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Cervical Cytology Screening and Management Guidelines 2013: Case Based Discussion

Cervical Cytology Screening and Management Guidelines 2013: Case Based Discussion. Evelyn Kieltyka, MSN, MS, FNP April 25, 2013 Maine Nurse Practitioner Association Spring Conference. Learning Objectives Summarize the current evidence for initiation and repeat testing across the lifespan

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Cervical Cytology Screening and Management Guidelines 2013: Case Based Discussion

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  1. Cervical Cytology Screening and Management Guidelines 2013: Case Based Discussion Evelyn Kieltyka, MSN, MS, FNP April 25, 2013 Maine Nurse Practitioner Association Spring Conference

  2. Learning Objectives • Summarize the current evidence for initiation and repeat testing across the lifespan • Detail the management of cervical cytology results utilizing the latest national clinical practice guidelines • Prevent overzealous management of precursor lesions

  3. Cervical Cancer Screening • Most successful cancer screening program in the US • -70% reduction in cervical cancer deaths in past 60 years • Most expensive cancer screening program in the US • Long-standing public health messages drive consumer behaviors, beliefs, and preferences • Advances in cervical cancer prevention • -Evidence-based cytology screening intervals • -Cytology technology: liquid-based cytology (LBC) • -Adjunctive test modalities: HPV-DNA testing • -Primary prevention through HPV vaccination

  4. Designing Cytology Screening Intervals • Screening interval of any test depends upon • -Error rate of screening test • (less sensitive→ more often) • -Progression rate of disease • (faster transit → more often) • Cervical cancer risk factors don’t impact interval • -(Slow) rate of growth of pre-invasive the same, irrespective of behavioral risk factors • -When transit time is faster (e.g., HIV positive, immunocompromise), then screen more often

  5. Evolution of Cervical Cancer • Screening Intervals • 1940-1989: annual “pap smear” for all women • -Linkage of “annual pap smear” to “annual health exam” • 1987: Walton Commission (British Columbia) • -Cytology screening every 3 years • 1989: AMA, ACOG, AMWA Consensus Statement • -Annually, starting at sexual activity or 18 years old • -After 3 negative smears, testing may be done less frequently • -Longer intervals based on the absence of risk factors

  6. Evolution of Cervical Cancer • Screening Intervals • 2002: American Cancer Society • -Start screening 3 years after first intercourse or at 21 y.o. • -Stop after hysterectomy for benign disease and at 65-70 y.o. if 3 normal and no abnormal results in the prior 10 years • -Everyone else: every 2-3 years • -Inform virginal women of screening “benefits and harms” • -If co-testing (HPV and cytology) result is negative/negative, re-screen “no earlier than every 3 years”

  7. Cervical Cytology Guidelines ACOG Practice Bulletin #109 (2009)

  8. USPSTF Cervical Cytology Guidelines March 2012

  9. Triple A Guideline: ACS, ASCCP, American Society for Clinical Pathology CA Cancer J CLIN March 2012 *If cytology result is negative or ASCUS + HPV negative

  10. Summary of Important Guideline Changes • 1st time that all 3 organizations involved with cervical cancer prevention and the USPSTF have endorsed equivalent guidelines • Co-testing is “ready for primetime” for women ≥ 30 • -But, co-testing every 5 years (NOT every 3 years) • Women 21-29: cytology every 3 years (NOT 1 or 2) • Stop screening women under 21 years of age • Stop screening women 65 and older if negative results and adequate prior screening

  11. HPV DNA + Cytology (“Co-testing”) • Wright, Obstetrics Gynecology 2004; 103:304 • Indications: • Women 30 years old and older • Immunocompetent • Cervix in place • Improves sensitivity over cytology alone or HPV-DNA alone • Very high negative predictive value; screen women who are HPV negative/cytology negative “no earlier” than 3 years

  12. Why Start Cervical Cytology at 21? • Most HPV infections are transient • When HPV infection persists, transit to cancer is quite long • Spontaneous regression of low grade lesions is common • Invasive cervical cancer is very rare in 15-19 year olds • -14 cervical cancers annually • -1-2 cases per 1 million women • In teens, screening does not reduce mortality • -Cervical cancer rates have not changed since 1973-1977, before practice of screening at 18 or first intercourse • ACOG Practice Bulletin No. 109, Dec 2009

  13. Why Start Cervical Cytology at 21? • Consequences of over-screening and over-treatment • -Psychological effects of screening, abnormal results, and treatment, including effects on sexual function • -After LEEP, doubling or tripling of preterm birth • Screening women < 21 may be harmful and lacks benefit • -Don’t begin until 21, regardless of first intercourse • ACOG Comm on Adolescent Health Care (6/2010) • -If being followed for an abnormal result, continue • ACOG Practice Bulletin No. 109, Dec 2009

  14. Discontinuation of Cervical Cytology • Women with a cervix • -May discontinue at 65 if low risk and after 3 consecutively negative tests in the prior decade • -Continue routine cytology if history of high-grade precancerous lesion 20 years after treatment or regression • Women with a total hysterectomy • -If benign pathology, discontinue routine screening • -Women who had high-grade CIN lesions can develop VaIN or carcinoma at the vaginal cuff years later • USPSTF June 2012

  15. Cervical Cytology in High Risk Women • Do not increase the screening interval beyond annual testing for women who are: • -HIV-positive • -Immunosuppressed (e.g., transplant) • -Were exposed in utero to diethylstilbestrol • Follow guidelines for women who have been treated for CIN 2 or 3 or adenocarcinoma in situ • ACOG Practice Bulletin No. 109, Dec 2009

  16. Other Important Messages • Women at any age should not be screened annually by any screening method • Do not screen any women under 21 years of age • For women 65 and older • -“Adequate screening” is defined as: • -3 consecutively negative results in prior 10 years, or • -2 negative co-tests, most recently within 5 years • -If screening stopped, do not restart for any reason • Women who have been treated for CIN 2+ or AIS must be regularly screened for 20 years, even if 65 or older • -With cytology alone Q 3 years or HPV+ cytology Q5 years

  17. Common Questions About • Cytology Intervals • Do virginal women need Pap smears? • Are the intervals any different for women: • -With multiple sexual partners? • -Using hormonal contraceptives, menopausal hormone therapy? • -Who only have female partners? • -Who are pregnant? • If a cytology is not scheduled or necessary, what about the need to perform a screening bimanual pelvic exam?

  18. 2012 Updated Consensus Guidelines for Management of Cervical Cancer Screening Tests and Cancer Precursors by the American Society for Colposcopy and Cervical Pathology -47 experts representing 23 professional societies, national and international health organizations and federal agencies. -Met in Bethesda MD, September 14-15 2012. -Goal to provide evidence-based consensus.

  19. HPV Positive, Cytology Negative • Occurs in 11% of women aged 30 to 34 years; 2.6% of women aged 60 to 65 years • Option 1: repeat co-testing in 12 months • -If HPV-positive or ASC-US+: colposcopy • -If HPV-negative or Cytology negative: rescreen with co-testing in 3 years • Option 2: reflex test for HPV16 or HPV16/18 genotypes • -If HPV16 or HPV 16/18 positive: colposcopy • -If HPV16 or HPV 16/18 negative: co-test in 12 months • Then manage as in option 1 • Do not immediately colposcope HPV positive/cyto negatives

  20. HPV + Cytology Co-Testing: Benefits • Compared to cytology alone, slightly improved cytology accuracy and earlier diagnosis of CIN 2+ • High negative predictive value important in women unable or unwilling to have every 3 year screening • While each co-test is more expensive, longer intervals and very high NPV could reduce overall costs • Alignment with clinical screening practices for many commercial health plan patients • -Cervical co-testing is a preventive service required by the ACA to be covered without cost-sharing

  21. HPV + Cytology Co-testing: Concerns • For women who are HPV Negative/cytology Negative , and who are re-screened earlier than 5 years, there is risk of: • -More false positive tests, leading to unnecessary colposcopies, biopsies, and treatments • -Default to a less cost-effective screening • Neither providers nor consumers have a motive to limit utilization as recommended by guidelines • Most healthcare systems have no mechanism to enforce the guidelines unless a robust EMR is available

  22. Unsatisfactory Cytology • Occurs 1% or less across all preparation types • Repeat Cytology in 2 to 4 months • -Treat a infection if present • -Reflex HPV testing is NOT recommended • Women 30 years old and older co-tested HPV Positive • -Repeat Cytology in 2 to 4 months OR • -Colposcopy • Women 30 years old and older-co-test HPV Negative • -Repeat Cytology in 2 to 4 months • -Repeat HPV test

  23. Cytology Negative but with EC/TZ Absent/Insufficient • Occurs in 10% to 20% and higher in older women • Women aged 21 to 29 years old • -Routine Screening-Repeat Pap in 3 years • -HPV Testing is Unacceptable • Women aged 30 years and older • -HPV testing is preferred if unknown • -HPV Positive-Repeat both tests in one year OR • -Genotyping for type 16/18 • If positive-Colposcopy • If negative-Repeat both tests in one year.

  24. Atypical Squamous Cells of Undetermined Significance (ASC-US) • Most common cytological abnormality • Option 1 : repeat Cytology in 12 months • -If Negative-Cytology in 3 years • -If ASC or greater-Colposcopy • Option 2 Preferred: Reflex HPV Testing • -If Positive: colposcopy • -If Negative: Repeat Co-testing in 3 years (Exception: women 65 years old-repeat screening in 12 months; co-testing preferred)

  25. ASC-US or Low-grade Squamous • Intraepithelial Lesion • Women Aged 21 to 24 years • Option 1 Preferred: repeat Cytology in 12 months • -If Negative, ASC-US, or LSIL repeat Cytology in 12 months (Negative X2: routine screening) • -If ASC-H or greater-Colposcopy • Option 2: Reflex HPV Testing (ASC-US only) • -If Positive: repeat Cytology in 12 months • -If Negative: Repeat Cytology in 3 years • Note: Even with a Positive HPV: Immediate Colposcopy is NOT Recommended

  26. Low-grade Squamous Intraepithelial Lesion (LSIL) • Negative HPV Test: repeat Cytology in 12 months • -If Negative Cytology and HPV: repeat Co- testing in 3 years • -If all tests negative at 3 years: routine screening is recommended • -If ASC or greater OR HPV Positive-Colposcopy • Positive or No HPV Test • -Colposcopy

  27. Case 1 • 33 year old woman with a history of HSIL/CIN3 treated with LEEP one year ago • At 12 months she has had Negative cytology/ Negative HPV • How long will she need “regular screening”? • 3 years • 10 years • 20 years • The rest of her life • What are her options for “regular screening”?

  28. Case 2 • 36 year old woman screened recently with co-testing. • The result returned cytology negative, HPV positive • What are her management options? • Repeat co-testing in 6 months • Repeat co-testing in 1 year (acceptable) • Reflex to a HPV 16/18 test (acceptable) • Colposcopy

  29. Case 3 • 19 year old woman is seen for contraceptive services and a well woman visit • Has been sexually active for 6 months; 2 serial partners • Has never had a cervical cytology or a speculum exam • According to the USPSTF and ACOG, which screening tests does she need?

  30. Check Up Visit: • 19 Year Old Female • Clinical breast exam • Cervical cytology (Pap smear) • Bimanual pelvic exam • Chlamydia NAAT • Gonorrhea NAAT • HIV-1 serology • HSV-2 serology • Syphilis (VDRL or RPR) • Hepatitis B serology • HPV test (Hybrid Capture)

  31. Check Up Visit: • 19 Year Old Female • Clinical breast exam • Cervical cytology (Pap smear) • Bimanual pelvic exam • Chlamydia NAAT • Gonorrhea NAAT • HIV-1 serology • HSV-2 serology • Syphilis (VDRL or RPR) • Hepatitis B serology • HPV test (Hybrid Capture)

  32. Routine Pelvic Examination and Cervical Cytology Screening • ACOG Comm on Gyn Practice, #431, • OG 2009; 113:1190 • The annual pelvic exam • -Is not a routine part of annual assessment for women 13-20 years old, unless medically indicated • -Is a routine part of preventive care for women 21 years old or older, even if cytology is not needed • No justification or evidence offered

  33. Case 4 • An 18 year old woman is seen for a well woman visit • She had been seen exactly one year ago at the same clinic at which time cytology showed LSIL • Given that she is < 21, should she have a cytology today? • Yes • No • If performed, with a benign result, what should be done? • Repeat in one year • Repeat when she turns 21 years of age

  34. Case 5 • A 30 year old woman is seen today for her well woman visit and a refill of her OC prescription • Review of her record shows that she has a HSIL cytology result last year that was not followed up • Would you refill her OC prescription? • Yes • No • Regarding her HSIL result a year ago, would you: • Refer her for colposcopy • Repeat a cytology today • Repeat her cytology today and refer her for colposcopy

  35. Case 6 • 42 year old woman seen for her well woman visit • She had cervical co-testing one year ago: negative/negative • Her mother died of invasive cervical cancer at 65 y.o. • Since she is anxious, she insists on co-testing today • Would you perform co-testing for her today? • Yes • No • If she had a negative cytology (only) one year ago? • Yes • No

  36. Case 7 • A 67 year old woman is seen for a well woman visit • Cytology performed; age 64, age 62 and age 61 results is Negative-Pap test only • Do you perform a Pap Test? • Yes • No • If she had CIN 3/LEEP at age 50 years old? • Yes • No

  37. For more information: Evelyn Kieltyka, MSN, MS, FNP Senior Vice President of Program Services Family Planning Association of Maine ekieltyka@fpam.org (207) 622-7524

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