Management of histologically confirmed high-grade squamous abnormalities

The practice of treating all cases of HSIL (CIN2/3) has been highly effective and has led to a reduction in the risk of subsequent cervical cancer.

A very small number of women with HSIL may be treated unnecessarily. However, it is not possible to identify these women in advance. This small risk must be weighed against the substantial evidence for the effectiveness of cervical screening and HSIL (CIN2/3) treatment to prevent the development of invasive cervical cancer. The benefits of treating HSIL (CIN2/3) outweigh the harms, and treating HSIL (CIN2/3) is the basis for the documented success of the National Cervical Screening Program (NCSP).

See the Benefits, harms and cost-effectiveness of cervical screening in the renewed National Cervical Screening Program (NCSP).

Back to top

Clinical practice

Recommendations regarding the management of women with HSIL (CIN2/3) are consistent with present clinical practice.

Resourcing

No additional costs are anticipated.

Barriers to implementation

Women treated for HSIL (CIN2/3) may choose not to attend for post-treatment co-testing as recommended. An Australian study using state registry data found that 53% of women treated for high-grade cervical dysplasia attended only a single HPV follow-up test.[1]

Some women will be very anxious if they have continuing abnormality (as may their GP) and a colposcopy may be needed for reassurance. However, treatment of LSIL (≤ CIN1), even if persistent, should be avoided wherever possible.

Back to top

Women who are undergoing Test of Cure, and who have a positive oncogenic HPV (16/18) test result with any LBC report, or LBC prediction of pHSIL/HSIL with any HPV test result, should be referred for colposcopy to exclude recurrent or residual disease. This more cautious posttreatment management of these women is warranted.

The National HPV Vaccination Program is expected to reduce the number of oncogenic HPV 16/18 infections, high-grade abnormalities and the risk of cervical cancer directly in vaccinated women, as successive vaccinated cohorts mature and indirectly in unvaccinated women, via a reduction in the circulation of vaccine included HPV types within the population.

Unresolved issues

Although two negative co-tests are required before returning women to routine screening after treatment for HSIL (CIN2/3), there is uncertainty regarding whether one negative co-test or a single negative HPV test would be sufficient before safely returning women to routine screening intervals of 5 years. This issue will be informed by the ongoing accumulation of national data by the Australian Institute of Health and Welfare (AIHW) and will be considered by the Quality and Safety Monitoring Committee of the renewed NCSP.

For some women with a negative co-test result at 12 months but a positive HPV test and negative cytology result at 24 months, there is a possibility that the lesion is ‘cured’ and the positive oncogenic HPV test may indicate re-infection rather than recurrence. However, the scientific evidence to support this is currently not available.

Future research priorities

The role of p16 and ki67 in the triage of HSIL (CIN2), and its use in the renewed NCSP, should be further investigated. Long-term follow-up studies of women with HSIL (CIN2/3) cervical abnormalities that evaluate the clinical use of p16 and other molecular biomarkers, alone or in combination, are needed to guide the management of this group of women.

Outcomes of various post-treatment screening scenarios in longitudinal studies are needed to inform future recommendations for test of cure. These should compare the 5-year cumulative risk of subsequent HSIL (CIN2+). Analysis by age groups (< 30 years and ≥ 30 years) would also be informative, as the specificity of HPV testing is lower in younger women.

The role of post-treatment HPV vaccination in unvaccinated women should be considered as a potential research activity.

Back to top