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Abstract 3266: Oral rinse point of care test to predict head and neck cancer

2017; American Association for Cancer Research; Volume: 77; Issue: 13_Supplement Linguagem: Inglês

10.1158/1538-7445.am2017-3266

1538-7445

Michael J. Donovan, Kris Curtis, Greg Ginn, Elizabeth Franzmann,

Head and Neck Cancer Studies

Abstract Background: Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cause of cancer mortality throughout the world affecting some 50,000 people in the US and 600,000 worldwide each year. The ability to detect the disease in a potentially malignant phase and earlier stage could have significant impact on overall outcome. Previous studies have demonstrated that a combined salivary CD44, a tumor-initiating marker, and total protein assay was able to aid in the diagnosis of HNSCC. We sought to understand the performance characteristics of these biomarkers in a prospective population using a qualitative, point-of-care assay (POC) which consists of a cassette with a colorimetric read-out based on a pre-determined threshold for both CD44 and total protein. We also performed results from same samples with a quantitative lab-based test. Methods: Saline oral rinse specimens (~5ml) from 134 patients (84 HNSCC cases; 50 controls) were obtained from biorepositories. Samples were thawed, gently swirled, placed in a standard collection cup. 600ul were removed for lab assay prior to POC test. The tapered end of the POC cassette was submerged in rinse for 20’; levels of CD44 and total protein (TP) were evaluated by two operators. POC test results were compared between operators and with lab test results using Cohen’s kappa coefficient and McNemar’s test, sensitivity(Se), specificity(Sp), NPV and PPV. Results: 95% HNSCC patients (cases) were mean 60 years of age, 60% male, 97% white and 74% smokers vs. 43 years, 28%, 96% and 0% respectively, for controls. POC was positive with either CD44 or TP above threshold. Weighted kappa yielded 75% and 72% for CD44 and TP respectively between operators. With a prevalence of 9.27: POC: NPV 94%, PPV 10%; variable TP cut-off produced Se71-84% and Sp30%-50%. McNemar and Kappa for both lab CD44 and TP vs POC indicated moderate agreement; independently both POC and lab produced NPV >90%. Conclusions: Concordance of the POC assay between operators and moderate agreement with a quantitative lab assay provides supportive evidence for clinical application of the POC assay as an aid in the diagnosis for HNSCC. Additional studies are underway to confirm these observations. Citation Format: Michael J. Donovan, Kris Curtis, Greg Ginn, Elizabeth J. Franzmann. Oral rinse point of care test to predict head and neck cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 3266. doi:10.1158/1538-7445.AM2017-3266