Transcript Document

ACCP Evidence base:
Implications for policy and
practice
R. Sankaranarayanan MD
Head, Screening Group
World Health Organization (WHO)
International Agency for Research on Cancer (IARC)
Lyon, France
http://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
ALTERNATIVE PROGRAMMATIC APPROACHES:

Reduced frequency of screening: one or twice
a life time

Reducing the number of visits and improving
adherence to treatment
 screen and treat (1 or 2 visits)*
 screen, see (colposcopy), and treat (1 to 2
visits) (with a posteriori histological
confirmation)**
*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%
OSMANABAD RCT OF CERVICAL SCREENING, INDIA
RESULTS OF TREATMENT OF CIN
Treatment
Total number
Cured (%)
Cryotherapy
562
477 (85%)
LEEP
422
357 (85%)
Study
SAFETY, ACCEPTABILITY, AND FEASIBILITY OF A
SINGLE-VISIT APPROACH TO CERVICAL CANCER
PREVENTION IN RURAL THAILAND
Acceptability of Cryotherapy Treatment
Women
700
600
630
Treatment Offered
501
Accepted Immediate Treatment
Postponed Treatment
500
Refused Treatment
400
300
200
100
127
2
0
Lancet 2003; 361:814-820
RANDOMISED CONTROLLED TRIAL OF SCREEN
AND TREAT APPROACH FOR CERVICAL CANCER
PREVENTION IN SOUTH AFRICA
Characteristic
6 months post
randomization
Evaluated
women
CIN 2+
prevalence
CIN 2 prevalence
12 months post
randomization
HPV test & Treat
(N=2163)
VIA & Treat
(N=2227)
Delayed Evaluation
(N=2165)
1879
15 (0.80%)
1929
43 (2.23%)
1859
3.55%
25 (1.42%)
54 (2.91%)
93 (5.41%)
Denny et al., JAMA 2005; 294: 2173-81
Study
Cluster Randomised Controlled
Trial of VIA Screening,
Dindigul 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 ACCP
CLUSTER RANDOMISED TRIAL OF VISUAL SCREENING FOR CERVICAL CANCER IN RURAL
SOUTH INDIA: DINDIGUL DISTRICT CERVICAL SCREENING STUDY, TAMIL NADU, INDIA
Study design
113 Village clusters
79 372 eligible women aged 30-59 years
Allocated to single round VIA screening by nurses,
57 clusters, 48 225 women
Allocated to usual care control group health
education, 56 clusters, 30167 women
Colposcopy/directed biopsy for screen +ve women
Cryotherapy/LEEP/conization for CIN
Diagnosis & treatment of
invasive cancer
Diagnosis & treatment of
invasive cancer
Follow-up of women for cervical cancer
incidence and deaths
Comparison of cervical cancer incidence and
deaths in the VIA and Control Groups
Study
CLUSTER RANDOMISED TRIAL OF VISUAL SCREENING FOR CERVICAL CANCER IN RURAL
SOUTH INDIA: DINDIGUL DISTRICT CERVICAL SCREENING STUDY, TAMIL NADU, INDIA
Interim results
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
Study
Cost-Effectiveness of Cervical Cancer
Screening 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
with acetic acid, HPV testing and
conventional cytology in cervical cancer
screening: a randomized intervention
trial 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 ACCP
OSMANABAD RCT OF CERVICAL SCREENING, INDIA
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
Study
OSMANABAD RCT OF CERVICAL SCREENING, INDIA
Study
FLOW CHART OF THE STUDY DESIGN AND FINDINGS
Eligible population
52 PHCs
(n=142,701)
Collaboration with Tata
Memorial Centre, Mumbai
and NDMCH, Barshi
Randomization
VIA arm
(13 PHCs)
Cytology arm
(13 PHCs)
HPV arm
(13 PHCs)
Screening coverage
71.9%
(positivity rate: 14.0%)
Screening coverage
72.9%
(positivity rate: 7.0%)
Screening coverage
69.5%
(positivity rate: 10.3%)
Compliance with
colposcopy in the field
98.5%
Compliance with
colposcopy at NDMCH
87.1%
Compliance with
colposcopy at NDMCH
88.2%
Detection rates
Detection rates
Detection rates
Condyloma/
CIN 1
5.6%
CIN 2-3
0.7%
cancer0
.3%
Condyloma/
CIN 1
2.0%
CIN 2-3
1.0%
cancer0
.3%
Condyloma/
CIN 1
2.3%
CIN 2-3
0.9%
Control arm
(13 PHCs)
cancer0
.2%
Stage of disease by group and
detection mode
Group
Detection mode
Control
Symptomatic
HPV
Screening
Stage 2+ (%)
Unknown stage (%)
Total
13 (22)
39 (66)
4 (7)
59
36 (47)
21 (27)
10 (13)
10 (13)
77
1 (4)
5 (21)
14 (58)
4 (17)
24
Total
37 (36)
26 (26)
24 (24)
14 (14)
101
Screening
40 (48)
20 (24)
7 (9)
16 (19)
83
1 (2)
4 (9)
35 (80)
4 (9)
44
Total
41 (32)
24 (19)
42 (33)
20 (16)
127
Screening
33 (41)
16 (20)
30 (37)
2 (2)
81
1 (2)
8 (20)
26 (63)
6 (15)
41
34 (28)
24 (20)
56 (46)
8 (6)
122
Symptomatic
VIA
Stage 1B (%)
3 (5)
Symptomatic
Cytology
Stage 1A (%)
Symptomatic
Total