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Ann Laros , MD University of Iowa Sept 17, 2013. 2013 Cervical cancer screening. 2012 Cervical cancer screening. Less is more (Pap smears) More is more (Vaccinate all). Source: NCI, 2005. Source: NCI, 2005. Cervical cancer.
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Ann Laros, MD University of Iowa Sept 17, 2013 2013 Cervical cancer screening
2012 Cervical cancer screening • Less is more • (Pap smears) • More is more • (Vaccinate all)
Source: NCI, 2005 Source: NCI, 2005
Cervical cancer • Cervical cancer was #1 cancer killer of US women until 40 years ago • Pap widely implemented through 1970s • Currently in US • 12,000 diagnosed annually • 4,000 die annually • Similar to US motorcycle fatalities • Most cancers are found in women who • NEVER had a Pap (50%) • OR had a Pap more than 5 years prior (10%)
HPV • More than 100+ HPV virus types • 40+ types infect the genitals of men and women • 14 HR HPV types (oncogenic) • HPV 16/18 most common • HPV vaccines protect against these • HPV2 HPV 16/18 • HPV4 HPV 6/11 and 16/18 • Nano-valent vaccine in Phase 3 trials
HPV • Genital HPV is spread by genital to genital contact. • HPV can be spread by same sex encounters. • Condoms decrease the spread by about 75%, but do not prevent it. • No real test for HPV • Most infections resolve in 1-2 years
HPV is everywhere • 60-70% sexually active college students have HPV • 20% risk with each partner • 70-80% life time risk • HPV causes genital warts • 1% young men/women get genital warts each year • 10% life time risk • HPV causes abnormal Paps • 10% of young women will have an abnormal pap each year • 40% life time risk
New Pap smear guidelines • Why? • Why so much change? • Did we really need to change? • Are they safe? • Are we going to miss cancers? • How do we do this and the Affordable Care Act too?
Wisdom from the future Dr. Melik: You mean there was no deep fat? No steak or cream pies or hot fudge? Dr. Aragon: Those were thought to be unhealthy—precisely the opposite of what we now know to be true. —From the 1973 Woody Allen comedy “Sleeper.”
2012 ACS, ASCCP, ASCP • Develop evidence based cervical cancer prevention guidelines to best serve women, independent of cost
Consensus Conference 2012 • 4,000 articles, 1.4 million women over 8 years • Stakeholders • ACHA, ACOG, AAFP, ACS • Nurse Practitioners in Women’s Health • Planned Parenthood, + 21 more • Recommendations were presented, discussed prior to vote • 66% agreement before acceptance
Change is hard First do no harm
Synopsis of screening changes (5) • NO Paps before age 21 • Paps every 3 years age 21-29 • Paps every 3-5 years 30-65 • Normal Pap, every 3 years • Normal Pap and negative HPV, every 5 years • No change based on HPV vaccine status • No Paps after 65 or hysterectomy, if no CIN2+
No Paps before age 21 • Seriously • Cervical cancer less than 21 is 1/1,000,000
Cervical cancer rates • Cervical cancer rates are low in young women • <21 year olds 1.4/1,000,000 • 21-25 year olds 1.4/100,000 • When the risk of cancer is low, the risks of a testing maybe higher.
Pap recommendation in EU (2006)(Cervical Cancer/100,000) • Age of first pap • <20 • 20 • 21 • 23 • 25 • 30 • 31 • EU country • Austria, Slovakia(18) • Germany, Greece(4.6), Slovenia(16) • US(8.5) • Denmark(12.9), Sweden(8.7) • Belgium, Czech Republic, France, Ireland, Italy(8.2), Poland, Romania(29), UK • Finland (4.4), Lithuania(25.6), Netherlands, Spain • Bulgaria(25.8) http://eu-cancer.iarc.fr
Paps every 3 years, age 21-29 • This is NOT new • The USPSTF recommends screening for cervical cancer in women ages 21 to 65 years with cytology (Pap smear) every 3 years . • Grade: A Recommendation • We are not alone
Screening interval in EU (2006)(Cervical cancer/100,000) • Pap interval • Every year • Every 2 years • Every 3 years • Every 3-5 years • Every 5 years • EU Country • Austria, Czech Rep, Germany, Greece (4.6), Slovakia (18) • Bulgaria (25.8) • Belgium, France, Italy (8.2), Lithuania (25.6), Poland, Sweden • US (8.5), Denmark (12.9), Ireland (12.9), Spain (7.6), Sweden, UK • Finland (4.4), Netherlands, Romania (29) http://eu-cancer.iarc.fr
Screening for all • The key is getting it done • 50% of cervical cancers in the US occur in women who have never had a Pap • Finland starts at 30, Paps every 5 years—4.4 • Slovakia starts at 18, Paps annually—18 • US starts at 21, every year—8.5 • Has your mother had a Pap smear?
Paps every 3-5 years, 30-65 • Two acceptable options for screening in this population • PREFERRED • Pap and HPV Co-testing every 5 • ACCEPTABLE • Pap every 3
HPV ordering options • No HPV testing • Reflex testing • Co-testing
What IS “co-testing”? • No HPV testing • Under 25 • Reflex testing • If Pap is ASCUS, then test for HPV • If ASCUS, +HPV—colposcopy • If ASCUS, -HPV—same as normal, follow-up in 3 years • Co-testing • If Pap is NORMAL, then test for HPV • Some systems get HPV on all co-tested Paps, not usually useful for LSIL and above
Pap after 30 • Pap after 30 • Normal Pap • Repeat in 3 years OR HPV testing • HPV negative HPV positive • Repeat in 1 year OR • HPV 16/18 testing • HPV 16/18 negative HPV 16/18 positive • Repeat in 5 years Repeat in 1 year Colposcopy
Co-testing • No sooner than age 30. • Pap based • PapHPVAction • Normal Negative Rescreen in 5 years • Normal Positive Repeat in 1 year w/ co-testing • OR Neg 16/18 Repeat in 1 year w/ co-testing • Pos 16/18Colposcopy • Normal No Co-testing Repeat in 3 years • LSIL or greater No HPV is done ASCCP guidelines, no change • ASCUS Negative Rescreen in 5 years • ASCUSPositive ASCCP guidelines, no change
Co-testing with +HPV (30-65) • NEGATIVE PAP LIQ CYTO • HPV HIGH RISK RESULT POSITIVE (A) • HPV 16 GENOTYPE POSITIVE (A) • HPV 18 GENOTYPE NEGATIVE
Pap after 65 • No screening following adequate negative prior screening • Even if they have a new partner!! • “Adequate negative prior screening” not defined • IF history of CIN2+, routine Pap for 20 years • Every 3 years
No Pap after Hysterectomy • Paps screen for cervical cancer, NOT vaginal cancer. • Vaginal cancer is NOT common (840 deaths/year) • Exceptions: • Cervix remains (supracervical hysterectomy) • Follow guidelines until age 65 • CIN2+ including cervical cancer
Pap after HPV vaccine • No changes in frequency. • As of 2010, 20.5% women age 19-26 reported > 1 HPV vaccine • This low vaccine uptake is a barrier to making population based changes. • Iowa was among the worst • Look for vaccine related changes no sooner than 10 years.
Iowa lags behind • Iowa Lags Behind Rest of US in HPV Vaccination • Iowa’s vaccination rate for genital human papillomavirus (HPV) is below the national average, which itself has a low rate of compliance, according to Philip Colletier, president for the Polk County Medical Society. A recent CDC report showed that only 33 percent of children had completed the three-shot sequence since the United States approved it in 2006 for girls and in 2009 for boys. Colletier said that Iowa’s completion rate was only 21 percent and education was the key to increasing this rate. • Des Moines Register (08.23.2013)
HPV vaccine message • Get the HPV vaccine, soon • Men can get the HPV vaccine • All men up to age 21 • Some men through to age 26 • Vaccinate your sons and daughters • Protect your daughters • Protect your sons • Vaccinate MSM
New guidelines for treatment • Based on “similar treatment for similar risk” • In addition to large population research studies, data from Kaiser in California with 1.4 million women over 8 years. • Women of different ages have different risks. • <21 • 21-24 • 25-29 • 30+
Same management for same risk • Risk for CIN3+ in 5 yrsRecommendation • 5% Colposcopy • 2-5% F/up 6-12 months • .01-2% Pap in 3 years • .01% Pap/HPV in 5 years
5 new rules • No paps under 21 • If LSIL or ASCUS, ignore those done • If +HPV, ignore it • No endocervicals cells, no worries • Age matters • 21-24 No HPV reflex testing • 21-24 No colp for LSIL • No more 6 month follow-up • More HPV testing (over 30 and in follow-up of abnormals)
5 More easy changes • 1. Unsatisfactory Pap—Repeat in 2-4 months • 2. No endocervical cells—Normal, repeat in 3 yrs • 3. ASCUS Pap—Repeat in one year (not 6 mns) • 4. ASCUS, -HPV Pap—Normal, repeat in 3 years • 5. AGUS—Colp. No HPV triage recommended
Unsatisfactory Pap • Represents inadequate cell collection • HPV testing requires adequate cell collection as well. • Many HPV tests don’t have a fail safe for inadequate vs not present. • Therefore can’t rely on NEGATIVE HPV in this setting. • If unsatisfactory x2, immediate colposcopy
No endocervical cells • With liquid based paps, occurs in 10-20%; higher in older women. • Review of KPNC, these women a have no higher risk for CIN 3+ • Including patients after treatment for CIN 2+ • Remember: In 1950, 4 out of 5 doctors recommended Camels
ASCUS • Repeat in one year • If ASCUS or worse—colposcopy • 2 ASCUS leads to colposcopy, but they may be 1 year apart, instead of 6 months • If normal—repeat in 3
ASCUS, women under 25 • Women under 25 (21-24) with ASCUS • PREFERRED: No reflex HPV testing; repeat in one year x2. • ACCEPTABLE: Reflex HPV testing, OK* • *Neither ASCUS HPV+ nor HPV- women go to colposcopy.
ASCUS, -HPV • “Normal” • Repeat in 3 years (not 5) • If 65, this should not be the last Pap • Repeat in one year
3 Harder changes • 1. No colp for women under 25 with < LSIL • 2. Moderate dysplasia can be followed in “young women”. • Followed with colp in 6 months for up to 2 years • 50% resolve • LSIL and HPV testing • Recommend reserve only for postmenopausal
Risks of over testing • Stigma of HPV • Anxiety of disease, follow-up • Cost and time for follow-up • Pain and injury from follow-up • Increased risks for preterm delivery
Engaging/educating our patients • Recommendations for women sexually active under 21 • Folic acid daily • Chlamydia testing yearly • Flu vaccine annually • (HPV vaccine complete) • (Effective contraception) • (Exercise and healthy diet) • No Pap
Educating younger women • 1 in 8 babies delivers prematurely in the US • Too much Pap testing led to too many biopsies and too many treatments and is one of the factors contributing to preterm birth • Cervical cancer is not hereditary. • Most HPV infections resolve in 1-2 years • We are not looking for mildly abnormal cells, but severely abnormal cells • On average it is 3-7 years from CIN3+ to cancer
Educating older women • Cervical cancer is a disease of younger women, peak age 40. • Breast, colon cancers increase • Heart disease increases more • Regular exercise and a healthy diet
Embracing and questioning change • Is it safe to • Do a physical without a routine UA? • Give the pill without a cholesterol? • Give the pill without a Pap? • Place an IUD in a nullipara? • Eat margarine? • Do Paps every 3 years?
Checking ourselves • How well are we doing? • Quality assurance audits • Paps under 21 • Colps/referrals under 25 (ASCH, HSIL, AGUS only) • HPV vaccinations men <21 • Back to back Paps after 2013
Were you paying attention ? • Test time