COMPACT 研究中 HPV16/18 部分基因分型用于 HPV 阳性、细胞学阴性女性分流的评估。
Evaluation of partial genotyping with HPV16/18 for triage of HPV positive, cytology negative women in the COMPACT study.
机构信息
Department of Obstetrics and Gynecology, Hokkaido University Faculty of Medicine, Sapporo, Japan.
Hokkaido Center for Environmental and Health Sciences, Sapporo, Japan.
出版信息
J Gynecol Oncol. 2021 Nov;32(6):e86. doi: 10.3802/jgo.2021.32.e86.
OBJECTIVE
While cytology-based screening programs have significantly reduced mortality and morbidity from cervical cancer, the global consensus is that primary human papillomavirus (HPV) testing increases detection of high-grade cervical intraepithelial neoplasia (CIN) and invasive cancer. However, the optimal triage strategy for HPV+ women to avoid over-referral to colposcopy may be setting specific. We compared absolute and relative risk (RR) of >CIN2/3 within 12 months of a negative cytologic result in women HPV16/18+ compared to those with a 12-other high-risk HPV (hrHPV) genotype to identify women at greatest risk of high-grade disease and permit less aggressive management of women with other hrHPV infections.
METHODS
Participants were 14,160 women aged 25-69 years with negative cytology participating in the COMparison of HPV genotyping And Cytology Triage (COMPACT) study. Women who were HPV16/18+ were referred to colposcopy. Those with a 12-other hrHPV type underwent repeat cytology after 6 months and those with >abnormal squamous cells of undetermined significance went to colposcopy.
RESULTS
Absolute risk of >CIN2 in HPV16/18+ women was 19.5% (95% CI=12.4%-29.4%). In women 25-29 years and HPV16+ it was 40.0% (95% CI=11.8%-76.9%). Absolute risk of >CIN3 in women HPV16/18+ was 11.0% (95% CI=5.9%-19.6%). For women 30-39 years and HPV16+ it was 23.1% (95% CI=5.0%-53.8%). Overall risk of >CIN2, >CIN3 in women with a 12-other hrHPV HPV type was 5.6% (95% CI=3.1%-10.0%) and 3.4% (95% CI=1.6%-7.2%) respectively. RR of >CIN2, >CIN3 in HPV16/18+ vs. 12-other hrHPV was 3.5 (95% CI=1.7-7.3) and 3.3 (95% CI=1.2-8.8), respectively.
CONCLUSION
Primary HPV screening with HPV16/18 partial genotyping is a promising strategy to identify women at current/future risk of >CIN2 in Japan without over-referral to colposcopy.
TRIAL REGISTRATION
Trial Registration: UMIN Clinical Trials Registry Identifier: UMIN000013203.
目的
细胞学为基础的筛查方案显著降低了宫颈癌的死亡率和发病率，但全球共识认为，人乳头瘤病毒（HPV）的初次检测增加了高级别宫颈上皮内瘤变（CIN）和浸润性癌的检出率。然而，对于 HPV 阳性女性的最佳分流策略，可能因具体情况而异。我们比较了 HPV16/18 阳性与其他 12 种高危型 HPV（hrHPV）的女性在细胞学阴性后 12 个月内发生 >CIN2/3 的绝对风险和相对风险（RR），以确定发生高级别疾病风险最高的女性，并允许对其他 hrHPV 感染的女性进行侵袭性较小的管理。
方法
本研究纳入了年龄在 25-69 岁、细胞学阴性的 14160 名女性，她们参加了 HPV 基因分型和细胞学分流（COMPACT）研究。HPV16/18 阳性的女性被转诊至阴道镜检查，而其他 12 种 hrHPV 阳性的女性则在 6 个月后行重复细胞学检查，如果发现 >非典型鳞状细胞意义不明确，行阴道镜检查。
结果
HPV16/18 阳性女性发生 >CIN2 的绝对风险为 19.5%（95%可信区间：12.4%-29.4%）。在 25-29 岁和 HPV16 阳性的女性中，该风险为 40.0%（95%可信区间：11.8%-76.9%）。HPV16/18 阳性女性发生 >CIN3 的绝对风险为 11.0%（95%可信区间：5.9%-19.6%）。在 30-39 岁和 HPV16 阳性的女性中，该风险为 23.1%（95%可信区间：5.0%-53.8%）。其他 12 种 hrHPV 阳性女性的总体 >CIN2 和 >CIN3 风险分别为 5.6%（95%可信区间：3.1%-10.0%）和 3.4%（95%可信区间：1.6%-7.2%）。HPV16/18 阳性 vs. 其他 12 种 hrHPV 的 >CIN2 和 >CIN3 的 RR 分别为 3.5（95%可信区间：1.7-7.3）和 3.3（95%可信区间：1.2-8.8）。
结论
在日本，使用 HPV16/18 部分基因分型进行原发性 HPV 筛查是一种很有前途的策略，可以识别当前/未来发生 >CIN2 的女性，而不会过度转诊至阴道镜检查。
试验注册
临床试验注册：UMIN 临床研究注册标识：UMIN000013203。
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