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According to a phase I clinical trial published in the Journal of Clinical Oncology, 22% of patients with recurrent or metastatic squamous cell cancer of the head and neck experienced a partial reduction of their cancer following treatment with Iressa® (gefitinib) and Celebrex® (celecoxib).

Head and neck cancers originate in the throat, larynx (voice box), pharynx, salivary glands, or oral cavity (lip, mouth, tongue). Most head and neck cancers involve squamous cells, which are the cells that line the mouth, throat, and other structures. When initially diagnosed, more than 70% of patients have cancer that has advanced locally, regionally, or to distant locations in the body.

Iressa is an anti-cancer agent that selectively blocks epidermal growth factor receptors (EGFR). EGFR is a protein involved in the growth and replication of a cell. In some cancers, the EGFR may not be working properly, leading to excessive replication of the cancer cell. Iressa is taken orally and binds to a portion of EGFR to inhibit cancer cell growth.

Celebrex is a pain reliever that inhibits the COX-2 enzyme. COX-2 is overexpressed in squamous cell carcinoma of the head and neck, and higher levels are associated with worse prognosis.

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To evaluate use of Iressa and Celebrex in patients with recurrent or metastatic squamous cell carcinoma of the head and neck, researchers conducted a phase I clinical trial in 19 patients. All patients had inoperable cancer and had experienced cancer progression after at least one previous regimen of chemotherapy or chemotherapy plus radiation therapy. Patients were treated with the combination of Iressa and Celebrex and received one of three different dose levels.

Complete information was collected from 18 patients. Four (22%) had a partial reduction in cancer following treatment. Of the four patients with a partial response, one had received the lowest dose or Iressa and Celebrex, two had received the middle dose, and one had received the highest dose. All of the dose levels administered during the study were well tolerated by patients. The most common adverse effects were rash, diarrhea, heartburn, and anemia.

The researchers conclude that the anticancer response observed in four patients with incurable head and neck cancer warrants additional studies. The combination of Iressa and Celebrex may have a role in relieving symptoms of advanced, previously treated squamous cell head and neck cancer.

Patients with head and neck cancer may wish to talk with their doctor about the risks and benefits of participating in a clinical trial further evaluating these or other therapeutic approaches.

Reference: Wirth LJ, Haddad RJ, Lindeman NI et al. Phase I study of gefitinib plus celecoxib in recurrent or metastatic squamous cell carcinoma of the head and neck. Journal of Clinical Oncology.2005;28:6976-6981.