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IARC’s CERVICAL CANCER IARC’s CERVICAL CANCER SCREENING PROGRAMME SCREENING PROGRAMME R. Sankaranarayanan MD R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer, Lyon, France

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Page 1: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER IARC’s CERVICAL CANCER

SCREENING PROGRAMME SCREENING PROGRAMME

R. Sankaranarayanan MDR. Sankaranarayanan MD

Screening GroupWorld Health Organization

International Agency for Research on Cancer,Lyon, France

Page 2: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

OBJECTIVEOBJECTIVE

To guide public health policies on cervical cancer control in

different regional, national and sub-national settings

Page 3: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

Evaluates the role of cytology and various non-cytology based screening in the early detection

and prevention of cervical neoplasia world-wide

Page 4: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

SCREENING TESTS EVALUATED SCREENING TESTS EVALUATED

Conventional cervical cytology

Unaided visual inspection (“downstaging”)

Naked eye visual inspection with 3-5% acetic acid (VIA)

Visual inspection with acetic acid using low-level (2-4X) magnification (VIAM)

Visual inspection with Lugol’s iodine (VILI)

HPV testing

Page 5: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

SCREENING APPROACHES EVALUATED SCREENING APPROACHES EVALUATED

Low-intensity screening(“once a life-time”)

Screen, triage, treat approaches with aposteriori histology (1- or 2-visit approach)

Page 6: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

EVALUATION OF TREATMENT OF CERVICAL EVALUATION OF TREATMENT OF CERVICAL PRECANCERS PRECANCERS

Cryotherapy by nurses

LEEP by mid-level clinicians

Cryotherapy LEEP (LLETZ)

Page 7: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

STUDY DESIGNS STUDY DESIGNS

Cross-sectional studies

Follow-up (cohort) studies

Non-randomised controlled trials

Cluster-randomised controlled trials

Randomised trials

Demonstration programmes

Page 8: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

OUTCOMES STUDIED OUTCOMES STUDIED

Accuracy

Reproducibility

Detection rates of CIN/Ca

Cure rates of CIN

Side-effects and complications of Rx of CIN

Stage-distribution

Reduction in incidence/mortality

Determinants of participation

Page 9: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

STUDY LOCATIONS STUDY LOCATIONS

Vientiane

Bangkok

Singapore

Trivandrum

EmakulamKannur

MumbaiBarshi/ Osmanabad

HyderabadCoimbatoreAmbillikai

Hyderabad

CalcuttaBhaktapur

BanepaBarathpur

New DelhiJaipur

Dar es Salaam

Luanda

Brazzaville

Ibadan

Ouagadougou

NiameyBamako

Nouakchott

Dakar

OuagadougouConakry

Lima

Bogota

Randomised control trials

Cross-sectional studies

Training facilities

Planned projected

Page 10: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

COLLABORATING INSTITUTIONS:COLLABORATING INSTITUTIONS:AFRICA, EUROPE AND SOUTH AMERICAAFRICA, EUROPE AND SOUTH AMERICA

Maternity Hospital, Luanda, and MOH, Angola University Hospital, Ouagadougou, Burkina Faso University Hospital, Brazzaville, Republic of Congo University Hospital, Conakry, and MOH, Guinea Hospital Point G, Bamako, Mali University Hospital, Nouakchoutt, Mauritannia Medical College, Ibadan, Nigeria University Hospital, Niamey, Niger Ocean Road Cancer Institute, Dar es Salaam, Tanzania Regional Office of the WHO, Arican Region (AFRO) Hospital Edouard Herriot, Lyon, France Centre Leon Berard, Lyon, France University Hospital, Grenoble, France INCTR, Brussels, Belgium Health Economics Research Centre, University of Oxford National Cancer Institute, Lima, Peru National Cancer Institute, Bogota, Columbia

Page 11: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

COLLABORATING INSTITUTIONS: COLLABORATING INSTITUTIONS: INDIA INDIA

Tata Memorial Centre, Mumbai, Nargis Dutt Memorial Cancer Hospital, Barshi Christian Fellowship Community Health Centre, Ambillikai Regional Cancer Centre, Trivandrum Chittaranjan National Cancer Institute, Kolkata Cancer Foundation of India, Kolkata Cancer Institute (WIA), Chennai All India Institute of Medical Sciences, New Delhi Bhagwan Mahaveer Cancer Hospital & Research Centre, Jaipur PSG Institute of Medical Sciences and Research, Coimbatore Christian Medical College, Vellore Malabar Cancer Care Society, Kannur MNJ Cancer Institute, Hyderabad Institute for Rural Health Studies, Hyderabad

Page 12: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

COLLABORATING INSTITUTIONS COLLABORATING INSTITUTIONS

BP Koirala Memorial Cancer Hospital, Bharatpur, Chitwan, Nepal

Bhakthapur Cancer Care Centre, Bhakthapur, Nepal

Nepal Network for Cancer Treatment & Research, Banepa, Nepal

University Hospital, Vientiane, Laos

National Cancer Institute, Bangkok, Thailand

Page 13: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

300,000 women in 11 countries

38 Institutions in 5 continents

436 investigators and workers

Page 14: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

CROSS-SECTIONAL STUDIES OF ACCURACY TO DETECT CIN 2-3 LESIONS CROSS-SECTIONAL STUDIES OF ACCURACY TO DETECT CIN 2-3 LESIONS

56,939 women

22,633 with cytology18,085 with HPV testing/HCII

54,918 tested with VIA16,900 withVIAM 49,080 with VILI

56,939 had colposcopy

9590 had biopsy

3369 CIN 1 

1063 CIN 2 & 3 

269 Cx Cancers

Page 15: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

Test No. of women (study sites)

Sensitivity % (range in study sites)

Specificity % (range in study sites)

Cytology 22,633 (5) 58 (29-77) 95 (89-99) HPV testing 18,065 (4) 67 (46-81) 94 (92-95)

VIA 54,981 (11) 77 (58-94) 86 (75-94) VIAM 16,900 (3) 64 (61-71) 87 (83-90) VILI 49,080 (10) 92 (76-97) 85 (73-91)

VIA + or VILI + 49,080 (10) 94 81 VIA + and VILI + 49,080 (10) 79 89

ACCURACY OF SCREENING TESTSACCURACY OF SCREENING TESTS

Int J Cancer 2004; 110-907-13; J Med Screening 2004; 11:77-84; Int J Cancer 2004 (in press); Cancer Detect Prev 2004 (in press)

Page 16: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

Cluster Randomised Controlled Cluster Randomised Controlled

Trial of VIA Screening, Trial of VIA Screening,

Dindigul District, IndiaDindigul District, India

Christian Fellowship Community Health Centre (CFCHC), Ambillikai, India

PSG Institute of Medical Sciences and Research (PSGIMSR), Coimbatore, India

Cancer Institute (WIA), Chennai, India

World Health Organization-International Agency for Research Cancer (WHO-IARC), Lyon, France

Page 17: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

Assessed for eligibility (n= 80,422)

Excluded (n=2,030)

Randomised 113 clusters (n= 78,392)

Allocated to VIA screening 57 clusters (n= 48,225)

124,144 PYO

Allocated to control group 56 clusters (n= 30,167)

90,172 PYO

Received VIA screening (n= 30,577)

Did not receive VIA screening (n= 17,648)

34 invasive cancers diagnosedCR: 37.7/100,000 PYO

ASR: 43.1/100,000 PYO

34 invasive cancers diagnosedCR: 37.7/100,000 PYO

ASR: 43.1/100,000 PYOScreened positiven=2,939 (9.6%)

CIN 1n= 1,778 (5.8%)

Treatedn= 1,263 (71.0%)

CIN 2-3n= 222 (0.7%)

Treatedn= 178 (80.2%)

Screen detected invasive cancer n=69 (0.2%)

Treatedn= 52 (75.4%)

Clinically detected invasive cancer n=28

97 invasive cancers diagnosedCR: 78.1/100,000 PYO

ASR: 92.4/100,000 PYO

97 invasive cancers diagnosedCR: 78.1/100,000 PYO

ASR: 92.4/100,000 PYO

PYO: person years of observation; CR: crude incidence rate; ASR: age-standardized incidence rate; CIN: cervical intraepithelial neoplasia; Percentages refer to proportion of screened women (N=30,577) except for treatment where they refer to lesion detected

Flow chart of the design and preliminary results of the studyFlow chart of the design and preliminary results of the study

DDINDIGULINDIGUL RCT RCT OF OF VIAVIA SSCREENING, CREENING, IINDIANDIA

Sankaranarayanan et al., Int J Cancer: 109,

461-467 (2004)

Page 18: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

Comparative efficacy of visual inspection Comparative efficacy of visual inspection

with acetic acidwith acetic acid, HPV testing and , HPV testing and

conventional cytology in cervical cancer conventional cytology in cervical cancer

screening: a randomized intervention screening: a randomized intervention

trial in Maharashtra state, Indiatrial in Maharashtra state, India

Tata Memorial Centre (TMC), Mumbai, India

Nargis Dutt Memorial Cancer Hospital (NCMCH), Barshi, India

International Agency for Research Cancer (WHO-IARC), Lyon, France

Page 19: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

FLOW CHART OF THE STUDY DESIGN AND FINDINGS

Eligible population52 PHCs

(n=142,701)

Eligible population52 PHCs

(n=142,701)

RandomizationRandomization

Cytology arm(13 PHCs)

Cytology arm(13 PHCs)

VIA arm(13 PHCs)VIA arm

(13 PHCs)Control arm(13 PHCs)

Control arm(13 PHCs)

HPV arm(13 PHCs)HPV arm(13 PHCs)

Screening coverage71.9%

(positivity rate: 14.0%)

Screening coverage71.9%

(positivity rate: 14.0%)

Screening coverage72.9%

(positivity rate: 7.0%)

Screening coverage72.9%

(positivity rate: 7.0%)

Screening coverage69.5%

(positivity rate: 10.3%)

Screening coverage69.5%

(positivity rate: 10.3%)

Compliance with colposcopy in the field

98.5%

Compliance with colposcopy in the field

98.5%

Compliance with colposcopy at NDMCH

87.1%

Compliance with colposcopy at NDMCH

87.1%

Compliance with colposcopy at NDMCH

88.2%

Compliance with colposcopy at NDMCH

88.2%

Detection ratesDetection rates Detection ratesDetection rates Detection ratesDetection rates

CIN 2-30.7%

CIN 2-30.7%

Condyloma/ CIN 15.6%

Condyloma/ CIN 15.6%

cancer0.3%

cancer0.3%

CIN 2-31.0%

CIN 2-31.0%

Condyloma/ CIN 12.0%

Condyloma/ CIN 12.0%

cancer0.3%

cancer0.3%

CIN 2-30.9%

CIN 2-30.9%

Condyloma/ CIN 12.3%

Condyloma/ CIN 12.3%

cancer0.2%

cancer0.2%

Page 20: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

STAGE DISTRIBUTION OF INVASIVE CANCER IN THE STUDY ARMS

VIA arm Cytology arm HPV arm Control arm Stage Number (%) Number (%) Number (%) Number (%)

I 52 (52.5) 61 (62.3) 50 (66.6) 10 (18.6)

II 18 (18.2) 12 (11.2) 14 (18.7) 8 (14.9)

III 24 (24.2) 24 (24.5) 10 (13.3) 33 (61.1)

IV 5 (5.0) 1 (0.0) 1 (1.3) 3 (5.6)

Total 99 (100.0) 98 (100.0) 75 (100.0) 54 (100.0)

OOSMANABAD SMANABAD RCTRCT OF OF CCERVICAL ERVICAL SSCREENING, CREENING, IINDIANDIA

StudyStudy

Page 21: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

OVERTREATMENT IN SCREEN, SEE AND TREAT OVERTREATMENT IN SCREEN, SEE AND TREAT APPROACH: OSMANABAD AND DINDIGUL APPROACH: OSMANABAD AND DINDIGUL DISTRICT SCREENING PROJECTS, INDIA DISTRICT SCREENING PROJECTS, INDIA

Disease status based on histology Number (%)

Normal 1595 (36)

CIN 1 2157 (49)

CIN 2 & 3 629 (15)

Total 4381

Supported by the ACCP through the Bill & Melinda Gates FoundationSupported by the ACCP through the Bill & Melinda Gates Foundation

Page 22: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

HOW EFFECTIVE ARE THE TREATMENT OF HOW EFFECTIVE ARE THE TREATMENT OF PRECANCERS IN THE DEVELOPING WORLD? PRECANCERS IN THE DEVELOPING WORLD? Cryotherapy: Data from Indian studies

Lesion Total Cured at 1 year

CIN 1 1264 90% (N=1137)

CIN 2 & 3 234 79% (N=184)

LEEP: Data from Indian studies Lesion Total Cured at 1 year

CIN 1 296 96% (N=283)

CIN 2 & 3 336 86% (N=288)

Supported by the ACCP through the Bill & Melinda Gates FoundationSupported by the ACCP through the Bill & Melinda Gates Foundation

Overall 1 cure rate in CIN = 89% (1892/2130)

Page 23: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

EFFICACY OF SINGLE- VS DOUBLE-FREEZE EFFICACY OF SINGLE- VS DOUBLE-FREEZE CRYOTHERAPY CRYOTHERAPY

300 women with CIN randomized

Preliminary findings indicate same efficacy : 89% NED at 1-year

Page 24: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

TRAININGTRAINING

QUALITY ASSURANCEQUALITY ASSURANCE

Page 25: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

TRAINING MATERIALS TRAINING MATERIALS

Page 26: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,
Page 27: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

DETERMINANTS OF PARTICIPATION IN DETERMINANTS OF PARTICIPATION IN SCREENING SCREENING

Low SES

Low income

Education

Parity

Contraceptive practice

Sankaranarayanan et al., Cancer Detect Prev 2003; 27: 457-65

Page 28: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

COST EFFECTIVENESS STUDIES COST EFFECTIVENESS STUDIES

Page 29: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

0 5 10 15

Biopsy lab processing**

Colposcopy in hospital

Transport to hospital

HPV test lab processing

Cytology lab processing

HPV screening clinic

Cytology screening clinic

VIA screening clinic*

Invitation

Recruitment

Eve

nt

Cost of event (in US $)

Staff

Transport

Equipment

Consumables`

Unit costs of intervention in Unit costs of intervention in Osmanabad district cervical cancer screening projectOsmanabad district cervical cancer screening project

Page 30: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

$0

$25,000

$50,000

$75,000

$100,000

$125,000

$150,000

0 20 40 60 80 100 120

Number of eligible women where CIN2-3 detected

Co

st

pe

r 1

0,0

00

elig

ible

wo

ma

n in

US

$ HPV

VIA

CYTO

8

$ 775

$ 1135

Costs per CIN 2/3 detected in Osmanabad Costs per CIN 2/3 detected in Osmanabad district cervical cancer screening projectdistrict cervical cancer screening project

Page 31: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

TRAINING CENTRES TRAINING CENTRES Chittaranjan National Cancer Institute, Kolkata,

India

Regional Cancer Centre, Trivandrum, India

University Hospital, Conakry, Guinea

Maternity Hospital, Luanda, Angola

Ocean Road Cancer Institute, Dar es Salaam, Tanzania

Instututo de Enfermedades Neoplasicas, Lima Peru

National Cancer Institute, Bogota Columbia

Page 32: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

SCREENING VS EARLY CLINICAL DETECTION SCREENING VS EARLY CLINICAL DETECTION

Awareness

Test

Recall

Follow-up

Page 33: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

Volume 10

Cervix Cancer Screening

2004(in press)

Page 34: IARCs CERVICAL CANCER SCREENING PROGRAMME R. Sankaranarayanan MD Screening Group World Health Organization International Agency for Research on Cancer,

IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME

SUPPORTED BY SUPPORTED BY The Bill & Melinda Gates Foundation through

the ACCP

WHO-AFRO

International Network for Cancer Treatment and Research (INCTR)

International Union Against Cancer (UICC)

Association for International Cancer Research (AICR)

Program for Appropriate Technology in Health (PATH)