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Cervical Cancer Prevention in CEE and the NIS: The Way Forward. John Sellors, MD PATH (Program for Appropriate Technology in Health) Seattle, USA. Overview of Presentation. Global burden of disease Regional statistics and challenges Overview of screening technologies and programmatic issues

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Cervical cancer prevention in cee and the nis the way forward
Cervical Cancer Prevention in CEE and the NIS:The Way Forward

John Sellors, MD

PATH (Program for Appropriate Technology in Health)

Seattle, USA


Overview of presentation
Overview of Presentation

  • Global burden of disease

  • Regional statistics and challenges

  • Overview of screening technologies and programmatic issues

  • Goals and objectives of the Albania Meeting


Cervical cancer a global problem
Cervical Cancer – A Global Problem

  • Over 230,000 women die from cervical cancer worldwide per year.

  • 470,000 new cases per year.

  • 80% are in poor countries.

  • A leading cause of cancer death in poor countries.


Cervical cancer incidence asr
Cervical Cancer Incidence (ASR)

  • Worldwide, cervical cancer is the second most common cancer in women - in many developing countries it remains the most common.

  • Hardest hit regions include

    • Latin America and Caribbean, 33.5 per 100,000

    • sub-Saharan Africa, 31 per 100,000

    • South Central Asia, 26.5 per 100,000

    • Melanesia, 43.8 per 100,000


Cervical cancer incidence
Cervical Cancer Incidence

Age standardized rates per 100,000 (based on world population)


Cervical cancer s impact on women in cee nis
Cervical Cancer’s Impact on Women in CEE/NIS

  • Incidence rates in Eastern Europe tend to range from 15-35 per 100,000 (ASR).

  • Hardest hit countries include

    • Poland, Hungary, Bulgaria (ASRs 20.1 - 30 per 100,000), and

    • Romania, 31.5 per 100,000

  • Remaining countries typically have ASRs between 10-20 per 100,000.


Mortality from cervical cancer in cee nis
Mortality from Cervical Cancer in CEE/NIS

  • Cervical cancer is a leading cause of death from cancer for women in the region (breast cancer is #1).

  • In developed countries, ASR for mortality is approx 4 per 100,000. In developing countries, the rate is more than twice as high, 9.8 per 100,000.

  • Mortality in several CEE/NIS countries exceeds 9.8



EasternEurope



Opportunities for advances in health services in cee nis
Opportunities for Advances in Health Services in CEE/NIS

  • Empower providers, improve clinical training and standards.

  • Implement evidence-based guidelines and practices (effectiveness and efficiency).

  • Implement quality improvement methods.

  • Empower communities to participate.

  • Encourage increased investment in public health services, including health promotion (shift: cure to prevention).

  • Understand country contexts (social, political, economic/CEA, cultural).



Cervical cancer risk factors
Cervical Cancer Risk Factors

  • Human papillomavirus (HPV) is the sexually transmitted cause of precancerous lesions and cervical cancer (Wallboomers et al., ’99).

  • Over a lifetime, 80 percent sexually active women will be infected with a cancer-causing type of HPV(Koutsky, ’97).

  • So…why don’t all women get cancer?


Hpv prevalence in ontario women carcinogenic types
HPV Prevalence in Ontario Women (Carcinogenic Types)

(Sellors et al., CMAJ 2000)


Natural history
Natural History:

  • Cervical cancer develops from an abnormal area - usually present for 15 to 20 years.

  • Precursor lesion does not cause symptoms but can be detected with various tests.

  • Screening = detection of the precancerous lesion in asymptomatic women.

  • Outpatient treatment of precancerous lesions is very effective.


Natural history of cervical cancer

~20% within

10 years

HPV

Infection

Low-

grade

(CIN 1)

High-

grade

(CIN 2/3)

Invasive

Cancer

60%

15%

10% in

2 years

Natural History of Cervical Cancer

Screening strategies are intended to identify these abnormalities.


Successful cervical cancer prevention programs it s not just about the test
Successful Cervical Cancer Prevention Programs: It’s not just about the test…

  • The screening test is just one of the key components in an effective cervical cancer prevention program.

Treatment

Education

Coverage

Screening

Test

Follow up


Methods of prevention vaccines
Methods of Prevention—Vaccines?

  • The most effective prevention would be a protectivevaccine, given at an early age before sexual activity begins.

  • Vaccine programs have a high cost.

  • An HPV vaccine probably will provide excellent protection** but the impact on population health will not seen for 20-30 years.

  • Screening and management would still be necessary, at least until unvaccinated women had grown older.

**Koutsky et al., NEJM, ‘02


Effect of age at vaccination on cc incidence
Effect of age at vaccination on CC Incidence

Barnabas and Garnett, ’02, unpublished


Key considerations for successful programs
Key considerations for successful programs

  • Policy and political will.

  • Infrastructure development.

  • Integration of testing, investigation/treatment, and follow-up care in health services.

  • Evaluation of effectiveness to reduce disease burden.


Screening tests for cervical neoplasia
Screening Tests for Cervical Neoplasia

  • Cytology

    • Conventional

    • Liquid based

    • Automated

  • Non-cytology methods

    • Visual inspection with acetic acid (VIA)

    • Visual inspection with Lugol’s iodine (VILI)

    • HPV-DNA testing



Cytology1
Cytology

  • Time tested method.

  • Moderately accurate.

  • Unable to achieve concurrently high. sensitivity and specificity in many settings.

  • Resource intensive: laboratory, consumables, personnel, quality assurance.

  • Programmatic issues.


Accuracy of conventional cytology to detect hsil

Study Site

No. Women

Sensitivity

(%)

Specificity

(%)

PPV

(%)

Fahey et al.

10 295

58.0

69.0

-

U. Harare/ JHPIEGO

2092

44.3

90.6

33.3

IARC-ACCP/ India

21 802

58.1

94.7

11.7

Accuracy of conventional cytology to detect HSIL


Pap test is problematic but

Conventional Pap test is still the only screening test ‘proven’ to reduce incidence and mortality rates of ICC.

CIN is slow growing.

Many low-grade CINs regress.

Abnormalities missed by one screening will probably be detected in next interval.

ICC usually due to lack of screening rather than cytologic errors.

Pap Test Is Problematic But…


Liquid based cytology lbc and computerized reading

ThinPrep ‘proven’ to reduce incidence and mortality rates of ICC. (Cytyc)

automated LBC sample prep system

~60,000 selected cells distributed in a thin layer

smaller area than conventional Pap

specimens read optically or digitally

*FDA approved for screening

As of Sept. 2001

AutoPap 300 (Tripath) and Trac Cell 2000 (Accumed International)

automated LBC sample prep

visual intelligence computer technology

sorts by probability of abnormality

*FDA approved only for mandatory rescreening

Liquid-Based Cytology (LBC) and Computerized Reading


Liquid based cytology other considerations

Pros ‘proven’ to reduce incidence and mortality rates of ICC.

randomly selected cells in thin layer

better quality fixation and less ‘debris’

quicker reading - 3.2 min (double for Pap)

amenable to HPV testing and immunohistochem. for different antigens

Cons

costly equipment

more costly than Pap - worse compliance?

retraining needed for smear-takers and pathology lab

morphology changes

Liquid-based Cytology: Other Considerations


Cost effectiveness of conventional pap and lbc
Cost-Effectiveness of Conventional Pap and LBC ‘proven’ to reduce incidence and mortality rates of ICC.

  • Base case – Conventional Pap screen every 3 yrs compared with no screening is $4,096/life-year saved

  • If thin-layer cytology can decrease the FNR (by factor of 0.6) and incremental cost/slide is $10, the incremental cost is $22,010/life-year saved, if interval every 3 yrs

  • If computer allows 100% re-reading (decreasing FNR by 0.85) and incremental cost per slide is $10, incremental cost is $45,375/life-year saved, if every 3 yrs


Hpv dna tests
HPV DNA Tests ‘proven’ to reduce incidence and mortality rates of ICC.


Hpv dna testing
HPV DNA Testing ‘proven’ to reduce incidence and mortality rates of ICC.

  • Dependent on proprietary technology:

    HC IITM (Digene, Inc) is the only FDA approved, commercially available test.

  • Higher sensitivity but somewhat lower specificity than Pap.

  • Used in combination with Pap achieves high sensitivity and increases negative predictive value—allows for increase in screening intervals.


Hpv testing
HPV Testing ‘proven’ to reduce incidence and mortality rates of ICC.

  • Testing expensive currently

  • Sophisticated testing infrastructure

  • Higher sensitivity, but lower specificity than cytology

  • Range in sensitivity: 80-100%

  • Range in specificity: 61-95%

  • 61.2% sensitivity and 93.8% specificity in Indian studies

  • Currently being evaluated in cross-sectional studies and RCTs


Self sampling vaginal swab
SELF-SAMPLING: Vaginal swab ‘proven’ to reduce incidence and mortality rates of ICC.


Sensitivity and specificity of HC II for the detection of CIN 2/3 infour specimen types

n=200, colposcopy clinic

Sellors et al, 2000



Visual inspection with acetic acid via
Visual Inspection with Acetic Acid (VIA) CIN 2/3 in

  • Promising low technology alternative to Pap smear.

  • Cervix is swabbed with 3-5% acetic acid and examined with a bright light to identify acetowhite lesions.

  • Results are immediate allowing for treatment and management decisions in the same session.


Visual inspection with lugol s iodine vili
Visual Inspection with Lugol’s Iodine (VILI) CIN 2/3 in

  • Normal squamous epithelial cells have substantial stores of glycogen.

  • Glycogen stains mahogany brown with iodine solution.

  • Abnormal areas of squamous epithelium (CIN or inflammation) do not contain glycogen to the same extent and do not stain brown.


a CIN 2/3 in

b

  • VIA-positive: A large acetowhite area

  • (b)VILI-positive: After Lugol’s iodine application, the lesion is iodine negative


Multi centered study of via and vili
Multi-Centered Study of VIA and VILI CIN 2/3 in

  • 11 sites in Africa and India, N=55,000

    Sens.*Spec.*

    VIA 77% 85%

    VILI 92% 85%

    *for high grade disease

Sankaranarayanan et al, Int J Cancer 2004


Screening tests summary
Screening Tests: Summary CIN 2/3 in

  • Given an adequate program with all necessary components, conventional cytology works when repeated at intervals.

  • Cytology not feasible in all settings.

  • Increasing evidence-base from a range of settings on cytology, VIA, VILI, and HPV.

  • Incremental life-year gains from newer cytology and HPV technologies are at considerable cost.



Key components for quality assurance in cee nis
Key Components for Quality Assurance in CEE/NIS CIN 2/3 in

  • Assess quality and effectiveness of current strategies

    • Identify common deficits & modify strategies as needed:

      • inadequate information systems

      • faulty transport mechanisms

      • poorly trained providers/laboratory specialists

      • poor quality of care

      • low participation rates


Key components for involving women in cee nis
Key Components for Involving Women in CEE/NIS CIN 2/3 in

  • Increase awareness of cervical cancer and preventive health seeking behavior among women ages 30-50.

  • Emphasize the need for screening in this age group.

  • Increase coverage first and add rescreening later.

  • Resources are always scarce – use CEA.


Key components of screening strategies for cee nis
Key Components of Screening Strategies for CEE/NIS CIN 2/3 in

  • Screen all women aged 30-50 at least once before expanding services to other age groups or decreasing the interval between screenings.

  • Refer screen-positive women for colposcopy.

  • Treat women with high-grade precancers, refer those with invasive disease, provide palliative care for women with advanced cancer.


Key components for monitoring impact
Key Components for Monitoring Impact CIN 2/3 in

  • Collect service delivery and quality control data that will facilitate ongoing monitoring and evaluation of program activities and outputs.



Objective of the conference
Objective of the Conference in CEE and the NIS

  • Unique opportunity to bring together the most interested and involved professionals and key Ministry of Health staff to:

    • Share experiences of implementing cervical cancer programs in CEE/NIS countries.

    • Provide technical update about cervical cancer prevention practices.

    • Facilitate exchange of information about key recommendations and potential policy change at the national level.


Anticipated success
Anticipated Success: in CEE and the NIS

  • Important step in strengthening cervical cancer prevention efforts in the region.

  • Raising profile of cervical cancer prevention in CEE/NIS via unified messages.

  • Accelerating progress through sharing materials, experience, lessons learned.

  • Using evidence base to inform cervical cancer prevention work.


Thank you
Thank you in CEE and the NIS



Screening management strategies
Screening & Management Strategies in CEE and the NIS

  • Test in primary care and refer women screened positive for treatment

  • Test, investigate, and treat in the same session

  • Test and treat in the same session


Longitudinal studies of pap sensitivity
Longitudinal Studies of Pap Sensitivity in CEE and the NIS

  • Ranges between 60-90% IARC (WHO, 1986)

  • Organized program: smear @ 30 and 45 yrs of age, with 80% coverage and public education can reduce mortality rate by 50% Ponten et al (Int J Cancer, 1995)

  • Incidence of stage > II disease is decreased by screening

  • Mortality also a good indicator since IA disease only contributes to incidence


Is an hpv test detecting the same thing as pap
Is an HPV Test Detecting the Same Thing as Pap? in CEE and the NIS

  • Hypothesis: CIN 3 lesions detected by new tests may be different (less likely to progress) than the lesions detected by Pap…and CIN 3 lesions missed are more likely to progress


Treatment options
Treatment Options in CEE and the NIS


Funding and support
Funding and Support in CEE and the NIS

  • Funding has been a remarkable catalyst to interest, research, and program efforts in cervical cancer prevention around the world, particularly in countries where the need is greatest and resources most limited.


Health services in cee nis
Health Services in CEE/NIS in CEE and the NIS

  • Countries in Central and Eastern Europe and the former Soviet Union inherited centralized Soviet models of health care.

  • Since the 1990s health reforms have been introduced including health financing, coordinated services, quality of care, community participation, and public health reforms.


Health services continued
Health Services (continued) in CEE and the NIS

  • Health expenditures have increased in all countries, although remain lower than countries in Western Europe.

  • More reforms are needed!


Proportion of HC II positive specimens with viral levels above a cutoff (RLU > 15.0)

n=200, colposcopy clinic


Via sensitivity and specificity
VIA Sensitivity and Specificity above a cutoff (RLU

  • VIA has equal or greater sensitivity but lower specificity than conventional cytology.


Important changes in terminology

CIN System above a cutoff (RLU

CIN 3 includes CIS

‘Condyloma/HPV effect’ separated from CIN 1 (together had been ‘Mild Dysplasia’)

Bethesda System

HSIL contains CIN 2 & 3

LSIL includes HPV

ASCUS distinct from atypia due to repair, reaction, infection

Important Changes in Terminology


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