• 8/30/2005
  • staff
  • CancerConsultants (cancerconsultants.com)

A recent phase III trial indicates that the addition of the targeted agent Erbitux (cetuximab) to radiation therapy improves survival in patients with advanced head and neck cancer.

Approximately 40,000 people in the United States are diagnosed with head and neck cancer every year. Cancers of the head and neck comprise several types of cancer; these include the nasal cavity and sinuses, oral cavity, nasopharynx, oropharynx and other sites throughout the head and neck area. According to the American Cancer Society, 11,000 people died from head and neck cancer in 2004. Standard treatment for head and neck cancer is largely determined by the stage, or extent to which the cancer has spread, as well as the specific locations within the head or neck area where the cancer has spread. The patient’s overall medical condition is also a deciding factor. Treatment typically consists of radiation therapy, chemotherapy with surgery or surgery alone. Once head and neck cancer has spread from its site of origin, long-term outcomes are generally suboptimal. In addition, treatment for head and neck cancer often results in a compromised quality of life. Research and development of newl therapeutic approaches that will improve long-term outcomes and quality of life for patients with this disease continues.

The epidermal growth factor receptor (EGFR) pathway is involved in 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 produced in a laboratory with the purpose of binding to the EGFR and inhibiting the receptor’s effects on cellular replication. Erbitux is currently FDA-approved in combination with irinotecan for the treatment of colorectal cancer that has stopped responding to irinotecan-based chemotherapy. The drug is also approved as a single agent in patients who are not able to tolerate treatment with irinotecan. Erbitux is currently being evaluated in clinical trials for the treatment of various types of cancers.

Recently results from a large phase III trial (phase of trial prior to FDA review) referred to as IMCL-9815) were analyzed by an Independent Clinical Review Committee (ICRC). This trial included 424 patients with advanced head and neck cancer whose cancer had spread throughout the head or neck region. Patients were treated with radiation therapy alone or radiation therapy plus Erbitux. Patients treated with radiation plus Erbitux showed significantly improved survival and progression-free survival times over those treated with radiation alone. Furthermore, the addition of Erbitux to radiation helped prevent the spread of cancer beyond the head and neck region more effectively than radiation alone. The data from these results will be presented in an upcoming scientific meeting.

Researchers concluded that the addition of Erbitux to radiation therapy improves overall survival, progression-free survival and controls the spread of cancer more than radiation therapy alone in patients with advanced head and neck cancer. Patients with advanced head and neck cancer may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial further evaluating Erbitux.

Reference:
ImClone Systems. Independent Clinical Review of Phase III Trial Shows Erbitux and Radiation Control Spread of Advanced Squamous Cell Cancer of the Head and Neck Better Than Radiation Alone; Primary and Secondary Study Endpoints Met with Statistical Significance. Available at:
http://phx.corporate-ir.net/phoenix.zhtml?c=97689&p=irol-news.