SCREENING MODALITIES Pap Test

Cervical Cancer
Screening
Recommendations
2012,
FDA Panel 2014
Goals of Screening ( & Management)
Prevent Morbidity and mortality from
Cervical Cancer
Not find HPV infection
Not find abnormal cytology
Prevent Overzealous management of
precursor lesions likely to regress or
disappear for which the risks of
management outweight the benefits
The new screening recommendations address
age-appropriate screening strategies
Initial screening primary screening approach
Starting age
Screening frequency ( interval)
Stopping age
Screening in older women
and after hysterectomy
Special Population
Frequency
(Interval)
The frequency of testing
is dependent upon the
screening test used.
SCREENING MODALITIES
Pap Test ; conventional or Liquid > = 21 y
every 3 year
Co-testing; every 5 year
pap smear + hrHPV test ; only ≥ 30 Y
Primary, Stand-alone HPV test ;
≥25 Y every 3 year
only FDA Approve: Cobas test
Screening Interval
Risk of developing invasive cancer
before next screen
should be unlikely
Rationale for Longer Pap
Screening Intervals
Sensitivity of Single Pap test 50-70%
Cancer risk
1.5/100,000
Cancer risk
4.7/100,000
99,997 women screened unnecesarily to help 3
RISKS OF SCREENING
MISUSE and Harms
2014 NEWS
What’s NEW
Other Issues to Consider with
Cytology
• Highly subjective test: substantial inter-and
intra-laboratory variability and limited
reproducibility
• Unable to identify those women who are at
future risk of developing cervical cancer
precursors
• Unclear how cytology will perform as HPV
vaccine uptake rates increase in the US
Summary of HPV Primary Screening
for Cervical Cancer
FDA approval of cobasHPV test, April, 2014
Athena end of trial results
–>40,000 participants ≥ age 25
–Followed up in 3 years if HPV test negative
–Colposcopy if HPV 16+ or 18+
–Cytology if HPV 16 neg. or 18 neg.
Concerns raised by the FDA
Panel(and others….)
Education, education, and
more education
3 screening options =
more confusion?
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