Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months The HPV FOCAL Randomized Clinical Trial
Effect of Screening With Primary Cervical HPV Testing vs Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months The HPV FOCAL Randomized Clinical Trial
复制标题
48个月时宫颈HPV筛查与细胞学检查对高度宫颈上皮内瘤变的影响HPV FOCAL随机临床试验
DOI：
10.1001/jama.2018.7464
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发表时间：
2018-07-03
影响因子：
120.7
通讯作者：
Coldman, Andrew J.
中科院分区：
文献类型：
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作者：
Ogilvie, Gina Suzanne;van Niekerk, Dirk;Coldman, Andrew J.
重要性在北美人群中，与细胞学检查相比，仅用原发性人乳头瘤病毒（HPV）检测进行宫颈癌筛查的相对有效性的信息有限。目的评价组织学证实的累积宫颈上皮内瘤样病变（CIN）3级或更严重（CIN 3+），仅用原发性HPV检测长达48个月（包括48个月）在加拿大一个有组织的宫颈癌筛查项目中进行的随机临床试验。参与者从2008年1月至2012年5月通过224名合作临床医生招募，随访至2016年12月。年龄在25至65岁之间的女性，过去5年内无CIN 2+病史，无浸润性宫颈癌病史，或无子宫切除术史;过去12个月内未接受过巴氏试验;干预共有19009名妇女被随机分配到干预组，（n = 9552）和对照组（n = 9457）。干预组的妇女接受HPV检测;结果为阴性的妇女在48个月时返回。对照组的妇女接受液基细胞学（LBC）检测;那些结果为阴性的妇女在24个月时返回LBC。对照组中24个月时阴性的妇女在48个月时恢复。在48个月退出时，两组均接受HPV和LBC联合检测。主要结果和测量主要结果是随机分组后CIN 3 + 48个月的累积发病率。CIN 2+的累积发生率是次要结局。结果：在19009名随机分配的女性中（平均年龄45岁[第10 - 90百分位数，30-59]），16374名（干预组8296名[86.9%]，对照组8078名[85.4%]）完成了研究。在48个月，显着减少CIN 3+和CIN 2+被检测到在干预vs control group.CONCLUSIONS和RELEVANCE在妇女接受宫颈癌筛查，使用初级HPV检测与细胞学检测相比，导致CIN 3+在48个月的可能性显着降低。需要进一步研究以了解长期临床结果以及成本效益。
IMPORTANCE There is limited information about the relative effectiveness of cervical cancer screening with primary human papillomavirus (HPV) testing alone compared with cytology in North American populations.OBJECTIVE To evaluate histologically confirmed cumulative incident cervical intraepithelial neoplasia (CIN) grade 3 or worse (CIN3+) detected up to and including 48 months by primary HPV testing alone (intervention) or liquid-based cytology (control).DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted in an organized Cervical Cancer Screening Program in Canada. Participants were recruited through 224 collaborating clinicians from January 2008 to May 2012, with follow-up through December 2016. Women aged 25 to 65 years with no history of CIN2+ in the past 5 years, no history of invasive cervical cancer, or no history of hysterectomy; who have not received a Papanicolaou test within the past 12 months; and who were not receiving immunosuppressive therapy were eligible.INTERVENTIONS A total of 19 009 women were randomized to the intervention (n = 9552) and control (n = 9457) groups. Women in the intervention group received HPV testing; those whose results were negative returned at 48 months. Women in the control group received liquid-based cytology (LBC) testing; those whose results were negative returned at 24 months for LBC. Women in the control group who were negative at 24 months returned at 48 months. At 48-month exit, both groups received HPV and LBC co-testing.MAINOUTCOMES AND MEASURES The primary out come was the cumulative incidence of CIN3+ 48 months following randomization. The cumulative incidence of CIN2+ was a secondary outcome. RESULTS Among 19 009 women who were randomized (mean age, 45 years [10th-90th percentile, 30-59]), 16 374 (8296 [86.9%] in the intervention group and 8078 [85.4%] in the control group) completed the study. At 48 months, significantly fewer CIN3+ and CIN2+ were detected in the intervention vs control group.CONCLUSIONS AND RELEVANCE Among women undergoing cervical cancer screening, the use of primary HPV testing compared with cytology testing resulted in a significantly lower likelihood of CIN3+ at 48 months. Further research is needed to understand long-term clinical outcomes as well as cost-effectiveness.