Latest Data on Marked Survival Improvement with Erbitux® in Head and Neck Cancer

Latest Data on Marked Survival Improvement with Erbitux® in Head and Neck Cancer

According to results recently presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, the addition of Erbitux® (cetuximab) to radiation therapy improved survival by nearly 20 months compared to radiation therapy alone in the treatment of head and neck cancer.

Approximately 40,000 people in the U.S. are diagnosed with head and neck cancer every year. Cancers of the head and neck comprise several types of cancer affecting the nasal cavity and sinuses, oral cavity, nasopharynx, oropharynx, and other sites throughout the head and neck. According to the American Cancer Society, it is estimated that 11,000 people will die from head and neck cancer in 2005.

Standard treatment for head and neck cancer is largely determined by the stage (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 consideration. 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. However, there is continuing research into and development of new therapeutic approaches to improve long-term outcomes and quality of life for patients with this disease.

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), is designed to bind to the EGFR and inhibit 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 cancer.

A large phase III clinical trial (the MCL-9815 trial) was recently conducted to evaluate the effectiveness of Erbitux in head and neck cancers. Although preliminary results of this trial were previously released, results including specific survival times have recently been presented.

This trial included over 420 patients with head and neck cancer that had spread from the site of origin within the head and neck area, but not to distant sites in the body. Approximately half of the patients were treated with Erbitux plus radiation, while the other half was treated with radiation alone.

The addition of Erbitux resulted in marked improvements in outcomes:

  • The median overall survival was improved by nearly 20 months in the group treated with Erbitux/radiation compared to radiation therapy alone (49 months versus 29.3 months, respectively).
  • The addition of Erbitux resulted in a 32% reduction in the risk of a cancer recurrence within the head and neck area.
  • Survival at 3 years was 56.1% for patients treated with Erbitux/radiation, compared with 45% for those treated with radiation only.
  • Rash and reactions during infusion of Erbitux were the only notable side effects associated with Erbitux.

The researchers concluded that the addition of Erbitux to radiation therapy significantly improves survival and reduces the risk of a cancer recurrence compared to radiation therapy alone in patients with head and neck cancer. Patients diagnosed with 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 or other novel therapeutic approaches.

Reference: Imclone. ERBITUX(R) Data on Locoregional Control and Overall Survival in Phase III Head and Neck Cancer Study Presented at AACR-NCI-EORTC Meeting. Available at: http://phoenix.corporate-ir.net/phoenix.zhtml?c=97689&p=irol-newsArticle&ID=783696&highlight=. Accessed November 2005.

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