Long-term cervical precancer outcomes after a negative DNA- or RNA-based human papillomavirus test result.
Long-term cervical precancer outcomes after a negative DNA- or RNA-based human papillomavirus test result.
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基于DNA或RNA的人乳头瘤病毒检测结果阴性后的长期宫颈癌前病变结局
DOI：
10.1016/j.ajog.2021.05.038
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发表时间：
2021-11
影响因子：
9.8
通讯作者：
Krajden M
中科院分区：
文献类型：
--
作者：
Strang THR;Gottschlich A;Cook DA;Smith LW;Gondara L;Franco EL;van Niekerk DJ;Ogilvie GS;Krajden M
宫颈癌是一种与人乳头瘤病毒（HPV）相关的可预防疾病，是全球发病率和死亡率较高的原因。原发性HPV检测在检测宫颈癌前病变方面比细胞学筛查更敏感，可以使用基于DNA或RNA的检测方法进行。由于有许多检测方法可用，筛查计划必须选择最适合其人群的检测方法，目前尚不清楚这些检测方法是否在长期内具有等效性，特别是在HPV检测结果为阴性的女性中。本研究旨在比较一次阴性HPV检测后，基于DNA和RNA的检测方法的长期安全性。我们比较了2级或以上和3级或以上的长期宫颈上皮内瘤变两种基于DNA的检测（CIN 2 +/CIN 3+）结果：Digene Hybrid Capture 2高危HPV DNA检测（QIAGEN;日耳曼敦，马里兰州）和cobas 4800 HPV检测（Roche; Indianapolis，印第安纳州）和一种基于信使RNA的测定：Aptima HPV测定（Hologic;圣地亚哥，加州，使用来自HPV FOCAL-DECADE队列的数据，首先比较检测之间的阳性率和阴性率，然后研究FOCAL-DECADE参与者随访期间CIN 2+和CIN 3+检测的累积发生率，根据HPV检测方法。HPV FOCAL（HPV FOCAL）是一项随机对照试验，旨在评估人乳头瘤病毒检测用于宫颈癌筛查的效果。HPV FOCAL-DECADE队列随后通过不列颠哥伦比亚省宫颈癌筛查项目数据库被动随访FOCAL参与者，在FOCAL研究退出后长达10年，以检查CIN 2 +/CIN 3+的比率。对于本研究，合格的参与者至少有一次检测的基线HPV阴性结果，并且在基线后进行了一次或多次细胞学筛查（基于DNA的检测比较N= 9，509，基于DNA与基于RNA的检测比较N= 3，473）。我们构建了累积发病率曲线，并根据检测方法比较了CIN 2 +/CIN 3+检测的风险比。在10年的随访中，CIN 2 +/CIN 3+的累积发病率在基于DNA的检测之间没有显著差异。（HR=0.95（95% CI=0.84-1.06），p=0.35和0.82（95% CI=0.66-1.01），对于CIN 2+和CIN 3+，p=0.06）或基于DNA和RNA的检测之间（对于CIN 2+和CIN 3+，HR=0.97（95% CI=0.87-1.06），p=0.48和0.94（95% CI=0.79-1.13），p=0.52）。在基线时HPV阴性的参与者中，无论是否使用基于DNA或RNA的人乳头瘤病毒检测方法，CIN 2 +/CIN 3+的长期风险均无显著差异。筛查计划的决策者可以确信，对于HPV检测阴性的女性，基于DNA和RNA的检测多年来具有相似的CIN 2+结果。在FOCAL-DECADE队列中，基线DNA或RNA阴性的人乳头瘤病毒检测后，高级别宫颈上皮内瘤变（CIN 2 +/CIN 3+）的长期风险无显著差异。
Cervical cancer, a preventable disease associated with human papillomaviruses (HPV), is responsible for significant morbidity and mortality globally. Primary HPV testing is more sensitive in detecting precancerous cervical lesions than cytologic screening and can be conducted using either DNA- or RNA-based assays. With many assays available, screening programs must select the most appropriate for their population, and it is not yet known whether these assays perform equivalently in the long-term, particularly among women who have a negative HPV test result. This study aims to compare the long-term safety after one negative HPV test across both DNA- and RNA-based testing assays. We compare the long-term cervical intraepithelial neoplasia grade 2 or higher and grade 3 or higher (CIN2+/CIN3+) outcomes of two DNA-based assays: Digene Hybrid Capture 2 High-Risk HPV DNA Test (QIAGEN; Germantown, Maryland) and cobas 4800 HPV Test (Roche; Indianapolis, Indiana), and one messenger RNA-based assay: Aptima HPV Assay (Hologic; San Diego, California, , using data from the HPV FOCAL-DECADE cohort, by first comparing the positive and negative rates between the assays and then investigating the cumulative incidence of CIN2+ and CIN3+ detection over follow-up among participants in FOCAL-DECADE, according to HPV testing assay. The HPV FOr CerviCAL Cancer Trial (HPV FOCAL) was a randomized controlled trial evaluating human papillomavirus testing for primary cervical cancer screening. The HPV FOCAL-DECADE cohort subsequently followed FOCAL participants passively through the British Columbia Cervix Screening Program Database for up to ten years after FOCAL study exit to examine rates of CIN2+/CIN3+. For the present study, eligible participants had baseline HPV negative results from at least one assay and had one or more cytology screens after baseline (N=9,509 for DNA-based and N=3,473 for DNA- versus RNA-based assay comparisons). We constructed cumulative incidence curves and compared hazard ratios for CIN2+/CIN3+ detection according to assay. Over ten years of follow-up, the cumulative incidence of CIN2+/CIN3+ did not significantly differ between the DNA-based assays (HR=0.95 (95% CI=0.84–1.06), p=0.35 and 0.82 (95% CI=0.66–1.01), p=0.06 for CIN2+ and CIN3+, respectively) or between the DNA- and RNA-based assays (HR=0.97 (95% CI=0.87–1.06), p=0.48 and 0.94 (95% CI=0.79–1.13), p=0.52 for CIN2+ and CIN3+, respectively). Among participants who were HPV negative at baseline, the long-term risk of CIN2+/CIN3+ did not significantly differ regardless of whether DNA- or RNA-based human papillomavirus testing assays were used. Screening program decision-makers can be confident that for women who test negative for HPV, DNA- and RNA-based assays have similar CIN2+ outcomes over many years. In the FOCAL-DECADE cohort, the long-term risk of high-grade cervical intraepithelial neoplasia (CIN2+/CIN3+) did not significantly differ following a baseline negative DNA- or RNA-based human papillomavirus test.
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影响因子：
9.4
作者：
Iftner, Thomas;Becker, Sven;Sasieni, Peter
通讯作者：
Sasieni, Peter
影响因子：
10.3
作者：
Gage, Julia C.;Schiffman, Mark;Kinney, Walter K.
通讯作者：
Kinney, Walter K.
在原发性人乳头瘤病毒DNA测试的一个筛查中，癌前和癌性宫颈病变的检测率：芬兰前瞻性随机试验。
DOI：
10.1136/bmj.e7789
发表时间：
2012-11-29
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Leinonen MK;Nieminen P;Lönnberg S;Malila N;Hakama M;Pokhrel A;Laurila P;Tarkkanen J;Anttila A
通讯作者：
Anttila A
影响因子：
6.4
作者：
Isidean, Sandra D.;Mayrand, Marie-Helene;Franco, Eduardo L.
通讯作者：
Franco, Eduardo L.
影响因子：
120.7
作者：
Ogilvie, Gina Suzanne;van Niekerk, Dirk;Coldman, Andrew J.
通讯作者：
Coldman, Andrew J.