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Oral rinse test as a diagnostic aid for oral cancer.

2016; Lippincott Williams & Wilkins; Volume: 34; Issue: 15_suppl Linguagem: Inglês

10.1200/jco.2016.34.15_suppl.e17509

1527-7755

Elizabeth Franzmann, Sally Bowden, Matthew Kim, Greg Ginn, Robert Bohannon,

Head and Neck Cancer Studies

e17509 Background: Oral cancer, defined as cancers of the oral cavity and oropharynx, is a deadly disease increasing in incidence. World-wide 5-year survival is only 50% due to delayed diagnosis whereas earlier detection and intervention yields survival rates as high as 80%-90%. Prior studies have shown that salivary CD44, a tumor-initiating marker, and total protein levels may identify individuals who are likely to have oral cancer, facilitating early detection. Here, we validate whether a combined CD44 and total protein laboratory test may aid in the diagnosis of oral cancer. Methods: Oral rinse specimens from 40 oral cancer cases and 46 controls were obtained from biorepositories. A CD44 sandwich ELISA and a BCA protein assay were performed on all samples. Prior work examining cancer cases at different stages established cutpoints for CD44 and total protein of at least 1.04 ng/ml and 0.25 mg/ml, respectively. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were determined. Data was obtained from 2 or more technicians for each sample. Agreement was measured using Cohen’s kappa coefficient (along with its 95% confidence interval) for each set of paired observers. Results: The sensitivity of the combined CD44 and total protein test was estimated to be 88% with a 2-sided 95% confidence interval of 77% to 98%. The specificity was estimated to be 74% with a 2-sided 95% confidence interval of 61% to 87%. Assuming disease prevalence of 9.27%, the NPV was 98.3% and PPV was 25.9%. The paired agreement ratings had kappa coefficients > 0.40, which is considered acceptable agreement. The lower limit of the 95% confidence interval was > 0.40 for the paired observations which indicates statistically acceptable agreement overall. Conclusions: This study validated previously set cutpoints for a combined CD44 and total protein laboratory assay. Results suggest a likelihood of oral cancer if CD44 levels are1.04 ng/mL or above and total protein is 0.25 mg/ml or above for cancer cases at different stages. Positive results from the combined CD44 and total protein laboratory test may be useful, along with other clinical evidence, to determine whether there is a presence of oral cancer.