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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. - PowerPoint PPT Presentation
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2013 Cervical cancer screening
Ann Laros, MDUniversity of IowaSept 17, 2013
2012 Cervical cancer screeningLess is more
(Pap smears)
More is more (Vaccinate all)
3Source: NCI, 2005Source: 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?
Learn from the past
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
Here’s where it gets dice-y
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 Pap HPV Action 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 16/18 Colposcopy
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 ASCUS Positive 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 yrs
Recommendation
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
Happy vaccinated children
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
Case 1
19 y/o presents for yearly and birth control Sexually active since 15 19 sexual partners, HSV Mother with cervical cancer Last Pap 3 years ago
Case 1
A. It has been 3 years, do Pap B. No Pap, test for HPV C. No Pap, test for Chlamydia D. She is at high risk, do Pap E. Chastity belt and Mom talk
Case 1
Answer, C. No Paps before age 21, SERIOUSLY Chlamydia testing is recommended for
all sexually active women under 26 yearly
Sexually active women are likely to have HPV, don’t test women under 30 for HPV
Cervical cancer is not heritable. It is caused by the HPV virus
Case 2
33 year old G2P2 for annual exam No abnormal Paps Pap today is normal
When is her next Pap due? A. Next year B. 3 years C. 5 years
Case 2
Answer, B Paps every 3 years If co-testing with HPV had been ordered
and HPV was negative, then 5 years
Take home lesson, Unless your provider is George Clooney
or McDreamy , ask for HPV co-testing with your Pap
Case 3
20 year old Pap: ASCUS, +HPV
Options A. Refer for colposcopy B. Repeat Pap in 6 mnths C. Repeat Pap in 12 mnths D. Repeat HPV in 12 mnths
Case 3 Answer, C.
Repeat the Pap in 12 months.
Send the referring provider, up to date and informative follow-up letter.
Set up a QI/QA survey in your own department.
STRONG recommendation for no Pap until age 21.
IF Pap obtained before 21, ignore unless CIN2+
Case 4
50 year old P5 Last Pap 201o. No abnormal Paps Hysterectomy for fibroids
When is her next Pap due? A. Today, it has been 3 years B. Every 5 years if HPV was negative C. Never more. Thank Gosh for
evidence based medicine
Case 4
Answer, C. Never more
Primary care providers ARE great
Start Paps at 25
Target Age (years)
Reduction in CA Incidence (%)
No. of Tests
20–64 84 925–64 84 830–64 81 735–64 77 6
Modeled using a 5-yr screening interval ,assuming a 70% sensitivity of the 1st screening test.Data from IARC: Working Group on Evaluation of Cervical Cancer Screening Programs: Screening for squamous cervical cancer. BMJ 293:659, 1986.
Modeled impact of target screening age on incidence of cervical cancer*
Case 5
40 year old P2 Supracervical hysterectomy Pap with HPV co-testing
▪ Pap= NORMAL▪ HPV=POSITIVE
Case 5
What do we do now? A. Repeat Pap in one year B. Repeat Pap in 3 years, it is normal C. Refer for colposcopy D. Refund her money, she didn’t need a
Pap, she had a hysterectomy
Case 5
Answer, A. Repeat in one year. Normal Pap Repeat in 3 years OR HPV testing
▪ HPV negative HPV positive▪ Repeat in 1
year OR
We are looking for precancerous cells, not HPV
If HPV 16/18 positive, then COLPOSCOPY Supracervical hysterectomy, leaves the
cervix
Case 6
25 year old Pap: ASCUS, HPV negative
Options: A. Refer for colposcopy B. Repeat Pap in 6 months C. Repeat Pap in one year D. Repeat Pap in 3 years
Case 6
Answer: D, Repeat Pap in 3 years
Question: Does the risk of precancerous change in women
with ASCUS, HPV- warrant greater surveillance than normal Pap, HPV-?No
Negative HPV is great. Studies show no different in risk
compared to negative co-test (neg Pap and neg HPV).
Case 7
21 year old First Pap: LSIL
Based on 3/2013 guidelines A. Colposcopy B. HPV testing, colposcopy of HPV+ C. HPV 16/18 testing, colposcopy if either
positive D. Repeat Pap in 6 months E. Repeat Pap in one year
Case 7
Answer: D, Repeat Pap in 1 year
In a young healthy woman, likelihood of resolution in 1-3 years is high, 90%
Likelihood of developing cancer in this time, low, low.
Case 8
21 year old First Pap: HSIL
PLAN: A. Colposcopy B. HPV testing, colposcopy if positive C. HPV 16/18 testing, colposcopy if
positive D. Repeat Pap in 1 year
Case 8
Answer, A. Colposcopy
High grade, is still high grade Avoid HPV testing under 30
Case 9
32 year old LEEP for moderate dysplasia age 22 All normal Paps yearly since Pap: Normal
Options: A. Colposcopy B. Repeat Pap in 1 year C. Repeat Pap in 3 years D. Repeat Pap and co-testing in 5 years
Case 8 Answer: C, repeat Pap in 3 years
After treatment for CIN2+, there is an increased risk for cancer that lasts 20 years.
Recommendation has been for regular/annual Pap smears for 20 years. Now, Pap every 3 years for 20 years, even if this puts her greater than 65.
Initial clearance, co-test (Pap and HPV) at 12 and 24 months. If all negative, every 3 years for 18 more years.
Case 9
27 year old Mild dysplasia on colposcopy
PLAN: A. Repeat Pap in 6 months x2 B. Repeat Pap in 1 year C. HPV testing D. Cryo
Case 9
Answer, C (preferred); (or A, acceptable)
HPV testing in one year If POSITIVE , repeat colposcopy If negative, return to routine screening OR
Pap x2 6 months apart. Colposcopy for ASCUS or greater
Case 10
21 year old Last Pap LSIL, 18 months ago No follow-up w/ recommended
colposcopy
Options A. Refer for colposcopy B. Pap with HPV testing C. Pap only today D. HPV testing only today
Case 10
Answer, C
Colposcopy is no longer recommended for women under 25 unless HSIL/AGUS.▪ After 1 year, 70% of mild dysplasia is resolved▪ After 3 years, 90% of mild dysplasia is resolved
Follow LSIL for 24 months in women <25. Generally avoid HPV testing in women <30,
▪ except with ASCUS or in follow-up of known MILD DYSPLASIA until age 30.
Case 11
53 year old Pap normal, no endocervical cells
Plan: A. Repeat in 2-4 months B. Repeat in 1 year C. Repeat in 3 years D. Repeat in 5 years
Case 11
Answer: C, repeat in 3 years
If she had had HPV “co-testing”, 5 years. 2-4 months is for UNSATISFACTORY,
meaning not enough cells, not no endocervical cells
Case 12
34 year old P5 with LSIL Pap Colp adequate, Cx bx: Mild dysplasia EndoPap: LSIL
Options A. LEEP or Cone biopsy B. Cryo or laser C. HPV testing at one year D. Pap x 2, 6 months apart
Case 12
Answer: C (preferred); D (acceptable)
LSIL or CIN 1 in endocervix is NOT indication for LEEP/Cone and should be treated like mild dysplasia.
Treatment is NOT recommended for Mild dysplasia
Case 13
23 year old with history of an abnormal Pap She thinks she had colposcopy. She recognizes mild or moderate
dysplasia, NOT severe. She does not remember cryo (freezing
and thawing), laser (burning with smoke evacuator/vacuum), LEEP
She recalls a normal Pap last year, 2011.
Case 13
Options (Records are not available) A. Pap only today B. Pap with HPV testing today C. HPV only testing D. Repeat pap in 3 years
Case 13
Answer: No true answer Based on her history recall and age,
most likely abnormal Pap is LSIL or ASCUS, +HPV.
IF colp was performed and no treatment was recommended, either unremarkable or mild dysplasia.
IF mild dysplasia, 2 Paps or one HPV test is adequate follow-up.
Case 13
MY answer Ask your gynecologist or referring entity A. Pap only today
Case 14
24 year old Humira for Rheumatoid Arthritis Pap last year normal
Does she need a Pap this year? A. Yes B. No
Case 14
Answer: No data. No recommendations
Probably yes, her medication weaken her immune system and her ability to clear the virus.