The phase II study focuses on patients with squamous cell carcinoma of the head and neck (SCCHN), which has a low five-year survival rate after standard treatment including surgery, radiation therapy or both surgery and radiation. More than two-thirds of patients with SCCHN are diagnosed with stage III or IV cancer, which represent advanced stages of the disease, and are at high risk for disease recurrence or the development of second primary tumors (SPTs).

“Given the poor survival rates from head and neck cancer, the study’s overall survival rates of 98 percent at one-year follow-up and 91 percent at two-year follow-up, are very promising indications of the potential of this treatment for patients with locally-advanced head and neck cancer,” said Dr. Shin, professor of medicine and otolaryngology, University of Pittsburgh School of Medicine and co-director, UPCI Head and Neck Cancer Program. “The finding that there are only mild to moderate negative side-effects from treatment, which primarily include flu-like symptoms and fatigue, is also especially encouraging.”

The study employs the combination of interferon-alfa (IFN-a), 13-cis-retinoic acid (13-cRA) and vitamin E (a-tocopherol) in the treatment of locally advanced-stage head and neck cancer to prevent cancer recurrence, inhibit the formation of SPTs and reduce the toxic effects from treatment. This treatment differs from standard chemotherapy in that it mobilizes the body’s immune system to fight the cancer rather than generally poisoning rapidly dividing cells. Forty-four patients diagnosed with SCCHN participated in the study and were treated for a 12-month period.

Head and neck cancer occurs in the oral cavity, pharynx, larynx, paranasal sinuses, nasal cavity and the salivary glands, and accounts for five percent of all cancers diagnosed in the United States. Nearly 45,000 cases of head and neck cancer are diagnosed annually in the United States, and 13,000 die from causes related to this disease. Survival rates have not improved significantly over the past 20 years and are among the lowest compared to other major cancers. Previous treatment studies over the past two decades have failed to demonstrate improved survival for patients diagnosed with locally advanced SCCHN.

“Until now, we have had little success preventing the development of second primary tumors in patients with head and neck cancer,” said Dr. Shin. “If confirmed by a follow-up phase III study, the results may have a profound impact on reducing the rate of recurrence of head and neck cancer and the formation of SPTs.”

According to Shin, the phase III study will be a randomized, multi-site study (including UPCI) and will enroll 300 patients who have previously received standard treatment for SCCHN.

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