Division of Cancer Epidemiology, Department of Oncology, McGill University, Montreal, QC, Canada.
Department of Pathology, McGill University and Jewish General Hospital, Montreal, QC, Canada.
Am J Obstet Gynecol. 2014 May;210(5):474.e1-7. doi: 10.1016/j.ajog.2013.12.033. Epub 2013 Dec 25.
The purpose of this study was to evaluate the feasibility and effectiveness of Viral Testing Alone with Pap (Papanicolaou) Triage for Screening Cervical Cancer in Routine Practice (VASCAR) in a publicly funded university-affiliated hospital in Montreal, Canada.
Women who are 30-65 years old are screened with the Hybrid Capture-2 assay. Women with negative results are retested at 3-year intervals; women with positive results are triaged with conventional cytologic methods. Women with Papanicolaou positive test results (≥atypical squamous cells of undetermined significance) are referred to colposcopy; women with Papanicolaou negative test results are retested with Hybrid Capture-2 assay and a Papanicolaou test in 1 year. Results were compared with a historic era (annual cytology with ≥atypical squamous cells of undetermined significance threshold for colposcopy referral) in the 3 years before VASCAR.
VASCAR included 23,739 eligible women, among whom 1646 women (6.9%) tested positive for the human papillomavirus (HPV). Because of the need for subsequent sampling for cytologic testing, follow-up evaluation for cytologic triage was relatively poor; only 46% and 24% of HPV-positive women were Papanicolaou-triaged and underwent biopsy, respectively. Protocol violations occurred mainly in the early phases of implementation (12%). Detection of high-grade cervical intraepithelial neoplasia increased nearly 3-fold (rate ratio, 2.78; 95% confidence interval [CI], 2.1-3.7) during VASCAR, mostly because of a doubling in the rate of high-grade cervical intraepithelial neoplasia (34.0%; 95% CI, 21.2-48.8) compared with the historic cytology-only era (16.3%; 95% CI, 13.2-19.8). VASCAR reduced the median time to colposcopy from a positive screen from 11 months (95% CI, 10.48-11.50) to 3 months (95% CI, 2.64-3.80).
VASCAR is feasible; however, it requires cosampling for HPV and cytology and for continuous education of healthcare providers of the HPV-Papanicolaou triage protocol. Efficacy in disease detection and reduction in time to colposcopy referrals compared with the historic cytology era is encouraging but should be considered preliminary because of the small number of patients who were tested.
本研究旨在评估在加拿大蒙特利尔一家公立大学附属医院的常规实践中，单独进行病毒检测联合巴氏涂片细胞学检查（Pap）用于宫颈癌筛查（VASCAR）的可行性和有效性。
对 30-65 岁的女性进行杂交捕获-2 检测。结果阴性的女性每 3 年重复检测一次；结果阳性的女性用传统细胞学方法进行分流。巴氏涂片检查结果阳性（≥非典型鳞状细胞不能明确意义）的女性转诊行阴道镜检查；巴氏涂片检查结果阴性的女性用杂交捕获-2 检测和 1 年内的巴氏涂片再次检测。将 VASCAR 前 3 年的历史时期（每年细胞学检查，以非典型鳞状细胞不能明确意义为阈值转诊行阴道镜检查）的结果与 VASCAR 进行比较。
VASCAR 共纳入 23739 名符合条件的女性，其中 1646 名（6.9%）女性 HPV 检测阳性。由于需要进行后续细胞学取样，细胞学分流的随访评估相对较差；仅 46%和 24%的 HPV 阳性女性进行了巴氏涂片分流和活检。主要在实施的早期阶段（12%）发生方案违规。VASCAR 期间，高级别宫颈上皮内瘤变的检出率几乎增加了 3 倍（比值比，2.78；95%置信区间[CI]，2.1-3.7），主要是因为高级别宫颈上皮内瘤变的检出率翻了一番（34.0%；95%CI，21.2-48.8），而与历史上仅细胞学检查相比（16.3%；95%CI，13.2-19.8）。VASCAR 将从阳性筛查到阴道镜检查的中位时间从 11 个月（95%CI，10.48-11.50）缩短至 3 个月（95%CI，2.64-3.80）。
VASCAR 是可行的；然而，它需要对 HPV 和细胞学进行联合取样，并且需要对医疗保健提供者进行 HPV-Pap 分流方案的持续教育。与历史上的细胞学时代相比，在疾病检测中的疗效和缩短阴道镜检查转诊时间令人鼓舞，但由于接受检测的患者数量较少，应将其视为初步结果。
