Abstract 3548: CD44, protein, demographics and risk factor data: A combined approach to detect head and neck squamous cell carcinoma.

Proceedings: AACR 104th Annual Meeting 2013; Apr 6-10, 2013; Washington, DC Head and neck squamous cell carcinoma (HNSCC) is a debilitating and deadly disease. The main risk factors are tobacco and alcohol use and human papillomavirus (HPV) infection. Early detection tests are needed because the majority of patients present in late stage when cure rates reach only 40%. Our group has developed a simple, inexpensive, noninvasive diagnostic test based on soluble CD44 (solCD44) and total protein levels. We used a case-control design to evaluate soluble markers for HNSCC in 150 oropharyngeal (OP) and lip/oral cavity (Lip/OC) patients and 150 controls frequency matched for age, gender, race, ethnicity, tobacco use and socioeconomic status. We compared patient groups with respect to important covariates using the chi-square, Fisher's exact test, or t-test. Markers’ mean levels were compared either by t-test or ANOVA, followed by pairwise multiple comparisons. Logistic regression analysis was used to evaluate predictivity of the salivary markers univariately and multivariately with adjustment for demographics and risk factors. We report odds ratio (OR) estimates with corresponding 95% confidence interval (95% CI) and area under the curve (AUC) of the operating characteristic curve (ROC) for fitted models. The case-control groups did not differ in regards to age, gender, race, ethnicity, history of ever vs. never smoking, current alcohol use, number of teeth removed, or county vs. private hospital system. The mean log2CD44 and protein levels were elevated in cases (log2 CD44= 1.94 ng/ml, protein=0.93 mg/ml) compared to controls (log2 CD44= 1.28 ng/ml, protein= 0.76 mg/ml), (p<.0001; p=.003, respectively). Log2CD44 levels were significantly elevated in older vs. younger cases (p<0.05). There were no significant mean log2 CD44 level differences between Lip/OC and OP cases, TNM or HPV status in cancer patients. In the cases for which HPV status was available (as measured by the surrogate marker p16), log 2 CD44 levels varied by smoking status (lower in never smokers), by drinking status in HPV + cases (lower in non-drinkers) and N-stage (higher levels in N0, Nx vs. N1-N3 in HPV-positive and the opposite effect in HPV-negative tumors). For protein, there were no differences in either the case or the control group based on demographic or risk variables. When we stratified by HPV status, race/ethnicity and drinking status did have an effect (higher levels in blacks vs. WNH and higher in current vs. former and never/mild drinkers in HPV positive tumors only). A specific model was developed for each of the 3 race/ethnicity groups with the highest AUC for blacks (AUC= .835) and WNH (AUC= .831) followed by HW (AUC= .777). Models included log2CD44, protein, smoking, gender and age; strongly suggesting that these factors play an important role for HNSCC early detection studies. Citation Format: Lutecia H. Mateus Pereira, Isildinha Reis, Robert Duncan, Judy Wen, Erika Reategui, Stephanie Bayers, Laurian Walters, Aymee Perez, Jennifer Hu, W Jarrard Goodwin, Elizabeth J. Franzmann. CD44, protein, demographics and risk factor data: A combined approach to detect head and neck squamous cell carcinoma. [abstract]. In: Proceedings of the 104th Annual Meeting of the American Association for Cancer Research; 2013 Apr 6-10; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2013;73(8 Suppl):Abstract nr 3548. doi:10.1158/1538-7445.AM2013-3548