背景:美国每年有54,000例新的口腔癌和口咽癌病例,全世界每年有超过476,000例。由于晚期诊断的流行,口腔和口咽鳞状细胞癌构成了大多数肿瘤,五年生存率为50%。迫切需要改进高风险个体的早期检测方法。我们旨在评估使用口腔冲洗作为负担得起的方便的癌症检测筛查工具测量的致瘤性生物标志物可溶性CD44(solCD44)和总蛋白(TP)。
方法:在这项前瞻性队列研究中,我们通过社区筛查计划招募了150名健康的现在或以前的吸烟者.从2011年3月至2016年1月进行了基线和四次年度访问,记录一直持续到2020年8月。参与者提供了口腔冲洗液,接受了头部和颈部检查,并填写了问卷。测量并跨各组和时间比较SolCD44和TP水平。如果在研究期间出现恶性肿瘤,则将参与者置于癌症组,如果体检涉及头颈部癌前疾病或癌症,则为可疑组,和健康组,如果没有可疑的发现。该分析使用双样本t检验进行均值比较,使用双样本Wilcoxon检验进行中位数比较。对于有随访的受试者,生物标志物的估计平均值是从拟合的重复测量方差分析(RANOVA)模型获得的,包括组,访问,和他们的互动。对solCD44的平均值进行了成对比较,包括不同年份的组间和组内数值比较。
结果:大多数参与者是男性(58.7%),<60岁。(90.7%),黑色(100%)与可疑组(1.849ng/ml)和健康组(1.779ng/ml)相比,癌症组的基线平均solCD44升高(2.781ng/ml)。
结论:这项研究支持基于CD44的口腔冲洗试验作为一种经济实惠且方便的辅助工具,用于在高危人群中早期检测呼吸消化道和其他癌症。
BACKGROUND: There are 54,000 new cases of oral cavity and oropharyngeal cancer in the United States and more than 476,000 worldwide each year. Oral cavity and oropharyngeal squamous cell carcinoma make up most tumors with five-year survival rates of 50% due to prevalence of late-stage diagnoses. Improved methods of early detection in high-risk individuals are urgently needed. We aimed to assess the tumorigenic biomarkers soluble CD44 (solCD44) and total protein (TP) measured using oral rinses as affordable convenient screening tools for cancer detection.
METHODS: In this prospective cohort study, we recruited 150 healthy current or former smokers through a community screening program. Baseline and four annual visits were conducted from March 2011-January 2016 with records followed until August 2020. Participants provided oral rinses, received head and neck exams, and completed questionnaires. SolCD44 and TP levels were measured and compared across groups and time. Participants were placed in the cancer group if malignancy developed in the study period, the suspicious group if physical exams were concerning for premalignant disease or cancer in the head and neck, and the healthy group if there were no suspicious findings. This analysis used two-sample t-test for comparison of means and two-sample Wilcoxon Test for comparison of medians. For subjects with follow-ups, estimated means of biomarkers were obtained from a fitted Repeated Measures Analysis of Variance (RANOVA) model including group, visit, and their interaction. Pairwise comparisons of mean solCD44 were made, including intergroup and intragroup comparison of values at different years.
RESULTS: Most participants were males (58.7%), < 60 years of age. (90.7%), and Black (100%). Baseline mean solCD44 was elevated (2.781 ng/ml) in the cancer group compared to the suspicious group (1.849 ng/ml) and healthy group (1.779 ng/ml).
CONCLUSIONS: This study supports the feasibility of a CD44-based oral rinse test as an affordable and convenient adjunctive tool for early detection of aerodigestive tract and other cancers in high-risk populations.