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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.

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Presentation Transcript
slide1

Cervical Cancer

Screening

Recommendations

2012,

FDA Panel 2014

slide3

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

slide4

The new screening recommendations address

age-appropriate screening strategies

Initial screening primary screening approach

Starting age

Screening frequency ( interval)

Screening in olderwomen

and after hysterectomy

Stopping age

Special Population

slide7

Frequency

(Interval)

The frequency of testing is dependent upon the screening test used.

slide8

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

slide9

Screening Interval

Risk of developing invasive cancer

before next screen

should be unlikely

slide10

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

slide20

RISKS OF SCREENING 

MISUSE and Harms

slide22

2014 NEWS

What’s NEW

slide25

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
slide27

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.

slide37

Concerns raised by the FDA Panel(and others….)

Education, education, and

more education

3 screening options =

more confusion?

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