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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

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)

Screening in olderwomen

and after hysterectomy

Stopping age

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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