Erbitux May Not Benefit Stage III Colon Cancer

Posted on April 6th, 2012 by

Among patients with Stage III colon cancer, the addition of Erbitux® (cetuximab) to adjuvant (post-surgery) chemotherapy did not improve outcomes. These results were published in the Journal of the American Medical Association.

Stage III colon cancer refers to cancer that has spread to lymph nodes surrounding the colon but not to other parts of the body.

Erbitux is a targeted therapy that inhibits growth of the cancer by binding to a portion of the epidermal growth factor receptor (EGFR), a protein located on the surface of many cancer cells. Erbitux is currently approved for the treatment of selected patients with advanced head and neck cancer or advanced colorectal cancer.

Among patients with metastatic colorectal cancer, response to Erbitux appears to vary by whether or not the tumor contains a mutation in a gene known as KRAS. Erbitux does not appear to benefit patients with KRAS gene mutations, but has been found to benefit patients with normal KRAS. This benefit among patients with metastatic colorectal cancer and normal KRAS prompted interest in the role of Erbitux among patients with earlier-stage colorectal cancer and normal KRAS.

To evaluate Erbitux among patients with Stage III colon cancer, researchers in North American conducted a Phase III clinical trial among 2,686 patients. After surgery, patients received FOLFOX chemotherapy (mFOLFOX6) alone or in combination with Erbitux.

  • Among patients with normal KRAS, three-year disease-free survival was 74.6% among patients who received chemotherapy alone, and 71.5% among patients who received chemotherapy plus Erbitux.
  • Among patients with a KRAS mutation, disease-free survival was 67.1% among patients who received chemotherapy alone, and 65.0% among patients who received chemotherapy plus Erbitux.
  • The addition of Erbitux increased serious side effects.

These results suggest that the addition of Erbitux to adjuvant chemotherapy does not improve outcomes among patients with Stage III colon cancer. The benefit seen in patients with metastatic colorectal cancer may not apply to patients with earlier-stage disease.

Reference: Alberts SR, Sargent DJ, Nair S et al. Effect of oxaliplatin, fluorouracil, and leucovorin with or without cetuximab on survival among patients with resected stage III colon cancer. JAMA. 307:1383-1393.

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Tags: Adjuvant (I-III, A-C) Colon Cancer, Colon Cancer, News

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