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Cervical cancer: Because the vaccine is not the worst case scenario. Jennifer L. Young, MD, MPH National Organization for Women Panel September 23, 2008. Objectives. Answer 2 questions Is cervical cancer worth preventing? How do we prevent it – the easy way or the hard way?.

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cervical cancer because the vaccine is not the worst case scenario

Cervical cancer: Because the vaccine is not the worst case scenario

Jennifer L. Young, MD, MPH

National Organization for Women Panel

September 23, 2008

objectives
Objectives
  • Answer 2 questions
    • Is cervical cancer worth preventing?
    • How do we prevent it – the easy way or the hard way?
epidemiology of cervical ca
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
risk factors for cervical cancer
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
slide7

HPV disease incidence by patient age

http://content.nejm.org/content/vol353/issue20/images/large/01f2.jpeg

risk factors for female genital hpv infection
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

other possible mechanisms of hpv transmission infection
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.

cervical cancer prevention
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
emotional cost
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
what is the treatment for an abnormal pap smear
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
costs to society
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
cervical cancer treatment
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
complications of treatment
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
recurrent cervical cancer
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
conclusions
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
hpv vaccination hot topics

HPV Vaccination: Hot Topics

Jennifer L. Young, MD, MPH

University of Virginia

September 23, 2008

hpv vaccine safety information obtained from the cdc vaers website
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
hpv vaccine safety information obtained from the cdc vaers website22
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
mandating the hpv vaccine
Mandating the HPV vaccine
  • Racial differences in vaccination rates may widen the gap
  • Mandate for your doctors
racial disparities in childhood vaccinations
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.
hpv vaccine legislation
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)
school mandates
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
virginia school mandate
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
debate continues in virginia
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
slide30

“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

current coverage of the hpv vaccine
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

cost effectiveness of hpv vaccine
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.

future information on vaccines
Future Information on Vaccines
  • Booster?
  • Older women?
  • Women with prior HPV disease?
immunogenicity of vaccines
Immunogenicity of vaccines

Olsson SE et al . Vaccine 2007; 25: 4931.

breaking news quadrivalent vaccine
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.