Follow-up Outcomes of a Large Cohort of Low-Risk Women With Negative Imaged Liquid-Based Cytology and Negative HPV Test Results

Abstract

Recently updated cervical screening guidelines have proposed a 5-year screening interval for women aged 30 years and older with "double-negative" Papanicolaou (Pap) and high-risk human papillomavirus (hrHPV) results (DNR); however, published US follow-up data on women with DNR tested with US Food and Drug Administration (FDA) - approved HPV testing are limited to studies from Kaiser Permanente using conventional Pap smear cytology. Between July 2005 and June 2006, 4,112 patients with DNR who were screened with computer-imaged liquid-based cytology (LBC) (ThinPrep) and Hybrid Capture 2 (HC2) hrHPV tests of LBC vial fluid were identified. Cytologic or histopathologic data were available for 3,211 patients who were followed up for a mean 44 months. Among 2,960 patients aged 30 years and older with DNR, follow-up cervical abnormalities of cervical intraepithelial neoplasia (CIN) 3 or more severe (CIN3+) were documented in 5 (0.17%), including 1 endocervical adenocarcinoma. After DNR, CIN+ diagnoses were significantly more likely in women younger than 50 years than in older women. These data are consistent with previously published US and international studies that have consistently documented low rates of histopathologic CIN3+ during years of follow-up after DNR. Large-scale nationwide data are needed to further assess the level of risk of invasive cervical cancer after DNR using different available hrHPV testing methods.

Hybrid Capture 2 Assay Based Evaluation of High-Risk HPV Status in Healthy Women of North-East India

“…It has also been confirmed by the work of multiple research groups in large population samples that cytological screening is less sensitive compared to High risk HPV (HR-HPV) DNA testing in detection of histological cervical intraepithelial lesions (CIN2/3) (Arbyn et al, 2012). Recently updated cervical screening guidelines have proposed a 5-year screening interval for women aged 30 years and older with "double-negative" Papanicolaou (Pap) and high-risk human papillomavirus (HR-HPV) results (Zhao et al, 2013). HR-HPV DNA negative women are unlikely to develop CIN 2 or 3 and invasive cervical cancer over a period of 5-10 years.…”

Clinical Performance of Hybrid Capture 2 Human Papillomavirus Testing for Recurrent High-Grade Cervical/Vaginal Intraepithelial Neoplasm in Patients With an ASC-US Papanicolaou Test Result During Long-Term Posttherapy Follow-up Monitoring

“…In a 3-year follow-up study at our institution for patients with negative SurePath Pap and negative HC2 results, we observed a low follow-up rate for CIN 3 (0.17%; M.G., unpublished data). Zhao et al 43 reported a similar CIN 3 rate (0.17%) with a mean follow-up period of 44 months for women with negative ThinPrep Pap and negative HC2 HPV testing results. Nevertheless, current guidelines for cervical cancer screening issued by the ASCCP and American College of Obstetricians and Gynecologists advise against unapproved off-label use of HPV testing.…”

Diagnostic sensitivity for invasive cervical carcinoma of high risk HPV tests performed on SurePath™ liquid-based pap specimens

“…As mentioned previously, we believe this is the kind of retrospective data that the laboratory profession should be monitoring nationwide,1,2 especially given proposed extended five year screening intervals for many women with negative high risk (hr) HPV test results 3…”

“…A study from Emory University of patients with ASC-H (atypical squamous cells - cannot exclude high grade squamous intraepithelial lesion) Sure-Path™ cytologic findings, for example, reported positive hrHPV HC2 LDT results from the SurePath™ vial in only 11 of 21 patients (52%) with follow-up CIN3 biopsy findings of 48 of 61 patients (79%) with follow-up CIN2 biopsy findings 4. More recently, Johns Hopkins University, reported positive hrHPV HC2 LDT results from the SurePath™ vial in 48 of 57 patients (84%) with HSIL SurePath™ cytology results, zero of six patients with SurePath™ cytologic findings of adenocarcinoma, and one of two patients with SurePath™ cytologic findings of squamous cell carcinoma 5.…”

“…Both the American Cancer Society and the American College of Obstetricians and Gynecologists now recommend that only FDA-approved HPV test methods be relied on in cervical screening 3. Laboratories choosing not to follow professional organization and manufacturer recommendations should make their validation data available upon request for independent review along with detailed information on the precise HPV testing method(s) they have used.…”