Addressing the need for enhanced risk stratification
As the inclusion of HPV triage testing in cervical screening results in the identification of more women at high risk, a new limitation is emerging — the lack of enhanced risk stratification that can identify those women who require more aggressive management.1
Current practice can involve repeating cytology and pooled hrHPV DNA testing in 6 or 12 months for women with borderline or low-grade dyskaryosis cytology and a positive hrHPV DNA result, following colposcopy without treatment of CIN1. This approach, while an improvement on cytology alone in the early detection of precancer or cervical cancer, remains limited by:
Since HPV 16 and 18 confer a higher risk of having precancerous lesions and cervical cancer than other genotypes,1 additionally focusing on these genotypes gives the clinicians useful details upon which to make effective treatment decisions. Distinguishing HPV 16 and 18 from other high-risk HPV types may identify women at the greatest risk of ≥CIN3.1
Today, as is supported by ACOG,2 individual genotyping could for instance be used as a follow-up test subsequent to a normal cytology and a positive pooled hrHPV testing result. In the UK this type of result may be seen at post-treatment follow-up or as a result of private referral testing.
Recent predictions from a study published by the BMJ showed that if test of cure/post treatment recommendations according to sentinel sites protocol are followed then per 1000 women treated 8.4 additional cases of ≥CIN3 are prevented and a cost reduction of £9388 is seen. Making test of cure/post treatment testing a more effective strategy than annual cytology follow-up for a 10 year period.3
Clinicians and their patients can save time and create further efficiencies by using the cobas® HPV Test for hrHPV testing— a single, integrated test that offers a pooled result and HPV 16 and 18 genotyping. Learn more about the test >
HPV 16/18 genotyping identifies women at the greatest risk of ≥CIN3.
In a seminal study of 20,810 women in the Kaiser Permanente healthcare system, of the population of women with normal cytology, those who were HPV 16 positive and those who were HPV 18 positive were shown to be at the highest risk of developing ≥CIN3.1
These case studies are intended to provide educational information and the materials and opinions referenced may not be supported by Roche in their entirety. While we do our best to fact check all information presented, you should not rely on this information as complete, or always up-to date. Nothing in the case studies is intended to constitute medical advice and the case studies should not be relied on for this or any other purpose.
1. cobas® 4800 HPV Test US package insert. April 2011.
2. Khan MJ, Castle PE, Lorincz AT, et al. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005;97(14):1072-1079.
3. The American Congress of Obstetricians and Gynecologists. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists: Screening for Cervical Cancer. November, 2012.
4. Legood R, Smith M, Lew JB, et al. Cost effectiveness of human papillomavirus test of cure after treatment for cervical intraepithelial neoplasia in England: economic analysis from NHS Sentinel Sites Study. BMJ 2012;345:e7086 doi: 10.1136/bmj.e7086. published 31 October 2011.
5. Bosch FX, de Sanjosé S. Human papillomavirus and cervical cancer — burden and assessment of causality. J Natl Cancer Inst Monogr. 2003;31:3-13.
6. Bulk S, Berkhof J, Bulkmans NW, et al. Preferential risk of HPV16 for squamous cell carcinoma and of HPV18 for adenocarcinoma of the cervix compared to women with normal cytology in The Netherlands. Br J Cancer. 2006;94(1):171-175.
7. Ault KA, Joura EA, Kjær SK, et al. Adenocarcinoma in situ and associated human papillomavirus type distribution observed in two clinical trials of a quadrivalent human papillomavirus vaccine. Int J Cancer. 2011;128(6):1344-1353.
8. de Sanjosé S, Quint WG, Alemany L, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010;11(11):1048-1056.
9. Kjær SK, Frederiksen K, Munk C, Ifner T. Long-term absolute risk of cervical intraepithelial neoplasia grade 3 or worse following human papillomavirus infection: role of persistence. J Natl Cancer Inst. 2010;102(19):1478-1488.-