Position Statement on Cervical Cancer Screening with HPV Testing

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Position Statement on Cervical Cancer Screening
with HPV Testing

• Early Detection Subcommittee and the Breast and
  Cervical Cancers Work Group
• October 24, 2003

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Thanks

• Early Detection Subcommittee
• Breast and Cervical Cancer Workgroup
• Drs. John Boggess and Evan Myers

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In the Beginning

• Unintended benefits of basic science
• Luck, recognition, and persistence

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Why Cervical Cancer?
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Substantial Mortality Decline
Women
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NC Womens Cancer Burden
SCHS 2000, 2001
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Disparity in Burden
All Ages, By White/Black
1.25
1.56
SCHS 2000, 2001
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Cervical Cancer Screening is Good
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Cervical Cancer Screening NC/US
BRFSS 2002
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NC Women Current Screening
Past 3 yrs
Past 2 yrs
Past yr
Past 5 yrs
BRFSS 2002
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NC Cervical Screening
Race/Ethnicity
Household Income
BRFSS 2002
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Progress Toward Goals
NC Cancer Control Plan 2001 - 2006

• Goal Increase Pap Smear rates
• Ever Had -- from 94 to 98
• Had Last 3 Yrs -- from 87 to 94
• Address disparities
• Current Status
• Ever Had -- 95
• Had Last 3 Yrs -- 90
• Disparities still exist

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Why Cervical Cancer?
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This is Why

• 50 of women diagnosed with invasive cervical
  cancer -- no Pap test in the past 5 years
• 1992 NC Cervical Cancer Task Force
• Screening detects prior to cancer
• Treatment following screening is effective
• Potential to reduce burden significantly
• Screening doesnt always work
• But, not screening doesnt work

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Standard Pap Test (Cytology)

• No clinical trial
• Dramatic falls in cervical cancer burden
• General consensus among expert groups
• Standard preparation v. liquid-based
• Relatively inexpensive test
• Liquid-based more expensive than standard
• Widespread use

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Human Papilloma Virus (HPV)

• Primary factor in cervical cancer
• 90 - 100 contain HPV DNA
• Necessary but insufficient
• HPV infection
• Endemic, transient, often no/minor changes
• HPV DNA test
• FDA approved for combined testing with Pap test
• More expensive and requires liquid-based test
• Not approved as primary screen

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Combined Testing

• Women ages 30 yrs and older
• May increase sensitivity
• Normal cytology negative HPV no screening for
  3 years
• Normal cytology or ASC-US positive HPV
  further evaluation
• ASC-US negative HPV followed without colposcopy

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Expert Group Agreement

• ACS, USPSTF asymptomatic, normal risk
• Areas of substantial agreement
• Who
• Where/How
• How often
• When to Stop
• When Not to Screen

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Expert Group Disagreement

• ACS, USPSTF
• Liquid-based cytology
• USPSTF insufficient evidence for or against
• ACS acceptable alternative
• HPV combined testing
• USPSTF insufficient evidence for or against
• ACS acceptable alternative

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Evidence for HPV/Combined Test

• Direct evidence
• No randomized trials or prospective studies
• HPV testing more sensitive
• Normal cytology negative HPV low risk of
  developing CIN 2 or 3 during next 3-5 years
• Indirect evidence from models
• Increased sensitivity increased cost without
  decreased frequency
• Cost effective if frequency reduced among women
  ages 35 and older

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Considerations

• Strong evidence lacking
• Extensive patient and provider education
  necessary to implement cost-effectively
• Guidelines lacking for management of normal
  cytology positive HPV

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Considerations

• Health insurance for HPV testing not uniform
• Increased screening will have the greatest effect
  on cervical cancer burden
• Initial costs of new technology may decrease
  number of women screened

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Recommendation for Position

• Subcommittee supports the USPSTF
• Insufficient evidence to recommend for or against
  combined testing
• Continue to review evidence and reconsider

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Additional Considerations

• Vaccines in development possible future strategy
• HPV as primary screen undergoing prospective
  trial evaluation
• HPV testing in management and triage of ASC-US
  outside scope of review
• HPV testing in research also outside scope of
  review

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Indirect evidence from models

• Increasing sensitivity (I.e. combined testing)
  increases costs UNLESS you decrease the frequency
• More sensitive tests can be more effective and
  less expensive than less expensive tests, if done
  at less frequent intervals
• In women over age 30-35, combined testing is a
  viable alternative, but only if done no more
  frequently than every 3 years

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Subcommittee Review

• On September 5th the Early Detection
  Subcommittee met to discuss the role of HPV
  screening in the screening for cervical cancer
  and to hear from 2 national experts
• John Boggess, MD, gynecology/oncology specialist
  and participating author on the evidence review
  for the USPSTF
• Evan Myers, MD, MPH, obstetrics/gynecologist,
  published author on cervical cancer screening,
  and participant on panel to develop ACS guidelines

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Estimated effects on the NC BCCCP program
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Guidelines addressing combined testing using HPV
screening

• UPSTF evidence is insufficient to recommend
  for or against the routine use of HPV testing as
  a primary screening test for cervical cancer
• ACS combined testing in women age 30 and older
  as an alternative to cervical cytology testing
  alone no more than every 3 years
• ACOG similar to ACS

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Screening failures

• 50-70 of cancers occur in women who have never
  been screened were not screened in the last 5
  years
• among screened women, failures occur due to
• failure to follow up abnormal results (22-63)
• rapid progression
• abnormalities missed by screening (14-33)

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N.C. Cervical Cancer Burden

• 8.7 per 100k incidence (2000 SCHS)
• 2.8 per 100k mortality (2001 SCHS)
• overall, declining incidence and mortality which
  parallel national trends
• pronounced disparities between African-American
  and white women, especially among those gt50 years

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Screening for cervical cancer

• 95 women report ever having had a Pap smear 90
  in the last 3 years (2002 BRFSS)
• little improvement in the last decade
• older age, low education or income, and not
  having had a recent checkup are associated with
  never having a Pap test