Cervical Cancer Screening Recommendations 2012,

1. Cervical Cancer Screening Recommendations 2012, FDA Panel 2014

3. 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

4. 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

7. Frequency (Interval) The frequency of testing is dependent upon the screening test used.

8. 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

9. Screening Interval Risk of developing invasive cancer before next screen should be unlikely

10. 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

20. RISKS OF SCREENING  MISUSE and Harms

22. 2014 NEWS What’s NEW

25. 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

27. 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.

37. Concerns raised by the FDA Panel(and others….) Education, education, and more education 3 screening options = more confusion?

38. سپاس