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Dr.Nisrin Anfinan Consultant Gynecology Oncology King Abdulaziz University Hospital
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64,928 Europe
67,078 Africa
49,025 South America
14,845 United States/
Canada
1,077 Australia/
New Zealand
39,648 Southeast
Asia
51,266
Eastern Asia 21,596
Central America
151,297 Southcentral
Asia
Cervical Cancer: Worldwide Prevalence, Incidence, and Mortality Es8mates
Prevalence: 2,274,000 women have cervical cancer1 Incidence: 510,000 new cases each year1
Mortality: Second leading cause of female cancer-‐related deaths (288,000 annually)1
1. World Health Organization. Geneva, Switzerland: World Health Organization; 2003:1–74. 2. Bosch FX, de Sanjosé S.
J Natl Cancer Inst Monogr. 2003;31:3–13.
2000 estimated incidence of invasive cervical cancer !by selected region2:
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Saudi Arabia
Cervical Cancer: In Saudi Arabia , Incidence, and Mortality Es8mates
1.9 cases per 100,000 women, accounting for 2.6% of diagnosed cancer cases in women
Every year, 152 women are diagnosed with cervical cancer and 55 die from the disease. new cervical cancer cases and deaths in 2025 are 309
Cancer Incidence Report Saudi Arabia 2007. Available at www.scr.org.sa/reports/SCR2007.pdf Accessed on June 26, 2011
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Cervical Cancer: Global Stats Age Standardized Incidence rate/100000 women
Total Cases
Deaths
World 15.3 530232 275008
Saudi Arabia 1.9 152 55
Western Asia 39.18 4.5 2.1
Canada 6.6 1419 544
Globocan 2008 IARC
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Cervical Cancer: Saudi Arabia � Very low incidence, 1.9/100,000 women � ? Any demographic data on “high risk groups”? � Very little known about HPV incidence and transmission
� Data on conventional pap triage is poor � Hospital based � No population based data
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Foreseeable Challenges: � To understand the prevalence of high-‐risk (HR)-‐HPV infections and the prevalence of abnormal cytology findings in general population.
To understand the sexual practices of the population. By region and population group.
Implementation of any screening program, either primary or secondary, will be difficult in patients with a sexually transmitted infection.
Vaccination – is it cost-‐effective given the low rates of cervical cancer?
Introduction of quality assurance in screening and colposcopy. Which screening method should be used and how does one triage the patients?
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Foreseeable Challenges: � To understand the prevalence of high-‐risk (HR)-‐HPV infections and the prevalence of abnormal cytology findings in general population.
� To understand the sexual practices of the population. � By region and population group.
Implementation of any screening program, either primary or secondary, will be difficult in patients with a sexually transmitted infection.
Vaccination – is it cost-‐effective given the low rates of cervical cancer?
Introduction of quality assurance in screening and colposcopy. Which screening method should be used and how does one triage the patients?
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Foreseeable Challenges: � To understand the prevalence of high-‐risk (HR)-‐HPV infections and the prevalence of abnormal cytology findings in general population.
� To understand the sexual practices of the population. � By region and population group.
� Implementation of any screening program, either primary or secondary, will be difficult in patients with a sexually transmitted infection.
Vaccination – is it cost-‐effective given the low rates of cervical cancer?
Introduction of quality assurance in screening and colposcopy. Which screening method should be used and how does one triage the patients
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Foreseeable Challenges: � To understand the prevalence of high-‐risk (HR)-‐HPV infections and the prevalence of abnormal cytology findings in general population.
� To understand the sexual practices of the population. � By region and population group.
� Implementation of any screening program, either primary or secondary, will be difficult in patients with a sexually transmitted infection.
� Vaccination – is it cost-‐effective given the low rates of cervical cancer?
Introduction of quality assurance in screening and colposcopy. Which screening method should be used and how does one triage the patients?
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Foreseeable Challenges: � To understand the prevalence of high-‐risk (HR)-‐HPV infections and the prevalence of abnormal cytology findings in general population.
� To understand the sexual practices of the population. � By region and population group.
� Implementation of any screening program, either primary or secondary, will be difficult in patients with a sexually transmitted infection.
� Vaccination – is it cost-‐effective given the low rates of cervical cancer?
� Introduction of quality assurance in screening and colposcopy.
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Foreseeable Challenges: � To understand the prevalence of high-‐risk (HR)-‐HPV infections and the prevalence of abnormal cytology findings in general population.
� To understand the sexual practices of the population. � By region and population group.
� Implementation of any screening program, either primary or secondary, will be difficult in patients with a sexually transmitted infection.
� Vaccination – is it cost-‐effective given the low rates of cervical cancer?
� Introduction of quality assurance in screening and colposcopy. � Which screening method should be used and how does one triage the patients?
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Cervical Cancer Preven8on
Normal Cervix
HPV Infection
Cervical Dysplasia
Cervical Cancer
Primary Prevention: Vaccination
Secondary Prevention: Screening
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PRIMERY PREVENSION
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Transmission of HPV
� Prevalence in asymptomatic North American women is 2-‐40 % mean 10.41% � Highest in young women
� Sexual contact primary route of transit, important factors � Earlier age at sexual debut � Increased number of partners
� More transmissible than any virus but less than bacterial infections
Burchell et al Vaccine 24S3 (2006)
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Ac8ve protec8on via vaccina8on is mediated by neutralizing an8bodies at the cervix
HPV
Cervical canal
Neutralizing an8bodies
Blood vessel
Epithelial tear
Basement membrane
Cervical epithelium
1. Stanley M. Vaccine 2006; 24:S16–S22; 2. Giannini S, et al. Vaccine 2006; 24:5937–5949; 3. Nardelli-‐Haefliger D, et al. J Natl Cancer Inst 2003; 95:1128–1137; 4. Poncelet S, et al. IPC 2007(poster).
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Product characteristics – prophylactic HPV vaccines
CervarixTM1 Gardasil®2
Antigen VLPs of HPV 16 & 18 VLPs of HPV 16, 18, 6 & 11
Administration
0, 1 & 6 months by intramuscular injection
0, 2 & 6 months by intramuscular injection
1. CervarixTM. European Summary of Product Characteris8cs, 2007; 2. Gardasil®. European Summary of Product Characteris8cs, 2008.
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HPV Vaccines: Cross Protec8on
Gardasil(Merck) Quadrivalent
Cervarix (GSK) Bivalent
HPV 45 (related to 18)
V/P 3/2
V/P 1/17 Reduction 94%
HPV 31 (related to 16)
V/P 5/21 Reduction 76%
V/P 14/30 Reduction 54%
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HPV Vaccines: Published data
Gardasil(Merck) Cervarix (GSK)
Dose and administration
0.5 ml IM 0.5 ml IM
Schedule 0,2,6 months 0,1,6 months
Trial size 17622 18644
comparator Placebo with alum Hepatitis A Site Up to 16 countries 14 countries
Age range 16-24; 15-26 15-25
eligibility < 4 sexual partners ( median 2)
< 6 sexual partners
exclusion Hx of abnormal pap smears; pregnancy
Hx of colposcopy, immunocompromised or pregnant
duration 48 month study, 3 year data
Mean 14.8 months
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HPV Vaccina8on Efficacy
Harper D; Expert Review Vaccines 2009
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Vaccine efficacy
� Safe effective vaccines � Trials show a reduction in CIN and treatment � Other trials have shown safety and immunogenicity in women 9-‐15 years old
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Safety/Adverse Events GARDASIL Quadravalent CERVARIX Bivalent
14 days after injection
Gardasil (14 days after injection) (n=5088)%
Alum Placebo (n=3470)%
Saline Placebo (n=320)%
Cervarix (7 days after injection) (n=22806)%
Alum Placebo (n=4485)%
HAV 720 (n=8750)%
Injection site
Pain 83.9 75.4 48.6 78 52.5 58.9 Swelling 25.4 15.8 7.3 25.8 8.2 10.1 Erythema 24.6 18.4 12.1 29.6 10.6 16.1 Puritis 3.1 2.8 0.6 Not noted Not noted Not noted
Systemic
Fever(>37.8oC)
10.3 8.6 5.1 5.2 4.6
Nausea 4.2 4.1 12.9 11.6 14.0 Diarrhea 1.2 1.5
Dizziness 2.8 2.6
Data taken from product monograph Canada and Australia
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When to vaccinate?
� Should vaccinate before sexual activity � Works best in a school based program
� High rates of vaccination in UK, Canada Australia etc; where school based programs are used
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Dura8on and Safety � Both vaccines have demonstrated efficacy beyond 7 years
� Antibody levels vary, but there has been no evidence of breakthrough infections thus far
� All evidence from the millions of doses given confirms that they are very safe vaccines
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HPV vaccine in Saudi Arabia Statement
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Saudi Gynecology Oncology Group( SGOG) statement � Health care providers should be encouraged to discuss HPV vaccine for women who wish to be vaccinated and help them in the decision making.
Primary Vaccination with three doses of cancer cervix vaccine should be given for females 15 to 26 years of age to decrease the risk of HPV infection and subsequently prevent cervical cancer. In addition catch-‐up immunization for women above age 26 years could be done .
Women who received the HPV vaccine should continue to follow the existing cervical cancer screening programs.
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Saudi Gynecology Oncology Group( SGOG) statement � Health care providers should be encouraged to discuss HPV vaccine for women who wish to be vaccinated and help them in the decision making.
� Primary Vaccination with three doses of cancer cervix vaccine should be given for females 15 to 26 years of age to decrease the risk of HPV infection and subsequently prevent cervical cancer. In addition catch-‐up immunization for women above age 26 years could be done .
� Women who received the HPV vaccine should continue to follow the existing cervical cancer screening programs.
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Saudi Gynecology Oncology Group( SGOG) statement � Health care providers should be encouraged to discuss HPV vaccine for women who wish to be vaccinated and help them in the decision making.
� Primary Vaccination with three doses of cancer cervix vaccine should be given for females 15 to 26 years of age to decrease the risk of HPV infection and subsequently prevent cervical cancer. In addition catch-‐up immunization for women above age 26 years could be done .
� Women who received the HPV vaccine should continue to follow the existing cervical cancer screening programs.
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Cervical Cancer Preven8on
Normal Cervix
HPV Infection
Cervical Dysplasia
Cervical Cancer
Primary Prevention: Vaccination
Secondary Prevention: Screening
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Op8ons in screening � PAP smear � VIA � HPV testing
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Collec8on methods
Physician / nurse collection Patient self collection
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Cervical cancer decrease with PAP smear
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Cervical Screening: Status and Challenges
� Well established system of cytology screening with colposcopy follow-‐up
� Successful in reducing the incidence and mortality from cervical cancer
However: � Realistically in Canada , they have been unable to screen more than 70% of the population well
� How would a cytology based program work in Saudi Arabia?
� What effect will vaccination have?
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Limita8ons of Cytology � Sensitivity of pap test to detect CIN3+: 55%
� Should be done in the context of an organized screening program
� Quality assurance of cytology needs to be very good
� system of communication to the women screened so that they may receive sufficient treatment.
� Requires colposcopy and biopsy to confirm dysplasia
� The necessity for multiple visits with cytology based screening results in significant loss to follow-‐up
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Limita8ons of Cytology � Sensitivity of pap test to detect CIN3+: 55%
� Should be done in the context of an organized screening program
� Quality assurance of cytology needs to be very good
� system of communication to the women screened so that they may receive sufficient treatment.
� Requires colposcopy and biopsy to confirm dysplasia
� The necessity for multiple visits with cytology based screening results in significant loss to follow-‐up
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Limita8ons of Cytology � Sensitivity of pap test to detect CIN3+: 55%
� Should be done in the context of an organized screening program
� Quality assurance of cytology needs to be very good
� system of communication to the women screened so that they may receive sufficient treatment.
� Requires colposcopy and biopsy to confirm dysplasia
� The necessity for multiple visits with cytology based screening results in significant loss to follow-‐up
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Authora Duration Total no Abnormal PAP
smear ASC-US ASC-H LSIL HSIL AGUS INVASIVE
CANCER
Al-Jaroudi (8) 2008-2009 241 7
(2.9%)
3
(1.2%)
1
(0.4%)
2
(0.83%)
NR 1
(0.4%)
NR
Jamal 1984-2000 22089 368
(1.66%)
88
(0.4%)
NR 81
(0.37%)
72
(0.32%)
36
(0.16%)
26
(0.1%)
Altaf 2001 3088 97
(3.14%)
14
(0.45%)
NR 29
(0.93%)
17
(0.55%)
4
(0.13%)
5
(0.16%)
Abdullah L (1) 1998 – 2005 5590 261
(4.7%)
103
(1.84%)
6
(0.10%)
5
(0.09%)
31
(0.55%)
30
(0.53%)
2
(0.04%)
Altaf 2000-2004 5132 241
(4.7%)
124
(2.4%)
NR 31
(0.6%)
22
(0.4%)
58
(1.1%)
6
(0.1%)
Summary of reported data on Pap smear abnormalities in Saudi Arabia
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Visual Inspec8on with Ace8c Acid (VIA)
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Op8ons in Screening
� VIA: Visual inspection with acetic acid � VILI: Visual inspection with Lugols iodine
� Both Low tech can be done by nurses � May need to utilize colposcopy to triage post positive test to rule out cancer
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Test Quali8es of VIA in Primary Healthcare Sefng (Phase 2)
TEST SENSITIVITY
(%)
SPECIFICITY (%)*
POSITIVE PREDICTIVE VALUE (%)*
NEGATIVE PREDICTIVE VALUE (%)*
VIA (n = 2,130)
77 (70–82)
64 (62–66)
19 96
Pap smear (n = 2,092)
44 (35–51)
91 (37–51)
33 94
95% Confidence Interval University of Zimbabwe/JHPIEGO Cervical Cancer Project 1999.
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HPV tes8ng in cervical cancer screening Approaches already implemented or being examined: Ø Serial: Cytology screening followed by HPV testing to
triage ASC-‐US (USA, Nfld) Ø Parallel: Cytology and HPV cotesting (approved in USA,
implemented in California(Kaiser),Quebec) Ø Serial: HPV testing followed by cytologic triage (being
examined in the Finnish trial, BC RCT, a.k.a., HPV FOCAL Study)
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HPV Tes8ng ADVANTAGES � Very sensitive � Better quality control � Decreases the number of cytologists needed
� Increase screening interval which decreases cost and improves convenience
DISADVANTAGES
� Need a second test due to lower specificity
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Role of HPV tes8ng • Triage equivocal or low grade cytology smears
(ALTS trial)
• FUP of women with abnormal cytology but normal
colposcopy
• Predict outcome after treatment of high grade disease
• Primary Screening
Cuzick J. Vaccine 2008
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CCCAST trial
PAP HPV 55.6% 94.6% Sensitivity
96.8% 94.1% Specificity
Mayrand et al.; Ø compare the relative efficacy of HPV DNA testing and Pap cytology in primary screening for cervical cancer and its high-‐grade precursors
NEJM 2007
Ø Pap screening followed by HPV (hc 2) vs hc2 testing followed by HPV in women 30-‐69 Ø 9,667 women
HPV testing is significantly more sensitive to detect CIN 2+
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HPV Screening for Cervical Cancer in India Sankaranarayanan,R: � RCT ,4 Arms of screening tool in India � HPV test vs. Pap test vs. VIA vs. Observation � Cervical cancer as an endpoint � 32000 women in each arm � Screen positive received colposcopy and treatment � Only significant screening method to reduce deaths from cervical cancer was HPV testing
� Significant reduction in Ca Cervix in the HPV negative compared to negative Pap and VIA
NEJM Apr2009 360(14)1385-‐94
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HPV tes8ng RCT Ronco etal � Trial in Italy � 94000 women 25-‐60 randomized in 2 phases Ø Cytology vs. HPV testing and cytology (phase 1) Ø HPV testing alone (phase 2).
� Same rate of cancer in round one of testing � Increased cancer in cytology group in round two
� HPV testing was more effective in preventing cancer by detecting high grade lesions earlier.
� However: HPV testing leads to over diagnosis of CIN 2 which is likely to resolve
Ronco G; Lancet March 2010
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Cost Effec8veness Several studies proved the cost effectiveness of HPV testing as screening test for Cervical cancer
� In developing countries � Screening program not well established � Middle income
Br J Cancer.2010 Dec 7;103(12):1773-‐82. Cancer Causes Control.2011 Feb;22(2):261-‐72. Eur J Cancer. 2011 Jul;47(11):1633-‐46
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Screening program in Saudi Arabia
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Suggested Screening Strategy � Use the high sensitivity of HPV test initially
� Digene Hybrid capture 2 test is suitable
� Positive HPV test has reflex pap testing � If both positive colposcopy is performed � If HPV neg repeat screen in 5 years � If HPV +ve and pap neg, repeat HPV and pap in 1 year
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HR-‐HPV tes8ng and Reflex PAP HR-‐HPV DNA in women 30 + years old
Negative
Negative
Negative
Pap test
Positive
Positive
Colposcopy
Positive
Repeat HR-‐DNA testing @ 5 year intervals till age
65
Repeat HR-‐HPV testing at
12 months
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Conclusions � Introduction of a cervical cancer prevention program in Saudi Arabia is possible
� Vaccination has the promise to prevent cervical cancer in a large group of women
� Screening should be done using HPV testing as the initial method
� All aspects, i.e. Screening, colposcopy, treatment and invasive cancer surveillance require very careful quality assurance processes.
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Thank you