1. Why new guidelines now?
- In 2012, newly published cervical cancer screening guidelines for women 30-64 stated that HPV/cytology cotesting was the preferred method. Now, providers who use cotesting will be receiving combinations of results, some of which will be discordant (e.g., HPV+/Pap -, HPV-/HSIL). Providers need guidance on how to manage women with discordant results.
- Analyses of data from more than one million women receiving care at Kaiser Permanente Northern California (KPNC) facilities show risk of precancer (CIN3+), over time, after various screening abnormalities. Women with similar risks should be managed similarly.
- ASCCP guidelines on management of women with cytology reports of ‘unsatisfactory’ or ‘missing endocervical/transformation zone component’ were never validated by a consensus conference. New research shows lower risk of existing abnormalities than previously thought and provides guidance on use of HPV testing.
- Screening is no longer recommended for adolescents. Data analysis shows that women ages 21-24 are at low risk for invasive cervical cancer, but high risk for HPV exposure and HPV-associated lesions. This suggests that less aggressive assessment will minimize potential harms of managing abnormalities likely to resolve spontaneously.
- HPV genotyping tests are now available. While their use is not required, clinicians electing to use genotyping need guidance on when to use and how to interpret these tests and how results affect management.
2. How were the new guidelines developed?
- Guidelines were developed by 1) conventional literature review and evidence weighting, and 2) risk-based assessment of various management strategies using observational data from KPNC.
- ASCCP convened a steering committee and invited representatives from national professional organizations, government agencies, and advocacy organizations to participate in guidelines development.
- Draft guidelines were created, published online for public comment, revised as needed and presented at a consensus conference in Bethesda, MD, Sept 14-15, 2012.
- All guidelines were passed by at least 66% of voting delegates.
3. How do I access the new guidelines?
- Algorithms are available at www.ASCCP.org
- Full explanatory articles are available at www.jlgtd.com* and www.greenjournal.org*
*Access to full articles may require publication subscription
4. How should I manage women with discordant cotesting results?
- Use cotesting management recommendations only for women ≥30 years of age.
HPV+/Pap- women can be managed in two ways:
- Repeat cotesting in one year, with colposcopy if HPV+ or ASC-US+ (including HPV-/ASC-US) and repeat cotesting in 3 years if cotest results are negative.
- Genotyping, with colposcopy if HPV16+ or18+ and repeat cotesting in 1 year if both HPV 16 and 18 are negative.
- HPV-/ASC-US results should be followed up with cotesting in 3 years, not 5 years, as these women are at marginally higher risk for CIN3+ than women who are cotest negative.
- Women with HPV- /LSIL results can be followed with cotesting in a year (preferred) or with colposcopy. Women with HPV+/LSIL or LSIL/no HPV result should have colposcopy.
- Women with HPV-/HSIL or HPV-/ASC-H are at high risk of high grade precancer and need colposcopy.
- Women with HPV-/AGC are at high risk and need colposcopy, often with endometrial sampling.
5. Why don’t the management algorithms return women to ‘routine’ screening in most instances?
KPNC data analyses show that after many screening and diagnostic abnormalities, from HPV+/Pap- cotesting to treated CIN3, risk for CIN3+ remains higher than after negative cotesting among women without prior abnormality. Therefore, women with abnormalities need more intensive follow-up. Because the KPNC follow up of patients covers less than 10 years, more time will be needed to see if these women can return to routine screening after multiple negative follow-up tests.
6. How should I manage women with unsatisfactory Pap results?
In general, cytology should be repeated in 2-4 months. An exception is that when genotyping is done and shows HPV16+ or 18+, colposcopy is indicated. Colposcopy is also recommended when two consecutive Paps are unsatisfactory.
7. How should I manage women with normal cytology but no or insufficient endocervical cells/transformation zone component?
This varies by age:
- For women 21-29 years of age, routine screening with cytology in 3 years is indicated.
- For women ≥30 years of age, in whom cotesting is preferred, the HPV result guides management:
- If HPV-, routine screening with cotesting in 5 years is indicated.
- If HPV+, then either cotesting in 1 year or genotyping is indicated.
- If HPV testing was not done, then HPV testing is recommended, with management guided by results.
8. How is management modified in women 21-24 years of age?
These low-risk women are at high risk for HPV exposure and lesions, and should be observed.
- After ASC-US or LSIL cytology, no colposcopy is needed. Paps should be repeated annually for 2 years, with colposcopy after 1 year only if HSIL and after 2 years if ASC-US or LSIL persist.
- HPV triage for ASC-US is not recommended, but if done, HPV- women should return to routine screening with a Pap test in 3y, and HPV+ women should have annual cytology testing for 2 years, with colposcopy after 1 year only if HSIL and after 2 years if ASC-US or LSIL persist.
- After ASC-H or HSIL cytology, colposcopy is recommended, but immediate treatment (see-and-treat LEEP) is unacceptable. Women with no CIN2,3 at colposcopy should be observed with colposcopy and cytology every 6 months for up to two years, until 2 consecutive negative Pap tests are reported and no high-grade colposcopic abnormality is observed. Repeat biopsies are indicated if ASC-H/HSIL fail to regress after one year, and diagnostic excision is recommended if HSIL cytology persists for 2 years.
- Management of CIN1 in women 21-24 years of age depends on the antecedent cytology report, since risk for CIN3+ also depends on the cytology result. If the prior Pap was ASC-US or LSIL, observation with annual cytology is recommended. If the prior Pap was ASC-H or HSIL, management depends on colposcopic findings. If colposcopy is inadequate, diagnostic excision is recommended. If colposcopy is adequate, then acceptable alternatives include observation with Pap and colposcopy every 6mo, diagnostic excision, or review of Pap/colposcopy/biopsies.
- When CIN2 is found in young women, observation is preferred but treatment is acceptable. When CIN3 is found in women of any age, treatment is recommended. When CIN2,3, not otherwise differentiated, is found in young women, observation or treatment is acceptable.
9. My lab reports biopsy results using the new Lower Anogenital Squamous Terminology (LAST) (LSIL, HSIL). How do I manage my patients?
Currently there are no outcome data available to determine different management strategies when using the new LAST histopathology terminology. Therefore, until evidence is available, results reported as histologic (not cytologic) LSIL should be managed as CIN1, and histologic (not cytologic) HSIL should be managed as CIN2,3.
10. What HPV tests should I use?
Testing should be restricted to high-risk (oncogenic) HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59).
Guidelines are intended for use only with HPV tests that have been analytically and clinically validated, as documented by Food and Drug Administration (FDA) licensing and approval or publication in peer-reviewed scientific literature
Management based on results of HPV tests that have not been similarly validated may not result in outcomes intended by these guidelines and may increase the potential for patient harm.
11. My patient’s course doesn’t fit into the guidelines. What should I do?
- Clinical judgement is always appropriate.
- As a service to members, ASCCP’s Practice Committee offers guidance on management of special situations. Contact ASCCP at http://www.asccp.org
12. What’s New?
- Returning to ‘routine’ screening
- Managing women with discordant cotest results:
i. (HPV+ /Cytology -
ii. HPV- /Cytology ≥ ASC-US
- Extending adolescent (age <21) management guidelines to women < age 25
- Treating CIN1 on ECC as + ECC or CIN1?
- Managing women with unsatisfactory cytology and specimens missing endocervical or transformation zone components