Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study
Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study
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DOI：
10.1016/s1470-2045(11)70188-7
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发表时间：
2011-09-01
期刊：
影响因子：
51.1
通讯作者：
Behrens, Catherine M.
中科院分区：
文献类型：
--
作者：
Castle, Philip E.;Stoler, Mark H.;Behrens, Catherine M.
背景 ATHENA 研究旨在评估致癌人乳头瘤病毒 (HPV) 检测和 HPV16 或 HPV18 基因分型与液基细胞学检查在美国 21 岁及以上人群中宫颈癌筛查的效果。我们对该人群进行了亚组分析，以比较 25 岁及以上女性中 cobas HPV 检测与液基细胞学检查的筛查效果，并评估 HPV 阳性女性的管理策略。 方法 参加常规宫颈筛查的 25 岁或以上女性来自美国 23 个州的 61 个临床中心。使用两种第一代检测（Amplicor HPV 检测和线性阵列 HPV 基因分型检测）和第二代 cobas HPV 检测（单独检测 HPV16 和 HPV18）获取宫颈标本进行液基细胞学和 HPV DNA 检测。对具有未确定意义的非典型鳞状细胞 (ASC-US) 或细胞学检查结果较差的女性、第一代 HPV 检测呈阳性的女性以及 HPV 和细胞学检测呈阴性的女性随机样本进行了阴道镜检查和诊断性活检。所有未选择接受阴道镜检查的女性都收到了结果并退出了研究。在阴道镜检查完成之前，参与者和阴道镜检查人员不知道细胞学和 HPV 检测结果。该亚组研究的主要终点是组织学证实的 3 级宫颈上皮内瘤变 (CIN3) 或更严重。本研究已在 ClinicalTrials.gov 注册，编号 NCT00709891；该研究正处于后续阶段，预计于 2012 年 12 月完成。调查结果 从 2008 年 5 月 27 日到 2009 年 8 月 27 日，共有 47 208 名女性入组，其中 41 955 名符合我们的资格标准。纳入本次分析的 40 901 名女性 (97%) 获得了有效的 cobas HPV 和液基细胞学检测结果。其中，4275 名女性 (10%) 检测出 cobas HPV 呈阳性，2617 名女性 (6%) 细胞学异常。 431 名女性被诊断患有 CIN2 或更严重，274 名女性被诊断患有 CIN3 或更严重。在接受阴道镜检查的女性中，cobas HPV 检测比液基细胞学检测更敏感（252/274 [92.0%, 95% CI 88.1-94.6] vs 146/274 [53.3%, 95% CI 47.4-59.1]；差异 38.7%, 95% CI 31.9-45.5；
Background The ATHENA study was designed to assess the performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping compared with liquid-based cytology for cervical cancer screening in a large US population aged 21 years and older. We did a subanalysis of this population to compare the screening performance of the cobas HPV test versus liquid-based cytology in women aged 25 years and older, and assess management strategies for HPV-positive women.Methods Women aged 25 years or older who were attending routine cervical screening were enrolled from 61 clinical centres in 23 US states. Cervical specimens were obtained for liquid-based cytology and HPV DNA testing with two first-generation assays (Amplicor HPV test and Linear Array HPV genotyping test) and the second-generation cobas HPV test (with individual HPV16 and HPV18 detection). Colposcopy and diagnostic biopsies were done on women with atypical squamous cells of undetermined significance (ASC-US) or worse cytology, those who tested positive with either first-generation HPV test, and a random sample of women who tested negative for HPV and cytology. All women not selected for colposcopy received their results and exited the study. Participants and colposcopists were masked to cytology and HPV test results until the colposcopy visit was completed. The primary endpoint for this substudy was histologically confirmed cervical intraepithelial neoplasia grade 3 (CIN3) or worse. This study is registered with ClinicalTrials.gov, number NCT00709891; the study is in the follow-up phase, which is due to be completed in December, 2012.Findings From May 27, 2008, to Aug 27, 2009, 47 208 women were enrolled, of whom 41 955 met our eligibility criteria. Valid cobas HPV and liquid-based cytology test results were available for 40 901 women (97%), who were included in this analysis. Of these, 4275 women (10%) tested cobas HPV positive and 2617 (6%) had abnormal cytology. 431 women were diagnosed with CIN2 or worse and 274 with CIN3 or worse. In women who had colposcopy, the cobas HPV test was more sensitive than liquid-based cytology for detection of CIN3 or worse (252/274 [92.0%, 95% CI 88.1-94.6] vs 146/274 [53.3%, 95% CI 47.4-59.1]; difference 38.7%, 95% CI 31.9-45.5; p