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Preventing Cervical Cancer: The Vaccine is Not the Worst Case Scenario

This panel discusses the importance of preventing cervical cancer and the various risk factors associated with it. It also explores the epidemiology of cervical cancer and the effectiveness of regular pap smears and HPV vaccination in preventing the disease. The discussion also covers the potential complications of cervical cancer treatment and the safety of the HPV vaccine.

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Preventing Cervical Cancer: The Vaccine is Not the Worst Case Scenario

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  1. Cervical cancer: Because the vaccine is not the worst case scenario Jennifer L. Young, MD, MPH National Organization for Women Panel September 23, 2008

  2. Objectives • Answer 2 questions • Is cervical cancer worth preventing? • How do we prevent it – the easy way or the hard way?

  3. Epidemiology of cervical ca • 11,070 new cases each year • 3,760 deaths from cervical ca • Risk factors same as for HPV infection for majority of patients • Early age of sexual debut • Multiple sexual partners • Smoking • HIV • History of sexually transmitted disease • 50% higher risk in black compared to white

  4. Risk factors for cervical cancer • Risk of HPV • Lifetime risk for women 80% • Not having adequate screening • No pap smear in last 3 years • Decreased access to medical care • Immunosuppressed • HIV • Diabetic • Other

  5. Cervical cancer by state

  6. Incidence of cervical cancer by race in Virginia

  7. HPV disease incidence by patient age http://content.nejm.org/content/vol353/issue20/images/large/01f2.jpeg

  8. Risk Factors for Female Genital HPV Infection • Sexual behavior of her male sexual partners • Risk increased if he has had > 3 partners1 • Risk increased if he has had a same sex partner (s) [bisexual contact(s)]. • Increased number of male sexual partners (>3)1 • (increases the risk of encountering an HPV infected male !) • Sexual Intercourse at a young age (before the age of 24 in the U.S)-the maturing cervical epithelium (T-Zone) is felt to be more easily infected by HPV. 1. Ley et al. J Natl Cancer Inst. 1991.83.997

  9. Other Possible Mechanisms of HPV Transmission & Infection • Non-Sexual Transmission • Mother to newborn [respiratory tract papillomatosis] (vertical transmission)2 • Skin to skin (thought to require breaks in skin surface) Winer RL, et al. Am J Epidemiol. 2003:157:318-226 Smith EM et al. Sex Transm Dis. 2004.31;57-62.

  10. Cervical cancer prevention • Pap smears performed once per year until age 30 • >30 yo- once every 3 yrs if pap and HPV negative • 75% reduction in cervical cancer in countries with adequate screening • At what cost? • 3 million abnormal pap smears a year • 300,000 high grade dysplasia • 11,000 cervical cancers

  11. Financial burden of HPV disease in the US1

  12. Emotional cost • Most women describe feelings of being dirty or unclean after the diagnosis of an abnormal pap smear • Decreased sexual drive • Poor self image • Decreased feelings of intimacy with their partner

  13. What is the treatment for an abnormal pap smear? • Microscopic examination of the cervix for abnormal cells • Removal of the abnormal cells • Laser • Freeze abnormal cells • Excise abnormal cells with a scalpel or by burning

  14. Costs to society • Risks of cervical procedures • Cervical scarring – infertility • Cervical weakening – pregnancy risk • 2.5x increased risk of preterm labor • 2.5x increased risk of low birth weight • 3x increased risk of cesarean section

  15. Cervical Cancer Treatment • Surgical management • Radical hysterectomy with lymph node removal • Goal is removal of all tumor • If LN positive – pt will need postop radiation • Chemoradiation • External beam radiation – usually 25 days • Weekly chemotherapy • Internal radiation 2-6 days

  16. Gynecologic Vaginal scarring Poor sexual function Menopause Gastrointestinal Chronic diarrhea Bowel obstruction Fistula Urologic Blockage of ureters with kidney failure Hemorrhagic cystitis Fistula Other Chronic back pain Skin changes Lymphedema in legs Complications of treatment

  17. Lymphedema

  18. Recurrent cervical cancer • 30% of cervical cancers will recur and most are fatal • If metastatic treated with chemotherapy • If localized, one potentially curative option • Pelvic exenteration curative 50% of the time

  19. Conclusions • Cervical cancer affects women in our community • Cervical cancer is a serious disease • Risks just from preventing cancer • 30% mortality from cervical cancer • Long term effects after treatment for cervical cancer • Cervical cancer is preventable • Regular pap smears • HPV vaccination

  20. HPV Vaccination: Hot Topics Jennifer L. Young, MD, MPH University of Virginia September 23, 2008

  21. HPV Vaccine SafetyInformation obtained from the CDC VAERS website • NO PROVEN ASSOCIATION of death from Gardasil • 21 deaths occurred after Gardasil vaccine • 12 investigated and found to be unrelated • 5 no patient identification in the report thus unable to be investigated • 4 in foreign countries, unable to be investigated

  22. HPV Vaccine SafetyInformation obtained from the CDC VAERS website • Guillan-Barre Syndrome (GBS) • Neurologic illness occuring after viral infection in 1-2/100,000 teenagers • 44 reported cases after Gardasil vaccination • 42 in US, 2 in foreign countries • 13 confirmed • 9 pending follow-up • 8 did not meet criteria for diagnosis • 11 unconfirmed • 1 had symptoms prior to vaccination • NO PROVEN ASSOCIATION • Rate is within range of that which would be expected by chance alone

  23. Mandating the HPV vaccine • Racial differences in vaccination rates may widen the gap • Mandate for your doctors

  24. National Coverage with 4:3:1:3:3:1 Series by Race/Ethnicity Childhood vaccination racial disparities: closing the gap 1. CDC. MMWR September 5, 2008; 57(35): 961-966.

  25. Racial disparities in childhood vaccinations • Since 2005, the CDC notes that racial disparities in childhood vaccines are closing1 • Largely attributed to Vaccines for Children (VFC) program • Remain large variation by state and between rural and urban • Virginia remains average with coverage rates 67-91% • Study of Hep B school mandate2 • Vaccination rates increased (85% vs. 37%) • Racial disparities decreased • Black vs. white (RR 0.94 from 0.70) • Hispanic vs. white (RR 0.97 from 0.88) • CDC. MMWR September 5, 2008; 57(35): 961-966. • Morita JY et al. Pediatrics 2008; 121(3): e547-e552.

  26. HPV Vaccine Legislation • Funding allocations • 8 states considered • 3 states have passed • Educational campaigns • 24 states have considered • 14 states have passed • Mandatory insurance coverage • 18 states have considered • 5 states have passed into law (CA, CO, IL, NM, RI)

  27. School mandates • Texas • Gov. Rick Perry signed Executive Order 4 Feb. 2, 2007 • H.B. 1098 reversed HPV mandate • New Mexico • HPV school mandate vetoed by the Governor • Virginia • HPV school mandate signed into law after revision • Increased ease of parental opt-out • District of Columbia • Mandate has passed City Council • Congressional review date has passed

  28. Virginia school mandate • Only HPV vaccination mandate in the country • Signed into law April 2007 • Requires all girls to have initiated the HPV vaccination series prior to entry into the sixth grade starting October 2008 • Verbal parental opt-out • 3 bills introduced to overturn • All failed in committee in 2008 General Session

  29. Debate continues in Virginia • 2008 General Assembly • HB 89 to repeal mandate • SB 722 to repeat mandate • HB 188 to delay mandate until 2010 • Out of committee with a 13/9 vote • Passed the House 57/39 • Defeated in Senate committee • School mandate to go into effect October 2008

  30. “None of us is going to be satisfied if the only women getting the vaccine are the same women already covered by screening programs.” - John Schiller National Cancer Institute

  31. Paying for the HPV vaccine

  32. Current Coverage of the HPV vaccine 3 shot regimen costing $120/injection or $360 total Coverage ≤ 18 years old Public: Federal Vaccines for Children program for Medicaid qualifiers Private: Most insurance companies cover but age range and reimbursements differ Coverage > 18 years old Public: Medicaid coverage of women 18-21 at high risk Private: Most insurance companies cover but age range and reimbursements differ

  33. Cost effectiveness of HPV vaccine • < $50,000 for QALY considered cost effective • Mammograms for breast ca $67,000 QALY • PSA for prostate cancer screening $113,000 • HPV vaccine in setting of current screening1 • $3,906-$14,723 per QALY • Lower if herd immunity achieved 1. Chesson HW. Emerg Infect Dis 2008 14(2): 244.

  34. Future Information on Vaccines • Booster? • Older women? • Women with prior HPV disease?

  35. Immunogenicity of vaccines Olsson SE et al . Vaccine 2007; 25: 4931.

  36. Breaking news: Quadrivalent vaccine • Efficacy in HPV + women1 • 100% effective in preventing CIN 2/3 from vaccine viral types for neg women • 94% effective in preventing vulvar/vaginal disease • Women aged 24-452 • Study of 3819 women • 67% naïve to 6,11,16,18 • Only 0.7% of women + for >1 vaccine viral types • FUTURE II Study Group. J Infect Dis 2007; 196: 1438. • Makhija S, FUTURE III Investigators. Gyn Oncology 2008, abstract.

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