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全自动p16/Ki-67双重染色在挪威宫颈癌筛查项目中对HPV阳性女性进行分流的临床价值

Clinical value of fully automated p16/Ki-67 dual staining in the triage of HPV-positive women in the Norwegian Cervical Cancer Screening Program.

作者信息

Ovestad Irene T, Dalen Ingvild, Hansen Elisabeth, Loge Janne L D, Dybdahl Britt Mona, Dirdal Marius B, Moltu Pia, Berland Jannicke M

机构信息

Department of Pathology, Stavanger University Hospital, Stavanger, Norway.

Section of Biostatistics, Department of Research, Stavanger University Hospital, Stavanger, Norway.

出版信息

Cancer Cytopathol. 2017 Apr;125(4):283-291. doi: 10.1002/cncy.21807. Epub 2016 Dec 5.

Abstract

BACKGROUND

More accurate biomarkers in cervical cytology screening could reduce the number of women unnecessarily referred for biopsy. This study investigated the ability of p16/Ki-67 dual staining to predict high-grade cervical intraepithelial neoplasia (CIN) in human papillomavirus (HPV)-positive women from the Norwegian Cervical Cancer Screening Program.

METHODS

Automated p16/Ki-67 dual staining was performed on liquid-based cytology samples from 266 women who were HPV-positive at their secondary screening. At a mean of 184 days after p16/Ki-67 staining, 201 women had a valid staining result and a conclusive follow-up diagnosis (histological diagnosis or HPV-negative diagnosis with normal cytology findings). The sensitivity and specificity for predicting the follow-up diagnosis were compared for cytology, p16/Ki-67 dual staining, and their combination.

RESULTS

Sixty-seven percent of the study sample was p16/Ki-67-positive. The sensitivity of p16/Ki-67 staining for predicting CIN-2/3 was statistically significantly higher than the sensitivity of cytology (0.88 vs 0.79; P = .008), but this was not true for the prediction of CIN-3 (0.94 vs 0.88; P = .23). The specificity of cytology for predicting CIN-3 was significantly higher than the specificity of p16/Ki-67 staining (0.35 vs 0.28; P = .002), but this was not true for CIN-2/3 (0.35 vs 0.31; P = .063). For predicting CIN-2/3 and CIN-3, combination testing gave potentially better sensitivity (0.95 and 0.96, respectively) and better specificity (0.49 and 0.50, respectively).

CONCLUSIONS

In a population of HPV-positive women, p16/Ki-67 dual staining was more sensitive but less specific than cytology for predicting high-grade CIN. The advantage of using both tests in different combinations is the potential for increasing the specificity or sensitivity in comparison with both methods performed individually. Cancer Cytopathol 2017;125:283-291. © 2016 American Cancer Society.

摘要

背景

宫颈细胞学筛查中更准确的生物标志物可减少不必要接受活检的女性人数。本研究调查了p16/Ki-67双重染色在挪威宫颈癌筛查项目中预测人乳头瘤病毒(HPV)阳性女性高级别宫颈上皮内瘤变(CIN)的能力。

方法

对266名在二次筛查时HPV呈阳性的女性的液基细胞学样本进行自动化p16/Ki-67双重染色。在p16/Ki-67染色后平均184天,201名女性获得了有效的染色结果和确定性的随访诊断(组织学诊断或细胞学检查结果正常的HPV阴性诊断)。比较了细胞学、p16/Ki-67双重染色及其联合检测对预测随访诊断的敏感性和特异性。

结果

研究样本中67%的人p16/Ki-67呈阳性。p16/Ki-67染色预测CIN-2/3的敏感性在统计学上显著高于细胞学检查(0.88对0.79;P = 0.008),但预测CIN-3时并非如此(0.94对0.88;P = 0.23)。细胞学检查预测CIN-3的特异性显著高于p16/Ki-67染色(0.35对0.28;P = 0.002),但预测CIN-2/3时并非如此(0.35对0.31;P = 0.063)。对于预测CIN-2/3和CIN-3,联合检测具有潜在更好的敏感性(分别为0.95和0.96)和更好的特异性(分别为0.49和0.50)。

结论

在HPV阳性女性群体中,p16/Ki-67双重染色在预测高级别CIN方面比细胞学检查更敏感,但特异性更低。与单独进行两种方法相比,以不同组合使用这两种检测的优势在于有可能提高特异性或敏感性。《癌症细胞病理学》2017年;125:283 - 291。©2016美国癌症协会。

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