Discussion: Management of HPV test results

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Unresolved issues

There is uncertainty about participation in the Renewed NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. over the 5-yearly interval and compliance with the follow-up recommendations for HPV-positiveWomen with a positive HPV test result of any oncogenic HPV types detected using HPV testing platforms in a pathology laboratory. women. There is also uncertainty about the timing of impact of HPV vaccination on the numbers of women referred to colposcopy, and about the transitional aspects of the program and impact on colposcopy volumes. These issues will be informed by modelled analysis (see Modelling reports, safety monitoring of the Renewed NCSP, and by emerging data from the Compass trials.

Women who test positive for HPV 16/18Only HPV types 16 and or 18 detected using routine HPV screening tests in laboratory. on a self-collected sample will need further investigation. It is unclear at present whether these women would prefer to visit their usual primary care health professional to have a cervical sample for liquid-based cytology taken by someone they know and trust, or be referred directly to specialist colposcopist and have the sample taken at that time. A stepwise protocol involving primary care would involve an extra examination, but might be perceived as less threatening. Several options might be offered, one of which should be further assessment by a female primary care practitioner or specialist.


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Ongoing clinical research

A large RCT (Compass) is underway comparing 5-yearly HPV testing with 2.5 yearly liquid-based cytology screening in women aged 25–69 years in Victoria.[1] The primary objectives of Compass are:[1]

  • to confirm that 5.5-year CIN3+-free survival is non-inferior for HPV screening compared with cytology screening in vaccinated and unvaccinated cohorts
  • (if HPV screening is not inferior to cytology screening) to determine if 5.5-year CIN3+ free survival is superior among HPV-screened women who were HPV-negative at baseline, compared with cytology-screened women who were cytology-negative at baseline and at 2.5-year follow-up.
  • Compass is providing information on colposcopy referral rates and outcomes and is acting as a sentinel experience for the Renewed NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears..

Future research priorities

The use of dual-stained cytology for the overexpression of the molecular markers p16 and Ki 67 has been proposed as a strategy for further stratification of risk among HPV-positiveWomen with a positive HPV test result of any oncogenic HPV types detected using HPV testing platforms in a pathology laboratory. women.[1][2][3] In particular, there is a need to determine whether or not dual staining (p16 and Ki67) for women who test positive to HPV (not 16/18) on partial genotyping would materially improve the prediction of cervical cancer risk. The Compass trial is also assessing the role of this technology and initial results are expected in 2017–2018.


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References

  1. 1.01.11.2 Canfell K, Castle P, Caruana M, Gebski V, Darlington-Brown J, Heley S, Brotherton J, Gertig D, Saville M. Protocol for Compass: a randomised controlled trial of primary HPV vs. cytology screening for cervical cancer in HPV-unvaccinated and vaccinated women in Australia. Victorian Cytology Service Inc and The University of Sydney 2014.
  2. Bergeron C, Schmidt D, Ikenberg H, Ridder R. High sensitivity and high specificity of p16/Ki-67 dual-stained cytology for high-grade CIN – results from screening and triage trials in over 28,000 women. Cancer Cytopathol, American Society of Cytopathology 58th Annual Scientific Meeting Platform and Poster Presentations 2010;(Supplement): 305–306.
  3. Uijterwaal MH, Polman NJ, Witte BI, van Kemenade FJ, Rijkaart D, Berkhof J, et al. Triaging HPV-positive women with normal cytology by p16/Ki-67 dual-stained cytology testing: baseline and longitudinal data. Int J Cancer 2015 May 15;136(10):2361-8 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25345358.
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