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

Initial screening primary screening approach

Screening in older women and after hysterectomy

Screening frequency ( interval) 

Starting age 

Stopping age 

Special Population

age-appropriate screening strategies

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

Frequency (Interval)

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

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.

Summary of HPV Primary Screening for Cervical Cancer

Education, education, and more education

3 screening options = more confusion?

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

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