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Among elderly patients with squamous cell skin cancer that could not be surgically removed, treatment with the targeted therapy Erbitux® (cetuximab) produced a promising rate of disease control. The results of this Phase II clinical trial were published in the Journal of Clinical Oncology.

Non-melanoma skin cancer refers to all types of skin cancer other than melanoma. Although there are several different types of non-melanoma skin cancer, the two most common types are basal cell carcinoma and squamous cell carcinoma.

Squamous cell carcinoma accounts for roughly 20% of all cases of non-melanoma skin cancer. Squamous cell carcinoma commonly involves the head or neck. The tumor may appear as a red bump or as a rough or scaly area on the skin. Squamous cell carcinoma is more likely than basal cell carcinoma to spread to lymph nodes or distant parts of the body, though this happens infrequently.

Treatment of squamous cell skin cancer often involves surgery to remove the cancer. This may not be possible for some patients, however, and other treatment approaches will need to be considered.

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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.

To asses Erbitux in the treatment of squamous cell skin cancer, researchers conducted a Phase II clinical trial among 36 patients. Half the patients were over the age of 79 years, and all had squamous cell skin cancer that could not be surgically removed. Study participants were treated with Erbitux for at least six weeks.

  • After six weeks, 69% of patients had cancer that had either improved or remained stable.
  • Out of the 36 patients, eight had a partial reduction in cancer and two had a complete disappearance of detectable cancer.
  • There were no treatment-related deaths, but there were three serious adverse events (two infusion reactions and one lung problem).
  • A majority of patients (78%) experienced an acne-like rash.

These results suggest that Erbitux is active against squamous cell skin cancer, and may provide an option for patients with cancer that cannot be surgically removed. The researchers recommend a Phase III clinical trial in order to further evaluate Erbitux for this purpose.

Reference: Maubec E, Petrow P, Scheer-Senyarich I et al. Phase II study of cetuximab as first-line single-drug therapy in patients with unresectable squamous cell carcinoma of the skin. Journal of Clinical Oncology.  Early online publication August 1, 2011.