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.