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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