Researchers from Canada, Australia, New Zealand, and Singapore have reported that Erbitux (cetuximab) alone improves overall survival and progression-free survival in patients with relapsed and refractory advanced colorectal cancer. The details of this study were published in the November 15, 2007 issue of the New England Journal of Medicine.¹ 

Erbitux is a chimeric monoclonal antibody that binds to the outer domain of the epidermal growth factor receptor (EGFR). It is currently approved, in combination with radiation therapy, for the treatment of locally or regionally advanced head and neck cancer, or as a single agent in the treatment of advanced, EGFR-expressing head and neck cancer that has failed prior platinum-based therapies. It is also approved for treatment with Camptosar® (irinotecan) in patients with EGFR-expressing, metastatic colorectal cancer that have failed prior Camptosar-based therapies, or as a single agent in EGFR-expressing, advanced colorectal cancer in patients who are ineligible for Camptosar-based therapies.

The Phase III trial, known as CO.17, enrolled 572 patients that had become resistant to all available chemotherapy. All patients had EGFR positive tumors. Half the patients received best supportive care alone and half received best supportive care along with weekly intravenous Erbitux. Patients treated with Erbitux experienced improvements in both overall and progression-free survival. Patients receiving Erbitux had a 23% improvement in overall survival and a 32% improvement in progression-free survival. The median survival was 6.1 months for the Erbitux group and 4.6 months for the supportive care group. Partial responses were observed in 8% of patients receiving Erbitux while none in the supportive care group responded. Disease stabilization occurred in 31% of Erbitux patients and 11% of control patients. The presence of rash was associated with improved survival. There were more side effects in the Erbitux group than in the control group. These researchers concluded that Erbitux improves survival and time to cancer progression among patients with chemotherapy-resistant metastatic colorectal cancer. They also suggested that Erbitux preserves quality of life better than supportive care alone.

Comments: It would appear that Erbitux alone has significant palliative effects in patients with refractory colorectal cancer who are unable to tolerate chemotherapy plus Erbitux.

Related News:

Erbitux® Improves Outcomes in Advanced Colorectal Cancer (5/3/2007)

Cetuximab (Erbitux®) Safely Added to FOLFIRI as First-Line Treatment in Metastatic Colorectal Cancer (6/19/2006)

Confirmation That Cetuximab (Erbitux®) Provides Benefit in Metastatic Colorectal Cancer Patients Who Fail Camptosar® (6/6/2006)

Addition of Cetuximab (Erbitux®) to Xeloda®/Eloxatin® Improves Responses in Metastatic Colorectal Cancer (6/5/2006)

Addition of Cetuximab (Erbitux®) to FOLFOX4 Appears Promising as First-Line Therapy for Metastatic Colorectal Cancer (5/15/2005)

Cetuximab (Erbitux®) Plus Camptosar® More Effective Than Cetuximab Alone For Colorectal Cancer Resistant to Camptosar® (7/26/2004)

Cetuximab (Erbitux®) And Camptosar® More Effective Than Cetuximab Alone For Colorectal Cancer (6/10/2003)

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