Human papillomavirus testing versus cytology in primary cervical cancer screening: End-of-study and extended follow-up results from the Canadian cervical cancer screening trial
Human papillomavirus testing versus cytology in primary cervical cancer screening: End-of-study and extended follow-up results from the Canadian cervical cancer screening trial
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DOI：
10.1002/ijc.30385
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发表时间：
2016-12-01
影响因子：
6.4
通讯作者：
Franco, Eduardo L.
中科院分区：
文献类型：
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作者：
Isidean, Sandra D.;Mayrand, Marie-Helene;Franco, Eduardo L.
加拿大宫颈癌筛查试验是一项随机对照试验，比较了人乳头瘤病毒(HPV)检测和巴氏细胞学检查的表现，以检测在蒙特利尔和加拿大圣约翰(n=10,154)接受常规宫颈癌筛查的30-69岁妇女中2级或更严重的宫颈上皮内瘤变(CIN2+)。我们检查了登记细胞学和HPV检测结果的筛查和预后价值。圣约翰会参与者(n=5,754；501,682.6人月)可获得延长的随访数据。HPV检测发现的CIN2+高于细胞学，分别为82.9%比44.4%和延长的随访期(54.2%比19.3%)。三年的风险从HPV阳性/巴氏阳性女性的0.87%(95%可信区间：0.37-2.05)到HPV+/巴氏阳性女性的35.77%(95%可信区间：25.88-48.04)。在HPV阴性和HPV16+女性中，特定的基因型别风险分别为0.90%(95%CI：0.40-2.01)到43.84%(95%CI：32.42-57.24)，超过了单独或联合检测Pap+或HPV+结果的风险。在检测HPV-和HPV16+的女性中，10年风险从1.15%(95%CI：0.60~2.19)到26.05%(95%CI：15.34~42.13)，而检测HPV-和HPV16+的女性的基因型风险分别为1.13%(95%CI：0.59~2.14)到32.78%(95%CI：21.15~48.51)。细胞学异常对HPV阳性女性风险分层最有意义。与目前推荐的筛查策略相比，每3年进行一次HPV初级检测可提供类似或更高水平的疾病风险保证。基于HPV的宫颈筛查可能比基于细胞学的筛查能够更好地检测疾病，并允许安全地延长筛查间隔；特定于基因的检测可以进一步提高此类筛查的阳性预测价值。有什么新消息？使用巴氏细胞学(巴氏)细胞学的筛查项目已经为全球宫颈癌预防带来了革命性的变化，但由于敏感性低和基础设施昂贵而受到仔细审查。在这里，作者报告了加拿大宫颈癌筛查试验的结果，该试验比较了巴氏细胞学和人乳头瘤病毒(HPV)检测作为筛查策略。事实上，在方案规定的(82.9%比44.4%)和延长(54.2%比19.3%)的随访期内，HPV检测分别比细胞学检测出更多的高级别宫颈病变和宫颈癌。基因分型检测被证明可以进一步对HPV阳性女性的风险进行分层，这可以进一步提高基于HPV的筛查的价值。由于这项研究旨在满足制定政策所需的严格标准，这些发现可能有助于加拿大和其他地方更高效和有效的宫颈癌筛查战略。
The Canadian Cervical Cancer Screening Trial was a randomized controlled trial comparing the performance of human papillomavirus (HPV) testing and Papanicolaou cytology to detect cervical intraepithelial neoplasia of grades 2 or worse (CIN2+) among women aged 30-69 years attending routine cervical cancer screening in Montreal and St. John's, Canada (n=10,154). We examined screening and prognostic values of enrollment cytologic and HPV testing results. Extended follow-up data were available for St. John's participants (n=5,754; 501,682.6 person-months). HPV testing detected more CIN2+ than cytology during protocol-defined (82.9 vs. 44.4%) and extended (54.2 vs. 19.3%) follow-up periods, respectively. Three-year risks ranged from 0.87% (95% CI: 0.37-2.05) for HPV-/Pap- women to 35.77% (95% CI: 25.88-48.04) for HPV+/Pap+ women. Genotype-specific risks ranged from 0.90% (95% CI: 0.40-2.01) to 43.84% (95% CI: 32.42-57.24) among HPV- and HPV16+ women, respectively, exceeding those associated with Pap+ or HPV+ results taken individually or jointly. Ten-year risks ranged from 1.15% (95% CI: 0.60-2.19) for HPV-/Pap- women to 26.05% (95% CI: 15.34-42.13) for HPV+/Pap+ women and genotype-specific risks ranged from 1.13% (95% CI: 0.59-2.14) to 32.78% (95% CI: 21.15-48.51) among women testing HPV- and HPV16+, respectively. Abnormal cytology stratified risks most meaningfully for HPV+ women. Primary HPV testing every 3 years provided a similar or greater level of reassurance against disease risks as currently recommended screening strategies. HPV-based cervical screening may allow for greater disease detection than cytology-based screening and permit safe extensions of screening intervals; genotype-specific testing could provide further improvement in the positive predictive value of such screening.What's new? Screening programs using Papanicolaou (Pap) cytology have revolutionized cervical cancer prevention worldwide but have been scrutinized for low sensitivity and costly infrastructure. Here the authors report the results of the Canadian Cervical Cancer Screening Trial, which compared Pap cytology with human papillomavirus (HPV) testing as screening strategies. Indeed, HPV testing detected more high-grade cervical lesions and cervical cancer than cytology during protocol-defined (82.9 vs. 44.4%) and extended (54.2 vs. 19.3%) follow-up periods, respectively. Genotype-specific testing was shown to further stratify risks among HPV+ women, which could provide further improvement in the value of HPV-based screening. As the study was designed to satisfy stringent standards required for policy-making, these findings will likely contribute to more efficient and effective cervical cancer screening strategies in Canada and elsewhere.