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According to results recently published in the Annals of Oncology, the addition of Erbitux® (cetuximab) to the chemotherapy combination consisting of Camptosar® (irinotecan), 5-fluorouracil (5-FU), and folinic acid (FA) is safe and suggests promising anticancer activity when used as initial therapy in metastatic colorectal cancer.

The colon and rectum comprise the final parts of the large intestine. Colorectal cancer is the second leading cause of cancer-related deaths in the US.

Metastatic colorectal cancer refers to cancer that has spread from its site of origin to distant sites in the body, often invading vital organs. Standard treatment for metastatic colorectal cancer often includes chemotherapy, targeted therapy, surgical removal of cancer (if possible), and possibly radiation therapy.

The epidermal growth factor receptor (EGFR) pathway is a focus of this research. This biologic pathway plays a role in cellular replication and is often over-expressed in cancer. Erbitux, a monoclonal antibody (or protein), has been developed in a laboratory; it is designed to bind to the EGFR and inhibit the receptor’s effects on cellular replication. It continues to be evaluated in different therapeutic combinations for the treatment of various types of cancers.

Erbitux is FDA-approved to be used in combination with irinotecan for the treatment of colorectal cancer that has stopped responding to prior irinotecan-based chemotherapy. The drug is also approved as a single agent in patients who are not able to tolerate treatment with irinotecan. Recently, Erbitux was also approved for treatment of advanced head and neck cancers.

Researchers from Germany recently conducted a clinical trial to evaluate the treatment combination Erbitux/irinotecan/5-FU/FA as initial therapy in metastatic colorectal cancer. This trial included 21 patients who had EGFR-expressing metastatic colorectal cancer and had not received prior therapy.

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The treatment combination was safe and provided promising results:

  • 67% of patients had an anticancer response.
  • 29% of patients achieved stabilization of their cancer.
  • The most common severe side effects were rash and diarrhea.
  • Median time to cancer progression was nearly 10 months.
  • Median survival time was nearly 3 years (33 months).

The researchers concluded that the treatment combination consisting of Erbitux/irinotecan/5-FU/FA appears safe and promising as initial therapy in the treatment of metastatic colorectal cancer. Future trials will help determine the true effectiveness of this combination for the treatment of these patients.

Patients diagnosed with metastatic colorectal cancer may wish to speak with their physician regarding their individual risks and benefits of participation in a clinical trial further evaluating Erbitux or other novel therapeutic approaches in the treatment of their disease. Two sources of information regarding ongoing clinical trials are the National Cancer Institute ( and

Reference: Folprecht G, Lutz M, Schoffski P, et al. Cetuximab and Irinotecan/5-Fluorouracil/Folinic Acid is a Safe Combination for the First-Line Treatmetn of Patients with Epidermal Growth Factor Receptor Expressing Metastatic Colorectal Carcinoma. Annals of Oncology. 2006; 17: 450-456.

Related News:Erbitux® May Extend the Life of Metastatic Colorectal Cancer Patients (6/21/05)

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