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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
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
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
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
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)
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)
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
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
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
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
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
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
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
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
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)
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
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)
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
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%
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
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
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)
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
IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME
TRAININGTRAINING
QUALITY ASSURANCEQUALITY ASSURANCE
IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME
TRAINING MATERIALS TRAINING MATERIALS
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
IARC’s CERVICAL CANCER SCREENING PROGRAMME IARC’s CERVICAL CANCER SCREENING PROGRAMME
COST EFFECTIVENESS STUDIES COST EFFECTIVENESS STUDIES
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
$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
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
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
Volume 10
Cervix Cancer Screening
2004(in press)
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)