Updates on Pap Smear Guidelines 2014. David Murphy, D.O. Indiana University Health Southern Indiana Physicians. Objectives. Review current recommendations Develop an algorithm for the appropriate use of screening cytology and HPV testing
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Updates on Pap Smear Guidelines 2014 David Murphy, D.O. Indiana University Health Southern Indiana Physicians
Objectives • Review current recommendations • Develop an algorithm for the appropriate use of screening cytology and HPV testing • Discuss and incorporate into practice the newest ASCCP/ACOG consensus guidelines for management of cytologic abnormalities or (+) HPV testing
Essential Changes From Prior Management Guidelines • Cytology reported as negative, but lacking endocervical cells can be managed without early repeat • Cytology reported as unsatisfactory requires repeat even if HPV negative • Genotyping triages HPV (+) women with 16 or 18 to earlier colposcopy • ASCUS- immediate colposcopy is not an option. Serial cytology at 12 months, and then if negative, cytology every 3 years
Essential Changes (continued) • HPV (-) and ASCUS results should be followed with co-testing q 3 years, rather than 5 years. • HPV (-) and ASCUS results do not allow exit from screening at age 65. • More strategies incorporate co-testing to reduce follow-up visits. • Women aged 21 – 24 are managed conservatively
Risk Factors for Cervical Cancer • HPV infection (16/18) • Early onset of sexual activity (<16) • High number of sexual partners (>4) • Hx of genital warts • Cigarette smoking • HIV seropositive • Immunosuppresive therapy
HPV and Cervical Cancer • Oncogenic (high risk) HPV types account for >99% of cervical cancer • 70% of invasive cervical cancer is due to HPV 16 (60%) and 18 (10%) • Nononcogenic (low risk) • 6/11 • Cause of genital warts • No role for low risk hpv screening in cancer prevention
HPV • Most young women have an effective immune response that clears the infection in an avg of 8 months. • CIN 1 is a manifestation of acute HPV and has a high rate of regression to normal cells • CIN 2 is a mix of low-grade and high-grade lesions • CIN 3 and AIS are cancer precursors • HSIL is associated with a persistent and transforming infection and cancer risk.
Colposcopy • With directed bx remains the standard for disease detection • Technique of choice for treatment decisions • Endocervical sampling
Screening Today • When to start? • When to stop? • How often? • HR HPV testing • Continue in patients after hysterectomy? • No change in women vaccinated against HPV
Principles in Interpreting Guidelines • Strategies developed based on risk where similar risk should have the same management. • Clinical judgment is necessary in application to individual patients. • Current strategies cannot eliminate the risk of developing cancer. • Attempts to eliminate often result in unanticipated harm from excessive evaluation and treatment.
Start screening at age 21 • 0.1% of cervical cancer cases • 1-2 cases/1 million females age 15-19 • US and UK studies demonstrated that earlier screening did NOT decrease cervical cancer rates in this population. • Barnholtz-Sloan, 2009; Sasieni, 2009 • If <21 and screened and abnormality detected, follow guidelines of 21 - 24
Screening 21 - 29 • Every 3 years • Co-testing with HPV should NOT be performed (HPV frequent in this population and >90% will spontaneously clear within 2 yrs)
Screening 30 - 65 • Every 5 yrs • Co-testing of HPV 16/18
Risk Factors for Continued Annual Screening • Hx of CIN2/3/cervical cancer within the past 20 yrs • HIV infection or immunosuppression (transplant recipients) • DES exposure in utero (last used in US >40 yrs ago)
When to stop? • Age 65 and not at high risk for cervical cancer (USPSTF, ACOG, ASCCP) • Discontinuation of screening assumes adequate prior negative screening • Three consecutive negative cytology results or 2 negative cytology results with (-) co-testing within the prior 10 yrs with one within 5 yrs • No prior hx of cervical cancer, CIN2/3. • If any present, continue screening for 20 yrs
When to stop? After hysterectomy (with cervix removal) if no CIN 2/3 or cervical cancer If CIN 2+, and cervix removed, continue screening of vaginal cuff for 20 yrs, even if > 65 If hysterectomy and cervix not removed, continue screening as recommended for age
High Risk HPV Testing • Use as a co-test in women 30 and older • Do not use at all in women < 30 • Not a screening test for STDs • Do not use as a test to determine whether to give HPV vaccine
Unsatisfactory Cytology • Repeat cytology in 2 – 4 months is recommended, with a negative or unknown HPV result • Triage using reflex HPV testing not recommended • Treatment to resolve atrophy or obscuring inflammation is acceptable • If 30+ with (+) HPV co-test, repeat cytology in 2-4 months or colposcopy is acceptable. • Colposcopy if 2 consecutive unsatisfactory cytology results.
Negative Cytology but EC/TZ Absent/Insufficient • 21 – 29: routine screening is recommended; HPV testing is unacceptable • 30+: HPV testing preferred. Repeat cytology in 3 years if not performed. If HPV (-) return to routine. • If HPV 16 or 18 (+), colposcopy, if (-) then repeat cytology in 1 yr • Not associated with an increased incidence of cervical disease after treatment of high grade disease
>30 Cytology Negative, (+) HPV • Repeat cytology in 1 year is acceptable • If repeat is (+) HPV, or ASCUS or worse, then colposcopy. • If repeat cytology (-) and HPV (-), then repeat 3 yrs • Risk of CIN 2+ is small with single HPV (+) and negative cytology. • Reflex testing of 16/18 if HPV (+) is acceptable
Women >25 with ASCUS • Reflex HPV testing is preferred. If neg, then recheck 3 years with co-testing • (+) HPV- colposcopy with ECC. If no CIN identified, then recheck pap w co-testing in 12 months • If ASCUS and no HPV results, repeat cytology at 1 year is acceptable • If >65, considered abnormal and should be rechecked in 12 months
ASCUS with (-)HPV and 3 year f/u • Risk of CIN 3 if ASCUS and HPV (-): 0.28% (Stoler 2011) • 5 year f/u (no treatment): CIN 3 – 0.54% (Katki 2011) • Normal cytology control (no HPV testing): risk of CIN 3 at 5 year f/u is 0.36%
ASCUS – new recommendations • ASCUS and HPV (-) co-testing in 3 years • ASCUS and HPV (+) colposcopy • ASCH manage like HSIL colposcopy
Low-Grade Squamous Intraepithelial Lesions (LSIL) • Major determinant in treatment is age • 21 – 24 • HPV status in 25+ • Routine co-testing in 30+ • Here is where reflex co-testing is acceptable • Reflex testing is NOT recommended in 21 - 24
HSIL in 25+ • Immediate LEEP or colposcopy is acceptable, except in special populations. • Diagnostic excisional procedure is recommended when colposcopy is inadequate EXCEPT pregnancy • ~60% have CIN 2+ on colposcopically directed bx and 2% have cervical cancer • 5 yr cancer risk is 8%among women aged 30+
ASC-H or HSIL 21 - 24 • Colposcopy • When CIN 2+ not identified, observation for up to 24 months using BOTH colposcopy and cytology testing at 6 month intervals is recommended. • If HSIL persists without identification of CIN 2+, a diagnostic excision procedure is recommended.
Atypical Glandular Cells • Colposcopy with ECC, regardless of HPV • Endometrial biopsy in 35+, or other risk of endometrial hyperplasia • May be associated with benign disease (e.g., polyps, reactive changes), BUT can be due to adenocarcinoma of the cervix, endometrium, fallopian tube, or ovary • 9 – 38% have significant neoplasia (CIN 2, AIS, or cancer) • 3 – 17% have invasive cancer
Subsequent Management of AGC • AGC-NOS: if CIN 2+ not identified, co-testing at 12 and 24 months recommended. • If both co-test results are neg, repeat co-testing in 3 yrs • AGC “favor neoplasia” or endocervical AIS: if invasive disease not identified at initial colposcopy diagnostic excisional procedure recommended
Endometrial Cells with Cervical cytology • No further evaluation in asymptomatic premenopausal women • If postmenopausal, endometrial assessment is recommended regardless of symptoms. • No further evaluation with benign glandular cells following hysterectomy
25+ and colposcopy demonstrates CIN 1 or less • Co-testing at 1 yr. If both neg, then age-appropriate retesting in 3 years recommended. • If CIN persists for at least 2 years, either continued f/u or treatment is acceptable. • A diagnostic excision procedure is recommended if colposcopic exam is inadequate
25+ after colposcopic evaluation of ASC-H or HSIL • If CIN 2 not present on histology, then either diagnostic excisional procedure or observation with co-testing at 12 and 24 months are acceptable. • If any result is abnormal repeat colposcopy • If repeat HSIL at either 1 or 2 yr visit diagnostic excisional procedure.