Position Statement on Cervical Cancer Screening with HPV Testing
Early Detection Subcommittee and the Breast and Cervical Cancers Work Group October 24, 2003
Thanks
• Early Detection Subcommittee • Breast and Cervical Cancer Workgroup • Drs. John Boggess and Evan Myers
In the Beginning
• Unintended benefits of basic science • Luck, recognition, and persistence
Why Cervical Cancer?
Substantial Mortality Decline
Women
NC Women’s Cancer Burden
150.3 Incidence 8.7 25.5 16.9 41.3 2.8 0 50
Cervical
42.0 47.4
Mortality
100
Lung Colon
150
Breast
200
SCHS 2000, 2001
Disparity in Burden
All Ages, By White/Black
60
40
1.25
20 8.3 10.4 2.5
1.56
3.9
0 Incidence White Black
SCHS 2000, 2001
Mortality
Cervical Cancer Screening is Good
Cervical Cancer Screening: NC/US
120 100 80 60 40 20 0 % Pap Ever NC US
BRFSS 2002
95
94
90
86
% Pap 3 yrs
NC Women: Current Screening
100 80 60
41 90 81
40 20 0 Pap Test Mamog
31
FOBT
Endoscopy
Past 3 yrs
Past 2 yrs
Past yr
Past 5 yrs
BRFSS 2002
NC Cervical Screening
Race/Ethnicity
120 100 80 60 40 20 0 % Pap Last 3 yrs A-A White Hispanic 96 120 88 90 100 80 60 40 20 0 % Pap Last 3 yrs <$15K/yr $15K-$25K >$75K 83 90
Household Income
96
BRFSS 2002
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
Why Cervical Cancer?
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 doesn’t always work But, not screening doesn’t work
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
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
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
Expert Group Agreement
• ACS, USPSTF – asymptomatic, normal risk • Areas of substantial agreement
– – – – – Who Where/How How often When to Stop When Not to Screen
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
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
Considerations
• Strong evidence lacking • Extensive patient and provider education necessary to implement cost-effectively • Guidelines lacking for management of normal cytology + positive HPV
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
Recommendation for Position
• Subcommittee supports the USPSTF
– Insufficient evidence to recommend for or against combined testing
• Continue to review evidence and reconsider
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
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
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
Estimated effects on the NC BCCCP program
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
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%)
N.C. Cervical Cancer Burden
• 8.7 per 100k incidence • 2.8 per 100k mortality
(2000 SCHS) (2001 SCHS)
• overall, declining incidence and mortality which parallel national trends • pronounced disparities between AfricanAmerican and white women, especially among those >50 years
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