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

Mark Schiffman, Laurence M. Vaughan, Tina R. Raine-Bennett, Philip E. Castle, Hormuzd A. Katki, Julia C. Gage, Barbara Fetterman, Brian Befano, Nicolas Wentzensen

Research output: Contribution to journalArticle

26 Citations (Scopus)

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 3.0 years. Using stratified random sampling, we typed 2079 archived enrollment specimens including 329 women subsequently diagnosed with CIN3+, 563 with CIN2, and 1187 with < CIN2. Adjusting for sampling, we computed 3-year cumulative CIN3+ risks for each Onclarity typing channel, using Kaplan-Meier methods. Results The 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 1 year instead. Cost-effectiveness analyses are needed.

Original languageEnglish (US)
Pages (from-to)573-578
Number of pages6
JournalGynecologic Oncology
Volume138
Issue number3
DOIs
StatePublished - Sep 1 2015

Fingerprint

Colposcopy
Benchmarking
Atypical Squamous Cells of the Cervix
Cost-Benefit Analysis
Cell Biology
Referral and Consultation

Keywords

  • ASC-US
  • Cervical screening
  • HPV testing
  • Triage

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

Cite this

Schiffman, M., Vaughan, L. M., Raine-Bennett, T. R., Castle, P. E., Katki, H. A., Gage, J. C., ... Wentzensen, N. (2015). A study of HPV typing for the management of HPV-positive ASC-US cervical cytologic results. Gynecologic Oncology, 138(3), 573-578. https://doi.org/10.1016/j.ygyno.2015.06.040

A study of HPV typing for the management of HPV-positive ASC-US cervical cytologic results. / Schiffman, Mark; Vaughan, Laurence M.; Raine-Bennett, Tina R.; Castle, Philip E.; Katki, Hormuzd A.; Gage, Julia C.; Fetterman, Barbara; Befano, Brian; Wentzensen, Nicolas.

In: Gynecologic Oncology, Vol. 138, No. 3, 01.09.2015, p. 573-578.

Research output: Contribution to journalArticle

Schiffman, M, Vaughan, LM, Raine-Bennett, TR, Castle, PE, Katki, HA, Gage, JC, Fetterman, B, Befano, B & Wentzensen, N 2015, 'A study of HPV typing for the management of HPV-positive ASC-US cervical cytologic results', Gynecologic Oncology, vol. 138, no. 3, pp. 573-578. https://doi.org/10.1016/j.ygyno.2015.06.040
Schiffman, Mark ; Vaughan, Laurence M. ; Raine-Bennett, Tina R. ; Castle, Philip E. ; Katki, Hormuzd A. ; Gage, Julia C. ; Fetterman, Barbara ; Befano, Brian ; Wentzensen, Nicolas. / A study of HPV typing for the management of HPV-positive ASC-US cervical cytologic results. In: Gynecologic Oncology. 2015 ; Vol. 138, No. 3. pp. 573-578.
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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 3.0 years. Using stratified random sampling, we typed 2079 archived enrollment specimens including 329 women subsequently diagnosed with CIN3+, 563 with CIN2, and 1187 with < CIN2. Adjusting for sampling, we computed 3-year cumulative CIN3+ risks for each Onclarity typing channel, using Kaplan-Meier methods. Results The 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 1 year instead. Cost-effectiveness analyses are needed.",
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AU - Castle, Philip E.

AU - Katki, Hormuzd A.

AU - Gage, Julia C.

AU - Fetterman, Barbara

AU - Befano, Brian

AU - Wentzensen, Nicolas

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N2 - 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 3.0 years. Using stratified random sampling, we typed 2079 archived enrollment specimens including 329 women subsequently diagnosed with CIN3+, 563 with CIN2, and 1187 with < CIN2. Adjusting for sampling, we computed 3-year cumulative CIN3+ risks for each Onclarity typing channel, using Kaplan-Meier methods. Results The 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 1 year instead. Cost-effectiveness analyses are needed.

AB - 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 3.0 years. Using stratified random sampling, we typed 2079 archived enrollment specimens including 329 women subsequently diagnosed with CIN3+, 563 with CIN2, and 1187 with < CIN2. Adjusting for sampling, we computed 3-year cumulative CIN3+ risks for each Onclarity typing channel, using Kaplan-Meier methods. Results The 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 1 year instead. Cost-effectiveness analyses are needed.

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