0.001). The median survival time was 8.6 months for the combination-therapy and 6.9 months for the monotherapy (p=0.48). Toxic effects were more frequent in the combination therapy group, but their severity and incidence were similar to those that would be expected with CPT-11 alone. Cetuximab has clinically significant activity when given alone or in combination with CPT-11 in patients with CPT-11-refractory colorectal cancer .
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