Department of Epidemiology and General Oncology, University of Texas- MD Anderson Cancer Center, Houston, Texas.
Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
AIDS. 2020 Dec 1;34(15):2249-2258. doi: 10.1097/QAD.0000000000002694.
HIV-infected women (WLHIV) have more than 10-fold higher risk for squamous cell cancer of the anus. Experts suggest cytology-based strategies developed for cervical cancer screening may prevent anal cancer by detecting anal cytologic or histological high-grade squamous intraepithelial lesion (hHSIL) for treatment. Currently, there is no consensus on anal-hHSIL screening strategies for WLHIV.
Between 2014 and 2016, 276 WLHIV were recruited at 12 US AIDS Malignancy Consortium clinical trials sites to evaluate hHSIL prevalence and (test) screening strategies.
Participants completed detailed questionnaire, underwent anal assessments including high-risk human papillomavirus (hrHPV) testing using hrHPV-Hybrid Capture 2 (HC2) and hrHPV-APTIMA, anal cytology, and concurrent high-resolution anoscopy. Screening test characteristics for predicting hHSIL validated by central review of histologic diagnosis were estimated sensitivity, specificity, positive predictive value, and false-omission rate. Paired analyses compared sensitivity and specificity for hrHPV single tests to anal cytology alone.
83% (229/276) of enrolled WLHIV had complete anal assessment data and were included in this analysis. Mean age was 50, 62% black and 60 (26%) had hHSIL. Anal cyotology (>atypical squamous cells of undetermined significance), hrHPV-HC2, and hrHPV-APTIMA sensitivity estimates were similarly high (83, 77, and 75%, respectively, P values > 0.2). Specificity was higher for both hrHPV-APTIMA and hrHPV-HC2 compared with anal cytology (67 vs. 50%, P < 0.001) and (61 vs. 50%, P = 0.020), respectively.
Anal hrHPV testing demonstrated similar sensitivity for anal cytology (>atypical squamous cells of undetermined significance) to predict anal hHSIL. Among tests with similar sensitivity, the specificity was significantly higher for hrHPV-APTIMA and hrHPV-HC2. Thus, anal hrHPV testing may be an important alternative strategy to anal cytology for anal hHSIL screening among WLHIV.
HIV 感染女性（WLHIV）患肛门鳞癌的风险高出 10 倍以上。专家建议，针对宫颈癌筛查制定的细胞学策略，通过检测肛门细胞学或组织学高级别鳞状上皮内病变（hHSIL）进行治疗，可能预防肛门癌。目前，针对 WLHIV 的肛门 hHSIL 筛查策略尚无共识。
2014 年至 2016 年，在 12 个美国艾滋病恶性肿瘤联盟临床试验点招募了 276 名 WLHIV，以评估 hHSIL 的患病率和（检测）筛查策略。
参与者完成详细的问卷调查，接受肛门评估，包括使用高危型人乳头瘤病毒（hrHPV）检测试剂盒（hrHPV-Hybrid Capture 2 [HC2] 和 hrHPV-APTIMA）检测 hrHPV、肛门细胞学检查和同时进行高分辨率肛门镜检查。通过对组织学诊断的中央审查来验证筛查试验对预测 hHSIL 的特征，估计敏感性、特异性、阳性预测值和假阴性率。配对分析比较了 hrHPV 单项检测与单独肛门细胞学检查的敏感性和特异性。
276 名入组的 WLHIV 中，83%（229/276）完成了完整的肛门评估数据，纳入本分析。平均年龄为 50 岁，62%为黑人，60 人（26%）患有 hHSIL。肛门细胞学检查（＞非典型意义不明确的鳞状细胞）、hrHPV-HC2 和 hrHPV-APTIMA 的敏感性估计值相似（分别为 83%、77%和 75%，P 值均＞0.2）。与肛门细胞学检查相比，hrHPV-APTIMA 和 hrHPV-HC2 的特异性更高（分别为 67%比 50%，P＜0.001；61%比 50%，P=0.020）。
肛门 hrHPV 检测在预测肛门 hHSIL 方面与肛门细胞学检查（＞非典型意义不明确的鳞状细胞）具有相似的敏感性。在具有相似敏感性的检测中，hrHPV-APTIMA 和 hrHPV-HC2 的特异性显著更高。因此，肛门 hrHPV 检测可能是 WLHIV 肛门 hHSIL 筛查的一种重要替代策略。
