CLINICAL EFFICACY OF MOLECULAR ANALYSIS OF SURGICAL MARGINS AND REGIONAL LYMPH NODES IN MANAGEMENT OF HEAD AND NECK SQUAMOUS CELL CARCINOMA

OBJECTIVES:

• Determine whether molecular detection of p53 mutation in cancerous cells of histologically negative tumor margins can predict local recurrence in patients with squamous cell carcinoma of the upper aerodigestive tract.
• Determine the incidence of p53 mutation in this population and its correlation with clinical parameters.
• Determine whether molecular detection of cancerous cells in lymph nodes from stage N0-1 neck dissections can predict survival and the risks of regional recurrence and distant metastases in these patients.

OUTLINE: This is a multicenter study.

Patients undergo standard curative resection and neck node dissection (if appropriate). Specimens are collected from tumor tissue (necrosis-free, if possible), each wound quadrant, any neck disease with clinically negative nodes, and any neck disease with a single positive node for histologic and molecular analysis. Tissue and cells are examined for p53 mutation and DNA microsatellite repeat alterations. Patients undergo adjuvant radiotherapy and/or chemotherapy, as appropriate for clinical staging and histopathology, at the discretion of the participating clinician.

Patients do not receive results of genetic testing and the results do not affect treatment.