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ACCP Evidence base: ACCP Evidence base: Implications for policy and Implications for policy and
practicepractice
R. Sankaranarayanan MDR. Sankaranarayanan MDHead, Screening Group
World Health Organization (WHO)International Agency for Research on Cancer (IARC)
Lyon, Francehttp://screening.iarc.fr
ACCP Evidence Base
Test characteristics
Efficacy of treatment of CIN
Effectiveness of reducing disease burden
Cost effectiveness issues
Acceptability of participation determinants
Reduced frequency of screening: one or twice Reduced frequency of screening: one or twice a life timea life time
Reducing the number of visits and improving Reducing the number of visits and improving adherence to treatmentadherence to treatment
screen and treat (1 or 2 visits)*
screen, see (colposcopy), and treat (1 to 2 visits) (with a posteriori histological confirmation)**
ALTERNATIVE PROGRAMMATIC APPROACHES:ALTERNATIVE PROGRAMMATIC APPROACHES:
*RTCOG/ JHPIEGO Lancet, 2003; 361: 814-20** Sankaranarayanan et al., Int J Cancer, 2004; 109: 461-7
* Denny et al., 2005 JAMA 294: 2173-81
Accuracy of screening tests in developing countries: range in sensitivity and specificity
Test Sensitivity Specificity
Cytology 31-78% 91-99%
HPV testing 61-90% 62-94%
VIA 50-96% 44-97%
VILI 44-93% 75-85%
RESULTS OF TREATMENT OF CIN
Treatment Total number Cured (%)
Cryotherapy 562 477 (85%)
LEEP 422 357 (85%)
OOSMANABAD SMANABAD RCTRCT OF OF CCERVICAL ERVICAL SSCREENING, CREENING, IINDIANDIA StudyStudy
630
501
127
2
0
100
200
300
400
500
600
700 Treatment Offered
Accepted Immediate Treatment
Postponed Treatment
Refused Treatment
Women
SAFETY, ACCEPTABILITY, AND FEASIBILITY OF A SAFETY, ACCEPTABILITY, AND FEASIBILITY OF A SINGLE-VISIT APPROACH TO CERVICAL CANCER SINGLE-VISIT APPROACH TO CERVICAL CANCER
PREVENTION IN RURAL THAILANDPREVENTION IN RURAL THAILAND
Acceptability of Cryotherapy TreatmentAcceptability of Cryotherapy Treatment
Lancet 2003; 361:814-820
RANDOMISED CONTROLLED TRIAL OF SCREEN RANDOMISED CONTROLLED TRIAL OF SCREEN AND TREAT APPROACH FOR CERVICAL CANCER AND TREAT APPROACH FOR CERVICAL CANCER
PREVENTION IN SOUTH AFRICA PREVENTION IN SOUTH AFRICA
Characteristic HPV test & Treat(N=2163)
VIA & Treat(N=2227)
Delayed Evaluation(N=2165)
6 months post randomization
Evaluated womenCIN 2+
prevalence
187915 (0.80%)
192943 (2.23%)
18593.55%
CIN 2 prevalence 12 months post randomization
25 (1.42%)
54 (2.91%)
93 (5.41%)
Denny et al., JAMA 2005; 294: 2173-81
StudyStudy
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
Supported by the Bill & Melinda Gates Foundation through the ACCPSupported by the Bill & Melinda Gates Foundation through the ACCP
Study designStudy design
StudyStudyCLUSTER RANDOMISED TRIAL OF VISUAL SCREENING FOR CERVICAL CANCER IN RURAL SOUTH INDIA: DINDIGUL DISTRICT CERVICAL SCREENING STUDY, TAMIL NADU, INDIA
113 Village clusters79 372 eligible women aged 30-59 years
Allocated to single round VIA screening by nurses, 57 clusters, 48 225 women
Colposcopy/directed biopsy for screen +ve women Cryotherapy/LEEP/conization for CIN
Follow-up of women for cervical cancer incidence and deaths
Comparison of cervical cancer incidence and deaths in the VIA and Control Groups
Diagnosis & treatment of invasive cancer
Diagnosis & treatment of invasive cancer
Allocated to usual care control group health education, 56 clusters, 30167 women
Interim resultsInterim resultsStudyStudy
CLUSTER RANDOMISED TRIAL OF VISUAL SCREENING FOR CERVICAL CANCER IN RURAL SOUTH INDIA: DINDIGUL DISTRICT CERVICAL SCREENING STUDY, TAMIL NADU, INDIA
VIA Group, 48 225 women 32 340 (67%) received VIA screening 3 088 (9.5%) women screened positive 1 882 (5.8%) had CIN 1 lesions 278 (8.6%) had biopsy 239 (0.7%) had CIN 2 & 3 lesions 75% with CIN received treatment Follow-up for cervical cancer incidence and mortality
continuing
Control Group, 30 167 women Follow-up for cervical cancer incidence and mortality
continuing
An interim analysis of final outcomes at the end of 2006
Cost-Effectiveness of Cervical Cancer Cost-Effectiveness of Cervical Cancer
Screening in Five Developing CountriesScreening in Five Developing Countries
The most cost-effective strategies were those that required the fewest
visits, resulting in improved follow-up testing and treatment.
Screening women once in their lifetime, at age 35, with a one- or
two-visit screening strategy involving visual inspection of the
cervix with acetic acid or DNA testing for human papillomavirus
(HPV) in cervical cell samples, reduced the lifetime risk of cancer
by approximately 25 - 36 %, and cost less than $500 per year of
life saved. Relative cancer risk declined by an additional 40 %
with two screenings (at ages 35 and 40), resulting in a cost per
year of life saved that was less than each country's per capita
gross domestic product — a very cost-effective result, according
to the Commission on Macroeconomics and Health.
Goldie et al., 2005 N Engl J Med 353; 20: 2158-68
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
Supported by the Bill & Melinda Gates Foundation through the ACCPSupported by the Bill & Melinda Gates Foundation through the ACCP
Primary Objectives
To evaluate the reduction in cervical cancer incidence and mortality associated with a single round of screening with visual inspection with acetic acid (VIA) or cytology or HPV testing, as compared to a control group with no screening
To evaluate the cost-effectiveness (CE) of the above three approaches
OOSMANABAD SMANABAD RCTRCT OF OF CCERVICAL ERVICAL SSCREENING, CREENING, IINDIANDIA StudyStudy
FLOW CHART OF THE STUDY DESIGN AND FINDINGSFLOW 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%
Collaboration with Tata Memorial Centre, Mumbai and NDMCH, Barshi
OOSMANABAD SMANABAD RCTRCT OF OF CCERVICAL ERVICAL SSCREENING, CREENING, IINDIANDIA StudyStudy
Stage of disease by group and Stage of disease by group and
detection modedetection mode Group Detection mode Stage 1A (%) Stage 1B (%) Stage 2+ (%) Unknown stage (%) Total
Control Symptomatic 3 (5) 13 (22) 39 (66) 4 (7) 59
HPV Screening 36 (47) 21 (27) 10 (13) 10 (13) 77
Symptomatic 1 (4) 5 (21) 14 (58) 4 (17) 24
Total 37 (36) 26 (26) 24 (24) 14 (14) 101
Cytology Screening 40 (48) 20 (24) 7 (9) 16 (19) 83
Symptomatic 1 (2) 4 (9) 35 (80) 4 (9) 44
Total 41 (32) 24 (19) 42 (33) 20 (16) 127
VIA Screening 33 (41) 16 (20) 30 (37) 2 (2) 81
Symptomatic 1 (2) 8 (20) 26 (63) 6 (15) 41
Total 34 (28) 24 (20) 56 (46) 8 (6) 122
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