Dataset Information

A study of HPV typing for the management of HPV-positive ASC-US cervical cytologic results.

ABSTRACT:

Background

In US cervical screening, immediate colposcopy is recommended for women with HPV-positive ASC-US (equivocal) cytology. We evaluated whether partial typing by Onclarity™ (BD) might identify HPV-positive women with low enough CIN3+ risk to permit 1-year follow-up instead.

Methods

The NCI-Kaiser Permanente Northern California Persistence and Progression cohort includes a subset of 13,890 women aged 21+ with HC2 (Qiagen)-positive ASC-US at enrollment; current median follow-up is 3.0years. Using stratified random sampling, we typed 2079 archived enrollment specimens including 329 women subsequently diagnosed with CIN3+, 563 with CIN2, and 1187 with ResultsThe 3-year CIN3+ risk for all HC2-positive women with ASC-US was 5.2%; this establishes the "benchmark" risk for colposcopic referral. Hierarchically, 3-year cumulative risks for each typing channel were 16.0% for HPV16, 7.4% for HPV18, 7.0% for HPV31, 7.1% for grouped HPV33/58, 4.3% for HPV52, 3.9% for HPV45, 2.7% for HPV51, 1.6% for HPV39/68/35, and 1.3% for HPV59/56/66.

Discussion

ASC-US linked to HPV16, HPV18, HPV31, or HPV33/58 warrants immediate colposcopy. Optimal management of women with HPV52 or HPV45 is uncertain. Risk of women with only HPV51, HPV39/68/35, or HPV59/56/66 might be low enough to recommend 1-year retesting permitting viral clearance. This strategy would defer colposcopy for 40% of women with HPV-positive ASC-US, half of whom would be cotest-negative at 1-year return. Approximately 10% of those with CIN3 diagnosable at enrollment would be delayed 1year instead. Cost-effectiveness analyses are needed.

SUBMITTER: Schiffman M

PROVIDER: S-EPMC4556538 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Publications

A study of HPV typing for the management of HPV-positive ASC-US cervical cytologic results.

Schiffman Mark M Vaughan Laurence M LM Raine-Bennett Tina R TR Castle Philip E PE Katki Hormuzd A HA Gage Julia C JC Fetterman Barbara B Befano Brian B Wentzensen Nicolas N

Gynecologic oncology 20150704 3

<h4>Background</h4>In US cervical screening, immediate colposcopy is recommended for women with HPV-positive ASC-US (equivocal) cytology. We evaluated whether partial typing by Onclarity™ (BD) might identify HPV-positive women with low enough CIN3+ risk to permit 1-year follow-up instead.<h4>Methods</h4>The NCI-Kaiser Permanente Northern California Persistence and Progression cohort includes a subset of 13,890 women aged 21+ with HC2 (Qiagen)-positive ASC-US at enrollment; current median follow- ...[more]

PMID: 26148763

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Project description:BackgroundSelf-sampling for human papillomavirus (HPV) testing is a feasible option to improve the cervical screening coverage. However, an ideal triage method for HPV-positive self-samples does not yet exist. The aim of this study was to explore the utility of HPV genotyping and p16INK4a immunostaining (p16) in triaging HPV-positive self-samples, focusing on HPV-positive, cytology-negative (HPCN) women.MethodsA total of 73,699 women were screened in a cervical screening project in China via SeqHPV assay on self-samples. HPV-positive women were called-back and collected cervical sample for p16 immunostaining and liquid-based cytology, those who met any result of HPV16/18+ or visual inspection with acetic acid (VIA) + or p16+ were referred for colposcopy, and HPCN women with adequate data on p16 and pathology were analyzed. A triage strategy was considered acceptable if the negative predictive value (NPV) for cervical intraepithelial neoplasia 3 or worse (CIN3+) was 98% or more, combined with an improvement of sensitivity and specificity for CIN2+/CIN3+ in reference to the comparator, being HPV16/18 + .ResultsA total of 2731 HPCN women aged 30-64 years were enrolled, 136 (5.0%) CIN2+ and 53 (1.9%) CIN3+ were detected. Five triage strategies met the criteria: p16+; HPV16/33+; 'HPV16+ or HPV33/58/31/35+&p16+'; 'HPV16/33+ or HPV58/31/35+&p16+'; HPV16/18/31/33/45/52/58 + & p16+. These strategies required less or similar colposcopy referrals, and less colposcopies to detected one case of CIN2+/CIN3+, achieving favorable false positive (negative) rates to the comparator. Among them, p16 staining detected 83.1% (79.2%) of underlying CIN2 + (CIN3+) in HPCN women. Moreover, three triage strategies were favorable in sensitivity and/or specificity to the 'HPV16/33+' strategy: p16+; 'HPV16+ or HPV33/58/31/35 + &p16+'; HPV16/18/31/33/45/52/58 + &p16 + .ConclusionsGenotyping for HPV16/33 could be utilized to optimize the management of HPCN women. Moreover, p16 immunostaining, either alone or combined with extended genotypes, is more effective than HPV genotypes alone in the triage of HPCN women.

Project description:BACKGROUND:Cervical cancer is caused by persistent human papillomavirus (HPV) infection. US consensus management guidelines for a positive cervical screening result typically focus on the current screening result only. A negative testing history may alter risk of the following positive screening results, caused by a new HPV infection, and therefore its optimal management. METHODS:Women ages 30 years and older were screened with triennial HPV and cytology co-testing at Kaiser Permanente Northern California from 2003 to 2014. We estimated the subsequent 5-year risks of cervical intraepithelial neoplasia grade 3 or more severe diagnoses (CIN3+) in a cohort of 1 156 387 women following abnormal (atypical squamous cells of undetermined significance [ASC-US] or worse) cytology and/or positive HPV testing, when the test result followed 0 (n = 990 013), 1 (n = 543 986), 2 (n = 245 974), or 3 (n = 79 946) consecutive negative co-test(s). All statistical tests were two-sided. RESULTS:Following 0-3 successive negative co-tests, 5-year CIN3+ risks following a positive HPV test decreased progressively from 7.2% (95% CI = 7.0% to 7.4%) to 1.5% (95% CI = 0.7% to 3.4%) (Ptrend < .001). Similarly, risks following an abnormal (ASC-US or worse) cytology result decreased from 6.6% (95% CI = 6.4% to 6.9%) to 1.1% (95% CI = 0.5% to 2.3%) (Ptrend < .001). Risks following low-grade squamous intraepithelial lesion, the risk threshold for referral to colposcopy in the United States, decreased from 5.2% (95% CI = 4.7% to 5.7%) to 0.9% (95% CI = 0.2% to 4.3%). Risks following high-grade squamous intraepithelial lesion or more severe, a specific marker for the presence of precancerous lesions, decreased from 50.0% (95% CI = 47.5% to 52.5%) to 10.0% (95% CI = 2.6% to 34.4%). CONCLUSIONS:Following one or more sequential antecedent, documented negative co-tests or HPV tests, women with HPV-positive ASC-US or low-grade squamous intraepithelial lesion might have sufficiently low CIN3+ risk that they do not need colposcopy referral and might instead undergo 6-12-month surveillance for evidence of higher risk before being referred to colposcopy.

Project description:OBJECTIVES:The aim of this study was to understand causes of attendance and non-attendance to a follow-up cervical cancer screening among human papillomavirus (HPV)-positive women. DESIGN:Semistructured, individual interviews with HPV-positive women and cervical cancer screening nurses. The interview guide and initial data analysis were guided by existing health behaviour theories. However, as the theories limited the potential of the data material, a grounded theory framework guided the final data analysis. SETTING:Interviews were conducted in Dar es Salaam, Tanzania, at Ocean Road Cancer Institute (ORCI) or in the homes of screening clients. PARTICIPANTS:15 interviews were conducted with women who had tested HPV-positive during a patient-initiated screening and been appointed for a follow-up screening 14 months later. Nine women had not attended the follow-up appointment, four had delayed attendance and two had attended on the scheduled date. Further, individual interviews were conducted with the two nurses working at ORCI's screening clinic. RESULTS:Perceived benefits for attending a patient-initiated screening include treatment of gynaecological symptoms and prevention of disease. The key perceived benefit of a health provider-initiated follow-up screening is prevention, which is challenged by the circumstance that it is seen by women as having merely potential benefit and therefore can be postponed when competing needs are present. Perceived challenges for screening attendance include emotional costs, in the form of fear of the disease, fear of the gynaecological examination as well as direct and indirect economic costs, such as transportation costs, lost income and waiting time. CONCLUSION:Cervical cancer screening is one among many tasks that women living in a low-income setting must attend to. Since health provider-initiated follow-up screening is seen as having only potential benefit, attendance can be postponed when competing needs exist. TRIAL REGISTRATION NUMBER:NCT02509702.

Dataset Information

A study of HPV typing for the management of HPV-positive ASC-US cervical cytologic results.

Background

Methods

Discussion

Publications

A study of HPV typing for the management of HPV-positive ASC-US cervical cytologic results.

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