Assessing 10-Year Safety of a Single Negative HPV Test for Cervical Cancer Screening: Evidence from FOCAL-DECADE Cohort.
Assessing 10-Year Safety of a Single Negative HPV Test for Cervical Cancer Screening: Evidence from FOCAL-DECADE Cohort.
复制标题
DOI：
10.1158/1055-9965.epi-20-1177
复制
发表时间：
2021-01
期刊：
影响因子：
--
通讯作者：
Ogilvie G
中科院分区：
文献类型：
--
作者：
Gottschlich A;van Niekerk D;Smith LW;Gondara L;Melnikow J;Cook DA;Lee M;Stuart G;Martin RE;Peacock S;Franco EL;Coldman A;Krajden M;Ogilvie G
单一阴性的人类乳头瘤病毒(HPV)检测用于宫颈癌筛查的长期安全性尚不清楚。HPV治疗宫颈癌试验(FOCUS)是一项随机试验，将HPV检测与细胞学进行比较。这项为期十年的队列追踪了在Focus期间接受一次HPV检测，并在长达10年的时间里HPV阴性的妇女，以确定通过省级筛查计划检测到的宫颈上皮内瘤变2级或更严重(CIN2+)和3级或更差(CIN3+)。包括接受一次HPV检测且阴性且至少有一次宫颈病灶后筛查的局部受试者(N=5537)。我们构建了CIN2+/CIN3+检测的累积发病曲线，分析了HPV检测后每隔一段时间检测的累积风险，计算了检测的平均发病率，并比较了不同年龄段的风险。在一次HPV阴性检测十年后，CIN2+检测到的概率低于1%，大多数病变在七年或七年后被发现。CIN2+/CIN3+病变的平均发病率分别为0.50(95%CI：0.31，0.78)和0.18(0.07，0.36)/1000人年。年轻人的风险更高(不明显的趋势)。在单一HPV检测阴性的女性中，CIN2+检测的长期风险很低，特别是通过七年的随访；因此，一次HPV检测阴性似乎可以提供对癌前病变的长期保护。即使是10年的风险也足够低，足以支持在中等风险人群中延长测试间隔。我们的发现支持单独使用HPV检测每五年或更长时间进行一次筛查政策的安全性。
Long-term safety of a single negative human papillomavirus (HPV) test for cervical cancer screening is unclear. The HPV FOr cerviCAL Cancer Trial (FOCAL) was a randomized trial comparing HPV testing to cytology. The FOCAL-DECADE cohort tracked women who received one HPV test during FOCAL, and were HPV negative, for up to 10 years to identify cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and grade 3 or worse (CIN3+) detected through a provincial screening program. FOCAL participants who received one HPV test and were negative and had at least one post-FOCAL cervix screen were included (N = 5537). We constructed cumulative incidence curves of CIN2+/CIN3+ detection, analyzed cumulative risk of detection at intervals post-HPV test, calculated average incidence rates for detection, and compared hazard across ages. Ten years after one negative HPV test, the probability of CIN2+ detection was lower than 1%, with most lesions detected seven years or later. Average incidence rates of CIN2+/CIN3+ lesions over follow-up were 0.50 (95% CI: 0.31, 0.78) and 0.18 (0.07, 0.36) per 1000 person-years, respectively. Hazards were higher for younger ages (non-significant trend). Among women with a single negative HPV test, long-term risk of CIN2+ detection was low, particularly through seven years of follow-up; thus, one negative HPV test appears to confer long-term protection from precancerous lesions. Even 10-year risk is sufficiently low to support extended testing intervals in average-risk populations. Our findings support the safety of screening policies using HPV testing alone at five-year or longer intervals.