The Effectiveness of Screening HIV-Infected Women for Anal Cancer Precursors

对感染艾滋病毒的女性进行肛门癌前体筛查的有效性

• 批准号: 8919285
• 负责人: Elizabeth Chiao
• 金额: $ 55.39万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-19 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8919285
• 关键词: Accounting; Address; Anal Intraepithelial Neoplasia; Anal carcinoma; Anus; Behavioral; Biological Assay; Biopsy; CD4 Lymphocyte Count; Cancerous; Cause of Death; Cervical; Cervical Cancer Screening; Characteristics; Cohort Studies; Cost-Benefit Analysis; Cytology; Data; Detection; Economics; Effectiveness; Epidemiologic Studies; Epidemiology; Epithelial; General Population; Gold; Guidelines; HIV; HPV-High Risk; Healthcare; High Prevalence; Highly Active Antiretroviral Therapy; Histology; Human Papillomavirus; Human papilloma virus infection; Hybrids; Immunologics; Incidence; Individual; Intraepithelial Neoplasia; Lesion; Life; Longitudinal Studies; Malignant Neoplasms; Malignant Squamous Cell Neoplasm; Malignant neoplasm of anus; Malignant neoplasm of cervix uteri; Messenger RNA; Methods; Morbidity - disease rate; Natural History; Neoplasms; New York; Opportunistic Infections; Participant; Persons; Policy Making; Population Study; Premalignant; Prevalence; Primary Health Care; Publishing; Quality of life; Recommendation; Recording of previous events; Reporting; Research; Resolution; Resources; Risk; Risk Factors; Sampling; Sensitivity and Specificity; Site; Specificity; Testing; Time; Triage; Visit; Vulva; Woman; antiretroviral therapy; cancer prevention; clinical decision-making; cohort; condyloma; cost effective; economic evaluation; economic impact; high risk; high standard; improved; men; mortality; multidisciplinary; screening; therapy adherence

DESCRIPTION (provided by applicant): HIV-infected women have at least fourteen times the risk of developing anal carcinoma compared with the general population despite the widespread use of highly active antiretroviral therapy (HAART). Like cervical cancer, anal cancer appears to be preceded by high-grade intraepithelial neoplasia and is strongly associated with human papillomavirus (HPV) infection. The prevalence of anal precancerous lesions among HIV-infected women has been shown to be as high as 10%. Due to this alarming increase in anal precancerous and cancerous lesions among HIV-infected women, there has been an increasing emphasis on anal cancer prevention, including recommendations in the 2007 New York state HIV primary care guidelines to perform annual anal cytology testing among HIV-infected women with a history of abnormal cervical or vulvar histology or history of anogenital condyloma. However, little to no evidence exists to define the optimal screening strategy for anal intraepithelial neoplasia (AIN) in the context of HIV-infected women. In the HAART era, there have been no studies of HIV-infected women in which high resolution anoscopy (HRA) with directed biopsy was performed on all participants with concurrent sampling for anal cytology and HPV testing. Therefore the prevalence of high-grade anal intraepithelial neoplasia (HGAIN) is not known, nor are the risk factors for developing this lesion. HPV testing has been shown to be a useful adjunct to cervical cytology for cervical cancer screening , however, we do not know if using HPV to triage HIV-infected women with abnormal anal cytology would be of benefit. Therefore, our specific aims are: Specific aim 1a: to determine the sensitivity (through confirmation of cytological abnormalities using HRA-guided anal biopsies) and specificity (through HRA confirmation of normal cytology) of anal cytology testing at the initial study visit among HIV-infected women. Specific aim 1b: to determine if anal high risk (HR) HPV testing using different methods of HPV detection, including HPV Hybrid Capture 2 (HC2) and HPV mRNA assays (APTIMA), will improve the screening test characteristics of routine anal cytology testing alone. Specific Aim 2: to determine the baseline prevalence rate, and risk factors associated with HGAIN and anal HPV; and to quantify HGAIN and anal HPV incidence, and prevalence rate changes over time among HIV-infected women undergoing routine anal cytologic testing, and specific Aim 3: to perform an economic evaluation of different anal cytology testing strategies among HIV-infected women. In order to address these aims, we propose a two-site, multidisciplinary study, utilizing data collected from a 2-year longitudinal cohort study of 300 HIV-infected women who will be evaluated at 6 month intervals. This cohort study will be the first to provide important information regarding the test characteristics, epidemiology, and natural history of anal HPV infection and HGAIN among a cohort of HIV-infected women undergoing routine anal cytology testing. The data will then be utilized to perform comprehensive cost-benefit analyses, which will direct clinical decision making on an optimal anal cancer screening approach for these women.

描述（由申请人提供）：尽管广泛使用高效抗逆转录病毒疗法（HAART），但感染艾滋病毒的女性患肛门癌的风险至少是普通人群的十四倍。与宫颈癌一样，肛门癌似乎先发生高级别上皮内瘤变，并且与人乳头瘤病毒 (HPV) 感染密切相关。研究表明，感染艾滋病毒的女性肛门癌前病变的患病率高达 10%。由于 HIV 感染女性肛门癌前病变和癌性病变的惊人增加，人们越来越重视肛门癌的预防，包括 2007 年纽约州 HIV 初级保健指南中建议对 HIV 感染者进行年度肛门细胞学检测有宫颈或外阴组织学异常史或肛门生殖器湿疣病史的女性。然而，几乎没有证据可以确定感染 HIV 的女性肛门上皮内瘤变 (AIN) 的最佳筛查策略。在HAART时代，还没有针对HIV感染女性的研究对所有参与者进行高分辨率肛门镜检查（HRA）和定向活检，同时采样进行肛门细胞学和HPV检测。因此，高级别肛门上皮内瘤变 (HGAIN) 的患病率以及发生这种病变的危险因素尚不清楚。 HPV 检测已被证明是宫颈细胞学筛查宫颈癌的有用辅助手段，然而，我们不知道使用 HPV 来对肛门细胞学异常的 HIV 感染女性进行分类是否有益。因此，我们的具体目标是： 具体目标 1a：确定 HIV 感染者初次研究访视时肛门细胞学检测的敏感性（通过使用 HRA 引导的肛门活检确认细胞学异常）和特异性（通过 HRA 确认正常细胞学）受感染的妇女。具体目标 1b：确定使用不同 HPV 检测方法（包括 HPV 混合捕获 2 (HC2) 和 HPV mRNA 检测 (APTIMA)）的肛门高危 (HR) HPV 检测是否会改善单独常规肛门细胞学检测的筛查检测特征。具体目标 2：确定基线患病率以及与 HGAIN 和肛门 HPV 相关的危险因素；并量化接受常规肛门细胞学检测的 HIV 感染女性中 HGAIN 和肛门 HPV 的发病率以及患病率随时间的变化，具体目标 3：对 HIV 感染女性中不同肛门细胞学检测策略进行经济评估。为了实现这些目标，我们提议开展一项两中心、多学科研究，利用对 300 名 HIV 感染女性进行的为期 2 年的纵向队列研究收集的数据，这些女性将每隔 6 个月进行一次评估。这项队列研究将首次提供有关接受常规肛门细胞学检测的 HIV 感染女性队列中肛门 HPV 感染和 HGAIN 的检测特征、流行病学和自然史的重要信息。然后，这些数据将用于进行全面的成本效益分析，这将指导针对这些女性制定最佳肛门癌筛查方法的临床决策。

项目成果

Total Lifetime and Cancer-related Costs for Elderly Patients Diagnosed With Anal Cancer in the United States.

• DOI: 10.1097/coc.0000000000000238
• 发表时间: 2018-03
• 期刊: American journal of clinical oncology
• 作者: Deshmukh AA;Zhao H;Franzini L;Lairson DR;Chiao EY;Das P;Swartz MD;Giordano SH;Cantor SB
• 通讯作者: Cantor SB

Clinical and Economic Evaluation of Treatment Strategies for T1N0 Anal Canal Cancer.

T1N0 肛管癌治疗策略的临床和经济评估。

• DOI: 10.1097/coc.0000000000000339
• 发表时间: 2018
• 期刊: American journal of clinical oncology
• 作者: Deshmukh,AshishA;Zhao,Hui;Das,Prajnan;Chiao,ElizabethY;You,Yi-QianNancy;Franzini,Luisa;Lairson,DavidR;Swartz,MichaelD;Giordano,SharonH;Cantor,ScottB
• 通讯作者: Cantor,ScottB

Long-Term Outcomes of Adding HPV Vaccine to the Anal Intraepithelial Neoplasia Treatment Regimen in HIV-Positive Men Who Have Sex With Men.

在男男性行为艾滋病毒阳性男性的肛门上皮内瘤变治疗方案中添加 HPV 疫苗的长期结果。

• DOI: 10.1093/cid/civ628
• 发表时间: 2015
• 期刊: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
• 作者: Deshmukh,AshishA;Chhatwal,Jagpreet;Chiao,ElizabethY;Nyitray,AlanG;Das,Prajnan;Cantor,ScottB
• 通讯作者: Cantor,ScottB

Screening strategies for the detection of anal high-grade squamous intraepithelial lesions in women living with HIV.

• DOI: 10.1097/qad.0000000000002694
• 发表时间: 2020-12-01
• 期刊: AIDS (London, England)
• 作者: Chiao EY;Lensing SY;Wiley DJ;Deshmukh AA;Lee J;Darragh TM;Einstein MH;Jay N;Berry-Lawhorn JM;Palefsky JM;Wilkin T;Barroso LF;Cranston RD;Levine R;Guiot HM;French AL;Citron D;Rezaei MK;Goldstone SE;Stier EA
• 通讯作者: Stier EA