Primary human papillomavirus screening for cervical cancer in the United States—US Food and Drug Administration approval, clinical trials, and where we are today

Nayar, Ritu; Goulart, Robert A.; Tiscornia-Wasserman, Patricia; Davey, Diane D.

doi:10.1002/cncy.21480

Cited by 16 publications

(11 citation statements)

References 38 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In terms of age, the majority of our cohort fell into the age group of 30-65 years when screening is most often recommended [7,12]. This is in contrast to earlier studies with a significant proportion of HSIL in women from 25 to 30 years of age [13,15].…”

Section: Discussioncontrasting

confidence: 54%

See 1 more Smart Citation

Relevance of the Pap Test: A Report of HPV-DNA Test-Negative High-Grade Squamous Intraepithelial Lesions of the Female Lower Genital Tract

Hui

Hansen²,

Murthy³

et al. 2016

Acta Cytologica

View full text Add to dashboard Cite

Objective: A vast majority of cervicovaginal intraepithelial lesions are caused by high-risk human papillomaviruses (HPVs). The Pap test has been the sole method used for the screening of cervicovaginal squamous intraepithelial lesions (SIL). Recently, the FDA approved an HPV-DNA assay as a method of primary screening. We report on a series of FDA-approved HPV-DNA test-negative SIL with HPV genotyping, using an alternative method on the corresponding surgical biopsy specimens. Study Design: A retrospective review identified cytology-positive HPV-negative cases over a 15-month period at a tertiary care gynecologic oncology institution. Corresponding biopsies were reviewed and genotyped for high-risk HPVs. Results: Of the 18,200 total cases, 17 patients meeting the study criteria were selected with 27 surgical specimens corresponding to their cytologic diagnoses. Four patients with high-grade lesions were identified, 3 of whom (75%) were positive for HPV. One of these 4 patients (25%) showed high-grade SIL on biopsies from 4 separate sites in the cervix and vagina. Multiviral HPV infections were frequent. Conclusions: We discuss the relevance of cotesting for screening cervical SILs and emphasize that false-negative results are possible with the FDA-approved HPV screening assay, also in patients with high-grade SIL. These cases may be detectable by cytologic examination and this suggests that the Pap test remains an important diagnostic tool.

show abstract

Section: Discussioncontrasting

confidence: 54%

“…However, the Pap smear is recognized to be imperfect, and testing strategies involving the detection of HPV have been developed to improve on the efficacy of cytologic evaluation alone [12]. …”

Section: Introductionmentioning

confidence: 99%

Relevance of the Pap Test: A Report of HPV-DNA Test-Negative High-Grade Squamous Intraepithelial Lesions of the Female Lower Genital Tract

Hui

Hansen²,

Murthy³

et al. 2016

Acta Cytologica

View full text Add to dashboard Cite

show abstract

“…The results of our current study, as well as limitations of the study that led to FDA approval of an HPV-only primary test, including abnormally low cytology performance, lack of a cotesting comparator algorithm, the inclusion of women aged <30 years, requiring up to 3 follow-up visits, and no long-term follow-up, all raise concerns regarding the suitability of HPV-only testing as a primary cervical cancer screen. 32,33 Because early detection and treatment of cervical cancer are critical to the overall health of women, it is important that the best and most sensitive diagnostic tools for cancer detection be identified and made available to all women. Our data support cotesting in women ages 30 to 65 years as the most effective screening test for detecting cervical cancer.…”

Section: Resultsmentioning

confidence: 99%

Comparison of cervical cancer screening results among 256,648 women in multiple clinical practices

Blatt

Kennedy

Luff

et al. 2015

Cancer Cytopathology

135

112

View full text Add to dashboard Cite

BACKGROUNDIn the United States, human papillomavirus (HPV) and Papanicolaou (Pap) testing (cotesting) for cervical screening in women ages 30 to 65 years is the preferred strategy, and cytology alone is acceptable. Recently, a proprietary automated test for identifying high-risk HPV types for primary cervical screening was approved by the US Food and Drug Administration. The objective of the current study was to document extensive cervical screening among these screening options.METHODSTo investigate the sensitivity of various testing options for biopsy-proven cervical intraepithelial neoplasia grade 3 or worse (≥CIN3) and cancer, the authors reviewed 256,648 deidentified results from women ages 30 to 65 years at the time of cotest who had a cervical biopsy specimen obtained within 1 year of the cotest.RESULTSA positive cotest result was more sensitive (98.8%; 4040 of 4090 cotests) for diagnosing ≥CIN3 than either a positive HPV-only test (94%; 3845 of 4090 HPV-only tests) or a positive Pap-only test (91.3%; 3734 of 4090 Pap-only tests; P <. 0001). A positive Pap-only result was more specific (26.3%; 66,145 of 251,715 Pap-only tests) for diagnosing ≥CIN3 than a positive HPV-only test (25.6%; 64,625 of 252,556 HPV-only tests) or a positive cotest (10.9%; 27,578 of 252,558 cotests; P <. 0001). Of 526 cervical cancers, 98 (18.6%) were HPV-only negative, 64 (12.2%) were Pap-only negative, and 29 (5.5%) were cotest negative.CONCLUSIONSCompared with HPV-only testing, cotesting was more sensitive for the detection of ≥CIN3 in women ages 30 to 65 years. The current data suggest that approximately 19% of women with cervical cancer may be misdiagnosed by an HPV-only cervical screen. It is important to consider these data as the guidelines for cervical cancer screening undergo revision. Cancer (Cancer Cytopathol) 2015;123:282–8. © 2015 The Authors. Cancer Cytopathology published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

show abstract

“…HR HPV is a prerequisite for the development of almost all types of cervical cancer, therefore HR HPV has become an integral part of new screening strategies. With the FDA approval of the first HPV test for primary cervical cancer screening of women ≥25 years [6], clinicians in the USA now have 3 different first-line screening options that they may offer to patients: the Pap test, cotesting with Pap and HPV, and HPV testing as a stand-alone test [7]. The choice of the cervical screening method may vary for a variety of reasons including patient and provider preference along with geographic, socioeconomic, and practice settings.…”

Section: Discussionmentioning

confidence: 99%

Review of Cytology Practice at Thomas Jefferson University Hospital before and after High-Risk Human Papillomavirus Testing

Bibbo

Wang²,

Jones³

et al. 2016

Acta Cytologica

View full text Add to dashboard Cite

Objective: We performed a retrospective review of Papanicolaou (Pap) testing to assess whether the cytology practice in our institution was affected by the introduction of high-risk (HR) human papillomavirus (HPV) assays over time. Study Design: Cytology, HPV and histopathology records were retrieved from our laboratory information system from 2003 to 2015. Records for Digene Hybrid Capture 2®, Hologic Cervista® and Roche Cobas® HPV assays were obtained. A 3-month follow-up for HPV detected cases was performed, and results were correlated with cytology and biopsies. A 1-year follow-up of HPV 16/18 and other HR HPV detected cases was also performed. Results: From 2008 to 2015, a noticeable decrease in Pap testing volume occurred, from 11,792 to 4,664, while the percentage of HPV testing increased from 19 to 59%. Similar HPV detection rates and follow-up results for both reflex and cotesting were observed in the 3 HPV assays. Conclusions: The decrease in Pap testing was due to the lengthening of the test interval when cotesting results were negative. Practitioners adhering to guidelines accounts for increased molecular testing volume. A trend towards higher-grade cervical intraepithelial neoplasia in the follow-up of detected HPV 16/18 was noted. So far there has been no demand for HPV as a stand-alone test.

show abstract

Primary human papillomavirus screening for cervical cancer in the United States—US Food and Drug Administration approval, clinical trials, and where we are today

Cited by 16 publications

References 38 publications

Relevance of the Pap Test: A Report of HPV-DNA Test-Negative High-Grade Squamous Intraepithelial Lesions of the Female Lower Genital Tract

Relevance of the Pap Test: A Report of HPV-DNA Test-Negative High-Grade Squamous Intraepithelial Lesions of the Female Lower Genital Tract

Comparison of cervical cancer screening results among 256,648 women in multiple clinical practices

Review of Cytology Practice at Thomas Jefferson University Hospital before and after High-Risk Human Papillomavirus Testing

Contact Info

Product

Resources

About