Current guidelines for Cervical Cancer Screening Rachael Chambers, DO May 29, 2015.
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Transcript of Current guidelines for Cervical Cancer Screening Rachael Chambers, DO May 29, 2015.
Current guidelines for Cervical Cancer Screening
Rachael Chambers, DO
May 29, 2015
Objectives
• Review current cervical cancer screening guidelines
• Discuss role of HPV testing in cervical cancer screening
• Discuss role of primary HPV testing in cervical cancer screening
Background
• Initial Bethesda system classification – revised in 2001
• ASCCP consensus conference 2006• Updated guidelines in 2008
– Not from a national consensus conference
• 2012 follow up consensus conference– Data from KPNC, NCI, ALTS
2012 Consensus Conference
• 47 experts • 23 professional societies• Goal to provide revised evidence-based
consensus guidelines for managing women with abnormal cervical cancer screening tests, cervical intraepithelial neoplasia and adenocarcinoma in-situ
Major changes 2012 guidelines
• ECC showing CIN 1 – manage as CIN 1
• Repeat unsatisfactory cytology– Even when HPV results are known
• Negative cytology with absent or insufficient endocervical cells can be managed without early repeat
Major changes 2012 guidelines
• Genotyping triages HR HPV positive women to colposcopy earlier after negative cytology– Colposcopy indicated for ASCUS +HPV
regardless of genotyping
• HPV negative ASCUS– Follow up at 3 years with co-testing
– Not sufficient for exiting women from screening at age 65
Major changes 2012 guidelines
• CIN 2+ follow up is more clearly defined with incorporation of co-testing
• Women age 21-24– Conservative management
– Pap only
– Co-test in certain circumstances
• Incorporate co-testing post colposcopy
Guidelines
• Available at:• www.asccp.org/Portals/9/docs/ASCCP%20Mana
gement%20Guidelines_August%202014.pdf
• App available for iPad, iPhone and Android
Routine Screening
• Cytology every 3 years• Co-testing every 5 years
– Women age 30-64 only
• Multi-year intervals ok only if risk of developing CIN 3+ is low
Case 1
• 55 year old G2P2• Menopause at age 52• No history of abnormal pap testing• Pap test with physical shows:
– Insufficient cellularity. HPV co-testing is negative.
• Now what?
Unsatisfactory Cytology
• 1% or less across all preparations• Decreased with use of liquid based pap• Most cases now due to insufficient squamous
cells
Case 2
• Same patient as in Case 1• Now pap test shows normal results, but no
EC/TZ• HPV remains negative
• Now what?
Cytology NILM but EC/TZ Absent/Insufficient
• Suggests squamocolumnar junction may not have been adequately sampled
• Reported rates 10-20%• More prevalent in older women• Good specificity and negative predictive value• HPV testing is independent of TZ sampling
– Adds margin of safety when co-testing is performed.
Management
• Age 21-29: routine screening• Age 30-64
– HPV negative: Routine screening
– HPV unknown: Test for HPV or repeat cytology in 3 years
– HPV positive: Cytology +HPV in 1 year or HPV genotyping
Case 3
• 32 year old G1P0• No previous pap testing available• Here for initial prenatal care• How do we screen her?
Case 3 continued
• Pap test normal• HPV co-test is positive
• Now what?
Management Negative Cytology, HPV positive
• Due to increased risk for CIN 3+ if hrHPV positive guidelines balance risk of observation vs intervention
• Return for earlier retesting• HPV genotyping
– Higher risk of CIN 3+ with type 16/18
• Colposcopy if 1 year follow up is ASC or HPV + or immediately if HPV 16/18 are positive
Case 4
• 30 year old referred to you for management of ASCUS pap
• What else do you want to know?
• Was she HPV co-tested?
Atypical Squamous Cells of Undetermined Significance
• Most common cytologic abnormality• Lowest risk of CIN 3+
– 2/3 are NOT HPV associated
• Women >60 years have higher risk for cervical cancer even if HPV negative compared to women with negative co-testing.
ASC-US
• Reflex HPV testing preferred– Type 16/18 positive women have twice the risk of
CIN 3+ compared to other hrHPV positive women
• HPV negative– Repeat cotesting in 3 years
• HPV positive– Colposcopy
– If no CIN co-test at 12 months
ASC-US
• Cytology only– Repeat cytology in 1 year
– Colposcopy if > ASC
– Routine screening if normal
ASC-US in Special Populations
• Postmenopausal– Manage the same as general population
• Women age 65 and older– Repeat screening in 1 year when considering exit
from screening• Cytology• Co-testing (preferred)
ASC-US in Special Populations
• Pregnant women– Identical to nonpregnant women
– Acceptable to defer colposcopy until 6 weeks postpartum
– ECC is unacceptable
– If no suspected CIN 2+ at initial colposcopy, follow up postpartum
Case 5
• 21 year old, G0• No previous pap test• Seen for complete physical• Pap test shows LSIL.
• What next?
Young Women
• No screening before age 21• Routine screening with initial normal pap test is
every 3 years– Cervical CA risk is low through age 25
– HPV is common
– Most lesions will regress
• Less intensive management• Encourage HPV vaccination, smoking cessation
Young women
• ASCUS/LSIL Cytology every 12 months preferred– HPV reflex is acceptable
• Follow up is repeat cytology if positive• Routine screening if negative
• Colposcopy only if ASC-H, AGC, HSIL at follow up
Low-grade Squamous Intraepithelial Lesions
• ALTS Trial showed natural history to be similar to ASC-US HPV+
• Women 21-24 have lower risk CIN 3+• Estimated 77% of LSIL are HPV positive
LSIL Management
• Colposcopy (recommended)– Manage based on colposcopic findings
• If co-test is negative, repeat co-test in 1 year– If cytology negative and HPV negative
• Repeat co-testing in 3 years
– If >ASC or HPV positive• Colposcopy
LSIL Management
• Pregnant women: – Colposcopy preferred
• ECC unacceptable• Acceptable to defer until 6 weeks postpartum
– If no CIN 2+, follow up post partum
LSIL Management
• Postmenopausal– Obtain HPV test
– Repeat cytology at 6 and 12 months
– Colposcopy
– Repeat cytology in 12 months if HPV negative or no CIN on colposcopy
– If HPV+ or ASC-US or greater on repeat cytology perform colposcopy
– Routine screening after 2 negative cytology
Atypical Squamous Cells, Cannot Exclude High-Grade
Squamous Intraepithelial Lesion• Higher risk of CIN 3+ compared to ASC-US or
LSIL– Risk also elevated for women age 21-24, but
overall CIN 3+ risk remains lower than older women
ASC-H Management
• Colposcopy for all women• High rate of HPV + makes reflex testing
unsuitable• 5 year cancer risk among ASC-H, HPV negative
is 2%
High-Grade Squamous Intraepithelial Lesion
• CIN 2+ identified in 60% of women at colposcopy
• Consider immediate excision of transformation zone
• Cervical cancer found in 2% at colposcopy– Risk rises with age
– Risk modifies with HPV result
• HPV result from co-test may help inform choice
Management HSIL
• Immediate LEEP• Colposcopy
– Diagnostic excisional procedure recommneded for inadequate colposcopy
• Except if pregnant
HSIL in Young Women
• Colposcopy– If no CIN 2+ observe with colposcopy and
cytology at 6 month intervals for 24 months.
– If CIN 2/3 present manage with colposcopy and biopsy or treat
Atypical Glandular Cells
• Interpretation is poorly reproducible and uncommon
• Associated with – Polyps – Metaplasia– Neoplasia
• Adenocarcinomas– Endometrium, cervix, ovary, fallopian tube and other
sites
AGC
• Risk of neoplasia higher if reported as AGC favor neoplasia or AIS
• Cancer risk is lower in women <35, but risk of CIN 2+ is higher
• Commonly associated with squamous lesions including CIN 1
AGC Management
• Colposcopy with ECC• Do not use HPV testing to triage• Endometrial sampling is recommended in
women 35+– Also for women <35 if clinical indictors suggesting
risk for endometrial neoplasia.
• If no CIN 2+ co-test at 12 and 24 months and routine screening if both are negative.
PRIMARY HPV SCREENING
What’s next?
Primary hrHPV screening
• Rate of hrHPV is common in sexually active population
• Most infections are transient• FDA previously approved hrHPV testing
– For triage of ASCUS
– Adjunct to cytology for women age 30+
• April 2014 FDA approved labeling of hrHPV assay to include primary hrHPV screening in women 25+
Primary hrHPV screening
• Highly sensitive• Specificity depends on subsequent evaluation
strategies and screening frequencies
2011 guidelines
• American Cancer Society, American Society for Colposcopy and Cervical Pathology and American Society for Clinical Pathology
• “in most clinical settings, women age 30-65 should not be screened with HPV testing alone as an alternative to co-testing at 5 year intervals or cytology alone at 3 year intervals”
Consensus panel
• Met via conference call and face to face• Invited to scientific summary presentation by
Roche Diagnostics of the Addressing the Need for Advanced HPV Diagnostics (ATHENA) trial
• MEDLINE database review– 11 papers reviewed in addition to significant
papers published prior to November 2011
Consensus panel: Primary question
• Is hrHPV testing for primary screening as safe and effective as cytology-based screening?
• Negative hrHPV provides greater reassurance of low CIN3+ risk than negative cytology.– Several large trials have evaluated this
Consensus panel: Primary question
• Can primary hrHPV screening be considered as an alternative to current US cervical cancer screening methods?
• hrHPV can be considered as an alternative to current cytology-based screening because of equivalent of superior effectiveness.
Additional questions
• How Should Positive hrHPV be managed?– Combination of triage of genotyping and reflex
cytology appears to be a reasonable approach• Based on data from ATHENA and other studies
• What is the Optimal Screening interval?– No sooner than every 3 years
• Limited data available
Additional questions
• At What Age Should One initiate primary HPV screening?– Not before age 25
Additional questions
• How does the performance of primary hrHPV screening compare to co-testing?– Most reassurance from co-test comes from the
HPV component.
– Data shows the 3 year risk following HPV negative test is less than the 5 year risk following co-testing.
– Primary hrHPV test every 3 years is at least as effective as 5 year co-testing.
• Currently only 1 hrHPV test is FDA-approved for primary screening.
• Comparative effectiveness studies are needed • Look for future updates
Summary
• Cervical cancer screening continues to evolve.• Trend is toward less invasive methods of
screening and managing.• hrHPV screening may become the primary
screening tool in the future.
References
• Massad, et al. 2012 Updated Consensus Guidelines for the Management of Abnormal Cervical Cancer Screening Tests and Cancer Precursors. Journal of Lower Genital Tract Disease, Volume 17, Number 5, 2013, S1-S27.
• Huh , et al. Use of Primary High-Risk Human Papillomavirus Testing for Cervical Cancer Screening: Interim Clinical Guidance. Journal of Lower Genital Tract Disease, Volume 19, Number 2, 2015, 91-96.
• Partridge et al. Cervical Cancer Screening: Featured Updates. Journal of the National Comprehensive Cancer Network. Volume 12, number 3, march 2014, 333-341.
• ACOG Practice Bulletin. Management of Abnormal Cervical Cancer Screening Test Results and Cervical Cancer Precursors. Number 140, Volume 122, No. 6, December 2013, 1338-1367
• Saraiya, et al. Evolution of cervical cancer screening and prevention in United States and Canada: Implications for public health practitioners and clinicians. Preventive Medicine, Volume 57, 2013, 426-433.
• Dinkelspiel and Kinney. State of the Science: Cervical cancer screening in transition. Gynecologic Oncology, 133, 2014, 389-393.
• Cannistra and Niolff. Cancer of the Uterine Cervix. The New England Journal of Medicine. Volume 334, number 16, 1996, 1030-1038.