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SCREENING WITH SCREENING WITH ALTERNATIVE ALTERNATIVE MODALITIESMODALITIES
Towards Comprehensive Cervical Cancer Towards Comprehensive Cervical Cancer Prevention and ControlPrevention and Control
CARLOS SANTOS, MDCARLOS SANTOS, MDIntituto Nacional de Enfermedades NeoplIntituto Nacional de Enfermedades Neopláásicassicas
LimaLima--PerPerúú
MMééxico 2008xico 2008
The Most Frequent Female Cancer Sites 1994-1997
The Most Frequent Female Cancer Sites 1994-1997
Female breastFemale breastCervix uteriCervix uteriStomachStomachOther skinOther skinLungLungOvary Ovary Non-Hodg.lymp.Non-Hodg.lymp.PSUPSUColon Colon Thyroid Thyroid Brain Brain Leukaemia Leukaemia GallbladderGallbladder
n = 21 051n = 21 051 n = 11 071n = 11 071
Incidence MortalityIncidence Mortality
Registro de Cáncer Lima MetropolitanaRegistro de Cáncer Lima Metropolitana
638643684703727774
853890938
1177
523480
393123
428630
474450
75393
14621247
14783738
19552751
32.3
23.5
17.6
7.5
7.5
8.7
10.6
7.0
6.6
5.6
5.6
5.2
5.1 4.9
3.8
3.3
3.9
5.7
4.2
4.1
7.0
13.1
10.9
13.2
Female Cancer IncidenceFemale Cancer Incidence
9.4
12.9
25.5
30
52.4
0 10 20 30 40 50 60
Cervix uteri
Breast
Stomach
Galbladder
NonHodgkinLimphoma
9.4
12.9
25.5
30
52.4
0 10 20 30 40 50 60
Cervix uteri
Breast
Stomach
Galbladder
NonHodgkinLimphoma
Age. - standarized rate 100,000
Registro de Cáncer de Trujillo 1991 - 95
Age. - standarized rate 100,000
Registro de Cáncer de Trujillo 1991 - 95
Female Cancer MortalityFemale Cancer Mortality
0 5 10 15 20
Cervix uteri
Stomach
Gallbladder
Breast
Hematopoye
Age. - standarized rate 100,000
Registro de Cáncer de Trujillo 1988 - 90
Age. - standarized rate 100,000
Registro de Cáncer de Trujillo 1988 - 90
18.2
17.1
7.7
7.4
7.4
CERVICAL CANCER IN LATIN AMERICA
Worldwide Highest Incidence Rates
CERVICAL CANCER IN LATIN AMERICA
Worldwide Highest Incidence Rates
47.1
53.5
64.3
67.2
83.2
87.3
0 20 40 60 80 100
PernambucoPernambuco
HarareHarare
BelénBelénTrujilloTrujilloAsunciónAsunción
Rate / 100,000Rate / 100,000
CIFC, IARC, 1982 - 87, 92, 97Globocan 2002CIFC, IARC, 1982 - 87, 92, 97Globocan 2002
HaitiHaiti
CIN MANAGEMENT INCIN MANAGEMENT INDEVELOPING COUNTRIESDEVELOPING COUNTRIES
Screening ProgramsScreening Programs
nn Classic cytology Classic cytology –– based: based: Developed worldDeveloped world
nn Non successful in developingNon successful in developingworldworld
Leopold Koss
CIN MANAGEMENT INCIN MANAGEMENT INDEVELOPING COUNTRIESDEVELOPING COUNTRIES
nn Established laboratoryEstablished laboratory
nn Highly trained personnel Highly trained personnel
nn At least 3 visitsAt least 3 visits
Cytologic ScreeningCytologic Screening
CIN MANAGEMENT INDEVELOPING COUNTRIES
CIN MANAGEMENT INCIN MANAGEMENT INDEVELOPING COUNTRIESDEVELOPING COUNTRIES
n PAP result = two weeks
n Colposcopy = up to 2 months
nn PAP result = two weeksPAP result = two weeks
nn Colposcopy = up to 2 monthsColposcopy = up to 2 months
Denny, 2002Denny, 2002
Controlled StudiesControlled Studies
CERVICAL CANCERCERVICAL CANCERCERVICAL CANCER
SCREENINGSteps of a Classic Program
Sampling ReportFixation Sending report backTransport ColposcopyProcessing ResultsReading Treatment
SCREENINGSCREENINGSteps of a Classic ProgramSteps of a Classic Program
Sampling ReportSampling ReportFixation Fixation Sending report backSending report backTransport ColposcopyTransport ColposcopyProcessing ResultsProcessing ResultsReadingReading TreatmentTreatment
CENTRALCENTRALCYTOLOGY
LAB
TREATMENT
SCREENING PARADOXSCREENING PARADOX
Alternative Screening TestAlternative Screening Test
nn High technologyHigh technology
nn Low technologyLow technology
Meeting 2007Meeting 2007
ACCURACY OF SCREENING TESTS: ACCURACY OF SCREENING TESTS: ACCURACY OF SCREENING TESTS:
How accurate is cytology in developing countries in detecting CIN 2 and 3 lesions? How accurate is cytology in developing countries in How accurate is cytology in developing countries in detecting CIN 2 and 3 lesions? detecting CIN 2 and 3 lesions?
Author, year and country of study
Number of participants
Sensitivity % Specificity %
U. Zimbabwe/JHPIEGO, 1999 Zimbabwe
2092 44 91
Cronje et al., 2003, South Africa
1093 48 96
Denny et al., 2002, South Africa
2754 57 96
Salmeron et al., 2003 7868 59 98
Sankaranarayanan et al., 2004, India
22 663 61 95
Denny et al., 2000, South Africa
2885 78 95
Denny et al., Cancer 2000; 89: 826-33; Denny et al., Cancer 2002; 94:1699-707; Lancet 1999; 353: 869-73;Cronje et al., Am J Obstet Gynecol 2003; 188: 395-400; Salmeron et al., Cancer Causes Control 2003; 14: 505-12; Sankaranarayanan et al., J Med Screening 2004; 110: 907-13.
Denny et al., Cancer 2000; 89: 826-33; Denny et al., Cancer 2002; 94:1699-707; Lancet 1999; 353: 869-73;Cronje et al., Am J Obstet Gynecol 2003; 188: 395-400; Salmeron et al., Cancer Causes Control 2003; 14: 505-12; Sankaranarayanan et al., J Med Screening 2004; 110: 907-13.
Meeting 2007Meeting 2007
ACCURACY OF VIA (for CIN 2 + Diseases)ACCURACY OF VIA (for CIN 2 + Diseases)ACCURACY OF VIA (for CIN 2 + Diseases)
Denny et al., Cancer 2000; 89: 826-33; Denny et al., Cancer 2002; 94:1699-707; Belinson et al., Obstet Gynecol 2001;98: 441-44; Lancet 1999; 353: 869-73; Cronje et al., Am J Obstet Gynecol 2003; 188: 395-400; Sankaranarayanan et al., Int J Cancer 2004;110:907-13.
Denny et al., Cancer 2000; 89: 826-33; Denny et al., Cancer 2002; 94:1699-707; Belinson et al., Obstet Gynecol 2001;98: 441-44; Lancet 1999; 353: 869-73; Cronje et al., Am J Obstet Gynecol 2003; 188: 395-400; Sankaranarayanan et al., Int J Cancer 2004;110:907-13.
Author, year and country of study Number of participants
Sensitivity % Specificity %
Denny et al, 2000, South Africa 2885 67 84
Denny et al., 2000, South Africa 2754 70 79
Belinson et al., 2001, China 1997 71 74
U. Zimbabwe/JHPIEGO, 1999 Zimbabwe
2148 77 64
Cronje et al., 2003, South Africa 1093 79 49
Sankaranarayanan et al., 2004 India & Africa
54 981 79 86
Santos et al Gyn Onc 61: 11(April 1996)Santos et al Gyn Onc 61: 11(April 1996)
29%
2%
69%
29%
2%
69%
N= 639N= 639
One Session CIN Management in Developing Countries
One Session CIN Management in Developing Countries
Adequacy of Day Management Adequacy of Day Management
Adequately ManagedAdequately Managed
UndermanagedUndermanaged
OvermanagedOvermanaged
Cervical Cancer ControlCervical Cancer ControlCervical Cancer Control
ALTERNATIVE APPROACH
Two concepts
♦ Diagnosis : VIAA - VIAAM
♦ Treatment : “See and Treat”
ALTERNATIVE APPROACH
Two concepts
♦ Diagnosis : VIAA - VIAAM
♦ Treatment : “See and Treat”
CCÁÁNCER DE CNCER DE CÉÉRVIXRVIX
IVA vs. IVAMIVA vs. IVAM(3 Observadores)(3 Observadores)
n = 218n = 218
Ojo Ojo Lupa pLupa p
44 Sensibilidad Sensibilidad 66.666.6 84.9 84.9 s.s.
44 Especificidad Especificidad 6868 52.8 s.52.8 s.
Santos. Tesis, 2005
CCÁÁNCER DE CNCER DE CÉÉRVIXRVIXIVA vs. IVAMIVA vs. IVAM
(3 Observadores)(3 Observadores)n = 218n = 218
RENDIMIENTO POR OBSERVADORRENDIMIENTO POR OBSERVADOR
MagnificaciMagnificacióónn ObservadorObservador SensibilidadSensibilidad EspecificidadEspecificidad
NONO112233
767681815555
606064648888
SSÍÍ112233
949485859090
464658585151
Santos. Tesis, 2005
TATI PROJECT
• GOALS
n Effectiveness VIA-screening VIAM-triage
n Effectiveness CO2 cryotherapy
n Cost and feasibility ofincorporating VIA,VIAM and cryotherapy in rutine delivery of women’s health services
• GOALS
n Effectiveness VIA-screening VIAM-triage
n Effectiveness CO2 cryotherapy
n Cost and feasibility ofincorporating VIA,VIAM and cryotherapy in rutine delivery of women’s health services
Magnified Visual InspectionMagnified Visual Inspection
AviscopeAviscope
§§ Device with Device with monocular lens, monocular lens, green and white green and white light, 4 x power.light, 4 x power.
§§ Portable (batteries) Portable (batteries)
Screening Screening –– Treatment Fluxogram Treatment Fluxogram
TATI PROJECTTATI PROJECT
Women25 - 49
VIA PAP
+ - - +VIAM
HSIL LSIL
+ -Bp
Cryo Follow up
3 years
+
RepeatPAP
6 monthsColpo
SECONDARY PREVENTION SECONDARY PREVENTION CERVICAL CANCERCERVICAL CANCER
Previous SituationPrevious Situation
TATI PROJECTTATI PROJECT
• Opportunistic
• Only 25% of positives completed diag/treat
• Opportunistic
• Only 25% of positives completed diag/treat
Intervention Team Intervention Team
TATI PROJECTTATI PROJECT
• 1 – 4 midwives
1 primary care physician
• 12 teams
• 30 base health centers
• 1 – 4 midwives
1 primary care physician
• 12 teams
• 30 base health centers
H.R. Saposoa
C.S. La Merced
H.R. Picota
H.R. Lamas
C.S. LlulluycuchaC.S. Nva. Rioja
C.S. Nva.Cajamarca
C.S. JuanGuerra
C.M.P Tarapoto
P.S. San Pablo
P.S. Naranjillo
H.R. San Josede Sisa
C.S. Morales
C.S. Pongo delCaynarachiI
C.S. SAN ANTONIO
C.S.9 de Abril
P.S. La Huarpia
P.S. Collpa
H.A. Bda. De Shilcayo
C.S. Chazuta
C.S. Cuñumbuque
C.S. Consuelo
P.S. Shatoja
C.S. Leoncio Prado
P.S.Tres Unidos
C.S. Huimbayoc
INTERVENTION TEAMS. TATI SAN MARTIN REGION
INTERVENTION TEAMS. TATI SAN MARTIN REGION
MIDWIFE
PHYSICIAN
48 Midwives VIAA
35 Physicians VIAAM – CRYO
4 Gynecologists COLPO – TTO
3 Cytotechnicians
3 Training courses
48 Midwives VIAA
35 Physicians VIAAM – CRYO
4 Gynecologists COLPO – TTO
3 Cytotechnicians
3 Training courses
REFERRAL CENTERS
REGION SAN MARTIN
REFERRAL CENTERS
REGION SAN MARTIN
InformationEducation
Community
Screening Treatment
VIAVIAM
Cryotherapy
Primary level
Especialized treatment
ColposcopyLEEP, Cone, Histerectomy
Secondary level
Follow-up
IdentificationEducation
Community
TATI PROJECT
Training of Providers Training of Providers
TATI PROJECTTATI PROJECT
• 48 midwives
35 primary care physicians
• 3 training courses
• 48 midwives
35 primary care physicians
• 3 training courses
Health Promotion
Client’s satisfaction
Education Community support
Research Subcomponent Research Subcomponent Cancer Research Fund UKCancer Research Fund UK
TATI PROJECTTATI PROJECT
n = 5,460
• HPV DNA: HC II
• Liquid – based cytology
n = 5,460
• HPV DNA: HC II
• Liquid – based cytology
RESULTSRESULTS
TATI PROJECTTATI PROJECT
TATI PROJECTTATI PROJECT
• Coverage: 35%
• First time: 19%
• 35 – 49 years: 45%
• Coverage: 35%
• First time: 19%
• 35 – 49 years: 45%
COVERAGECOVERAGE
Table 3: What most influenced women to participate in the TATI pTable 3: What most influenced women to participate in the TATI project San roject San Martin, Peru November 2000 Martin, Peru November 2000 –– October 2003October 2003
Number of women
Proportion (%)
Education session or awareness raising meeting in women’s organizations 8,636 23.6
Individual contact with a health professional 8,437 23.0
Education session or awareness raising in health centers 5,352 14.6
Contact with the TATI project team 4,412 12.0
Relative/neighbor who had been screened 2,667 7.3
Mass media: Tv/radio/magazine 1,045 2.9
Other 1,013 2.7
Table 5: Women Served in the TATI ProjectTable 5: Women Served in the TATI ProjectSan Martin, Peru November 2000 San Martin, Peru November 2000 –– October 2003October 2003
Activity Number of women Proportion
(%)
Nª women screened 36,759 100
Nº women VIA positive 6,473 17.6
Nº women VIAM positive 2,732 7.4
Nº women eligible for treatment 1,491 4.0
Nº women eligible treated1,398 3.8
VIA vs. VIAM by physician VIA vs. VIAM by physician
TATI PROJECTTATI PROJECT
• Aviscope had no discernable
advantage over VIA
• Triage can be done by physician
with naked eye
• Aviscope had no discernable
advantage over VIA
• Triage can be done by physician
with naked eye
TATI PROJECTTATI PROJECT
• Most women felt satisfied (90%)
• Cryotherapy is an acceptable procedure
• Most women felt satisfied (90%)
• Cryotherapy is an acceptable procedure
Women’s satisfaction with cryotherapyJuly - October 2001
TATI PROJECT: lost to follow-up
VIAVIA
Treatment Cryotherapy
Colposcopy
8%lost
Treatment
44% lost
9%lost
9%lost9%lost
VIAMVIAM
Cost of ScreeningMethods
Cost of ScreeningMethods
Procedures CostUS$
VIA 1.60VIAA 2.80PAP 3.47LBC 3.92
Procedures CostUS$
VIA 1.60VIAA 2.80PAP 3.47LBC 3.92
CostCost--Effectiveness for age groupEffectiveness for age group
Cost for CIN treatment proceduresCost for CIN treatment procedures
Procedure
Cryotherapy
Cold conizationLEEP
Cost
TATI PROJECTSan Martín - PerúTATI PROJECTTATI PROJECTSan MartSan Martíín n -- PerPerúú
HPV positivity
12.6 %
HPV positivityHPV positivity
12.6 %12.6 %
Almonte M., et alInt J. Cancer (2007)
TATI PROJECTTATI PROJECT
0
2
4
6
8
10
12
14
16
25 30 35 40 45
HPV positivity by ageHPV positivity by age
Almonte et al, 2007age
HPV
+ %
Yielding of screening tests Yielding of screening tests -- TATITATISan MartSan Martíín, Pern, Perúú
CIN 2 +CIN 2 +
MethodMethod Senstivity (%) Senstivity (%) Especificity (%) Especificity (%)
VIAVIA 54.954.9 76.776.7
VIAMVIAM 42.742.7 90.990.9
PAPPAP 26.226.2 98.698.6
LBCLBC 69.669.6 83.783.7
HPVHPV 77.377.3 89.389.3
Almonte M, Ferreccio C, Winkler JL, Cuzick J, Tsu V, Robles S, Takahashi R, Sasieni P. Cervical screening by visual inspection, HPV testing, liquid-based and conventional cytology in Amazonian Peru. In press
Effectiveness of CryotherapyEffectiveness of Cryotherapy
TATI PROJECTTATI PROJECT
CIN 418/472 88%
CIN 3 49/70 70%
CIN 418/472 88%
CIN 3 49/70 70%
Luciani S., et al
5
4.5
4
3.5
3
2.5
2
1.5
1
0.5
0
0 2 4 6 8 10 12 14 16 18
Required Depth Of NecrosisRequired Depth Of Necrosis
Dep
th o
f n
ecr
osi
s (m
m)
Dep
th o
f n
ecr
osi
s (m
m)
IndividualIndividual
3 minute5 minute
DEPTH OF NECROSIS IN CO2 CRYOTHERAPY OF THE CERVIXDEPTH OF NECROSIS IN CO2 CRYOTHERAPY OF THE CERVIX
Santos y col, Int. J. Gynaec. Ca.,2004Santos y col, Int. J. Gynaec. Ca.,2004
Figure 1. Profundidad de necrosis del labio anterior y posterior del cérvix con crioterapia N2O y CO2. Se calculo las diferencias para significancia estadística (p<005) usando ANOVA. El cuadro inferior muestra un resumen descriptivo de la profundidad de necrosis
Dep
th o
f Nec
rosi
s (m
m)
0
1
2
3
4
5
6
7
8
9
10
N20Upper Lip
N20Lower Lip
CO2
Upper LipCO2
Lower Lip
P < 0.001
P < 0.001
Dep
th o
f Nec
rosi
s (m
m)
0
1
2
3
4
5
6
7
8
9
10
N20Upper Lip
N20Lower Lip
CO2
Upper LipCO2
Lower Lip
P < 0.001
P < 0.001
Prof
undi
dad
de N
ecro
sis (
mm
)
Labio anterior Labio posterior Labio anterior Labio posterior
N N 2020 2020 2020 1919
Media Media 5.35.3 5.05.0 3.43.4 3.13.1
MMíínimonimo 3.53.5 3.03.0 1.51.5 1.51.5
MMááximo ximo 7.07.0 7.07.0 6.06.0 5.05.0
% % ≥≥4.8mm4.8mm 75%75% 60%60% 15%15% 5%5%
Mariategui,Santos,Jerónimo 2007
SUMMARY SUMMARY SUMMARY
v Visual tests have similar sensitivity as that of good quality cytology, but lower specificity.
v Visual screening is feasible in low resource settings, but require adequate inputs in training of test providers, close monitoring of test positivity, CIN detection and treatment rates on a continuing basis.
v Visual tests have similar sensitivity as that of good quality cytology, but lower specificity.
v Visual screening is feasible in low resource settings, but require adequate inputs in training of test providers, close monitoring of test positivity, CIN detection and treatment rates on a continuing basis.
LESSONS LEARNED LESSONS LEARNED
TATI PROJECTTATI PROJECT
• Achieve higher coverage
• Discard magnification
• Improve fast treatment availability
• Improve training and quality assurance
• Engaging communities
• Achieve higher coverage
• Discard magnification
• Improve fast treatment availability
• Improve training and quality assurance
• Engaging communities
CONCLUSIONS CONCLUSIONS
TATI PROJECTTATI PROJECT
• It is safe to incorporate VIA – Cryo inhealth services
• Feasible• Affordable
• It would be feasible to replicate this program in low resources settings
• It is safe to incorporate VIA – Cryo inhealth services
• Feasible• Affordable
• It would be feasible to replicate this program in low resources settings
ESCUELA LATINOAMERICANA DE
CÁNCER DE CÉRVIX
INEN - IARC
INCTR
Regional Training Center
ESCUELA LATINOAMERICANA DE ESCUELA LATINOAMERICANA DE
CCÁÁNCER DE CNCER DE CÉÉRVIX RVIX
INEN INEN -- IARCIARC
INCTR INCTR
Regional Training Center Regional Training Center