Purpose: The aim of this study was to test the hypothesis about the protective role of high stefin A and stefin B concentrations in operable carcinoma of the head and neck.
Methods and materials: Stefins A and B concentrations were measured in tissue cytosols of nontumorous mucosa and primary tumors from 92 patients. For quantitative analysis of stefins in tumor cytosols, commercially available enzyme-linked immunosorbent assays were used.
Results: Stefin A was upregulated in 53 patients (higher concentrations were measured in tumor samples than in nontumorous mucosa) and was downregulated in 39 patients. The corresponding numbers for stefin B were 49 and 43, respectively. A significantly higher proportion of downregulated cases were found among patients with disease re-appearance. In the Cox model, high stefin A concentrations appeared as independent predictors for favorable disease-free survival. Assuming a "broken stick" model, a significant increase in the recurrence rate after the threshold of 1063 ng/mgp (the 64th percentile in the group) was found, the hazard ratio reaching 3% of the reference value with doubling of the level of stefin A. These results were reconfirmed after pooling the data with two historical data sets into a uniform series involving 182 patients.
Conclusions: A group of patients at high risk for disease progression was identified, characterized by the downregulated stefin A protein in the tumor compared with the nontumorous mucosa. Stefin A was recognized as a promising candidate marker for prognosis in patients with operable carcinoma of the head and neck.