Abstract 820: Molecular markers for head and neck cancer detection

Abstract Introduction: Fifty thousand new cases of HNSCC are diagnosed in the United States each year. Unfortunately, most of these cases are advanced and only cured about 40% of the time. Cure rates could reach over 80% if diagnosed in earlier stages. We are developing a simple and inexpensive molecular screening test for the early detection of HNSCC. The markers under investigation are detectable in oral rinses and include soluble CD44 (solCD44), hyaluronic acid (HA) and total protein. Materials and Methods: To study the population most likely to benefit from this early detection test, high-risk controls were identified by their smoking and/or drinking behavior from primary care clinics. They received a complete head and neck exam and had no clinical evidence of malignancy or premalignancy. Low-risk controls were normal volunteers. All subjects completed a detailed questionnaire including demographic, socioeconomic, risk factor and general health information. Oral samples were collected using a previously described swish and gargle method. We performed the solCD44, HA and protein assays in blinded fashion on oral rinses from 18 HNSCC cases, 18 frequency-matched high-risk controls and 21 low-risk controls using previously reported ELISA and ELISA-like assays. Results: We statistically assessed the adequacy of matching between the cases and high-risk controls with respect to age, gender, race, socioeconomic status, tobacco and alcohol exposure and oral health. There were no significant differences between cases and controls for any of these variables except for a borderline significant difference in race. Log2solCD44 levels were significantly higher in cancer cases (2.42 ng/ml) and high-risk controls (2.12 ng/ml) compared to low risk controls (0.64 ng/ml, p<0.05). Log2protein levels were also higher in cancer cases (0.88 mg/ml) and high-risk controls (0.97 mg/ml) compared to low-risk controls (0.52, p<0.05). Following receiver operating curve analysis, the AUC for distinguishing high-risk controls from low-risk controls was 0.94 for solCD44 and 0.82 for protein. The AUC for distinguishing cancer from low-risk controls was 0.95 for solCD44 and 0.77 for protein. After adjusting for race, the AUC for distinguishing cancer from high-risk controls was 0.76 for solCD44 and 0.68 for protein. Both of these were better for the nonwhite group (0.84 for solCD44 and 0.83 for protein). Conclusions: In this preliminary data set, the solCD44 and protein test appear to effectively distinguish HNSCC cases from high and low-risk controls. Race may have an impact on results. Further work including more subjects with longer follow-up must be done to confirm or refute these findings. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 101st Annual Meeting of the American Association for Cancer Research; 2010 Apr 17-21; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2010;70(8 Suppl):Abstract nr 820.