Cervical Screening and HPV Vaccine Guidelines In Saudi Arabia. Prof. Mohammed Addar Chairmen Gyneoncology section KKUH, King Saud University

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1 Cervical Screening and HPV Vaccine Guidelines In Saudi Arabia Prof. Mohammed Addar Chairmen Gyneoncology section KKUH, King Saud University

2 Burden of HPV related cancers l l Cervical Cancer of the cervix the second most common cancer among women worldwide. estimated 529,409 new cases l 274,883 deaths in l l l l 86% of the cases occur in developing countries, representing 13% of female cancers Worldwide, mortality rates of cervical cancer are substantially lower than incidence with a ratio of mortality to incidence to 52% (IARC, GLOBOCAN 2008 ). The majority of cases are squamous cell carcinoma and adenocarcinomas are less common

3 Epidemiology of cancer cervix in USA l l l In 2006, an estimated 9,710 cases of invasive cervical cancer will be diagnosed in the United States. estimated 3,700 women will die from this disease. l In developing countries, cervical cancer is often the most common cancer in women. l Virtually all cervical cancers are causally related to infections by HPV l Approximately 70% of cervical cancers are caused by HPV types 16 or 18. l About 500,000 precancerous lesions (cervical intraepithelial neoplasia [CIN2 and CIN3]) are diagnosed each year. l l 50% to 60% are attributable to HPV16 and HPV18. CIN1 is caused by a variety of HPV types, about 25% by either HPV16 or HPV18, and about 5% by HPV6 or HPV11.

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6 Incidence and Prevalence of HPV HPV the most common sexually transmitted infection globally l There is significant regional variability in the prevalence of HPV even in regions of close proximity and common ancestry, due to differences in sexual and cultural norms. l In the United States, each year it is estimated that over 6 million people are infected with genital HPV. l An estimated 20 million people in the USA, approximately 15% of the population, are currently infected as detected by HPV DNA assays.

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9 Clinical Manifestations Cervical Cell Abnormalities l Usually subclinical l Detected by Pap test, colposcopy, or biopsy l Usually caused by high-risk HPV types Most of the time high-risk HPV types do not cause any abnormalities. Most women infected with high-risk HPV types have normal Pap test results. l Often regress spontaneously without treatment 9

10 Pathogenesis HPV Genotyping System l Low-risk types Most visible warts caused by HPV types 6 and 11 Recurrent respiratory papillomatosis associated with HPV types 6 and 11 l High-risk types HPV types 16 and 18 found in more than half of anogenital cancers Most women with high-risk HPV infection have normal Pap test results and never develop precancerous cell changes or cervical cancer 10

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12 Epidemiology Incidence and Prevalence of HPV-associated Diseases l Genital warts Incidence may be as high as 100/100,000. An estimated 1.4 million are affected at any one time. l Cervical cancer Rates of cervical cancer have fallen by approximately 75% since the introduction of Pap screening programs. Incidence is estimated at 8.3/100,

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14 Clinical Manifestations Anogenital Squamous Cell Cancers l l l HPV infection is causally associated with cervical cancer and probably other anogenital squamous cell cancers (e.g., anal, penile, vulvar, vaginal). Over 99% of cervical cancers have HPV DNA detected within the tumor. Persistent infection with a high-risk HPV type is necessary but not sufficient for the development of cervical cancer. 14

15 Clinical Manifestations Recurrent Respiratory Papillomatosis l l HPV infections in infants and children may present as laryngeal papillomatosis, also known as juvenile onset recurrent respiratory papillomatosis (JORRP). Respiratory papillomatosis is a rare condition, usually associated with HPV types 6 and

16 Cancer cervix in Saudi Arabia l Saudi Arabia has a population of 6.51 millions women ages 15 years and older who are at risk of developing cervical cancer. l l Current estimates indicate that every year 152 women are diagnosed with cervical cancer and 55 die from the disease. Cervical cancer ranks as the 11th most frequent cancer among women in Saudi Arabia, and the 8th most frequent cancer among women between 15 and 44 years of age. l Data is not yet available on the HPV burden in the general population of Saudi Arabia l In Western Asia, about 2.2% of women in the general population are estimated to harbour cervical HPV infection at a given time.

17 " " l Statistics on Saudi Arabia Women at risk for cervical cancer (Female population aged >=15 yrs) 6.51 millions " l Burden of cervical cancer and other HPV-related cancers " l Annual number of cervical cancer cases 152 " l Annual number of cervical cancer deaths 55 " l Projected number of new cervical cancer cases in 2025* 309 " l Projected number of cervical cancer deaths in 2025* 117 " l Crude incidence rates per 100,000 population and year : Male Female " l Cervical cancer " l Anal cancer - - " l Vulva cancer - - " l Vaginal cancer - - " l Penile cancer - - " l Oral cavity " l Pharynx (excluding nasopharynx)

18 Incidence of cervical cancer l Saudi Arabia : 1.3 l Western Asia: 3.6 l World Crude incidence:15.8 Annual number of new cancer cases l SA: 152 l Western Asia: 3931 l World: In 2025 SA 309 (120%) l Cancer registry SA : No Data

19 Annual number of new cases of cervical cancer by age group Saudi Arabia Western Asia l yrs l yrs l yrs

20 HPV prevalence in women with normal cytology Country/region NO. women tested HPV prevalence % Saudi Arabia % CI Western Asia ( ) world ( )

21 Prevalence of pre and malignant diseases of cervix in Saudi population Pap smear: 261 patients ( 5%) abnormal Pap smear ASCUS : 103 (40%) H Atypical cells 6 (2%) LGSIL :56 (22%) HGSIL : 31 (12%) Abnormal glandular cell : 30 (11%) Invasive sq.cell Ca. :21 (9%) L. Abdullah KAAH Jeddah ( Jan )

22 NGH Jeddah ( ) l 3088 cases l Abnormal 97/3088 (3.14%) l ASCUS 14 (0.45%) l LGSIL 29 (0.93%) l HGSIL 17 (0.55%) l Inv.sq.ca 4 (0.13%) l AGUS 4 (0.13%) l Adeno.ca 1 (0.03%) Fadwa altaf annals of Saudi med. 2001

23 l smears ( ) 15 yrs l Abnormal smear : 368 (1.66%) l CIN I: 62 (16.8%) l CINII : 27 (7.3%) l CINIII : 22 (6%) l Atypical endocervical cells 88 (23.9%) l Atypical sq.cell : 6 (1.6%) l HPV : 2 (0.5%) l Malignant cells: 36 (9.8%) l Adenocarcinoma Cx : 7 (1.9%) Ibrahim Mansoor,KAAUH,Jeddah internet journal of gynecology &obstetrics 2002 Jamal a-lmaghrabi Saudi Med J 2003

24 l 120 patients l Overall HPV- 16/18 prevalence (38/120) 31.6% l HPV-16 (16/120) prevalence alone 13.3% l HPV-18 (prevalence alone (4/120) 3.3% l Mixed HPV-16 &18 (18/120) 15% l al-muammar, Annals of Saudi medicine.2007 KFSH&RC Riyadh

25 l Pap smear done for 241/493 subfertile women l Normal 166/241 patients (67.9%) l Abnormal 71/241 patients (29.5%) l Epithelial abnormalities 7/241 (2.9%) l ASCUS 3/241 (1,2%) l ASC-H 1/241 (0.4%) l LSIL 2/241 (0.83%) l AGS 1/241 (0.4%) Al-jaroudi, Annals of Saudi Medicine 2010 KFMC,Riyadh

26 Canadian statistics l 550 women in Ontario are diagnosed with cervical cancer each year l 175 of those will die as a result l There has been a dramatic decline in the last half-century, largely due to screening

27 Principles of Screening l The condition should be an important health problem (significant prevalence and cause of mortality). l The natural history of the condition, including development from latent to declared disease should be adequately understood. l There should be a recognizable latent or early symptomatic stage in which treatment improves outcome. l There should be a suitable test or examination that is acceptable to the population.

28 Principles of Cervical Screening (cont d) l There should be efficacious treatment for patients with recognized disease. l Facilities for diagnosis and treatment should be available. l There should be an agreed policy on whom to treat. l The screening program must be cost effective. l The screening tests should have a high sensitivity to detect disease a high specificity and high positive and negative predictive values.

29 Optimal Tool For Pap Smear l Conventional Cytology l Liquid Based Cytology l LBC is the preferred tool (B-II)

30 Ontario Cervical Screening Initiation Guidelines l All women who are or have ever been sexually active should have a pap test l Screening should be initiated within three years of the first vaginal sexual activity (vaginal intercourse, vaginal/oral and/or vaginal/digital activity) C-III

31 Screening Interval l Annually until there are three consecutive negative Pap tests (C-III) l Every two to three years after three consecutive negative Pap tests (B-II) l Women with abnormal Pap tests should be screened more frequently l Any woman who has not been screened in more than 5 years should have annual screening until there are three consecutive negative Pap tests (C-III)

32 Cessation of Screening l Screening may be discontinued after the age of 70 if there is an adequate negative screening history in the previous ten years (i.e. three or more negative tests) (B-II) l Women should continued to be screened as above, even if they are no longer sexually active.

33 Women with Special l Limited evidence Circumstances l No studies for pregnant women or women post-hysterectomy l Few studies regarding HIV+ women, though none outlined a screening strategy l Some evidence regarding women who have sex with women

34 Current Recommendations l Immunocompromised or HIV positive women: annual screening (C-III) l Total hysterectomy: screening can be discontinued (C-III) l Pregnant women: screening frequency the same as non-pregnant women (B-III) l Women who have sex with women: same screening routine as women who have sex with men(b-ii)

35 Women With Abnormal Cytology l ASCUS (in women older than 30) HPV-DNA testing for women (C-III) Referral to colposcopy if HPV-DNA is positive Repeat cytology in 12 months if HPV-DNA is negative l ASCUS (in women younger than 30) Repeat Pap test in six months Abnormal à colposcopy Normal à repeat Pap in six months Return to normal screening after two normal Pap tests

36 Women with Abnormal Cytology l ASC-H Colposcopy (A-II) l LSIL (cont d) Colposcopy or repeat cytology in six months (B-II) Cytology abnormal à colposcopy Cytology negative à repeat cytology in six months Return to routine screening after two negative Pap tests

37 Women with Abnormal Cytology l HSIL Colposcopy (A-II) l AGC Colposcopy (A-II) (cont d) Endocervical and endometrial sampling (A- II)

38 The Evidence l The evidence supporting this guideline was obtained from seven practice guidelines, six technology assessments, one meeting press release, one systematic review, three randomized controlled trials, one metaanalysis, eight cross-sectional studies, one prospective cohort study, four case-control studies, seven retrospective studies and one conference report.

39 HPV In Canada l 75% of Canadians who are sexually active will have at least 1 HPV infection in their lifetime l Genital HPV can be spread by sexual touching (hands, genitals, objects) l Causes cervical and other genitourinary (anal, penile, vaginal, vulvar) and head and neck (conjunctivae, mouth, oropharynx, larynx) cancers CMAJ, 2007

40 Guidelines for HPV Vaccine In Saudi Arabia

41 Unknowns l Will HPV vaccines affect cervical cancer incidence and mortality? l Is the priming vaccine series sufficient or will a booster dose be required? l Will exposure to wild-type HPV contribute to natural boosting? l Will other HPV genotypes fill the niche previously filled by HPV types 16 and 18? Taken from: Dewar, Deeks, Dobson. Human papillomavirus vaccines launch a new era in cervical cancer prevention. CMAJ 2007;177: Box 2

42 Unknowns l Are there rare but serious adverse effects of vaccination that have not yet been detected? l How will vaccination program affect current cytology screening programs? l Will current cytology screening programs need to be adapted to identify vaccine failures? l Will compliance with screening decrease? Taken from: Dewar, Deeks, Dobson. Human papillomavirus vaccines launch a new era in cervical cancer prevention. CMAJ 2007;177: Box 2

43 Remember our job l Interpret guidelines l Offer information l Dispel myths l Prescribe vaccine if requested l Administer vaccine

44 American Cancer Society (ACS) l HPV vaccination is not currently recommended for women over age 26 years. l Ideally the vaccine should be administered prior to potential exposure to genital HPV l the potential benefit is likely to diminish with increasing number of lifetime sexual partners for males. l Screening for cervical intraepithelial neoplasia and cancer should continue in both vaccinated and unvaccinated women according to current ACS early detection guidelines l Insufficient evidence of benefit in women aged 19 to 26 years refers to (1) clinical trial data in women with an average of 2, and not more than 4, lifetime sexual partners, indicating a limited reduction in the overall incidence of cervical intraepithelial neoplasia (CIN)2/3; (2) the absence of efficacy data for the prevention of HPV16/18-related CIN2/3 in women who have had more than 4 lifetime sexual partners; and (3) the lack of cost-effectiveness analyses for vaccination in this age group. *

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56 Summary of national HPV vaccine recommendations and programmatic aspects in Saudi Arabia

57 1637 complaints involving Gardasil, filed as of May to the Vaccine Adverse Event Reporting System including seizures, paralysis and worst of all, three deaths, including one girl who died of a blood clot three hours after getting the Gardasil vaccine Cervical cancer rates are low, detection rate is high through national screening programs, treatment is widely available Vaccine (if all 3 doses given) only up to 70% effective at preventing Cervical Ca and long term effectiveness is unknown Study sample size is small (~1200, only 100 age 9) False sense of security = less compliance with Pap screening

58 What Needs to be Done in Saudi Arabia l Develop screening program l Develop recording system l Find reliable pathology lab l Develop follow-up systems Untreated positives Post treatment patients l Develop system for referral for treatment l Teach local physicians and nurses to perform screening

59 Conclusion l Our Tasks l - study the real prevalence of the problem in our country l - establish mass screening program l - establish proper recording and registry l - encourage researches l - review international guidelines l - education and media awareness l - involved higher health authority l - financial support

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