Cervical cancer risk for women undergoing concurrent testing for human papillomavirus and cervical cytology: a population-based study in routine clinical practice.
Cervical cancer risk for women undergoing concurrent testing for human papillomavirus and cervical cytology: a population-based study in routine clinical practice.
复制标题
DOI：
10.1016/s1470-2045(11)70145-0
复制
发表时间：
2011-07
期刊：
影响因子：
51.1
通讯作者：
Castle, Philip E.
中科院分区：
文献类型：
--
作者：
Katki, Hormuzd A.;Kinney, Walter K.;Fetterman, Barbara;Lorey, Thomas;Poitras, Nancy E.;Cheung, Li;Demuth, Franklin;Schiffman, Mark;Wacholder, Sholom;Castle, Philip E.
对于 30 岁及以上的女性，同时进行 HPV 检测和宫颈细胞学检查（联合检测）是一种经过批准且有前途的替代单独细胞学检查的方法。然而，由于缺乏关于联合测试在常规临床实践中表现的证据，阻碍了联合测试的广泛接受。我们评估了三年筛查间隔对细胞学检查正常（巴氏阴性）的 HPV 阴性女性（巴氏阴性）的安全性，并评估了五年内联合检测识别 CIN3+ 或宫颈癌高风险女性的能力。我们分析了 331,818 名 30 岁及以上的 30 岁及以上女性的宫颈癌和 3 级或以上宫颈上皮内瘤变 (CIN3+) 的五年累积发病率，她们从 2003 年至 2005 年开始在北加州 Kaiser Permanente 参加了联合检测（并且有足够的登记联合检测结果），并随访至 2009 年 12 月 31 日。所有 315,061 名 HPV 阴性女性的五年累积癌症发病率是极低（每年每 100,000 名女性 3.8 例），仅略高于 306,969 名 HPV 阴性和巴氏涂片阴性女性（每年每 100,000 名女性 3.2 名），并且是所有 319,177 名巴氏涂片阴性女性的一半癌症风险（每年每 100,000 名女性 7.5 名）。几乎所有（99.5%；313,465）HPV 阴性女性的细胞学检查正常或轻微异常。五年内，16,757 名 HPV 阳性女性的细胞学异常导致 CIN3+ 累积发生率大大增加（12% vs. 5.9%，p<0.0001）。相比之下，虽然具有统计学意义，但细胞学异常并未将 HPV 阴性女性的 5 年 CIN3+ 风险增加到显着水平（0.86% 与 0.16%）。 73% 的 HPV 阳性女性没有细胞学异常（12,208 名女性）。没有细胞学异常的 HPV 阳性女性患有 34% 的 CIN3+、29% 的癌症和 63% 的腺癌。对于常规临床实践中 30 岁及以上的女性来说，一次 HPV 检测呈阴性就足以在五年内对宫颈癌提供强有力的保障，证明了 HPV 阴性/巴氏涂片阴性女性每 3 年筛查一次的安全性，并表明每 5 年筛查一次也可能是安全的。同时进行 HPV 检测可以更早地识别出患有宫颈癌（尤其是腺癌）高风险的女性。不进行辅助细胞学检查的 HPV 检测对于原发性宫颈癌筛查可能足够敏感。
Concurrent HPV testing and cervical cytology (co-testing) is an approved and promising alternative to cytology alone in women aged 30 and older. However, broad acceptance of co-testing is being hindered by a lack of evidence about its performance in routine clinical practice. We evaluated the safety of three-year screening intervals for women testing HPV-negative with normal cytology (Pap-negative) and assessed the ability of co-testing to identify women at high risk of CIN3+ or cervical cancer over five years. We analyzed five-year cumulative incidence of cervical cancer and cervical intraepithelial neoplasia grade 3 or worse (CIN3+) for 331,818 women aged 30 and older who enrolled in co-testing at Kaiser Permanente Northern California starting 2003-2005 (and had adequate enrollment co-test results) and were followed through December 31, 2009. Five-year cumulative incidence of cancer for all 315,061 HPV-negative women was extremely low (3.8 per 100,000 women per year), only slightly higher than for the 306,969 women who were both HPV-negative and Pap-negative (3.2 per 100,000 women per year), and half the cancer risk of all 319,177 women who were Pap-negative (7.5 per 100,000 women per year). Almost all (99.5%; 313,465) HPV-negative women had either normal cytology or minor abnormalities. Abnormal cytology greatly increased cumulative incidence of CIN3+ over five years for the 16,757 HPV-positive women (12% vs. 5.9%, p<0.0001). In contrast, although statistically significant, abnormal cytology did not increase 5-year CIN3+ risk for HPV-negative women to a substantial level (0.86% vs. 0.16%). 73% of HPV-positive women had no cytologic abnormality (12,208 women). HPV-positive women with no cytologic abnormality experienced 34% of the CIN3+, 29% of the cancers, and 63% of the adenocarcinomas. For women aged 30 and older in routine clinical practice, a single negative HPV test sufficed to provide strong reassurance against cervical cancer over five years, demonstrating the safety of 3-year screening intervals for HPV-negative/Pap-negative women and suggesting that five-year intervals may also be safe. Concurrent HPV testing resulted in earlier identification of the women at high risk of cervical cancer, especially adenocarcinoma. HPV testing without adjunctive cytology may be sufficiently sensitive for primary cervical cancer screening.