Lauren O Sullivan, D.O. February 19, 2015

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1 Lauren O Sullivan, D.O. February 19, 2015

2 1. Review basics of Pap smear, cervical dysplasia/cancer and HPV infection. 2. Review 2012 updated screening guidelines. 3. Discuss how and where to find updated management guidelines/algorithms. 4. Discuss HPV vaccination (old and new) and how to achieve higher rates of vaccination.

3 George Papanicolaou, developed the Pap smear in the 1930 s. Widely implemented in mid-1950 s. The Pap smear has been the most successful cancer screening technique in the history of medicine. Pap has become a household word that most women incorporate into their yearly medical routine.

4 For the first 40 years we used the conventional Pap smear Used spatula to scrape cells off the cervix and literally smear them onto a microscope slide Several limitations of conventional Pap 1996 liquid-based cytology (Thin Prep) was FDA approved and since then accounts for 90% of Pap s

5 Uses a broom instead of spatula to sweep cells from both endo- and ectocervix Use water-based gel sparingly on posterior blade only Twist broom 2 full turns clockwise

6 Then sent to lab where centrifuged (separates out blood, mucous, semen) Spread by machine in thin mono-layer More uniform Easier for pathologists to see single cell characteristics Thin Prep don t have to reschedule due to bleeding, intercourse, infection etc.

7 Since implementation 1950 s, the Pap smear has reduced the rate of cervical cancer by 70%. Reduced mortality by 50%.

8 According to American Cancer Society This year alone in the U.S. there will be 13,000 new cases of cervical cancer This year alone in the U.S. there will be 4,000 deaths from cervical cancer This is a PREVENTABLE cancer

9 Cervical cancer ranks #21 on list of cancers that affect women Median age at diagnosis = 49yo Median age at death = 57 5 year overall survival is 68% Stage 1 = 90% Stage 4 = 16%

10 In U.S. risk by Ethnicity: Hispanic African American Asians/Pacific Islanders Caucasian Risk by Age:

11 1. Anxiety over a positive test 2. Stigma of an STI 3. Pain/bleeding from colposcopy or conization 4. Treatment-related pregnancy complications

12 Treatment for cervical dysplasia is conization 3 types popular over the years Cold-knife cone LASER cone LEEP cone

13 1. Women who ve had a LEEP are more likely to have: Preterm birth (O.R. 1.7) Low birth weight (O.R. 1.8) PPROM preterm premature rupture of membranes (O.R. 2.7) 2. These increase with # and depth of cones 3. All types Cold vs. LEEP vs. LASER

14 For the first time separating pap & annual exam Educate women that pap annual exam Patient: I am here for my Pap. Doctor: You don t need a Pap for 5 years. Patient: Great! See you in 3 years! Doctor: No, you still need an annual exam annually. Analogy: Pap is to annual exam as dental xrays are to teeth cleaning

15 As screening interval increases, significance of each Pap is increased Important to do them correctly and on schedule Many missed opportunities for STI, pregnancy prevention, counseling, other cancer screening, menopause, etc

16 Prevent morbidity and mortality from cervical cancer Prevent overzealous management of precursor lesions - that would otherwise spontaneously resolve Prevent treatment that would incur higher risk than benefit

17 American Cancer Society (ACS) American Society of Colposcopy and Cervical Pathology (ASCCP) American Society of Clinical Pathology these 3 groups formed 6 working groups that looked at the research from

18 1. Optimal screening interval 2. Screening women 30+ y.o. 3. Managing discordant Pap/HPV results 4. Impact of HPV on screening 5. Potential for HPV-only screening (without Pap) 6. Exiting women from screening

19 1. Preventing 100% of cervical cancer is unrealistic 2. Performing Pap alone every 2-3yrs has a good risk: benefit ratio 3. Women at similar risk for cervical cancer should be managed the same 4. Conventional and liquid-based technology perform the same

20 1. HPV tests in use should have >90% sensitivity for CIN 2+ and CIN3+. (Not all FDA-approved HPV tests necessarily meet that criteria). 2. CIN3 is more reasonable treatment threshold than actual cancer 3. Earlier detection of CIN3+ better than later 4. Risk of developing cancer between screening intervals should be unlikely

21 When to begin screening? Screening begins at age 21 Women < 21yo should NOT be screened regardless of age of sexual activity

23 Women < 21 still need: Contraception STI screening/treatment by urine Treatment for irregular or heavy bleeding Do not need: Speculum exam with rare exception STI screening can be done by urine

24 Cytology alone every 3 years HPV testing should NOT be used to screen Do not do cotesting Do not do HPV alone

25 Sensitivity of single Pap 50-70% Having 3 negative paps After 18 months cancer risk = 1.5/100,000 After 36 months cancer risk = 4.7/100,000 99, 997 women screened unnecessarily to prevent 3 cancers Risk of HSIL/cancer <3yrs after negative pap is not significantly higher than after 1 yr Interval longer than 3yrs inappropriate for very mobile population

26 Screening Q1yr = 2000 colpos/1000 women Screening Q2yrs = 1080 colpos/1000 women Screening Q3yrs = 760 colpos/1000 women

28 Incidence of HPV in this population approaches 20% Most HR HPV infections resolve spontaneously Positive HPV results in this age group result in procedures, call backs and anxiety for no added value in cancer prevention

29 Preferred Cytology + HR HPV (cotest) every 5 years Acceptable Cytology alone every 3 years

30 Minimizes colposcopy Increases detection of AIS and adenocarcinoma of the cervix Increases detection of CIN 3

31 Some sites may lack access to HPV testing Financial Logistical Cytology still remains effective Requires more visits Requires more colposcopy for equivocal results

34 Stop at age 65yo if: Adequate negative prior screening No hx CIN 2+ in the past 20yrs Adequate negative prior screening defined: 3 negative pap s in the past 10yrs (at least 1 within the past 5yrs) Or 2 consecutive negative HR HPV tests Screening should not resume for any reason, even if she has new partners

35 HPV still present in 5-10% of women at that age but very unlikely to lead to cancer within remaining lifetime CIN 2+ unusual after age 65yo Colpo/evaluation/treatment all more difficult so harms of overtreating are magnified

36 After hysterectomy if Cervix removed a total hysterectomy Increased # of hysterectomies that are supracervical means cervix still in situ and needs screening No history of CIN 2+ Do not need adequate negative prior screening

37 Rate of vaginal cancer is 7/1,000,000/year Risk of Pap abnormality after hyst is 1/100 Followed 2,000 women after hyst for 7yrs 3% had VAIN, 0 had vaginal cancer Risk of vaginal cancer post hysterectomy is analogous to male breast cancer for which routine screening is not recommended

38 History of CIN2, CIN3 or AIS in the past 20yrs (Continue screening for 20yrs from resolution even if that extends beyond age 65)

39 Follow same screening guidelines for vaccinated women Some women do not recall correctly whether they completed series at correct intervals Some women are NOT HPV naïve when vaccinated allow up to age 26

40 What do I do with discordant results? Pap = ASCUS HR HPV = negative treat as if both negative follow age appropriate screening Pap = negative HR HPV = positive or repeat cotesting in 12 months do genotype testing for HPV 16/18

41 What do I do with discordant results? Pap = negative HR HPV = positive repeat cotesting in 12 months or if both negative routine screening if either positive - colpo do genotype testing for HPV 16/18 if 16/18 negative routine screening if either positive - colpo

42 Go to Info on Screening Under guidelines select screening guidelines Info on Management (when Pap abnormal) Under guidelines select screening guidelines

43 Quadrivalent vaccine (Gardasil) HPV 16/18 account for 75% of cervical cancer HPV 6/11 account for 90% of genital warts Approved in 2006 for girls and 2011 for boys Series of 3 shots over 6 months Now almost universally covered by insurance

44 President s Annual Cancer Report Target vaccination rate is 80% In 2012: Girls age % had received 1 shot 33% had completed all 3 shots Boys age % received 1 shot 6% received all 3 shots

45 Just approved by FDA in December 2014 Includes Gardasil additional HR HPV strains Protects against cancer of: Cervix Vulva Vagina Anus Mouth and throat?

46 Same target age group 9-26 both boys and girls Same injection schedule series of 3 shots Given at O, 2 and 6 months The 5 added strains increase protection against cervical cancer from 75% 90%

48 Reduce missed clinical opportunities 1. One survey of 11-17yo boys and girls that have not received vaccine 80% had been to doctor in that past 12 months 2. Like you incorporate other cancer or accident prevention talks smoking cessation, seatbelts

49 1. Interval for Pap s has changed to Q3yrs for 21-29yo, and 5 years with cotesting for year olds. 2. Pap is NOT equivalent to annual exam. Women still need annual exams annually. 3. Physicians need to communicate clearly and strongly that HPV vaccination is safe and recommended to boys and girls.

50 NORMAL ASCUS LSIL HSIL CANCER? ASCUS HR HPV - consider normal HR HPV + 90% spont resolve LSIL CIN I 60% spont resolve HSIL CIN II/III studies vary widely 40% spont resolve but majority will persist <5% progress to cancer

Samuel B. Wolf, D.O., F.A.C.O.G. Emerald Coast Obstetrics and Gynecology Panama City Florida

Making sense of the new Pap smear screening guidelines. Samuel B. Wolf, D.O., F.A.C.O.G. Emerald Coast Obstetrics and Gynecology Panama City Florida Case 17 year old G1P0010 with first sexual encounter